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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Aug 5, 2022 | Insertion Kit for use with SENSATION PLUS 8F. 50cc Intra-Aortic Balloon Catheter | Certain lots containing undersized dilator. | Class II | Datascope Corporation |
| Aug 5, 2022 | Sensation Plus 8Fr 50cc Intra-Aortic Balloon Catheter | Certain lots containing undersized dilator. | Class II | Datascope Corporation |
| Aug 5, 2022 | MEGA 8Fr 50cc Intra-Aortic Balloon Catheter | Certain lots containing undersized dilator. | Class II | Datascope Corporation |
| Aug 5, 2022 | LINEAR 7.5Fr. 40cc IAB with Accessories (APA), Model No. 0684-00-0480-02. in... | The balloon volume is incorrectly described as 34cc instead of 40cc on one of the three internal ... | Class II | Datascope Corporation |
| Jul 27, 2020 | Datascope Intra-Aortic Ballon Catheters (IABs)-Sensation 7Fr 34cc IAB Kit, P... | Potential Endotoxin Contamination | Class II | Datascope Corporation |
| Jul 27, 2020 | Datascope Intra-Aortic Ballon Catheters (IABs)-Linear 7.5Fr 40cc IAB Kit P/N... | Potential Endotoxin Contamination | Class II | Datascope Corporation |
| Jul 27, 2020 | Datascope Intra-Aortic Ballon Catheters (IABs)-Sensation 7Fr 40cc IAB Kit P/N... | Potential Endotoxin Contamination | Class II | Datascope Corporation |
| Jul 27, 2020 | Datascope Intra-Aortic Ballon Catheters (IABs)-TRANS-RAY PLUS 7.5Fr 40cc IAB ... | Potential Endotoxin Contamination | Class II | Datascope Corporation |
| Jul 27, 2020 | Datascope Intra-Aortic Ballon Catheters (IABs)-Sensation Plus 7.5 Fr 40cc IAB... | Potential Endotoxin Contamination | Class II | Datascope Corporation |
| Jul 27, 2020 | Datascope Intra-Aortic Ballon Catheters (IABs)-YAMATO PLUS-R 7.5Fr 30cc IAB (... | Potential Endotoxin Contamination | Class II | Datascope Corporation |
| Jul 27, 2020 | Datascope Intra-Aortic Balloon Catheters (IABs)-MEGA 7.5Fr 40cc IAB Kit P/N: ... | Potential Endotoxin Contamination | Class II | Datascope Corporation |
| Jul 27, 2020 | Datascope Intra-Aortic Ballon Catheters (IABs)-Trans-Ray 7Fr 34cc IAB (Japan)... | Potential Endotoxin Contamination | Class II | Datascope Corporation |
| Jul 27, 2020 | Datascope Intra-Aortic Ballon Catheters (IABs)-YAMATO PLUS-R 7.5Fr 40cc IAB (... | Potential Endotoxin Contamination | Class II | Datascope Corporation |
| Jul 27, 2020 | Datascope Intra-Aortic Ballon Catheters (IABs)-MEGA 7.5Fr 30cc IAB, P/N: 0... | Potential Endotoxin Contamination | Class II | Datascope Corporation |
| Jul 27, 2020 | Datascope Intra-Aortic Ballon Catheters (IABs)-YAMATO PLUS-R 7.5Fr 35cc IAB (... | Potential Endotoxin Contamination | Class II | Datascope Corporation |
| Jul 27, 2020 | Datascope Intra-Aortic Ballon Catheters (IABs)-Linear 7.5Fr 25cc IAB Kit P/... | Potential Endotoxin Contamination | Class II | Datascope Corporation |
| Jul 27, 2020 | Datascope Intra-Aortic Ballon Catheters (IABs)-Sensation Plus 8Fr 50cc IAB Ki... | Potential Endotoxin Contamination | Class II | Datascope Corporation |
| Jul 27, 2020 | Datascope Intra-Aortic Ballon Catheters (IABs)-MEGA 8Fr 50cc IAB Kit P/N: 068... | Potential Endotoxin Contamination | Class II | Datascope Corporation |
| Jul 27, 2020 | Datascope Intra-Aortic Ballon Catheters (IABs)-TRANS-RAY PLUS 7.5Fr 35cc IAB ... | Potential Endotoxin Contamination | Class II | Datascope Corporation |
| Jul 27, 2020 | Datascope Intra-Aortic Ballon Catheters (IABs)-Trans-Ray 7Fr 40cc IAB (Japan)... | Potential Endotoxin Contamination | Class II | Datascope Corporation |
| Jul 27, 2020 | Datascope Intra-Aortic Ballon Catheters (IABs)-Linear 7.5Fr 34cc IAB Kit P/N:... | Potential Endotoxin Contamination | Class II | Datascope Corporation |
| Nov 20, 2019 | Reinforced Introducer Sets Maquet 7.5 Fr., Part Number: 068400040305. It is ... | Potential for compromised sterility in breached pouches of specific lots of Reinforced Introducer... | Class II | Datascope Corporation |
| Nov 20, 2019 | Reinforced Introducer Sets Maquet 7 Fr., Part Number: 0684 00 0403 06. It i... | Potential for compromised sterility in breached pouches of specific lots of Reinforced Introducer... | Class II | Datascope Corporation |
| Nov 20, 2019 | Reinforced Introducer Sets Maquet 8 Fr., Part Number: 068400040310. It is an... | Potential for compromised sterility in breached pouches of specific lots of Reinforced Introducer... | Class II | Datascope Corporation |
| May 28, 2019 | Sensation Plus 7.5Fr. 40cc Intra-Aortic Balloon Catheter with accessories, Pa... | The device was distributed with the outer carton labeled with the manufacture date and the expiry... | Class II | Datascope Corporation |
| Feb 21, 2018 | Intra-Aortic Balloon Catheter Mega 8FR 50cc Product Usage: The intra-aortic... | The U.S. Instructions For Use for the Mega Intra-Aortic Balloon (IAB) Catheter was missing the Co... | Class II | Datascope Corporation |
| Feb 21, 2018 | Intra-Aortic Balloon Catheter Mega 7.5FR 40cc Product Usage: The intra-ao... | The U.S. Instructions For Use for the Mega Intra-Aortic Balloon (IAB) Catheter was missing the Co... | Class II | Datascope Corporation |
| Feb 21, 2018 | Intra-Aortic Balloon Catheter Mega 7.5FR 30cc Product Usage: The intra-ao... | The U.S. Instructions For Use for the Mega Intra-Aortic Balloon (IAB) Catheter was missing the Co... | Class II | Datascope Corporation |
| Oct 19, 2017 | BEQ-T 25501 3/8" Better Bladder Pack, Custom Tubing Kit, Catalog No. 709000370 | 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 50900 Custom ECC Pack-Neonatal 1/4, Custom Tubing Kit, Catalog No. 70... | 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 | Small Patient ECC Pack BEQ-TOP 22301, 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 33500 3/8" ECC PACK, Catalog No. 701053752 | 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 50903 Custom ECC Pack-Pedriatric , Custom Tubing Kit, Catalog No. 70... | 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 8504 1/4X1/4 PACK W/QP, Custom Tubing Kit, Catalog No. 701066949R02 | 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 40700 HUNTINGTON, Catalog No. 701062899 | 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 24202 ADULT ECC, Catalog No. 701054295 | 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 25500 ECC 3/8 w/QiD, Custom Tubing Kit, Catalog No. 701052461 | 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-T 9410 Lurie Chldns Small 1/4, Custom Tubing Kit, Catalog No. 709000430 | 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 24500 ADULT ECC, Custom Tubing Kit, Catalog No. 701050253 | 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 41201 ECC 3/8 PUMP PAC, Custom Tubing Kit, Catalog No. 701064867 | 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 | BO-TOP 20705 SMALL PATIENT 1/4, Catalog No. 701053486 | 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 | NICU ECC Pack BEQ-TOP 39202, Custom Tubing Kit, Catalog No. 701067313R01 | 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 49101 Childrens Large ECC Pack, Custom Tubing Kit, Catalog No. 701067... | 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-T 25502 1/4 Better Bladder , Custom Tubing Kit, Catalog No. 709000434 | 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 38900 ECC PACK, Custom Tubing Kit, Catalog No. 701056368 | 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 22701, Catalog No. 701050790 | 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 5210 ECC Set - Respiratory, Custom Tubing Kit, Catalog No. 701055604R01 | 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 | BO-TOP 20700 SMALL PATIENT 3/8, Custom Tubing Kit, Catalog No. 701050966 | 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 | ECC Small - Respiratory BEQ-TOP 5210, Custom Tubing Kit, Catalog No. 701055604 | 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 | BO-TOP 13901 RAPID RESPONSE, Custom Tubing Kit, Catalog No. 701054874 | The Better Bladder device provided as part of some custom tubing kits has been recalled by its ma... | Class II | 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.