Browse Device Recalls
5,424 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 5,424 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 5,424 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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. |
| Aug 6, 2021 | Zoll, REF 8700-000871-40, Quattro (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 8700-0781-40 (CL-2295AE), 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: 8700-0793-14 (SL-2593CO), SOLEX 7 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 8700-0695-40 (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 8700-0657-40 (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 8700-0787-40 (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 8700-0793-40 (SL-2593AE) SOLEX 7, 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 4, 2021 | Ultrasound Gel labeled under the following brand names: MediChoice Ultrasoun... | Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial co... | Class I | Mac Medical Supply Co Inc |
| Jul 29, 2021 | ECHELON Oval MRI System | There was no label on the pad packaging or notification in the user manual that the table pads c... | Class II | Hitachi Healthcare Americas Corporation |
| Jul 29, 2021 | ECHELON MRI System | There was no label on the pad packaging or notification in the user manual that the table pads c... | Class II | Hitachi Healthcare Americas Corporation |
| Jul 29, 2021 | OASIS MRI System | There was no label on the pad packaging or notification in the user manual that the table pads c... | Class II | Hitachi Healthcare Americas Corporation |
| Jul 29, 2021 | Alinity c CRP Vario Cardiac High Sensitivity Calibrator Kit (ref 07P5605) - P... | Calibrator vials were incorrectly labeled. Use of incorrectly labeled vials will cause the instru... | Class III | Sentinel CH SpA |
| Jul 22, 2021 | Baxter PrismaFlex, REF numbers: a) 106696 (M 60 SET) b) 106697 (M 100 SET... | Products labeled as sterile were distributed, but may not have been sterilized. " Baxter confirm... | Class II | Baxter Healthcare Corporation |
| Jul 22, 2021 | Baxter prismaflex, HF 1000 PAES membrane, REF 107140 Used with Prismaflex... | Products labeled as sterile were distributed, but may not have been sterilized. Baxter confirmed... | Class II | Baxter Healthcare Corporation |
| Jul 21, 2021 | STEALTH 360 GEN2 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM, 1.25MM MICRO, 145 CM,... | There is a potential mislabeling of the OAD crown sizes: 1.50mm Sold Crown OADs may be packaged ... | Class II | Cardiovascular Systems Inc |
| Jul 21, 2021 | DIAMONDBACK 360 GEN2 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM, 1.5MM SOLID, 145 ... | There is a potential mislabeling of the OAD crown sizes: 1.50mm Sold Crown OADs may be packaged ... | Class II | Cardiovascular Systems Inc |
| Jul 21, 2021 | MPR Slotted Mallet, labeling etched onto devices as follows: Medical Prod... | Potential for mallet head to become separated from mallet handle. There is also significant defo... | Class II | Implant Resource Inc |
| Jul 20, 2021 | FilmArray Blood Culture Identification (BCID) Panel Product Pouch Label: ... | Due to product complaints received for false negative results (dropouts) with blood culture ident... | Class II | BioFire Diagnostics, LLC |
| Jul 16, 2021 | Philips, HEARTSTART, INFANT/CHILD - SMART PADS CARTRIDGE, REF: M5072A, (0-8 Y... | Infant/Child defibrillator pads contain incorrect labeling. This could lead to a delay in therapy... | Class II | Philips North America LLC |
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.