Browse Device Recalls
4,686 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 4,686 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 4,686 FDA device recalls in CA.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 | Ion Flexison Biopsy Needle, 19G, Extension Range : 0-3 cm, Ref: 490104-09 and... | Potential for the sheath tip on the biopsy needle to separate from the sheath shaft. | Class II | Intuitive Surgical, 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 | TECNIS Eyhance IOLs are permanent intraocular implants intended for implantat... | Nonconforming product was distributed in error. Product was nonconforming due endotoxin levels h... | Class II | Johnson & Johnson Surgical Vision 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 5, 2021 | Access SARS CoV-2 IgG (1st IS) Assay: Access Immunoassay Systems REAGENT P... | Firm's submission for Emergency Use Authorization (EUA) contained insufficient evidence to be gra... | Class II | Beckman Coulter Inc. |
| Aug 2, 2021 | BD ADD-ON Burette Set V/NV Needle-Free Valve, REF: 82113E-0006 | Needle-free connector valves, either standalone or attached to extension sets, may have issues in... | Class II | CAREFUSION |
| Aug 2, 2021 | BD Extension Set SMALLBORE Tubing SmartSite VALVE, REF: 10010511; BD SmartSi... | Needle-free connector valves, either standalone or attached to extension sets, may have issues in... | Class II | CAREFUSION |
| Aug 2, 2021 | BD Alaris Pump Infusion Buerette Set Smallbore Tubing Smartsite Port (Burette... | Needle-free connector valves, either standalone or attached to extension sets, may have issues in... | Class II | CAREFUSION |
| Aug 2, 2021 | BD SmartSite Bag Access Device Needle-Free Valve, REF: 2300E; BD Bag access D... | Needle-free connector valves, either standalone or attached to extension sets, may have issues in... | Class II | CAREFUSION |
| Aug 2, 2021 | BD Gravity Burette Set 60 DP 3 SmartSite VALVES BALL VALVE DRIP CHAMBER, REF:... | Needle-free connector valves, either standalone or attached to extension sets, may have issues in... | Class II | CAREFUSION |
| Aug 2, 2021 | BD Syringe Set 20 DP MIC TBG 0.2MF CKV Anti-Siphon SmartSite VLV Sensing Disc... | Needle-free connector valves, either standalone or attached to extension sets, may have issues in... | Class II | CAREFUSION |
| Aug 2, 2021 | BD SmartSite, REF: 2000E CHINA; BD SmartSite Connector, REF: 2000E-04; BD Sma... | Needle-free connector valves, either standalone or attached to extension sets, may have issues in... | Class II | CAREFUSION |
| Aug 2, 2021 | BD BURETTE GRAVITY SET 60 DROP 2 Smartsite VALVES VENTED/NONVENTED, REF: 42163E | Needle-free connector valves, either standalone or attached to extension sets, may have issues in... | Class II | CAREFUSION |
| Aug 2, 2021 | BD SmartSite 'Y' Extension Set 2 Needle-Free Valves, REF: 20019E7D | Needle-free connector valves, either standalone or attached to extension sets, may have issues in... | Class II | CAREFUSION |
| Aug 2, 2021 | BD SmartSite Bag Access Device, REF: 2300E-0500; BD BAG ACCESS DEVICE CHECK V... | Needle-free connector valves, either standalone or attached to extension sets, may have issues in... | Class II | CAREFUSION |
| Aug 2, 2021 | BD Extension Set SMALLBORE Tubing with 2 SmartSite VALVES, REF: 20019E | Needle-free connector valves, either standalone or attached to extension sets, may have issues in... | Class II | CAREFUSION |
| Aug 2, 2021 | BD Alaris Pump Infusion Buerette Set 0.2 Micron Filter Smallbore Tubing Smart... | Needle-free connector valves, either standalone or attached to extension sets, may have issues in... | Class II | CAREFUSION |
| Aug 2, 2021 | BD SE Burette Set 20 Drops 2 Injection Ports Vented/NonVented, REF: 72103E-0006 | Needle-free connector valves, either standalone or attached to extension sets, may have issues in... | Class II | CAREFUSION |
| Aug 2, 2021 | BD Gravity IV Set 3-port Closed Manifold Back Check Valve 3 Needle-Free Y-sit... | Needle-free connector valves, either standalone or attached to extension sets, may have issues in... | Class II | CAREFUSION |
| Aug 2, 2021 | BD Gravity Burette Set 60 DROP 1.2 MF 2 SmartSite VALVES BALL VALVE DRIP CHAM... | Needle-free connector valves, either standalone or attached to extension sets, may have issues in... | Class II | CAREFUSION |
| Jul 29, 2021 | HANA/PROFx CLASSIC FEMORAL HOOK RIGHT REF 6850-144 | One batch of "regular" femoral hooks were incorrectly etched with the "classic" femoral hook mode... | Class II | Mizuho OSI |
| Jul 28, 2021 | Power Processor 3K, 3K High Speed Stockyards Module Nameplate: PP 3K Stockya... | Missing splash guard which may expose users to hazardous materials. . | Class II | Beckman Coulter Inc. |
| Jul 22, 2021 | BD" Mouse IgG2a Isotype Control APC X39 ASR | Complaints have been received for performance issues related to high background and staining. th... | Class II | Becton, Dickinson and Company, BD Biosciences |
| Jul 21, 2021 | DxA 5000 (DxA Automation System, DxA 5000 fit), "For in Vitro Diagnostic Use"... | There is a potential that sample carriers (w or w/o samples) within automated sampling system ma... | Class II | Beckman Coulter Inc. |
| Jul 20, 2021 | Nihon Kohden NKV-550 Ventilator, REF: NKV-550-U, CE 0344, UDI: (01) 008436851... | Potential defective gas inlet pressure regulator within ventilator which could result in gas rel... | Class II | NIHON KOHDEN ORANGEMED, INC |
| Jul 15, 2021 | Cell Marque Antibodies, PSA (ER-PR8) Mouse Monoclonal Antibody, REF: 324M-15,... | Mouse Monoclonal Antibody labelled with an incorrect expiry date of 31 Dec 2023. The correct expi... | Class III | Cell Marque Corporation |
| Jul 15, 2021 | Normand Remisol Advance Data Manager, REF: C69412, C69413, C44703, and C57017... | There is a potential that the data management system may add additional cells to the patient requ... | Class II | Beckman Coulter Inc. |
| Jul 14, 2021 | FLASH Ostial System, Dual Balloon Angioplasty Catheter, REF: OAB6014BA | Angioplasty system has a manufacturing issue that has the potential to result in difficulty defla... | Class II | Ostial Corporation |
| Jul 13, 2021 | Pipeline Flex Embolization Device | Due to potential push wire fractures in the delivery system during use. The issue presents as a ... | Class I | Micro Therapeutics Inc, |
| Jul 13, 2021 | EV3 Pipeline Flex Embolization Device with Flex Shield Technology | Due to potential push wire fractures in the delivery system during use. The issue presents as a ... | Class I | Micro Therapeutics 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.