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Browse Device Recalls

394 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 394 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 394 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
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
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.
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
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.
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
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
Jul 14, 2014 ***Baxter***Non-DEHP***BURETROL Solution Set 105" (2.7 m), 150 mL Burette***... Baxter Healthcare Corporation is voluntarily issuing a recall for specific lots of Buretrol Solut... Class II Baxter Healthcare Corp
Jul 14, 2014 ***Baxter***Buretrol Solution Set***105" (2.7 m)***150 mL Burette***Drip Cham... Baxter Healthcare Corporation is voluntarily issuing a recall for specific lots of Buretrol Solut... Class II Baxter Healthcare Corp
Jul 11, 2014 FlowCOUPLER. An implantable device that is used to detect blood flow in ves... Baxter Healthcare is recalling the FlowCOUPLER Device because there is a possibility that some un... Class II Baxter Healthcare Corporation
Jun 17, 2014 Baxter MiniCap with Povidone-Iodine Solution, 5C4466P, Baxter Healthcare Corp... Inadequate iodine and packaging related defects. Class II Baxter Healthcare Corp.
Apr 28, 2014 Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp - Extra Short. ... Connection issues between the PD transfer set catheter connector and an adapter may lead to leaks... Class II Baxter Healthcare Corporation
Feb 7, 2014 SIGMA SPECTRUM Volumetric Infusion Pump with Master Drug Library Product U... Baxter Healthcare Corporation has issued an Urgent Device Correction for the SIGMA SPECTRUM Volum... Class I Baxter Healthcare Corp.
Dec 3, 2013 ABACUS TPN Calculation Software, Baxa: 8300-0045 ABACUS CE (Calculator Editio... Baxter Healthcare Corporation is issuing a voluntary correction for ABACUS Total parenteral Nutri... Class II Baxter Corporation Englewood
Sep 25, 2013 Baxter, VIAL-MATE Adaptor, 2B8071, Rx Only, STERILE R, Baxter Healthcare Corp... Incomplete foil seal on one lot of sterile product. Class II Baxter Healthcare Corp.
Sep 24, 2013 SIGMA SPECTRUM Infusion Pump with Master Drug Library component (SHARP LCD sc... Baxter Healthcare Corporation is recalling the LCD display screen on the SIGMA SPECTRUM Infusion ... Class II Baxter Healthcare Corp.
Sep 4, 2013 Baxter CLEARLINK System Non-DEHP Three Lead Extension Set. 6.0" (15 cm), 1.0 ... The firm is issuing a voluntary recall due to the potential for pinholes in the packaging. Pinhol... Class II Baxter Healthcare Corp.
Aug 30, 2013 Vented Spike Adapter Product Code 2C0471, Sterile, nopyrogenic. Manufactured ... Potential tears in the pouch of six lots of Vented Spike Adapter Product Code 2C0471 Class II Baxter Healthcare Corp.
Aug 22, 2013 Baxa Vial Adapter, 14mm - Luer Lock, Order No. REF: 90, Quantity: 50 each, Si... Baxter Healthcare Corporation is voluntarily recalling one lot of Baxa Vial Adapters, 14mm - Luer... Class II Baxa Corporation
Jun 10, 2013 SIGMA SPECTRUM Infusion Pump with Master Drug Library. Intended to be used... Baxter Healthcare Corporation issued an Urgent Device Correction for the SIGMA SPECTRUM Infusion ... Class II Baxter Healthcare Corp.
Jun 7, 2013 Brand Name: Basal/Bolus Infusor. Indicated for the intravenous administrat... Baxter Healthcare Corporation (Baxter) is issuing an Urgent Product Recall for the products liste... Class II Baxter Healthcare Corp.
Jun 7, 2013 Brand Name: Infusor SV and LV Elastomeric Infusion Devices. Indicated for ... Baxter Healthcare Corporation (Baxter) is issuing an Urgent Product Recall for the products liste... Class II Baxter Healthcare Corp.
Jun 7, 2013 Brand Name: SV Elastomeric Infusion Device. Indicated for the intravenous ... Baxter Healthcare Corporation (Baxter) is issuing an Urgent Product Recall for the products liste... Class II Baxter Healthcare Corp.
Jun 7, 2013 Brand Name: Multirate Infusor Devices. Indicated for the intravenous admin... Baxter Healthcare Corporation (Baxter) is issuing an Urgent Product Recall for the products liste... Class II Baxter Healthcare Corp.
Jun 7, 2013 Brand Name: Intermate Infusion Pump. Indicated for the intravenous adminis... Baxter Healthcare Corporation (Baxter) is issuing an Urgent Product Recall for the products liste... Class II Baxter Healthcare Corp.
Jun 7, 2013 Brand Name: Regional Analgesia Infusor System with Patient Control. Indica... Baxter Healthcare Corporation (Baxter) is issuing an Urgent Product Recall for the products liste... Class II Baxter Healthcare Corp.
Jun 7, 2013 Brand Name: Intermate Infusion Pump. Indicated for the intravenous adminis... Baxter Healthcare Corporation (Baxter) is issuing an Urgent Product Recall for the products liste... Class II Baxter Healthcare Corp.
May 21, 2013 Baxter, MiniCap with Povidone-Iodine solution, 5C4466P, Baxter Healthcare Cor... leaking pouches Class II Baxter Healthcare Corp.
Jul 6, 2012 Extraneal and/or DIANEAL LOW CALCIUM Peritoneal Dialysis Solution in Plastic ... Baxter discovered that a Baxter technical service representative was providing incorrect instruct... Class II Baxter Healthcare Renal Div
Jul 6, 2011 Sigma Spectrum VOLUMETRIC INFUSION PUMP, with or without Master Drug Library,... Recall expansion; the infusion pumps have the potential to fail causing inaccurate flow condition... Class I Baxter Healthcare Corporation

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.