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Browse Device Recalls

74 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 74 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 74 FDA device recalls.

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DateProductReasonClassFirm
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.
Jul 13, 2012 AUTOMIX Plus High Speed Compounder System, product 2M8075; automated nutritio... After fluid ingress into the keypad of the AUTOMIX Compounder's (AUTOMIX) control module, the AUT... Class I Baxter Healthcare Corp.
Jul 13, 2012 AUTOMIX 3+3 Compounder with Accusource Monitoring System, product 2M8287; aut... After fluid ingress into the keypad of the AUTOMIX Compounder's (AUTOMIX) control module, the AUT... Class I Baxter Healthcare Corp.
Jul 13, 2012 AUTOMIX High Speed Compounder System, product 2M8077; automated nutrition com... After fluid ingress into the keypad of the AUTOMIX Compounder's (AUTOMIX) control module, the AUT... Class I Baxter Healthcare Corp.
Mar 4, 2011 Mini-Infuser Model 300XL Multispeed Infusion Pump, an Rx battery operated syr... Should a battery with the minimum contact diameter (.51 inches) be placed on the battery spring (... Class III Baxter Healthcare Corp.
Mar 4, 2011 Mini-Infuser Model 150XL Single Speed Infusion Pump, an Rx battery operated s... Should a battery with the minimum contact diameter (.51 inches) be placed on the battery spring (... Class III Baxter Healthcare Corp.
Jul 31, 2009 Baxter's elastomeric infusion pumps are non-electronic, ambulatory, disposabl... There are reported incidents of leakage on the INFUSOR and FOLFUSOR pumps at the connection of th... Class II Baxter Healthcare Corp.
Jul 31, 2009 Baxter's elastomeric infusion pumps are non-electronic, ambulatory, disposabl... There are reported incidents of leakage on the INFUSOR and FOLFUSOR pumps at the connection of th... Class II Baxter Healthcare Corp.
Jul 31, 2009 Baxter's elastomeric infusion pumps are non-electronic, ambulatory, disposabl... There are reported incidents of leakage on the INFUSOR and FOLFUSOR pumps at the connection of th... 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.