Recalls & alerts

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

• openFDA · August 26, 2026Moderate risk

  American Contract Systems Inc : American Contract Systems medical procedure kits and trays labeled as: 1) CRANI PACK - 208400, Model Item Number UDCP57AI; 2) SPINE PACK, Model Item Number…

  American Contract Systems is recalling medical procedure kits and trays, including Crani Pack, Spine Pack, and others, distributed in Minnesota, Missouri, and Iowa. The kits contain Ritmed Neurological Sponges with potentially variable endotoxin levels, posing a risk to patients undergoing procedures. Consumers should check the recall notice for affected model numbers and contact American Contract Systems for instructions.

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• openFDA · August 26, 2026Moderate risk

  Foundation Medicine, Inc. : Hamilton Microlab STAR Liquid Handler; Protocol Configuration Tool (PCT) v2.0.0. Used to conduct F1CDx and F1LCDx.

  Foundation Medicine's Hamilton Microlab STAR Liquid Handler with Protocol Configuration Tool v2.0.0 is recalled. The software issue increases spontaneous software closures, which can affect patients whose diagnostic tests are run on this system. Users should stop using the affected software and contact Foundation Medicine for instructions.

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• openFDA · August 26, 2026Moderate risk

  Kico Knee Innovation Company : Brand Name: Kico Knee Innovation Product Name: ARVIS SURGICAL NAVIGATION SYSTEM GEN 2 Model/Catalog Number: IN-29200 Software Version: ARVIS Hip and Knee Gap…

  The recalled product is the Kico Knee Innovation ARVIS Surgical Navigation System Gen 2, model IN-29200. An internal sensor issue can make the eyepiece image appear tilted, exposing surgeons and patients to incorrect navigation during orthopedic surgery. Users should stop using the affected system and contact Kico Knee Innovation for instructions.

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• openFDA · August 26, 2026Moderate risk

  Tobii Dynavox Llc : TD Navio Midi Speech Generating Device Model/Catalog Number: 1000798

  Tobii Dynavox LLC is recalling the TD Navio Midi Speech Generating Device, model 1000798. Damaged battery mounting tabs can let the battery move, causing an internal short circuit, localized heating, and gas venting, affecting users nationwide. The recall is voluntary and firm-initiated.

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• openFDA · August 26, 2026Moderate risk

  Paragonix Technologies Inc. : Paragonix Technologies Inc. KidneyVault Portable Renal Perfusion System REF# PRGNX-8008-001

  Paragonix Technologies Inc. is recalling its KidneyVault Portable Renal Perfusion System, REF# PRGNX-8008-001. A firmware defect can cause the datalogger to lose configuration, resulting in a blank screen and loss of displayed preservation parameters, putting the transported

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• openFDA · August 26, 2026Moderate risk

  Siemens Healthcare Diagnostics, Inc. : Syva EMIT 2000 Quinidine Assay REF: 4Q019UL Contents: 1x28 mL, 1x14mL

  Siemens Healthcare Diagnostics is recalling its Syva EMIT 2000 Quinidine Assay, REF 4Q019UL. The assay may produce falsely high quinidine measurements, which can lead to sub-optimal treatment, including life-threatening cardiac arrhythmias or inadequate antimalarial therapy for patients. Consumers should follow the instructions from Siemens Healthcare Diagnostics regarding this voluntary recall.

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• openFDA · August 26, 2026Moderate risk

  restor3d Inc. : Brand Name: Veritas Standard Reverse Total Shoulder Product Name: Veritas Standard Glenoid Baseplate Model/Catalog Number: 1500-1030; 1500-1035 Software…

  The recall affects restor3d Veritas Standard Reverse Total Shoulder glenoid baseplate models 1500-1030 and 1500-1035. The baseplate has incorrectly machined screw holes, which may cause peripheral screws to engage improperly, exposing patients to potential implant failure. Patients should contact their surgeon or restor3d for instructions on returning or replacing the affected device.

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• openFDA · August 26, 2026Moderate risk

  Gentherm Medical, LLC : Blanketrol II Model 222S; Thermal regulating system.

  Gentherm Medical, LLC is recalling its Blanketrol II Model 222S thermal regulating system. Overheating of the 115V CPU board may cause the device to shut down, affecting patients worldwide. The recall is voluntary and firm-initiated, with no consumer action specified.

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• openFDA · August 26, 2026Moderate risk

  Siemens Healthcare Diagnostics, Inc. : Beckman Coulter, Emit 2000 Quinidine Assay REF: OSR4Q229 Contents: R1: 2 x 23 mL;R2 2x13 mL

  The Beckman Coulter Emit 2000 Quinidine Assay REF OSR4Q229 is affected. The hazard is unacceptable precision performance causing erroneously elevated quinidine measurements, risking life-threatening cardiac arrhythmias or inadequate antimalarial therapy for patients. The recall notice does not specify a consumer action; it is a voluntary firm-initiated recall.

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• openFDA · August 26, 2026Moderate risk

  American Contract Systems Inc : American Contract Systems medical procedure kits and trays labeled as: 1) ANTERIOR CERVICAL PACK - 205988, Model Item Number MHAC65AH; 2) SPINE PACK - 206013,…

  American Contract Systems is recalling its Anterior Cervical Pack (model MHAC65AH) and Spine Pack (model MHSP99AF) medical procedure kits and trays. The kits contain Ritmed Neurological Sponges that may have unexpected endotoxin levels, posing a risk to patients during surgery. Consumers should stop using the recalled kits and contact American Contract Systems for return or replacement.

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• openFDA · August 26, 2026Moderate risk

  Intersurgical Inc : One-Piece Guedel Airway, size 00, ISO 5.0, Blue. Oropharyngeal Airway Device.

  The recall affects Intersurgical Inc's One-Piece Guedel Airway, size 00, ISO 5.0, Blue, an oropharyngeal airway device. The device could be occluded or partially occluded, posing a risk to patients who use it. Consumers should stop using the recalled airway and contact Intersurgical for instructions.

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• openFDA · August 26, 2026Moderate risk

  AVID Medical, Inc. : Halyard LAVH PACK, Model/Catalog Number: USAR053-11 containing Clearify Visualization System (5303907).

  AVID Medical, Inc. is recalling the Halyard LAVH PACK, model USAR053-11, which contains the Clearify Visualization System. The component was sterilized with ethylene oxide against manufacturer guidance, which may cause it to leak, exposing patients to risk. Consumers should stop using the affected kits and contact AVID Medical for return instructions.

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• openFDA · August 26, 2026Moderate risk

  Boston Scientific Corporation : OverStitch Suture Cinch, 1pk. Endoscopic tissue approximation device.

  Boston Scientific is recalling its OverStitch Suture Cinch, a single-pack endoscopic tissue approximation device. The device may fail to deploy the cinch implant or cut the suture, posing a risk to patients undergoing the procedure. Consumers and healthcare providers should stop using the affected devices and contact Boston Scientific for return and replacement instructions.

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• openFDA · August 26, 2026Moderate risk

  Intersurgical Inc : One-Piece Guedel Airway, size 000, ISO 3.5, Light Green. Oropharyngeal Airway Device.

  Intersurgical Inc's One-Piece Guedel Airway, size 000, ISO 3.5, Light Green oropharyngeal airway device is recalled. The device could be occluded or partially occluded, posing a risk to patients who use it. Consumers should stop using the recalled device and contact Intersurgical for return or replacement instructions.

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• openFDA · August 19, 2026Moderate risk

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. : Philips Azurion Rystem, Model Numbers: 722063, 722064, 722067, 722068, 722078, 722079, 722221, 722222,722223, 722224, 722225, 722226, 722227, 722228, 722280*,…

  Philips is recalling its Azurion Rystem interventional fluoroscopic X-ray systems with software versions R2.2.10 and R2.1.10. Two software issues can degrade image quality or cause loss of geometry movements, leading to delayed therapy, procedural complications, or inappropriate treatment for patients. The voluntary, firm-initiated recall requires users to contact Philips for corrective action.

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• openFDA · August 19, 2026Moderate risk

  BioFire Diagnostics, LLC : BIOFIRE Respiratory Panel 2.1 (RP2.1) REF 423742 UDI code: 00815381020529 PCR-based multiplexed nucleic acid test, in vitro diagnostic

  BioFire Diagnostics, LLC is recalling its BIOFIRE Respiratory Panel 2.1 (RP2.1) REF 423742 test. The test may give false negative results, affecting patients tested in Alabama, Arkansas, Iowa, Illinois, Kansas, Louisiana, Minnesota, Missouri, Texas, and Wisconsin. Consumers should contact their healthcare provider for guidance on next steps.

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• openFDA · August 19, 2026Moderate risk

  OBP Medical Corporation : OBP Medical , ER-Spec Single-Use Vaginal Speculum with LED Light Source, X-Small REF: C020130-1

  OBP Medical is recalling its ER-Spec Single-Use Vaginal Speculum with LED Light Source, X-Small REF C020130-1. The device may contain a burr on the proximal plastic blade, posing a sharp-edge injury risk to patients and healthcare providers. Consumers should stop using the recalled speculum and contact OBP Medical for return and replacement.

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• openFDA · August 19, 2026Moderate risk

  Covidien, LP : Dermalon 88861757-31 DERMALON* 4-0 BLU 75CM C13 88861757-31 88861799-31 DERMALON* 4-0 BLU 75CM C14 88861799-31

  Covidien, LP is recalling Dermalon 4-0 blue 75cm sutures with catalog numbers 88861757-31 and 88861799-31. The sterile packaging may have a tear or perforation, allowing contamination that could cause infection, vision loss in eye surgery, or longer surgery for patients. Consumers and healthcare providers should stop using affected sutures, check inventory, and contact Covidien for return instructions.

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• openFDA · August 19, 2026Moderate risk

  Cardinal Health 200, LLC : Cardinal Health Presource Kits: 1) BASIC PACK , Catalog Number: SBA73BPGCA; 2) SPINE PACK , Catalog Number: SNE11SPHKC; 3) SPINE PACK , Catalog Number:…

  Cardinal Health Presource Kits, including Basic Pack, Spine Pack, and Craniotomy Pack with specific catalog numbers, are affected. The kits contain Medicom Ritmed Neurological Sponges with unexpected variability in endotoxin levels, exposing patients to potential harm. Consumers should stop using the recalled kits and contact Cardinal Health for return and replacement instructions.

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• openFDA · August 19, 2026Moderate risk

  Covidien, LP : Surgipro SP-623 SURGIPRO* 2-0 BLU 75CM SC2 X36 SP-623

  Covidien, LP is recalling its Surgipro SP-623 SURGIPRO 2-0 BLU 75CM SC2 X36 SP-623 sutures. The sterile barrier packaging may have a perforation or tear, causing biocontamination that can lead to infection, vision loss in ophthalmic use, or prolonged surgery for patients. Consumers should stop using the affected sutures and contact Covidien, LP for instructions.

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• openFDA · August 19, 2026Moderate risk

  Bioporto Diagnostics A/S : ProNephro AKI (NGAL) Reagent Kit (100 tests). IVD Acute Kidney Injury Test System.

  The affected product is the ProNephro AKI (NGAL) Reagent Kit by Bioporto Diagnostics. A non-validated rework process could lead to missed diagnosis or inappropriate treatment of renal disease in patients. Consumers should contact Bioporto Diagnostics for instructions on the recalled product.

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• openFDA · August 19, 2026Moderate risk

  Straumann USA LLC : GM Helix Implant, Endosseous Dental Implant Article No. 109.984

  Straumann USA LLC is recalling its GM Helix Implant, Endosseous Dental Implant Article No. 109.984. The implant inside the packaging may not match the label, which could cause bone compression or difficulty during installation for patients. Consumers should verify the implant matches the label before use.

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• openFDA · August 19, 2026Moderate risk

  Cardinal Health 200, LLC : Cardinal Health Presource Kits: 1) SEPTO RHINO PACK , Catalog Number: SEN73NSKCF; 2) PACK NEURO MINOR CRANIOTOMY , Catalog Number: SNE30CNOHE; 3) NEURO MAJOR 2…

  Cardinal Health Presource Kits, including Septo Rhino Pack, Neuro Minor Craniotomy, and other neurological and spine packs, are affected. The kits contain MEDICOM Ritmed Neurological Sponges with unexpected variability in endotoxin levels, exposing patients to potential harm. Consumers should stop using these kits and contact Cardinal Health for return or replacement instructions.

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• openFDA · August 19, 2026Moderate risk

  Waldemar Link GmbH & Co. KG (Mfg Site) : Endo-Model, Replacement Set, Tibial Plateau, right/left, L, UHMWPE, CoCrMo, Rotating Hinge Item Number 15-0027/16

  Waldemar Link GmbH & Co. KG is recalling its Endo-Model Replacement Set Tibial Plateau, item number 15-0027/16. The set incorrectly contains a Pure Hinge plateau, which can cause prolonged surgery or, if implanted, increased wear and reduced implant life for patients. Consumers should contact their healthcare provider or the firm to arrange return of the affected product.

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• openFDA · August 19, 2026Moderate risk

  BD SWITZERLAND SARL : 60 In Non-DEHP Minibore Extension Set RES ME2010 UDI-DI code: 10885403236235 MaxPlus Ext Set w/Needleless and Y-Site REF MPX5305-C UDI-DI code: 10885403274619…

  BD Switzerland SARL is recalling its 60-inch Non-DEHP Minibore Extension Set, MaxPlus Ext Set with Needleless and Y-Site, and 9-inch Extension Set with Max Y. The devices may not have received adequate sterilization, posing infection risk to patients who receive fluids through them. Consumers should stop using affected products and contact BD or their healthcare provider for return instructions.

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• openFDA · August 19, 2026Moderate risk

  Spacelabs Healthcare, Inc. : Brand Name: Xhibit Product Name: Xhibit Central Station Model/Catalog Number: 96102 Software Version: N/A Product Description: The Spacelabs Healthcare…

  Spacelabs Healthcare's Xhibit Central Station, model 96102, is affected. The DisplayPort audio/video splitter can fail, causing loss of patient data on external monitors, affecting clinicians and patients. Users should contact Spacelabs Healthcare for instructions.

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• openFDA · August 19, 2026Moderate risk

  W L Gore & Associates, Inc. : GORE VIABIL Short Wire Biliary Endoprosthesis, Model No. VSWVN1006. Flexible, self-expanding endoprosthesis designed to maintain luminal patency of the common…

  The recall affects GORE VIABIL Short Wire Biliary Endoprosthesis, Model No. VSWVN1006, distributed in Georgia and Rhode Island. The device may be mislabeled as a different size and type, posing a risk of incorrect placement for patients needing bile duct treatment. Consumers and healthcare providers should stop using the device, verify the label, and contact W L Gore & Associates for return instructions.

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• openFDA · August 19, 2026Moderate risk

  Cardinal Health 200, LLC : Cardinal Health Presource Kits: 1) NEWNAN SMR PACK, Catalog Number: SEN21SPPMB

  Cardinal Health Presource Kits, specifically the NEWNAN SMR PACK with catalog number SEN21SPPMB, are affected. The kits contain MEDICOM Ritmed Neurological Sponges with unexpected variability in endotoxin levels, exposing patients to potential harm. Consumers should stop using these kits and follow the firm's recall instructions for return or disposal.

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• openFDA · August 19, 2026Moderate risk

  Straumann USA LLC : Straumann Bone Level Tapered (BLT) Implant, D 4.1mm RC, SLActive 14mm, Roxolid, Loxim (Article 021.5314); implant, endosseous, root-form

  Straumann USA LLC is recalling its Straumann Bone Level Tapered (BLT) Implant, D 4.1mm RC, SLActive 14mm, Roxolid, Loxim (Article 021.5314). The implant may actually be 12mm long instead of the labeled 14mm, posing a risk to patients receiving this dental device. Consumers should contact their dentist or Straumann to determine if their implant is affected and what to do next.

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• openFDA · August 19, 2026Moderate risk

  Covidien, LP : V-Loc 90 Absorbable Wound Closure Device VLOC 90 0 VL 22 GS-21 VLOCM0336 VLOC 90 0 VL 22 GS-25 VLOCM0436 VLOCM0436 VLOCM0003 V-LOC* 90 4-0 CLR 15CM P12X12…

  Covidien is recalling its V-Loc 90 Absorbable Wound Closure Device sutures. The sterile barrier packaging may have a tear or perforation, risking contamination and infection for patients, including vision loss in eye surgery. Consumers should stop using affected lots and contact Covidien for return or replacement.

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• openFDA · August 19, 2026Moderate risk

  Erbe USA Inc : ERBECRYO 2 Cryosurgical Unit Model/Catalog Number: 10402-000

  The recalled product is the Erbe USA Inc ERBECRYO 2 Cryosurgical Unit, model/catalog number 10402-000. A strong pull on the high-pressure transfer hose can cause a pneumatic short circuit, leading to CO2 leaking into the return path and excessive pressure that may rupture the cryoprobe, exposing patients and operators to injury. Consumers must comply with the voluntary recall initiated by the firm.

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• openFDA · August 19, 2026Moderate risk

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. : Philips Azurion, Model Numbers: 722229, 722230, 722231, 722232, 722233, 722234, 722235, and 722236, with Software Version Numbers: R3.0 and R3.1;…

  Philips Azurion interventional fluoroscopic x-ray systems, model numbers 722229 through 722236 with software versions R3.0 and R3.1, are affected. Two software issues can degrade image quality or cause loss of geometry movements, leading to delayed therapy, procedural complications, or inappropriate treatment for patients. Consumers should contact their healthcare provider or Philips for instructions on the voluntary recall.

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• openFDA · August 19, 2026Moderate risk

  Remel Europe Ltd. : Thermo Fisher Diagnostics Neisseria meningitidis Gp C 2ml/VL, Product Number R30166901; invitro diagnostics

  Thermo Fisher Diagnostics Neisseria meningitidis Gp C 2ml/VL, product number R30166901, is affected. Certain lots do not perform to the intended criteria, which could cause false test results for patients. Users should check their lot numbers and follow the firm's recall instructions.

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• openFDA · August 19, 2026Moderate risk

  Medline Industries, LP : Medline Micro-Kill Bleach Germicidal Bleach Wipes,7" x 8", 150 count, 150 count, Product Number MSC351400AN

  Medline Industries is recalling Medline Micro-Kill Bleach Germicidal Bleach Wipes, 7 by 8 inches, 150 count, product number MSC351400AN. The wipes may lose bleach

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• openFDA · August 19, 2026Moderate risk

  Cardinal Health 200, LLC : Cardinal Health Presource Kits: 1) CHI STD NEURO CRANI OPT 2 , Catalog Number: CHIP99NC27; 2) CHI STD NEURO CRANI OPT 2 , Catalog Number: CHIP99NC28; 3) CHI…

  Cardinal Health Presource Kits, including specific catalog numbers for neuro, nasal, and ENT procedures, are affected. The kits contain Medicom Ritmed Neurological Sponges with unexpected endotoxin levels, exposing patients to potential infection or adverse reactions. Consumers should stop using the affected kits, verify catalog numbers, and contact Cardinal Health for instructions.

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• openFDA · August 19, 2026Moderate risk

  Ventana Medical Systems, Inc. : navify Digital Pathology (on-prem) v2.5, Material Number 10092343001 navify Digital Pathology (Cloud) v2.5. Material Number 09453733001 UDI-DI Code:…

  Ventana Medical Systems (Roche) is recalling navify Digital Pathology software v2.5, both on-prem and Cloud versions. The software can show image/metadata discrepancies in the Viewer window, affecting pathologists and healthcare providers using the system. Consumers should stop using the affected software and contact the firm for correction or replacement.

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• openFDA · August 19, 2026Moderate risk

  Cardinal Health 200, LLC : Cardinal Health Presource Kits: 1) FAT GRAFT ADD KIT , Catalog Number: 21-4720B; 2) TRAY FAT GRAFT ADD , Catalog Number: 21-4720C; 3) KIT,BOSC…

  Cardinal Health is recalling its Presource procedure kits, including fat graft, nasal pack, spine, neuro, and craniotomy packs. The kits contain Medicom Ritmed Neurological Sponges with unexpected endotoxin variability, exposing patients to risk during procedures. Consumers should stop using affected kits, check catalog numbers, and contact Cardinal Health for return instructions.

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• openFDA · August 19, 2026Moderate risk

  Covidien, LP : Surgipro II S8698GX SURGIPRO II BL 5/0 18 P-13 S8698GX

  Covidien, LP is recalling its Surgipro II S8698GX sutures (SURGIPRO II BL 5/0 18 P-13). The sterile packaging may have a tear or perforation, exposing patients to contaminated sutures that can cause infection, vision loss in eye surgery, or longer operations. Consumers should stop using the affected product and contact Covidien for return and replacement instructions.

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• openFDA · August 19, 2026Moderate risk

  Galt Medical Corporation : Boston Scientific Enhance Transcarotid/Peripheral Access Kit REF: SR-4F21G7D-MP (Kit-075-03) Sheath with Dilator , Stiffen Dilator, Nitinol Mandrel Wire w/…

  Boston Scientific is recalling its Enhance Transcarotid/Peripheral Access Kit, model REF SR-4F21G7D-MP. The black depth markings on the sheath can detach, posing a risk to patients during procedures. Patients or users should contact their healthcare provider to arrange return or replacement.

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• openFDA · August 19, 2026High risk

  Baxter Healthcare Corporation : Baxter Duo-Vent Solution Set and Male Luer Lock Adapter, Product Code 1C8507; Solution Administration Sets

  Baxter Healthcare Corporation is recalling its Duo-Vent Solution Set and Male Luer Lock Adapter, Product Code 1C8507, and Solution Administration Sets. The devices can produce air bubbles in the drip chamber and tubing when a pressure cuff is used or the tubing is flushed fully open, posing a risk to patients. Consumers should stop using the affected products and contact Baxter Healthcare for further instructions.

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• openFDA · August 19, 2026High risk

  Spectra Medical Devices, Llc : Brand Name: Elevaris/Spectra Medical Devices Product Name: Sodium Chloride Injection, 0.9%, USP 10mL Ampule Model/Catalog Number: AMPUL10MLK. Sodium Chloride…

  Spectra Medical Devices' Elevaris brand Sodium Chloride Injection 0.9% USP 10mL Ampule is recalled. The product may have compromised sterility, exposing patients using it for IV tubing and indwelling intravascular access devices to microorganisms, endotoxins, or foreign matter, which can cause infections or organ failure. Consumers should stop using the recalled ampules and follow the firm's recall instructions.

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• openFDA · August 19, 2026Moderate risk

  Medline Industries, LP : Medline Micro-Kill Bleach Germicidal Bleach Wipes, 6" x 5", 150 count, Product Number MSC351410AN

  Medline Industries is recalling its Micro-Kill Bleach Germicidal Bleach Wipes, 6" x 5", 150 count, product number MSC351410AN. The wipes may lose bleach strength before the 12-month shelf life ends, reducing disinfection and allowing harmful germs to survive, which poses a risk to users. Consumers should stop using the wipes and contact Medline for a refund or replacement.

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• openFDA · August 19, 2026Moderate risk

  Medline Industries, LP : Medline Micro-Kill Bleach Germicidal Bleach Wipes, 12" x 12", 110 Count, Product Number MSC351450AN

  Medline Industries is recalling Medline Micro-Kill Bleach Germicidal Bleach Wipes, 12 by 12 inches, 110 count, product number MSC351450AN. The wipes may lose bleach strength before their 12-month shelf life ends, reducing disinfection and allowing harmful germs to survive, which poses a risk to users. Consumers should stop using the affected wipes and contact Medline for return or disposal instructions.

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• openFDA · August 19, 2026Moderate risk

  Terumo Medical Corporation : GLIDESHEATH SLENDER A-KIT 6F 10CM .021GW. 5 units per box. Product Code: 60-1060. The Glidesheath Slender is used to facilitate placing a catheter through the…

  Terumo Medical Corporation is recalling its Glidesheath Slender A-Kit 6F 10CM .021GW, product code 60-1060, used to guide catheters into the radial artery. The kit contains a 0.025 guidewire instead of the required 0.021 guidewire, which could lead to procedural complications for patients undergoing catheterization. Consumers should stop using the affected kits and contact Terumo or their distributor for return and replacement instructions.

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• openFDA · August 19, 2026Moderate risk

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. : Allura Xper FD. Model Numbers: 722026, 722027, 722028, 722029, 722035, 722038, 722039, 722058. Interventional fluoroscopic x-ray system.

  Philips Medical Systems is recalling its Allura Xper FD interventional fluoroscopic x-ray systems, models 722026, 722027, 722028, 722029, 722035, 722038, 722039, and 722058. A firmware issue can cause loss of geometry movements, exposing patients and staff to potential harm during procedures. Users should contact Philips for instructions on correcting the firmware issue.

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• openFDA · August 19, 2026Moderate risk

  Cardinal Health 200, LLC : Cardinal Health Presource Kits: 1) KIT, MER NEURO BACK , Catalog Number: PN33NBMYD; 2) KIT,CHP BASIC NEURO , Catalog Number: PN36NBCH4; 3) KIT,CHP BASIC NEURO…

  Cardinal Health Presource Kits, including neuro, cervical disc, and laminectomy procedure kits, are affected. The kits contain MEDICOM Ritmed Neurological Sponges with unexpected variability in endotoxin levels, exposing patients to risk. Consumers should stop using the recalled kits and follow the firm's instructions for return or disposal.

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• openFDA · August 19, 2026Moderate risk

  Medline Industries, LP : Medline Micro-Kill Bleach Germicidal Bleach Wipes, 12" x 12", 110 Count Bag, Product Number MSC351450BG4

  Medline Micro-Kill Bleach Germicidal Bleach Wipes, 12" x 12", 110 Count Bag, product number MSC351450BG4, are recalled. The wipes may lose bleach strength before the 12-month shelf life ends, which can reduce disinfection and allow harmful germs to survive for users. Consumers should stop using the recalled wipes and contact Medline Industries for instructions.

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• openFDA · August 19, 2026Moderate risk

  Cardinal Health 200, LLC : Cardinal Health Presource Kits: 1) HARMONIZED SPINE VCH PHC PACK , Catalog Number: SOP30SPBCC

  Cardinal Health Presource Kits, specifically the Harmonized Spine VCH PHC Pack (catalog SOP30SPBCC), are affected. The kits contain Medicom Ritmed Neurological Sponges with unexpected variability in endotoxin levels, posing a risk to patients during procedures. Consumers should stop using the affected kits and contact Cardinal Health for return or disposal instructions.

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• openFDA · August 19, 2026Moderate risk

  MICROVENTION INC. : BOBBY Balloon Guide Catheter REF: BOB-895-CN BOB-895-EMEA BOB-895-EMEA-AL BOB-895-US MV-BGA01095 For use in facilitating the insertion and guidance of an…

  Microvention Inc. is recalling its BOBBY Balloon Guide Catheter, models BOB-895-CN, BOB-895-EMEA, BOB-895-EMEA-AL, BOB-895-US, and MV-BGA01095. The balloon may have pinhole defects, posing a risk to patients undergoing vascular procedures. Consumers should stop using the affected catheters and contact Microvention or their distributor for instructions.

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• openFDA · August 19, 2026Moderate risk

  Covidien, LP : V-Loc 180 Absorbable Wound Closure Device BOX BEDSIDE STAPLING IS KING BOX06614V4 BOX BY PASS FINAL BOX07405V1 BOX BYPASS CARDON BOX01056V2 BOX BYPASS DR LAGAE…

  Covidien, LP is recalling its V-Loc 180 Absorbable Wound Closure Device. The sterile barrier packaging may have a perforation or tear, risking biocontamination of sutures and causing infection, vision loss, or prolonged surgery for patients. Consumers should stop using affected devices and contact Covidien or their healthcare provider for return instructions.

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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.