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Browse Device Recalls

67 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 67 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 67 FDA device recalls.

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DateProductReasonClassFirm
Oct 19, 2017 Adult ECC Pack BEQ-TOP 22300, Catalog No. 701049504 The Better Bladder device provided as part of some custom tubing kits has been recalled by its ma... Class II Datascope Corporation
Oct 19, 2017 BEQ-TOP 33700 ECC 3/8" PACK, Custom Tubing Pack with Bioline Coating, Catalog... The Better Bladder device provided as part of some custom tubing kits has been recalled by its ma... Class II Datascope Corporation
Oct 19, 2017 BEQ-TOP 22301, Custom Tubing Kit, Catalog No. 701049513 The Better Bladder device provided as part of some custom tubing kits has been recalled by its ma... Class II Datascope Corporation
Oct 19, 2017 BEQ-TOP 27610 ECC PACK 3/8, Custom Tubing Kit, Catalog No. 701065622 The Better Bladder device provided as part of some custom tubing kits has been recalled by its ma... Class II Datascope Corporation
Oct 19, 2017 BEQ-TOP 22300, Custom Tubing Kit, Catalog No. 701049504 The Better Bladder device provided as part of some custom tubing kits has been recalled by its ma... Class II Datascope Corporation
Oct 19, 2017 BEQ-TOP 22702 ECC W/HMOD 30000, Catalog No. 701051179 The Better Bladder device provided as part of some custom tubing kits has been recalled by its ma... Class II Datascope Corporation
Jul 27, 2017 Maquet Cardiopulmonary Bypass Custom Tubing kit BO-TOP 38600 ADULT CPB, Part ... There is a potential for the over-pressure safety (OPS) valve in the tubing kits to not allow flo... Class II Datascope Corporation
Jul 27, 2017 Maquet Cardiopulmonary Bypass Custom Tubing kit BEQ-T 4906 PEDIARIC CPB PACK,... There is a potential for the over-pressure safety (OPS) valve in the tubing kits to not allow flo... Class II Datascope Corporation
Jul 27, 2017 Maquet Cardiopulmonary Bypass Custom Tubing kit BO-TOP 38600 ADULT CPB, Part ... There is a potential for the over-pressure safety (OPS) valve in the tubing kits to not allow flo... Class II Datascope Corporation
Apr 12, 2017 SENSATION PLUS¿ 8Fr. 50cc Intra-Aortic Balloon Catheter with Insertion Kit & ... Maquet/Getinge is initiating a voluntary product removal involving four lot numbers of SENSATION ... Class II Datascope Corporation
Feb 16, 2017 Custom Tubing Pack with Bioline Coating UDI code: 00607567208230 Part Numbe... A complaint was received on January 1, 2017 stating the pigtail on line 2 of the oxygenator was a... Class II Datascope Corporation
May 13, 2016 MEGA¿ 7.5Fr. 30cc Intra-Aortic Balloon Catheter with Insertion Kit & STATLOCK... It was discovered during post-quarantine packaging on 2/16/2016 that the IFU for the STATLOCK She... Class II Datascope Corporation
May 9, 2016 Small Patient ECC Pack, REF BEQ-TOP 24100, Product Usage: The HLM Tubing Set... Custom Tubing Set BEQ-TOP-24100 (Small Patient ECC Pack) was identified as possessing a level of ... Class II Datascope Corporation
Mar 11, 2016 Maquet Cardiopulmonary Bypass Custom Tubing kit BEQ-TOP 15801 Neonatal Specia... There is a potential problem with the cuvette where failure of the cuvette would cause an error m... Class III Datascope Corporation
Mar 11, 2016 Maquet Cardiopulmonary Bypass Custom Tubing kit BEQ-T 5208 ECC SET, Part Numb... There is a potential problem with the cuvette where failure of the cuvette would cause an error m... Class III Datascope Corporation
Mar 11, 2016 Maquet Cardiopulmonary Bypass Custom Tubing kit BEQ-TOP 5909 14 Pack QPID, Pa... There is a potential problem with the cuvette where failure of the cuvette would cause an error m... Class III Datascope Corporation
Aug 11, 2014 LINEAR 7.5 FR. 40cc IAB Catheter Maquet Getinge Group During label reconciliation a duplicate serial number label was detected to be printed for the LI... Class III Datascope 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.