Moderate risk
Recalls & alerts
493 alerts recorded, refreshed every six hours. Filter by source or category.
- Moderate risk
ASP Global, LLC. : Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 38" X 4" 1-LINE (CS 10) Model/Catalog Number: 564044 Software Version: Not Applicable Product…
- Moderate risk
ASP Global, LLC. : Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 18" X 4" 2-LINE (CS 10) RED Model/Catalog Number: 564007 Software Version: Not Applicable…
- Moderate risk
Cardinal Health 200, LLC : Presource Packs Containing Stryker StrykeFlow PS and AHTO tube sets: 1) KIT,GU DAVINCI , Catalog Number: PGVMDVBWU; 2) KIT,GU DAVINCI , Catalog Number:…
- Moderate risk
Philips North America : Evolution upgrade 1.5T amd Evolution upgrade 3.0T; Model number (REF): 1. 782116 (1.5T), 2. 782148 (1.5T), 3. 782166 (1.5T), 4. 782201(1.5T), 5. 782117 (3.0T),…
- Moderate risk
Shanghai United Imaging Healthcare Co., Ltd. : Positron Emission Tomography and Computed Tomography System, Model: uMI Panorama 35 with software
- Moderate risk
ASP Global, LLC. : Brand Name: ASP Global Product Name:DISPOSABLE TOURNIQUET CUFF, 34" X 4" 1-Line, Blue Model/Catalog Number: ASP-564012 Software Version: Not Applicable Product…
- Moderate risk
Shanghai United Imaging Healthcare Co., Ltd. : Computed Tomography X-ray System, Model: uCT 550 with software
- Moderate risk
Philips North America : Ingenia 1.5T, 1.5T CX, and 1.5T S; Model number (REF): 1. 781315 (1.5T), 2. 781341 (1.5T), 3. 781396 (1.5T), 4. 782115 (1.5T), 5. 782140 (1.5T), 6. 781262…
- Moderate risk
ASP Global, LLC. : Brand Name: Expressaire Product Name:DISPOSABLE BB TOURNQUET CUFF, 20" X 6" DUAL BLADDER 1-LINE (CS 12) NAVY BLUE Model/Catalog Number: A70107014 Software…
- Moderate risk
Penumbra Inc. : Brand Name: Penumbra System (RED 62 Reperfusion Catheter) Product Name: Penumbra System (RED 62 Reperfusion Catheter) Model/Catalog Number: THNDRRED62SKIT…
- High risk
Medline Industries, LP : Medline Basic Homecare Beds and Medlite Homecare Beds and Accessories, Hand Pendants: MDR510094 PENDANT F/ MDR107002E MDR520094 PENDANT F/ MDR107003E MDR530094…
- Moderate risk
American Nitrile Operations Llc : Brand Name: Performance Pro Product Name: Performance Pro Model/Catalog Number: 72-RM50601,72-RM50602, 72-RM50603,72-RM50604 Product Description: Blue Nitrile…
- Moderate risk
Percussionaire Corporation : Intrapulmonary Percussive Ventilation, IPV-2C, Product Number: S00002-C; Phasitron 5, Product Number: P5 used with Instruction Manual
- Moderate risk
Custom Interventional Pain Management, LLC : Brand Name: Ferndale Laboratories; Medline; Custom Interventional Pain Management CIPM Product Name: Mastisol Skin Adhesive Model/Catalog Number: 24161B…
- Moderate risk
ASP Global, LLC. : Brand Name: Expressaire Product Name:DISPOSABLE TOURNIQUET CUFF, 24" X 4" 1-LINE (CS 18) YELLOW Model/Catalog Number: A70107008 Software Version: Not…
- Moderate risk
Volcano Corp : Philips IntraSight Plus REF: 797423 and 797417 100-120v-220-240v,50/60hZ, 1000 VA
- Moderate risk
American Contract Systems Inc : Medical convenience kits containing BD CliniClean Pericare Wipes within BD Urinary Catheter Trays ABDOMINAL HYSTERECTOMY - 205989 Model No. MHAH55AM LAVH-LAP…
- Moderate risk
ASP Global, LLC. : Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 30" X 4" 1-LINE (CS 18) WHITE Model/Catalog Number: 553322 Software Version: Not Applicable…
- Moderate risk
ASP Global, LLC. : Brand Name: ASP Global Product Name:DISPOSABLE TOURNIQUET CUFF, 12" X 3.5" 2-Line, Plum Model/Catalog Number: ASP-564003 Software Version: Not Applicable…
- Moderate risk
ASP Global, LLC. : Brand Name: Expressaire Product Name:DISPOSABLE TOURNIQUET CUFF, 18" X 4" 2-LINE (CS 18) RED Model/Catalog Number: A70107007 Software Version: Not Applicable…
- Moderate risk
ASP Global, LLC. : Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 30" X 4" 1-LINE (CS 10) WHITE Model/Catalog Number: 564010 Software Version: Not Applicable…
- Moderate risk
SPECTRUM MEDICAL SRL : Brand Name: Quantum PureFlow Product Name: Quantum PureFlow Standard Heat Exchanger High Flow 3/8 Model/Catalog Number: HX55W-S0 Software Version: N/A Product…
- Moderate risk
Cardinal Health 200, LLC : Presource Packs Containing Stryker StrykeFlow PS and AHTO tube sets: 1) KIT, GYN LAPAROSCOPY NEW HAN , Catalog Number: PB23GLNLAC; 2) KIT, GYN LAPAROSCOPY NEW…
- Moderate risk
ASP Global, LLC. : Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 20" X 6" 1-LINE (CS 10) NAVY BLUE Model/Catalog Number: 564017 Software Version: Not…
- Moderate risk
Philips North America : MR 7700; Model number (REF): 1. 782120, 2. 782153, 3. 782155, 4. 782199; Software Versions: R11, R12 and R13;
- Moderate risk
ASP Global, LLC. : Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 44" 2 LINE (10) Model/Catalog Number: DT-7044-02Q Software Version: Not Applicable Product Description:…
- Moderate risk
Percussionaire Corporation : Intrapulmonary Percussive Ventilation, IPV HC, Product Number: S00009; Phasitron, P5-HC
- Moderate risk
Shanghai United Imaging Healthcare Co., Ltd. : Computed Tomography X-ray System, Model: uCT 530 with software
- Moderate risk
Merit Medical Systems, Inc. : Embosphere 500-700 micrometer 2 mL Syringe Sterile Steam, REF: S420GH/EUA, S620GH/EUA; Embosphere 700-900 micrometer 2 mL Syringe Sterile Steam, REF:…
- Moderate risk
SPECTRUM MEDICAL SRL : Brand Name: Quantum PureFlow Product Name: Quantum PureFlow Standard Heat Exchanger High Flow 3/8 W Model/Catalog Number: HX55V-S0W Software Version: N/A…
- Moderate risk
ASP Global, LLC. : Brand Name: Expressaire Product Name:DISPOSABLE BB TOURNQUET CUFF, 26" X 6" DUAL BLADDER, 2-LINE (CS 12) ORANGE Model/Catalog Number: A70107017 Software…
- Moderate risk
ASP Global, LLC. : Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 8" X 2.5" 2-LINE (CS 12) LIGHT BLUE Model/Catalog Number: A70107001 Software Version: Not…
- Moderate risk
Philips North America : Ingenia 3.0T and 3.0T CX; Model number (REF): 1. 781342 (3.0T), 2. 781377 (3.0T), 3. 782103 (3.0T), 4. 781271 (3.0T CX); Software Versions: R11, R12 and R13;
- High risk
Medline Industries, LP : Medline Basic Homecare Beds and Medlite Homecare Beds and Accessories MDR107000P BED, MANUAL, MEDLITE
- Moderate risk
ASP Global, LLC. : Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 30" X 4" 2-LINE (CS 18) WHITE Model/Catalog Number: 553323 Software Version: Not Applicable…
- Moderate risk
Medline Industries, LP : Medline Convenience Kits: 1) MAJOR PACK, Catalog Number: DYNJ81325A
Medline Industries is recalling its Convenience Kit MAJOR PACK, catalog number DYNJ81325A. The neurological sponges inside may have elevated endotoxin levels, posing health risks like fever, nausea, or neurovascular problems for patients. Consumers should stop using the kits and contact Medline for instructions on return or replacement.
- Moderate risk
Medline Industries, LP : Medline Convenience Kits: 1) PEDS SINUS PACK, Catalog Number: DYNJ02516G; 2) SINUS PACK-LF, Catalog Number: DYNJ0342705J; 3) NASAL-LF, Catalog Number:…
Medline Industries is recalling certain Convenience Kits, including PEDS SINUS PACK, SINUS PACK-LF, NASAL-LF, ENT PACK, and EENT PACK, with specific catalog numbers. The kits contain neurological sponges with potentially elevated endotoxin levels, which can cause febrile response, hypotension, nausea, or other serious health issues for patients. Consumers should stop using the recalled kits and follow the recall instructions for return or disposal.
- Moderate risk
Philips North America Llc : SmartPath to dStream for 1.5T, SmartPath to dStream for 3.0T, SmartPath to dStream for XR and 3.0T, SmartPath to Ingenia Elition X; Model Numbers (REF): 1.…
Philips SmartPath to dStream for 1.5T, 3.0T, XR and 3.0T, and Ingenia Elition X are affected. A software issue can terminate an examination during image reconstruction if scan parameters are manually adjusted beyond available system memory, affecting patients and operators. Consumers should avoid manually adjusting scan parameters that exceed the system's memory capacity.
- Moderate risk
Philips North America Llc : Achieva 1.5T, Achieva 1.5T Conversion and Achieva 1.5T Initial system; Model Numbers (REF): 1. 781196 (Achieva 1.5T), 2. 781343 (Achieva 1.5T), 3. 781283…
Philips is recalling its Achieva 1.5T, Achieva 1.5T Conversion, and Achieva 1.5T Initial systems. A software issue can terminate an examination during image reconstruction if manual scan settings exceed available memory, affecting patients receiving MRI scans. Consumers should contact their healthcare provider or Philips for further instructions.
- Moderate risk
Medline Industries, LP : Medline Convenience Kits: 1) MFC CRANIOTOMY PACK, Catalog Number: DYNJT8784; 2) SLUH CRANIOTOMY PACK-LF, Catalog Number: DYNJ0369348Q; 3) SLUH CRANIOTOMY…
Medline Industries is recalling certain Medline Convenience Kits, including craniotomy packs with catalog numbers DYNJT8784 and DYNJ0369348Q through DYNJ0369348T. The kits contain neurological sponges with potentially elevated endotoxin levels, which can cause fever, nausea, low blood pressure, or neurovascular problems in patients. Consumers should stop using these kits, check the catalog numbers, and follow the firm's return instructions.
- Moderate 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.
- Moderate 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.
- Moderate 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.
- Moderate 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.
- Moderate 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.
- Moderate 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.
- Moderate 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.
- Moderate 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.
- Moderate 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.
Data comes from official CPSC and FDA publications (United States). Summaries are generated automatically from those publications: the cited source prevails.