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Vehicle Recalls320,000+ NHTSA safety recalls Browse VehiclesEvery make, model and year Complaints2.1M+ consumer safety complaints TSBs4.7M technical service bulletins VIN LookupDecode any vehicle VIN instantly OBD Codes12,000+ diagnostic trouble codes Fuel EconomyEPA MPG data for all vehicles Safety Ratings11,700+ NHTSA crash test ratings Investigations5,300+ NHTSA defect investigations StatisticsRecall trends & safety analysis Compare VehiclesTwo vehicles side by side

Consumer Safety

Product Safety9,700+ CPSC product recalls Food Safety28,600+ FDA food recalls Pet Safety1.3M FDA animal adverse events Drug Safety17,500+ FDA drug recalls Device Safety38,400+ FDA device recalls Workplace Safety102,900+ OSHA injury reports Brand HistoryRecall lookup by company

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Browse Device Recalls

474 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 474 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Medical Device Recalls

Browse 474 FDA device recalls.

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DateProductReasonClassFirm
Jul 12, 2018 power cord for: (a) AMIA Automated PD Cycler, Product Code: 5C9320; (b) Kaguy... There were instances where the power cord socket detached from the back of the AMIA cycler when t... Class II Baxter Healthcare Corporation
Jun 21, 2018 Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6), pro... The flow rate test verification was not properly executed for certain Sigma Spectrum infusion pum... Class II Baxter Healthcare Corporation
May 30, 2018 FLOSEAL Special Applicator Tips in cartons labeled in part, "Floseal SPECIAL ... Baxter r recalled this device due to the use of an incorrect plastic formulation in the manufactu... Class II Baxter Healthcare Corporation
May 8, 2018 Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6), inf... The firm will be updating the Instructions for Use for the product. Current IFUs instruct users t... Class II Baxter Healthcare Corporation
May 8, 2018 Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8), inf... The firm will be updating the Instructions for Use for the product. Current IFUs instruct users t... Class II Baxter Healthcare Corporation
Apr 25, 2018 Baxter EXACTAMIX Inlet, Syringe Inlet, REF H938176 Usage: Exacta-Mix 2400... Specific lots of EXACTAMIX Inlets listed below due to incorrectly performed over-labeling. The i... Class II Baxter Healthcare Corporation
Apr 25, 2018 Baxter EXACTAMIX Inlet, Vented, Micro-Volume Inlet, REF H938175 Usage: Ex... Specific lots of EXACTAMIX Inlets listed below due to incorrectly performed over-labeling. The i... Class II Baxter Healthcare Corporation
Apr 25, 2018 Baxter EXACTAMIX Inlet, Non-Vented, High-Volume Inlet, REF H938173 Product... Specific lots of EXACTAMIX Inlets listed below due to incorrectly performed over-labeling. The i... Class II Baxter Healthcare Corporation
Apr 25, 2018 Baxter EXACTAMIX Inlet, Vented, High-Volume Inlet, REF H938174 Usage: Exa... Specific lots of EXACTAMIX Inlets listed below due to incorrectly performed over-labeling. The i... Class II Baxter Healthcare Corporation
Apr 24, 2018 Prismaflex 5.10 US, Product Code 113081 Intended Use: The Prismaflex Cont... Baxter Healthcare will be installing new firmware on all Prismaflex control units to address the ... Class II Baxter Healthcare Corporation
Apr 24, 2018 Prismaflex 7.XX ROW, Product Code 114870 Intended Use: The Prismaflex Con... Baxter Healthcare will be installing new firmware on all Prismaflex control units to address the ... Class II Baxter Healthcare Corporation
Apr 24, 2018 Prismaflex 7.XX US, Product Code 115269 Intended Use: The Prismaflex Cont... Baxter Healthcare will be installing new firmware on all Prismaflex control units to address the ... Class II Baxter Healthcare Corporation
Apr 24, 2018 Prismaflex System, Product Code 107493 Intended Use: The Prismaflex Contr... Baxter Healthcare will be installing new firmware on all Prismaflex control units to address the ... Class II Baxter Healthcare Corporation
Apr 24, 2018 Prismaflex 7.20 US, Product Code 955542 Intended Use: The Prismaflex Cont... Baxter Healthcare will be installing new firmware on all Prismaflex control units to address the ... Class II Baxter Healthcare Corporation
Apr 3, 2018 Baxter Sigma Spectrum Infusion Pump with Master Drug Library (Version 6) 3570... Service technician improperly documented final release testing on product, indicating that the fu... Class II Baxter Healthcare Corporation
Apr 3, 2018 Baxter Sigma Spectrum Infusion Pump with master Drug Library (Version 6) 3570... Service technician improperly documented final release testing on product, indicating that the fu... Class II Baxter Healthcare Corporation
Apr 3, 2018 Baxter Sigma Spectrum Infusion Pump with master Drug Library (Version 6) 3570... Service technician improperly documented final release testing on product, indicating that the fu... Class II Baxter Healthcare Corporation
Apr 3, 2018 Baxter Sigma Spectrum Infusion Pump with Master Drug Library (Version 6) 3570... Service technician improperly documented final release testing on product, indicating that the fu... Class II Baxter Healthcare Corporation
Apr 3, 2018 Baxter Sigma Spectrum Infusion Pump with Master Drug Library (Version 6) 3570... Service technician improperly documented final release testing on product, indicating that the fu... Class II Baxter Healthcare Corporation
Feb 6, 2018 Sterile EXACTAMED Oral Dispenser, Clear, Individually Packaged, 5 mL, Product... Affected lot of 5 mL oral dispensers was packaged in individual pouches that are mislabeled with ... Class II Baxter Healthcare Corporation
Dec 21, 2017 MARS Treatment Kit, Use only with MARS(R) Monitor 1TC, GAMBRO, Product Code 8... Baxter has received customer complaints regarding leakage in the albumin circuit. The leakage was... Class II Baxter Healthcare Corporation
Oct 6, 2017 Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6) (GTI... Certain infusion pumps may exhibit excessive wear of the pumping mechanism caused by a lack of lu... Class II Baxter Healthcare Corporation
Sep 1, 2017 Baxter Amia Automated Peritoneal Dialysis Set with Cassette, REF 5C5479 The firm received increased customer complaints for Missing Red Line, Patient Slow Flow, Solution... Class II Baxter Healthcare Corp
Jul 27, 2017 Empty IntraVia Container with Non-DEHP Fluid Path, 500mL Containers are in... A leak may allow for microbial contamination of the sterile fluid path. Class II Baxter Healthcare Corporation
Jul 5, 2017 HomeChoice Pro Automated PD system Model numbers: 5C8310, 5C8310R Product... Baxter Healthcare Corporation has been made aware that users may not be following the instruction... Class II Baxter Healthcare Corporation
Jul 5, 2017 HomeChoice Automated PD system Model numbers: 5C4471, 5C4471R Product Usa... Baxter Healthcare Corporation has been made aware that users may not be following the instruction... Class II Baxter Healthcare Corporation
Feb 15, 2017 Prismaflex Control Unit. Dialyzer, high permeability with or without sealed ... Firm has received reports of device operators failing to adhere to instructions for use pertainin... Class II Baxter Healthcare Corporation
Jan 26, 2017 Baxter SIGMA Spectrum Infusion Pump with Master Drug Library, Model #/Product... SIGMA Spectrum Infusion Pumps with Master Drug Library, Software V8.00.02 contains an anomaly tha... Class II Baxter Healthcare Corporation
Jan 4, 2017 Maintenance Kit PH1, Cod. 6997266 The Phoenix Hemodialysis delivery system i... Baxter Healthcare Corporation is issuing a voluntary product recall for several lots of Phoenix D... Class II Baxter Healthcare Corporation
Jan 4, 2017 Maintenance Kit PH2, Cod. 6997274 The Phoenix Hemodialysis delivery system i... Baxter Healthcare Corporation is issuing a voluntary product recall for several lots of Phoenix D... Class II Baxter Healthcare Corporation
Dec 16, 2016 APD Set with Cassette 3-Prong Peritoneal Dialysis Set Indicated for use in... Customer complaints received for the presence of leaks Class II Baxter Healthcare Corporation
Oct 12, 2016 GAMBRO Capillary Dialyzer, Polyflux(R) Revaclear MAX, STERILE, Product code 1... Potential presence of particulate matter on the blood side of the dialyzer Class II Baxter Healthcare Corp.
Sep 28, 2016 Baxter SIGMA Spectrum INFUSION PUMP with Master Drug Library, V8 Spectrum In... A correction was issued for the SIGMA Spectrum Infusion Pump with Master Drug Library in order to... Class II Baxter Healthcare Corp.
Sep 28, 2016 sigma spectrum VOLUMETRIC INFUSION PUMP with Master Drug Library, V6 Spectrum... A correction was issued for the SIGMA Spectrum Infusion Pump with Master Drug Library in order to... Class II Baxter Healthcare Corp.
Sep 28, 2016 V6 Rear Case Assembly, Product Code 35701, a replacement part for the SIGMA S... A correction was issued for the SIGMA Spectrum Infusion Pump with Master Drug Library and Rear Ca... Class II Baxter Healthcare Corp.
Aug 24, 2016 0.2 Micron Filter, 50 mm Product Usage: The 0.2 Micron Filter is a bacter... Baxter Healthcare Corporation is issuing a voluntary product recall for all unexpired lots of the... Class I Baxter Corporation Englewood
Jun 24, 2016 Synovis VASCU-GUARD Peripheral Vascular Patch in the following sizes and prod... Baxter is issuing a safety alert in response to postmarketing reports received for the VASC U-GUA... Class II Baxter Healthcare Corp.
May 23, 2016 PrismaSate BGK2/0 Dialysis Solution for Continuous Renal Replacement Therapy Presence of leaks near top of the PrismaSate bags Class II Baxter Healthcare Corp.
May 12, 2016 COSEAL Surgical Sealant Kit, 2 mL, Product Code: 934070; For use in vascular ... Potential for incomplete dissolution of the polyethylene glycol (PEG) component during the recons... Class II Baxter Healthcare Corp
May 12, 2016 COSEAL Surgical Sealant Kit, 8 mL, Product Code: 934072; For use in vascular... Potential for incomplete dissolution of the polyethylene glycol (PEG) component during the recons... Class II Baxter Healthcare Corp
May 12, 2016 COSEAL Surgical Sealant Kit, 4 mL, Product Code: 934071; For use in vascular... Potential for incomplete dissolution of the polyethylene glycol (PEG) component during the recons... Class II Baxter Healthcare Corp
Apr 21, 2016 GEM(TM), FLOWCOUPLER(R), 4.0 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF GEM2... Instructions for use booklet may puncture the outer Tyvek lid. Class II Baxter Healthcare Corp.
Apr 21, 2016 GEM(TM), FLOWCOUPLER(R), 3.5 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF GEM2... Instructions for use booklet may puncture the outer Tyvek lid. Class II Baxter Healthcare Corp.
Apr 21, 2016 GEM(TM), FLOWCOUPLER(R), 3.0 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF GEM2... Instructions for use booklet may puncture the outer Tyvek lid. Class II Baxter Healthcare Corp.
Apr 21, 2016 GEM(TM), FLOWCOUPLER(R), 2.0 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF GEM2... Instructions for use booklet may puncture the outer Tyvek lid. Class II Baxter Healthcare Corp.
Apr 21, 2016 GEM(TM), FLOWCOUPLER(R), 2.5 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF GEM2... Instructions for use booklet may puncture the outer Tyvek lid. Class II Baxter Healthcare Corp.
Feb 16, 2016 Automated peritoneal dialysis (APD) cycler Baxter Healthcare Corporation is sending this communication to inform you of incomplete instructi... Class II Baxter Healthcare Corp.
Nov 30, 2015 Baxter Y-Type Spike Adapter, 7" (18 cm), 1C8433, Product Usage: C8433: F... Potential for dark loose particulate matter (400 microns or smaller) on the spike of the spike ad... Class II Baxter Healthcare Corp.
Nov 30, 2015 Baxter CLEARLINK System, Blood Bag Spike Adapter, Luer Activated Valve for I.... Potential for dark loose particulate matter (400 microns or smaller) on the spike of the spike ad... Class II Baxter Healthcare Corp.
Nov 30, 2015 Baxter INTERLINK System, Y-Type Solution Set, 78 (2.0 m), 2 Injection Sites, ... Potential for dark loose particulate matter (400 microns or smaller) on the spike of the spike ad... Class II Baxter Healthcare Corp.

Frequently Asked Questions

When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.

All types, from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.

Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.