Browse Device Recalls
5,543 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 5,543 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 5,543 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Sep 2, 2021 | REF/Catalogue Number GSXE0025B, GORE CARDIOFORM SEPTAL OCCLUDER 25 mm Diamete... | Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiratio... | Class II | W L Gore & Associates, Inc. |
| Sep 2, 2021 | REF/Catalogue Number GSX0020A, GORE CARDIOFORM SEPTAL OCCLUDER 20 mm Diameter... | Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiratio... | Class II | W L Gore & Associates, Inc. |
| Sep 2, 2021 | REF/Catalogue Number GSXE0030, GORE CARDIOFORM SEPTAL OCCLUDER 30 mm Diameter... | Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiratio... | Class II | W L Gore & Associates, Inc. |
| Sep 2, 2021 | Endoskeleton" TAS Interbody System with Titan nanoLOCK" Surface Technology, N... | Engraving on implants may not match what is listed on the pouch labels. | Class II | Medtronic Sofamor Danek USA Inc |
| Sep 2, 2021 | REF/Catalogue Number GSX0025A, GORE CARDIOFORM SEPTAL OCCLUDER 25 mm Diameter... | Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiratio... | Class II | W L Gore & Associates, Inc. |
| Sep 2, 2021 | Endoskeleton" TCS Interbody System with Titan nanoLOCK" Surface Technology, N... | Engraving on implants may not match what is listed on the pouch labels. | Class II | Medtronic Sofamor Danek USA Inc |
| Sep 2, 2021 | REF/Catalogue Number GSX0030H, GORE CARDIOFORM SEPTAL OCCLUDER 30 mm Diameter... | Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiratio... | Class II | W L Gore & Associates, Inc. |
| Aug 30, 2021 | OPTETRAK Comprehensive Knee System, labeled as the following: a. OPTETRAK ... | Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer. | Class II | Exactech, Inc. |
| Aug 30, 2021 | TRULIANT Knee System including TRULIANT Tibial Inserts, also labeled as the f... | Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer. | Class II | Exactech, Inc. |
| Aug 30, 2021 | OPTETRAK LOGIC Polyethylene Tibial Inserts, labeled as the following: a.... | Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer. | Class II | Exactech, Inc. |
| Aug 30, 2021 | OPTETRAK Comprehensive Knee System custom devices labeled as the following: ... | Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer. | Class II | Exactech, Inc. |
| Aug 25, 2021 | HemosIL Liquid Anti-Xa- Automated chromogenic assay for the quantitative dete... | Labeled On-board instrument stability issue for current and future lots, reduced On-board Instrum... | Class II | Instrumentation Laboratory |
| Aug 25, 2021 | HemosIL Liquid Anti-Xa- automated chromogenic assay for in vitro diagnostic ... | Labeled On-board instrument stability issue for current and future lots, reduced On-board Instrum... | Class II | Instrumentation Laboratory |
| Aug 25, 2021 | HemosIL Liquid Anti-Xa- Automated chromogenic assay for the quantitative dete... | Labeled On-board instrument stability issue for current and future lots, reduced On-board Instrum... | Class II | Instrumentation Laboratory |
| Aug 25, 2021 | Atrium ADVANTA VXT Vascular Graft, Part No. 22059, UDI 00650862220599 - Produ... | The product package may potentially contain a mismatched graft that does not contain the radial s... | Class II | Atrium Medical Corporation |
| Aug 20, 2021 | DuoDERM Control Gel Formula Border Dressings 15x15cm (1x5pk) | Primary packaging labeling may be incorrect. | Class II | ConvaTec, Inc |
| Aug 16, 2021 | BF-P180 EVIS EXERA II Bronchovideoscope, Model No. BF-P180 | The firm is issuing validated, new reprocessing instructions according to the FDA 2015 guidance, ... | Class II | Olympus Corporation of the Americas |
| Aug 16, 2021 | BF-XP160F EVIS EXERA Bronchovideoscope, Model No. BF-XP160F | The firm is issuing validated, new reprocessing instructions according to the FDA 2015 guidance, ... | Class II | Olympus Corporation of the Americas |
| Aug 16, 2021 | BF-Q180-AC EVIS EXERA II Bronchovideoscope, Model No. BF-Q180-AC | The firm is issuing validated, new reprocessing instructions according to the FDA 2015 guidance, ... | Class II | Olympus Corporation of the Americas |
| Aug 16, 2021 | BF-P60 OES Bronchofiberscope, Model No. BF-P60 | The firm is issuing validated, new reprocessing instructions according to the FDA 2015 guidance, ... | Class II | Olympus Corporation of the Americas |
| Aug 16, 2021 | BF-N20 OES Bronchofiberscope, Model No. BF-N20 | The firm is issuing validated, new reprocessing instructions according to the FDA 2015 guidance, ... | Class II | Olympus Corporation of the Americas |
| Aug 16, 2021 | BF-1T60 OES Bronchofiberscope, Model No. BF-1T60 | The firm is issuing validated, new reprocessing instructions according to the FDA 2015 guidance, ... | Class II | Olympus Corporation of the Americas |
| Aug 16, 2021 | BF-XT160 EVIS EXERA Bronchovideoscope, Model No. BF-XT160 | The firm is issuing validated, new reprocessing instructions according to the FDA 2015 guidance, ... | Class II | Olympus Corporation of the Americas |
| Aug 16, 2021 | BF-3C40 OES Bronchofiberscope, Model No. BF-3C40 | The firm is issuing validated, new reprocessing instructions according to the FDA 2015 guidance, ... | Class II | Olympus Corporation of the Americas |
| Aug 16, 2021 | BF-1T180 EVIS EXERA II Bronchovideoscope, Model No. BF-1T180 | The firm is issuing validated, new reprocessing instructions according to the FDA 2015 guidance, ... | Class II | Olympus Corporation of the Americas |
| Aug 16, 2021 | BF-XP60 OES Bronchofiberscope, Model No. BF-XP60 | The firm is issuing validated, new reprocessing instructions according to the FDA 2015 guidance, ... | Class II | Olympus Corporation of the Americas |
| Aug 9, 2021 | Ad-Tech TECH ATTACH Cable- Product Usage: Designed for the purpose of connect... | Incorrect version of labels were used. | Class II | Ad-Tech Medical Instrument Corporation |
| Aug 9, 2021 | Ad-Tech Lightweight CABRIO Cable - Product Usage: Designed for the purpose of... | Incorrect version of labels were used. | Class II | Ad-Tech Medical Instrument Corporation |
| Aug 9, 2021 | Ad-Tech Lightweight TECH ATTACH Cable - Product Usage: Designed for the purpo... | Incorrect version of labels were used. | Class II | Ad-Tech Medical Instrument Corporation |
| Aug 6, 2021 | Zoll, REF 8700-0782-03 (IC-3893AE), ICY Intravascular Heat Intravascular Heat... | Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing | Class II | ZOLL Circulation, Inc. |
| Aug 6, 2021 | Zoll REF: 8700-0783-01 (IC-4593), QUATTRO Intravascular Heat Exchange Cathete... | Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing | Class II | ZOLL Circulation, Inc. |
| Aug 6, 2021 | Zoll REF: 8700-0783-14 (IC-4593CO), QUATTRO Intravascular Heat Exchange Cath... | Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing | Class II | ZOLL Circulation, Inc. |
| Aug 6, 2021 | Zoll REF: 8700-0783-40 (IC-4593AE), QUATTRO Intravascular Heat Exchange Cathe... | Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing | Class II | ZOLL Circulation, Inc. |
| Aug 6, 2021 | Zoll REF: 8700-0782-01 (IC-3893), ICY Intravascular Heat Exchange Catheter Ki... | Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing | Class II | ZOLL Circulation, Inc. |
| Aug 6, 2021 | Zoll, REF 8700-000869-40, Cool Line (Heparin) IVTM Disposable Pack and Start ... | Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing | Class II | ZOLL Circulation, Inc. |
| Aug 6, 2021 | Zoll, REF 8700-000766-01, Quattro IVTM Premium Disposable Pack and Start UP K... | Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing | Class II | ZOLL Circulation, Inc. |
| Aug 6, 2021 | Zoll, REF 8700-000872-40, SOLEX 7(Heparin) IVTM Disposable Pack and Start UP ... | Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing | Class II | ZOLL Circulation, Inc. |
| Aug 6, 2021 | Zoll, REF 8700-000868-01, Solex 7 IVTM Disposable Pack and Start UP Kit (6 ft.) | Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing | Class II | ZOLL Circulation, Inc. |
| Aug 6, 2021 | Zoll REF: 8700-0782-40 (IC-3893AE), ICY Intravascular Heat Exchange Catheter ... | Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing | Class II | ZOLL Circulation, Inc. |
| Aug 6, 2021 | ZOLL, REF 8700-0781-14 (CL-2295CO), COOL LINE Intravascular Heat Exchange Cat... | Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing | Class II | ZOLL Circulation, Inc. |
| Aug 6, 2021 | ZOLL, REF: 8700-0781-01 (CL-2295), COOL LINE, Intravascular Heat Exchange Cat... | Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing | Class II | ZOLL Circulation, Inc. |
| Aug 6, 2021 | ZOLL, REF 8700-0793-01 (SL-2593) Premium Access Kit SOLEX 7, Intravascular He... | Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing | Class II | ZOLL Circulation, Inc. |
| Aug 6, 2021 | Zoll, REF 8700-000867-01, Quattro IVTM Disposable Pack and Start UP Kit (6 ft.) | Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing | Class II | ZOLL Circulation, Inc. |
| Aug 6, 2021 | Zoll, REF: 8700-0783-03 (IC-4593AE) QUATTRO Intravascular Heat Exchange Cathe... | Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing | Class II | ZOLL Circulation, Inc. |
| Aug 6, 2021 | Zoll, REF 8700-000865-01, Cool Line IVTM Disposable Pack and Start UP Kit (6 ... | Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing | Class II | ZOLL Circulation, Inc. |
| Aug 6, 2021 | Zoll, REF 8700-000870-40, ICY (Heparin) IVTM Disposable Pack and Start UP Kit... | Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing | Class II | ZOLL Circulation, Inc. |
| Aug 6, 2021 | Zoll REF: 8700-0782-14 (IC-3893CO), ICY Intravascular Heat Exchange Catheter ... | Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing | Class II | ZOLL Circulation, Inc. |
| Aug 6, 2021 | Zoll, REF 8700-0781-03 (CL-2295AE), COOLINE Intravascular Heat Intravascular ... | Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing | Class II | ZOLL Circulation, Inc. |
| Aug 6, 2021 | Zoll, REF: 8700-0791-01 (IC-4593), Premium Access Kit QUATTRO, Intravascular ... | Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing | Class II | ZOLL Circulation, Inc. |
| Aug 6, 2021 | Zoll, REF 8700-000866-01, ICY IVTM Disposable Pack and Start UP Kit (6 ft.) | Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing | Class II | ZOLL Circulation, Inc. |
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.