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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
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.
Jun 10, 2014 EXACTAMIX 1200 Compounder, model numbers 1200-DY, 1200-DX, 1200-DYR and 1200-... If the universal ingredient (UI) in an active configuration is changed using the Configuration Ed... 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
Apr 24, 2014 Baxter Amia Automated PD systems are used in the treatment of adult renal fai... System error 01779 is produced when the battery cannot be charged due to specific voltage differe... Class II Baxter Healthcare Corp.
Apr 17, 2014 The Patient Control Module (PCM) is used in conjunction with a Baxter infusor... Potential for device malfunction resulting in flow when the device should not be flowing Class II Baxter Healthcare Corp.
Apr 3, 2014 AMIA v1.0 APD System. For Automated Peritoneal Dialysis (APD) therapy for p... Additional warning in the AMIA APD System labeling for patients vulnerable to unintended Increase... Class II Baxter Healthcare Corp.
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
Nov 8, 2013 IntelliFill i.v. Pharmacy Compounding Device (PCD). Intended to fill syrin... Following a retrospective review for Baxter Daytona Complaint CR-954, it was identified that the ... Class II Baxter Healthcare Corp.
Oct 17, 2013 15 L Cycler Drainage Bag Product Usage: For use with Baxter Cycler Tubin... The large tube clamp used to close the drain tube on the 15 L Cycler Drainage Bag may not fully c... Class II Baxter Healthcare Corp
Oct 16, 2013 The HomeChoice Pro APD System is a peritoneal dialysis system. The HomeCho... The occluder in affected devices 1) may have sharp edges that could cut the pneumatic tubing that... Class II Baxter Healthcare Corp.
Oct 7, 2013 1) The HomeChoice automated peritoneal dialysis system. Dataplate located on... In systems with version 10.4 software Initial Drain logic, the device will attempt to drain the p... Class II Baxter Healthcare Corp.
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 10, 2013 Dual Luer Lock Cap The device is intended for use as a cap for male or fem... The firm is recalling lots 10043 and 10044 due to loose particulate matter found in the packaging... 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
Jul 8, 2013 Baxter, MiniCap with Povidone-Iodine solution, 5C4466P. For dialysis. the white printed paper layer on the pouch packaging may not be fully adhered to the pouch foil ... Class II Baxter Healthcare Corp.
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: Multiday lnfusor, Seven Day lnfusor and the Basal/Bolus lnfusor:... Due to an increase in complaints for leaks at the distal male Luer and Luer cap. Baxter implement... 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: Coiled Tube Infusors (Portable Elastomeric Infusion Systems). Bax... Due to an increase in complaints for leaks at the distal male Luer and Luer cap. Baxter implement... 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.
May 15, 2013 Four Lead Arthroscopic Irrigation Set, for use with ARTHROMATIC Plastic Conta... A firm's internal investigation led to the discovery of pinholes in the packaging of the products... Class II Baxter Healthcare Corp.
May 15, 2013 Four Lead TUR irrigation Set, for use with UROMATIC Plastic Containers, Prod... A firm's internal investigation led to the discovery of pinholes in the packaging of the products... Class II Baxter Healthcare Corp.
May 15, 2013 Two Lead Arthroscopic Irrigation Set, for use with ARTHROMATIC Plastic Contai... A firm's internal investigation led to the discovery of pinholes in the packaging of the products... Class II Baxter Healthcare Corp.
Mar 28, 2013 A) Product Code 2N8371: Non-DEHP Y-Type Catheter Extension Set Kit, 6.0", Vol... Customers have reported that when separating an individual package from its attached grouping, th... Class II Baxter Healthcare Corp.
Mar 28, 2013 A) Product Code 2N8220: Non-DEHP Catheter Extension Set Kit, Single use only,... Customers have reported that when separating an individual package from its attached grouping, th... Class II Baxter Healthcare Corp.
Mar 28, 2013 A) Product Code 2N3371: Non-DEHP Y-Type Catheter Extension Set, 5.7", Vol. 0... Customers have reported that when separating an individual package from its attached grouping, th... Class II Baxter Healthcare Corp.
Mar 28, 2013 A) Product Code 2N1191: Non-DEHP Y-Type Catheter Extension Set, 4.8", Vol. 0... Customers have reported that when separating an individual package from its attached grouping, th... Class II Baxter Healthcare Corp.
Feb 25, 2013 MiniCap Extended Life PD Transfer Set Extra Short (4") with Twist Clamp. Prod... Labeling Revision: Additional instructions for the use of peritoneal dialysis transfer sets inclu... Class II Baxter Healthcare Corp.
Feb 25, 2013 CAPD Solution Transfer Set with Locking Connector. Product Code: 5C4160. ... Labeling Revision: Additional instructions for the use of peritoneal dialysis transfer sets inclu... Class II Baxter Healthcare Corp.
Feb 25, 2013 MiniCap Extended Life PD Transfer Set. Product Code 5C4449. intended for ... Labeling Revision: Additional instructions for the use of peritoneal dialysis transfer sets inclu... Class II Baxter Healthcare Corp.
Feb 25, 2013 MiniCap Extended Life PD Transfer Set (6") with Twist Clamp. Product Code: 5... Labeling Revision: Additional instructions for the use of peritoneal dialysis transfer sets inclu... Class II Baxter Healthcare Corp.
Dec 14, 2012 Baxter Non-DEHP Micro-Volume Extension Set, Male Luer Lock Adapter, 36 (91 cm... Some of the individual extension set packages were improperly sealed, compromising the sterility ... Class II Baxter Healthcare Corp.
Sep 7, 2012 Baxter Interlink System Buretrol Solution Set with 150 mL Burette (Ball-Valve... Baxter has determined that the ball-valve feature of the Buretrol Solution Sets may not function ... Class I Baxter Healthcare Corp.
Sep 7, 2012 Baxter Clearlink System Buretrol Solution Set, 115" (2.9 m) with 150 mL Clear... Baxter has determined that the ball-valve feature of the Buretrol Solution Sets may not function ... Class I Baxter Healthcare Corp.
Sep 7, 2012 Baxter Interlink System Buretrol Solution Set, 117" (3.0 m), with 150 mL Bur... Baxter has determined that the ball-valve feature of the Buretrol Solution Sets may not function ... Class I Baxter Healthcare Corp.
Sep 7, 2012 Baxter Clearlink System Buretrol Solution Set, 115" (2.9 m) with 150 mL Clear... Baxter has determined that the ball-valve feature of the Buretrol Solution Sets may not function ... Class I Baxter Healthcare Corp.
Jul 13, 2012 AUTOMIX 3+3 Compounder System, product 2M8286 (115V) and 2M8286K (230V), auto... After fluid ingress into the keypad of the AUTOMIX Compounder's (AUTOMIX) control module, the AUT... Class I 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.