Recalls & alerts

602 alerts recorded, refreshed every six hours. Filter by source or category.

• openFDA · September 30, 2026Moderate risk

  Baxter Healthcare Corporation : PRO+ 36" MRS SURFACE, mattress with Advanced Microclimate Technology (AMT) uses a non-powered system of intake and output valves to provide weight-based…

  Baxter Healthcare Corporation is recalling its PRO+ 36" MRS SURFACE mattress, model P7924A13. The UDI label has an error that may cause incorrect product selection, possibly leading to use with an incompatible bed frame, affecting patients and caregivers. Consumers should contact Baxter Healthcare Corporation for instructions on returning or correcting the affected mattress.

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• openFDA · September 30, 2026Moderate risk

  Baxter Healthcare Corporation : PRO+ MRS SURFACE FOR VERSACARE, mattress with Advanced Microclimate Technology (AMT) uses a non-powered system of intake and output valves to provide…

  Baxter Healthcare Corporation is recalling its PRO+ MRS Surface for VersaCare mattress, model P3255A08. The UDI label has an error that could cause incorrect product identification or selection, leading to use with an incompatible bed frame, affecting users worldwide including the US and Canada. Consumers should contact Baxter Healthcare Corporation for instructions on returning or correcting the product.

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• openFDA · September 30, 2026Moderate risk

  Baxter Healthcare Corporation : Brand Name: VOLARA System Product Name: VOLARA, HC, NA A Model/Catalog Number: M08594A Software Version: N/A Product Description: VOLARA, HOMECARE, NORTH…

  Baxter Healthcare Corporation is recalling the VOLARA System, model M08594A, a homecare nebulizer. Contamination in test equipment may have affected the nebulizer flow rate accuracy, exposing users in Colorado and Florida to potential incorrect dosing. Consumers should return the affected device to Baxter for testing.

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• openFDA · September 30, 2026Moderate risk

  Becton, Dickinson and Company : ForeSight Elite Tissue Oximetry Cable REF HEMFSM10 UDI-DI code: 00690103210927 The non-invasive ForeSight oximeter cable is intended for use as an adjunct…

  Becton, Dickinson and Company's ForeSight Elite Tissue Oximetry Cable REF HEMFSM10 is affected. Incorrect switching of channels and flag labels can cause wrong oxygen readings, exposing patients to risk. Consumers should stop using the cable and contact Becton, Dickinson and Company for return instructions.

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• openFDA · September 30, 2026Moderate risk

  Philips North America Llc : Ingenia Ambition S and Ingenia Ambition X; Model Numbers (REF): 1. 781359 (S), 2. 782108 (S), 3. 782139 (S), 4. 781356 (X), 5. 782109 (X), 6. 782138 (X);

  Philips is recalling its Ingenia Ambition S and Ingenia Ambition X MRI systems with model numbers 781359, 782108, 782139, 781356, 782109, and 782138. A software issue can stop an exam during image reconstruction when scan settings are changed, affecting patients undergoing MRI scans. Users should contact Philips to arrange for a software update or correction.

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• openFDA · September 30, 2026Moderate risk

  Ventec Life Systems, Inc. : HF2P0ST9 HomeFill Oxygen System HomeFill Cylinder M9 with CGA870 Compatible Post Valve

  Ventec Life Systems is recalling its HF2P0ST9 HomeFill Oxygen System HomeFill Cylinder M9 with CGA870 Compatible Post Valve. The oxygen cylinders lack required medical gas labeling, posing a risk to patients using the system. Consumers should follow the recall instructions from Ventec Life Systems.

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• openFDA · September 30, 2026Moderate risk

  Medline Industries, LP : Medline convenience kits containing Healthmark Instrument Channel Brushes. SINUS PACK DYNJ48258D and SINUS PACK DYNJ48258F.

  Medline convenience kits containing Healthmark Instrument Channel Brushes, models SINUS PACK DYNJ48258D and DYNJ48258F, are affected. The brush end may have a sharp edge or burr, posing cut injury, abrasion, and infection risks to users. Consumers should stop using these kits and contact Medline for return or replacement.

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• openFDA · September 30, 2026Moderate risk

  Philips North America Llc : Name (Model Number): 1. Intera 1.5T (781195), 2. Intera 1.5T (781295), 3. Intera 1.5T Achieva IT Nova (781175), 4. Intera 1.5T Achieva Nova (781172), 5. Intera…

  Philips North America is recalling its Intera 1.5T MRI systems, including models 781195, 781295, 781175, 781172, 781173, 781104, and 781171. A software issue can terminate an examination during image reconstruction if scan parameters exceed available memory, affecting patients undergoing MRI scans. Consumers should contact their healthcare provider or Philips for further instructions.

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• openFDA · September 30, 2026Moderate risk

  AVID Medical, Inc. : Halyard IV START KIT NON-STERILE; 48 kits per case. Containing BD ChloraPrep Clear - 1 mL Applicator. Kit Model Number: KRIV26-01

  AVID Medical, Inc. is recalling the Halyard IV START KIT NON-STERILE, model KRIV26-01, containing BD ChloraPrep Clear 1 mL Applicators. The applicator packaging may have an open or incomplete seal, exposing patients nationwide to a loss of sterility. Consumers should stop using the affected kits and contact AVID Medical for instructions.

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• openFDA · September 30, 2026Moderate risk

  Medline Industries, LP : Medline Convenience Kits: 1) MAJOR NEURO VCH, Catalog Number: DYNJ39218I; 2) NEURO PACK-LF, Catalog Number: DYNJ41246F; 3) CRANIOTOMY PACK (CRSJE)227-LF,…

  Medline Industries is recalling several Medline Convenience Kits for neurological procedures, including Major Neuro VCH, Neuro Pack-LF, Craniotomy Pack, and others. The kits contain neurological sponges that may have elevated endotoxin levels, posing risks like febrile response, hypotension, or nausea to patients. Consumers should stop using the recalled kits, verify catalog numbers, and contact Medline for instructions.

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• openFDA · September 30, 2026High risk

  CooperSurgical, Inc. : INCA (Infant Nasal Cannulae Assy) Infant Nasal CPAP, Complete Set. Stay-Flex tubing component. 5 units per box. Model Numbers: 44-2707, 44-2709, 44-2710,…

  CooperSurgical Inc. is recalling its INCA Infant Nasal CPAP Complete Set with Stay-Flex tubing, model numbers 44-2707, 44-2709, 44-2710, 44-2712, and 44-2715. The tubing may have a loose connection to the nasal cannula, causing loss of CPAP pressure and decreased oxygenation in infants. Consumers should stop using the affected sets and contact CooperSurgical for replacement.

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• openFDA · September 30, 2026Moderate risk

  SEASPINE ORTHOPEDICS CORPORATION : SeaSpine Mariner Deformity Product Name: Extended Polyaxial Head, Attached Gimbal, 12mm REF: MD1-300010-12

  The recalled product is the SeaSpine Mariner Deformity Extended Polyaxial Head, Attached Gimbal, 12mm REF MD1-300010-12. The proximal thread depth is out of design specification, posing a hazard to patients who receive this spinal device. Consumers should contact SeaSpine Orthopedics Corporation for further instructions.

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• openFDA · September 30, 2026Moderate risk

  Philips Ultrasound, LLC : Philips EPIQ Elite Diagnostic Ultrasound System Model # 795234

  Philips EPIQ Elite Diagnostic Ultrasound System Model # 795234 is affected. A software issue displays the doppler sample shallower than its actual location, causing inaccurate blood flow velocity measurements and misdiagnosis for patients. Consumers should follow the voluntary recall instructions from the firm.

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• openFDA · September 30, 2026Moderate risk

  Midmark Corporation : Midmark IQvitals Zone, automatically and noninvasively measures systolic and diastolic blood pressure, pulse rate, temperature (temporal), and oxygen…

  Midmark IQvitals Zone, model 1-200-0360 with kit 4-000-0724, is affected. The device may give inaccurate blood pressure readings when using the Linear Deflation Method, affecting adult and pediatric patients. Consumers should contact Midmark Corporation for further instructions.

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• openFDA · September 30, 2026Moderate risk

  Olympus Corporation of the Americas : Olympus BiCOAG Hemostasis Probe 10Fr Fixed Pin Connector. Model/Catalog Number: CD-B612LA.

  Olympus is recalling the BiCOAG Hemostasis Probe 10Fr Fixed Pin Connector, model CD-B612LA. The ceramic tip may detach during surgery because the device was made without enough adhesive, posing a risk to patients. Users should stop using the affected probes and contact Olympus or their healthcare provider for return and replacement instructions.

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• openFDA · September 30, 2026Moderate risk

  Philips North America Llc : Ingenia 3.0T and Ingenia 3.0T CX; Model Numbers (REF): 1. 781342(3.0T), 2. 781377(3.0T), 3. 782103(3.0T), 4. 781271(3.0T CX), 5. 782105(3.0T CX);

  Philips North America is recalling its Ingenia 3.0T and Ingenia 3.0T CX MRI systems, including model numbers 781342, 781377, 782103, 781271, and 782105. A software issue can terminate an examination during image reconstruction if scan parameters are manually adjusted to exceed system memory, affecting patients undergoing MRI scans. Consumers should follow the recall instructions from Philips and the FDA.

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• openFDA · September 30, 2026Moderate risk

  Cardinal Health 200, LLC : Presource Convenience Kits: 1) KIT, USGPIV , Catalog Number: PVMHIVMHD; 2) KIT, USGPIV , Catalog Number: PVMHIVM14; 3) KIT, USGPIV , Catalog Number: PVMHIVM15

  Cardinal Health 200, LLC is recalling certain Presource Convenience Kits with catalog numbers PVMHIVMHD, PVMHIVM14, and PVMHIVM15. The kits contain applicators that may have an open or incomplete seal, exposing users to possible skin, soft tissue, or systemic infection. Consumers should check their kits for these catalog numbers and follow the firm's voluntary recall instructions.

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• openFDA · September 30, 2026Moderate risk

  Maquet SAS : PowerLED 300 Concealed Lighting System (PWD30+SF W K3 SPRING ARM A2 FC3 50-100nm) Model Numbers: 1. ARD568474114A, 2. ARD567501286;

  Maquet SAS is recalling its PowerLED 300 Concealed Lighting System, models ARD568474114A and ARD567501286. The device can detach at the junction between the spring arm and suspension arm and fall, posing injury risk to users. Consumers should follow the recall instructions from Maquet SAS, as this is a voluntary firm-initiated recall.

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• openFDA · September 30, 2026Moderate risk

  Philips North America Llc : Evolution upgrade 1.5T and Evolution upgrade 3.0T; Model Numbers (REF): 1. 782116 (1.5T), 2. 782148 (1.5T), 3. 782117 (3.0T), 4. 782143 (3.0T);

  Philips North America is recalling its Evolution upgrade 1.5T and 3.0T MRI systems, model numbers 782116, 782148, 782117, and 782143. A software issue can stop an exam during image reconstruction when manual scan parameter changes exceed available memory, affecting patients undergoing MRI scans. Consumers should contact their healthcare provider or Philips for further instructions.

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• openFDA · September 30, 2026Moderate risk

  Ventec Life Systems, Inc. : REF:HF2PC9 HomeFill Oxygen System, HomeFill Cylinder M9 with Integrated Conserver

  Ventec Life Systems is recalling its HomeFill Oxygen System and HomeFill Cylinder M9 with Integrated Conserver. The oxygen cylinders lack required medical gas labeling, which can confuse users and pose a risk to patients. Consumers should stop using the affected devices and contact Ventec Life Systems for instructions.

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• openFDA · September 30, 2026Moderate risk

  CooperVision, Inc. : Brand Name: Pearle Vision 1 day Product Name: (somofilcon A) Contact Lens Model/Catalog Number: Pearle Vision 1 day

  Pearle Vision 1 day (somofilcon A) contact lenses from a specific affected lot are recalled. A small number of lenses in that lot have incorrect power, posing a vision hazard to consumers who wear them. Consumers should stop using lenses from the affected lot.

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• openFDA · September 30, 2026High risk

  Boston Scientific Corporation : Imager II Angiographic Catheters M001314001 IMAGER II/5/ST/65/038 BX5; M001314011 IMAGER II/5/ST/100/038 BX5; M001314021 IMAGER II/5/ST/65/035 BX 5; M001314031…

  Boston Scientific is recalling its Imager II Angiographic Catheters. The catheter tip may fracture or detach, leaving fragments in the patient or blood vessels, which can cause life-threatening embolism. Patients should contact their healthcare provider to determine if their device is affected and what to do.

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• openFDA · September 30, 2026Moderate risk

  Cardinal Health 200, LLC : Presource Convenience Kits: 1) KIT, PRE OP , Catalog Number: AMN548616A; 2) KIT, NICU ADMIT NEW HAN , Catalog Number: BA1DH0116B; 3) KIT, PRE PROCEDURE ,…

  Cardinal Health is recalling certain Presource Convenience Kits used in pre-op, NICU, IV, delivery, and other procedures. The kits contain applicators with open or incomplete seals, which may expose patients to contamination and cause skin, soft tissue, or systemic infection. Consumers should stop using the affected kits and contact Cardinal Health for return and replacement instructions.

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• openFDA · September 30, 2026Moderate risk

  Olympus Corporation of the Americas : Olympus BiCOAG Hemostasis Probe 7Fr Coaxial Connector. Model/Catalog Number: CD-B620LA.

  The recalled product is the Olympus BiCOAG Hemostasis Probe 7Fr Coaxial Connector, model CD-B620LA. The ceramic tip may detach due to insufficient adhesive, posing a risk to patients during procedures. Consumers should contact Olympus for instructions on returning or replacing the device.

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• openFDA · September 30, 2026Moderate risk

  AVID Medical, Inc. : Halyard IV START KIT NON-STERILE; 48 kits per case. Containing BD ChloraPrep Clear - 1 mL Applicator. Kit Model Number: KRIV26-02

  AVID Medical, Inc. is recalling Halyard IV START KIT NON-STERILE kits containing BD ChloraPrep Clear - 1 mL Applicator, model KRIV26-02. The applicator packaging may have an open or incomplete seal, exposing patients and healthcare providers to potential contamination or infection. Consumers should stop using these kits and contact AVID Medical, Inc. for return or replacement.

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• openFDA · September 30, 2026Moderate risk

  Baxter Healthcare Corporation : PRO+ 40" MRS SURFACE, mattress with Advanced Microclimate Technology (AMT) uses a non-powered system of intake and output valves to provide weight-based…

  Baxter Healthcare Corporation is recalling its PRO+ 40" MRS SURFACE mattress, model P7924A14. The UDI label has an error that could cause wrong product selection and use with an incompatible bed frame, posing a risk to patients. Consumers should stop using the mattress and follow Baxter's recall instructions for return or correction.

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• openFDA · September 30, 2026Moderate risk

  Philips North America Llc : Achieva XR; Model Numbers (REF): 1. 781153, 2. 781253;

  Philips Achieva XR, model numbers 781153 and 781253, are affected. A software issue can terminate an examination during image reconstruction if scan parameters are manually adjusted to exceed system memory, exposing patients to an incomplete scan. The recall notice does not specify a consumer action.

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• openFDA · September 30, 2026Moderate risk

  DeRoyal Industries Inc : REF: 81-030415 Myocardial Probe Non-Pyrogenic , 400 Series

  DeRoyal Industries is recalling its REF 81-030415 Myocardial Probe Non-Pyrogenic, 400 Series. The probe contains an 18mm needle instead of the correct 15mm needle, which could lead to improper placement or patient injury during cardiac procedures. Users should stop using the affected probes and contact DeRoyal Industries for return instructions.

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• openFDA · September 30, 2026High risk

  AVID Medical, Inc. : Halyard IV START KIT NON-STERILE; 48 kits per case. Containing BD ChloraPrep Clear - 1 mL Applicator. Kit Model Number: KRIV26-02.

  AVID Medical is recalling Halyard IV START KIT NON-STERILE (model KRIV26-02) containing BD ChloraPrep Clear 1 mL applicator. The applicator may be contaminated with Aspergillus penicillioides, exposing patients to risk of fungal infection during IV insertion. Stop using the recalled kits and contact AVID Medical for return and replacement instructions.

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• openFDA · September 30, 2026Moderate risk

  New York Embroidery Studio, Inc. : New York Embroidery Studio Trinity Non-Surgical Isolation Gown, AAMI PB70 Level 2, X-Large. Model Number: NYES100-2. Packaged in inner packs of 10 and 100…

  The recall affects New York Embroidery Studio Trinity Non-Surgical Isolation Gowns, model NYES100-2, in X-Large. The gowns may not meet the required liquid-barrier performance, exposing wearers to fluid contact. Consumers should stop using them and contact the firm for instructions.

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• openFDA · September 30, 2026Moderate risk

  Ventec Life Systems, Inc. : REF: HF2POSTD HomeFill Oxygen System HomeFill cylinder D with CGA870 Compatible Post Valve

  Ventec Life Systems is recalling its HomeFill Oxygen System cylinder D with CGA870 compatible post valve (REF HF2POSTD). The oxygen cylinders lack required medical gas labeling, which poses a risk of misuse or confusion for patients and caregivers in Florida, Iowa, Ohio, Nebraska, and Tennessee. Consumers should stop using the affected cylinders and contact Ventec Life Systems for instructions on return or replacement.

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• openFDA · September 30, 2026Moderate risk

  Heidelberg Engineering GmbH : Brand Name: Heidelberg Engineering GmbH Product Name: SPECTRALIS with Flex Module Model/Catalog Number: S3610, S2610, S2000, S1610 multimodal imaging platform…

  Heidelberg Engineering is recalling its SPECTRALIS with Flex Module multimodal imaging platforms, models S3610, S2610, S2000, and S1610. The wheels may come loose during movement, causing the stand to tip over and strike the operator or nearby persons, leading to impact or crushing injuries. Consumers should contact Heidelberg Engineering for instructions because the recall is voluntary and firm-initiated.

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• openFDA · September 30, 2026Moderate risk

  Medline Industries, LP : Medline Convenience Kits: 1) ANTERIOR SPINE PACK, Catalog Number: DYNJT10197; 2) CRANIOTOMY #IMF 56646-LF, Catalog Number: DYNJVB91001; 3) CRANIOTOMY PACK-LF,…

  Medline Industries, LP is recalling 28 Medline Convenience Kits, including spine, craniotomy, and laminectomy packs. The kits contain neurological sponges with potentially elevated endotoxin levels, which can cause neurovascular adverse events, fever, inflammation, hypotension, or nausea in patients. Consumers should stop using the affected kits and follow Medline's recall instructions.

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• openFDA · September 30, 2026Moderate risk

  Olympus Corporation of the Americas : Olympus EZDilate Endoscopic Balloon Dilator Wired-guided 11, 12, 13mm. Model Number: BD-420X-1355.

  Olympus Corporation is recalling its EZDilate Endoscopic Balloon Dilator Wired-guided 11, 12, 13mm, model BD-420X-1355. The inflation chart label on the device shaft may be incorrect, showing 18, 19, or 20 mm, which could lead to improper balloon sizing for patients during procedures. Consumers should stop using the recalled device and contact Olympus or their healthcare provider for instructions on returning it.

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• openFDA · September 30, 2026Moderate risk

  Philips North America Llc : Ingenia 1.5T, Ingenia 1.5T CX and Ingenia 1.5T S; Model Numbers (REF): 1. 781315(1.5T), 2. 781341(1.5T), 3. 781396(1.5T), 4. 782101(1.5T), 5. 782115(1.5T), 6.…

  Philips is recalling its Ingenia 1.5T, Ingenia 1.5T CX, and Ingenia 1.5T S MRI systems. A software issue can terminate an exam during image reconstruction if manual scan adjustments exceed system memory, affecting patients undergoing MRI scans. Patients should contact their imaging facility to confirm the software update is applied.

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• openFDA · September 30, 2026Moderate risk

  Olympus Corporation of the Americas : Olympus BiCOAG Hemostasis Probe 10Fr Coaxial Connector. Model/Catalog Number: CD-B610LA.

  Olympus BiCOAG Hemostasis Probe 10Fr Coaxial Connector, model CD-B610LA, is recalled. The ceramic tip may detach because it was made without the required adhesive, posing a risk to patients during procedures. Consumers should stop using the affected device and contact Olympus for instructions.

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• openFDA · September 30, 2026Moderate risk

  INTERVASCULAR, SAS : Cardioroot Woven Collagen Coated Vascular Graft; Model Numbers: 1. HEWROOT0024, 2. HEWROOT0026, 3. HEWROOT0028, 4. HEWROOT0030, 5. HEWROOT0032, 6. HEWROOT0034;

  Intervascular is recalling its Cardioroot Woven Collagen Coated Vascular Graft in model numbers HEWROOT0024 through HEWROOT0034. The graft may leak blood because it failed water permeability testing, posing a risk to patients undergoing surgery to receive it. Patients and caregivers should contact their surgeon or hospital to confirm whether their device is affected and follow recall instructions.

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• openFDA · September 30, 2026Moderate risk

  Philips North America Llc : MR 5300 Model Number (REF): 1. 782110, 2. 782152;

  Philips is recalling its MR 5300 imaging systems, model numbers 782110 and 782152. A software issue can terminate an examination during image reconstruction if scan parameters exceed available memory, affecting patients and operators. Consumers should contact their healthcare provider or Philips for instructions on how to proceed.

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• openFDA · September 30, 2026Moderate risk

  Philips North America Llc : MR 7700 and Upgrade to MR 7700; Model Number (REF): 1. 782120, 2. 782153, 3. 782130 (Upgrade);

  Philips MR 7700 and Upgrade to MR 7700, model numbers 782120, 782153, and 782130, are affected. A software issue can stop an exam during image reconstruction when scan parameters exceed system memory, affecting patients undergoing MRI scans. Consumers should contact their healthcare provider or the facility where the scan is performed for instructions.

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• openFDA · September 30, 2026Moderate risk

  Biomerieux Inc : VITEK 2 AST-N461 TEST KIT, GRAM NEGATIVE SUSCEPTIBILITY TESTING - AUTOMATED, Reference Number 424811

  Biomerieux Inc is recalling its VITEK 2 AST-N461 test kit, reference number 424811, for gram negative susceptibility testing. Damaged card pouches in certain lots may cause false resistant results, leading to less effective antibiotic treatment or harmful side effects for patients. Consumers should stop using affected kits and contact Biomerieux for return and replacement instructions.

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• openFDA · September 30, 2026Moderate risk

  Midmark Corporation : Midmark IQvitals Zone, automatically and noninvasively measures systolic and diastolic blood pressure, pulse rate, temperature (temporal), and oxygen…

  Midmark Corporation is recalling its IQvitals Zone device, model 1-200-0320 with kit 4-000-0622. The device may give inaccurate blood pressure readings when using the Linear Deflation Method, affecting adult and pediatric patients. Consumers should contact Midmark Corporation for further instructions.

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• openFDA · September 30, 2026Moderate risk

  Criticare Technologies, Inc. : nGenuity Patient Monitor with Capnography (ETCO2) CAT 8100E1-ST-US, CAT 8100E1-US, CAT 8100EP1, CAT 8100EP1-ST, CAT 8100EP1-ST-US, CAT 8100EP1-US, CAT 8100EP1R

  Criticare Technologies is recalling its nGenuity Patient Monitor with Capnography (ETCO2) models 8100E1 and 8100EP1 series. The monitor may show a Checkline Error alarm during setup, making CO2 monitoring inoperable and delaying procedures for patients and clinicians. Consumers should contact Criticare Technologies for instructions on returning or correcting the device.

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• openFDA · September 30, 2026Moderate risk

  Philips North America Llc : Ingenia Elition S and Ingenia Elition X; Model Numbers (REF): 1. 781357(S), 2. 782106(S), 3. 782137(S), 4. 781358(X), 5. 782107(X), 6. 782119(X), 7. 782136(X),…

  Philips is recalling its Ingenia Elition S and Ingenia Elition X MRI systems. A software issue can stop an exam during image reconstruction when scan settings are changed, affecting patients being scanned. Users should contact Philips or their imaging facility for a software update.

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• openFDA · September 30, 2026Moderate risk

  Fresenius Medical Care Renal Therapies Group, LLC : CombiSet Hemodialysis Blood Tubing Set with Attached Priming Set and Transducer Protectors; Model Number: 03-2522-1;

  Fresenius Medical Care Renal Therapies Group, LLC is recalling its CombiSet Hemodialysis Blood Tubing Set with Attached Priming Set and Transducer Protectors, Model 03-2522-1. The recall is a communication to review the instructions for use because improper preparation or handling could affect treatment for patients and healthcare providers using the device. Consumers must review the instructions for use and ensure all treatment preparation and handling steps are performed as instructed.

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• openFDA · September 30, 2026Moderate risk

  Midmark Corporation : Midmark IQvitals Zone, automatically and noninvasively measures systolic and diastolic blood pressure, pulse rate, temperature (temporal), and oxygen…

  The Midmark IQvitals Zone, model 1-200-0350 with kit 4-000-0722, is affected. The device may give inaccurate blood pressure readings when using the Linear Deflation Method, affecting adult and pediatric patients. Consumers should follow the voluntary recall initiated by Midmark Corporation.

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• openFDA · September 30, 2026High risk

  CooperSurgical, Inc. : INCA (Infant Nasal Cannulae Assy) Neonatal Nasal CPAP, Replacement Set. Stay-Flex tubing component. 5 units per box. Model Numbers: 44-0712, 44-0707, 44-0709,…

  CooperSurgical's INCA Neonatal Nasal CPAP Replacement Set with Stay-Flex tubing, models 44-0712, 44-0707, 44-0709, and 44-0715, is affected. The tubing may have a loose

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• openFDA · September 30, 2026Moderate risk

  Abiomed, Inc. : Automated Impella Controller (AIC) with the below product descriptions and corresponding Product Codes. 1. Impella Controller, Packaged, CA; Product Code:…

  Abiomed's Automated Impella Controller (AIC) is recalled, including packaged models for CA, EU, UK, US, and optical versions. Firmware and software defects can cause inaccurate pressure signals, unreliable placement signals, unresponsive start keys, and false alarms, exposing patients to potential harm. Consumers should contact their healthcare provider to ensure the firmware and software patches are applied.

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• openFDA · September 30, 2026Moderate risk

  Philips North America Llc : Achieva 3.0T; Model Numbers (REF): 1. 781177, 2. 781277, 3. 781278, 4. 781344, 5. 781345;

  Philips Achieva 3.0T MRI systems with model numbers 781177, 781277, 781278, 781344, and 781345 are affected. A software issue can stop an exam during image reconstruction when scan parameters are manually adjusted, exposing patients and operators to interrupted procedures. Consumers should contact Philips for correction instructions.

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• openFDA · September 30, 2026Moderate risk

  Midmark Corporation : Midmark IQvitals Zone, automatically and noninvasively measures systolic and diastolic blood pressure, pulse rate, temperature (temporal), and oxygen…

  Midmark Corporation is recalling its IQvitals Zone device, model 1-200-03300 with kit 4-000-0624, which measures blood pressure, pulse, temperature, and oxygen. The device may give inaccurate blood pressure readings when using the Linear Deflation Method, affecting adult and pediatric patients. Consumers should contact Midmark Corporation for instructions.

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• openFDA · September 30, 2026Moderate risk

  Medline Industries, LP : Medline convenience kits containing Healthmark Instrument Channel Brushes. SINUS PACK DYNJ48258D and Sinus Pack DYNJ48258F.

  Medline convenience kits containing Healthmark Instrument Channel Brushes, specifically Sinus Pack DYNJ48258D and DYNJ48258F, are recalled. The brush may have a sharp edge or burr, causing cut injury, abrasion, and infection to users. Consumers should stop using the affected kits.

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Data comes from official CPSC and FDA publications (United States). Summaries are generated automatically from those publications: the cited source prevails.