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Browse Device Recalls

460 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 460 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 460 FDA device recalls.

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DateProductReasonClassFirm
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.
Oct 6, 2015 Baxter 15L Cycler Drainage Bag Sterile, nonpyrogenic fluid path Leakage from the inlet port of the 15L Cycler Drainage Bags. Class II Baxter Healthcare Corp.
Jun 29, 2015 Baxter HomeChoice and HomeChoice Pro APD systems, designed to provide Automat... Loud operating sounds, which was unacceptable to the end users when the device was powered on. Th... Class III Baxter Healthcare Corp.
May 21, 2015 ONE-LINK NON-DEHP Y-TYPE MICROBORE CATHETER EXTENSION SET NEEDLE-FREE IV CONN... Potential for a leak at the tubing to luer bond. Class II Baxter Healthcare Corp
Mar 2, 2015 Master Drug Library Software version 8.0, Product Code 35723V080, to be used ... Loading/Bolus default dose settings in the Master Drug Library and the values shown on the pump d... Class II Baxter Healthcare Corp
Jan 22, 2015 MiniCap with Povidone-Iodine Solution, item number 5C4466P, for hemodialysis. Product may have separating or protruding sponges Class II Baxter Healthcare Corp.
Jan 14, 2015 Product Code 2C4013, Four Lead TUR Irrigation Set, for use with UROMATIC Pla... Potential for failure of the pouch packaging seal at high altitudes. Class II Baxter Healthcare Corp.
Dec 8, 2014 Baxter Integrated APD Set with Cassette 3-Prong, Sterile, nonpyrogenic fluid ... Baxter is issuing a recall for one lot of Integrated Automated Peritoneal Dialysis set with Casse... Class II Baxter Healthcare Corp.
Dec 4, 2014 Self-Righting Luer Lock Tip Cap, Green and Self-Righting Luer Slip Tip Cap, Y... Baxter Corporation initiated a recall of two lots of Self-Righting Luer Lock Tip Caps because the... Class II Baxter Corporation Englewood
Oct 21, 2014 HomeChoice/HomeChoice Pro Automated Personal Cycler, for Automated Peritoneal... The keypad buttons on HomeChoice devices may be activated without the operator pressing them. Class II Baxter Healthcare Corp.
Oct 6, 2014 HomeChoice Automated PD system and HomeChoice Pro Automated PD system Baxter'... There are additional and updated warning and cautions that are not in the Patient At-Home Guide f... Class II Baxter Healthcare Corp.
Sep 16, 2014 Baxter 2B8011 Empty INTRA VIA Container with PVC Ports, Sterile fluid path, ... Particulate matter found inside the fluid path. Class I Baxter Healthcare Corp
Sep 16, 2014 Baxter 2B8013 Empty INTRA VIA Container with PVC Ports (Sterile, nonpyrogen... Particulate matter found inside the fluid path. Class I Baxter Healthcare Corp
Sep 3, 2014 SPECTRUM Pump, Model No. 35700BAX. Intended to be used for the controlled... One Service Technician may not have correctly serviced specific Sigma Spectrum Infusion Pumps acc... Class II Baxter Healthcare Corp.
Jul 14, 2014 ***Baxter***BURETROL Solution Set***105" (2.7 m) 150 mL Burette***Drip Chamb... Baxter Healthcare Corporation is voluntarily issuing a recall for specific lots of Buretrol Solut... 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.