Browse Device Recalls
4,602 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 4,602 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 4,602 FDA device recalls in CA.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Sep 8, 2021 | Vit Kit-Freeze is intended for use in assisted reproductive procedures for vi... | Due to a component in kit being labeled with the incorrect Expiration Date | Class II | Fujifilm Irvine Scientific, Inc. |
| Sep 7, 2021 | GEL CONDUCTOR, Description/REF: 5 LITER W/DISP/4238, 24-8.5OZ BOTTLES/4248, 5... | Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial co... | Class I | DJO, LLC |
| Sep 7, 2021 | Ultra-Myossage Lotion 1-gallon bottle, REF: 4262; Myossage Lotion 1-gallon b... | Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial co... | Class I | DJO, LLC |
| Sep 2, 2021 | MOSAIQ Oncology Information System | A drug strength in MOSAIQ can be changed during the ordering process and approved, but the saved ... | Class II | Elekta, Inc. |
| Aug 27, 2021 | United Orthopedics USTAR II Knee System USTAR II Knee System Segment Part,... | Due to product not meeting specification for concentricity and failing to meet requirements of dy... | Class II | Uoc Usa Inc |
| Aug 27, 2021 | Norco Ultrasound Gel, Item/Description: NC70479/Norco Ultrasound Gel, 250 mL;... | Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial co... | Class I | North Coast Medical Inc |
| Aug 27, 2021 | EcoLotion Transmission Lotion, used in ultrasound procedures. Item/Descripti... | Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial co... | Class I | North Coast Medical Inc |
| Aug 23, 2021 | Action De Gala, FuSion Conductive Gel - Product Usage: Intended for use in ac... | Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial co... | Class I | Aesthetics Systems Usa Inc |
| Aug 13, 2021 | Imperative Care, ZOOM 71 Reperfusion Catheter, REF: ICRC071137, TRX Tip, 137... | There is a potential for distal end of catheters to fracture and become detached. | Class I | IMPERATIVE CARE INC |
| Aug 9, 2021 | Access hsTnI High Sensitivity Troponin I, REF B52699 Access Immunoassay Sy... | Through customer feedback, testing a sample with cardiac troponin I concentration that are >270,0... | Class II | Beckman Coulter Inc. |
| 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 | 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 |
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.