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 |
|---|---|---|---|---|
| Jun 15, 2020 | POWERWAND XL 4Fr 8cm Maximum Barrier Kit (Introducer with an Extended Dwell C... | Convenience kit mislabeled with the incorrect catheter effective length on the device label and t... | Class III | Access Scientific LLC |
| Jun 10, 2020 | ION Reprocessing Accessories Kit, IF1000 (Part Number: 490024-03) UDI:0088687... | One type of the ION Catheter Reprocessing Covers (PN 490114-02) has the potential to become disen... | Class II | Intuitive Surgical, Inc. |
| Jun 10, 2020 | Nuvasive NVM5 EMG Module, REF 8020015, Rx ONLY, CE2797, Nonsterile, UDI: 008... | The NVM5 EMG Module kit intended for intraoperative neurophysiologic monitoring during spinal sur... | Class II | NuVasive Inc |
| Jun 10, 2020 | Ion Catheter Reprocessing Cover, IF1000 (Part Number:490114-02) UDI:008868741... | One type of the ION Catheter Reprocessing Covers (PN 490114-02) has the potential to become disen... | Class II | Intuitive Surgical, Inc. |
| May 21, 2020 | VistaSolution, physiological signal transmitter. A software graphical user in... | A healthcare provider (HCP) noticed a patient had a lowered historic SpO2 reading that the softwa... | Class II | Vitalconnect Inc. |
| May 12, 2020 | MOL3650 Simplexa VZV Direct - Product Usage: is intended for use on the LIAIS... | Due to a software malfunction in the Multi Assay Suite, there is the probability of increased occ... | Class II | DiaSorin Molecular LLC |
| May 12, 2020 | MOL2150 Simplexa HSV 1&2 Direct -CSF -Genital Swab -Cutaneous / Mucocutaneous... | Due to a software malfunction in the Multi Assay Suite, there is the probability of increased occ... | Class II | DiaSorin Molecular LLC |
| May 12, 2020 | MOL3655 Simplexa VZV Swab Direct - Product Usage: is intended for use on the ... | Due to a software malfunction in the Multi Assay Suite, there is the probability of increased occ... | Class II | DiaSorin Molecular LLC |
| May 6, 2020 | Ovation iX Abdominal Stent Graft Systems, REF: TV-AB2080-I, TV-AB2080-J, TV-A... | A material weakness adjacent to the polymer fill channel may become compromised during pressuriza... | Class I | Endologix, Inc. |
| Apr 30, 2020 | MiniMed 630G with SmartGuard, insulin pump, Ref/Model # MMT-1754K, MMT-1714K... | Missing solder battery connection, which could interrupt power of insulin pump. | Class II | Medtronic Inc. |
| Apr 30, 2020 | MiniMed 640G, insulin pump, Ref/Model # MMT-1711K, MMT-1752K, MMT-1752, Rx On... | Missing solder battery connection, which could interrupt power of insulin pump. | Class II | Medtronic Inc. |
| Apr 30, 2020 | MiniMed 670G, insulin pump, Ref/Model # MMT-1760KPK, MMT-1762KCN, MMT-1762WWK... | Missing solder battery connection, which could interrupt power of insulin pump. | Class II | Medtronic Inc. |
| Apr 23, 2020 | BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 4Fr 10cm Max ... | Saline Flush Syringe compromised sterility due to holes in the packaging. | Class II | Access Scientific LLC |
| Apr 23, 2020 | BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 3Fr 6cm Quick... | Saline Flush Syringe compromised sterility due to holes in the packaging. | Class II | Access Scientific LLC |
| Apr 23, 2020 | BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 4Fr 8cm Max B... | Saline Flush Syringe compromised sterility due to holes in the packaging. | Class II | Access Scientific LLC |
| Apr 23, 2020 | BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 4Fr 8cm Quick... | Saline Flush Syringe compromised sterility due to holes in the packaging. | Class II | Access Scientific LLC |
| Apr 23, 2020 | BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 4Fr 10cm Quic... | Saline Flush Syringe compromised sterility due to holes in the packaging. | Class II | Access Scientific LLC |
| Apr 23, 2020 | BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND" ED Quick Kit 3F... | Saline Flush Syringe compromised sterility due to holes in the packaging. | Class II | Access Scientific LLC |
| Apr 23, 2020 | BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 5Fr 8cm Quick... | Saline Flush Syringe compromised sterility due to holes in the packaging. | Class II | Access Scientific LLC |
| Apr 23, 2020 | BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 4Fr 10cm Exte... | Saline Flush Syringe compromised sterility due to holes in the packaging. | Class II | Access Scientific LLC |
| Apr 23, 2020 | BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 5Fr 10cm Quic... | Saline Flush Syringe compromised sterility due to holes in the packaging. | Class II | Access Scientific LLC |
| Apr 23, 2020 | BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND"XL Alternate Sit... | Saline Flush Syringe compromised sterility due to holes in the packaging. | Class II | Access Scientific LLC |
| Apr 23, 2020 | BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 3Fr 6cm Pedia... | Saline Flush Syringe compromised sterility due to holes in the packaging. | Class II | Access Scientific LLC |
| Apr 23, 2020 | BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 5Fr 8cm Max B... | Saline Flush Syringe compromised sterility due to holes in the packaging. | Class II | Access Scientific LLC |
| Apr 22, 2020 | PENTARAY NAV eco HIGH-DENSITY MAPPING CATHETER ELECTRODE EA 22 Rx only S... | Mapping Catheter can become entrapped in the cardiac valvular apparatus while the user is attempt... | Class II | BIOSENSE WEBSTER |
| Apr 22, 2020 | PENTARAY NAV HIGH-DENSITY MAPPING CATHETER ELECTRODE EA 22 Rx only STERI... | Mapping Catheter can become entrapped in the cardiac valvular apparatus while the user is attempt... | Class II | BIOSENSE WEBSTER |
| Apr 10, 2020 | Medtronic Implantable Insulin Pump System, REF: MMT-2007D, Sterile EO, CE 045... | Internal testing results showed endotoxin-related test result did not meet specifications for im... | Class II | Medtronic Inc. |
| Mar 31, 2020 | Analyte specific reagent. REF/UDI: 641408/641408-4012-1-1 (US); 641417/641417... | False positive reaction on the reagent. | Class II | Becton, Dickinson and Company, BD Biosciences |
| Mar 30, 2020 | iQ200 Series Urine Microscopy Analyzer- All part numbers | A defect in the SATA power adapter cable within the instrument s computer has the potential risk ... | Class II | Beckman Coulter Inc. |
| Mar 30, 2020 | iChem¿VELOCITY Urine Chemistry System- | A defect in the SATA power adapter cable within the instruments computer has the potential risk f... | Class II | Beckman Coulter Inc. |
| Mar 27, 2020 | Sterile Oxymetry Oligon Catheter Kit. Pressure injectable. REF/UDI:XA3816SAFK... | Sterile catheter kit packaging compromised. | Class II | Edwards Lifesciences, LLC |
| Mar 25, 2020 | Xience Sierra TM Everolimus Eluting Coronary Stent System, RX 3.5mm x 33mmStr... | Incorrect expiration date | Class II | Abbott Vascular |
| Mar 23, 2020 | Triever20 Aspiration Guide Catheter a component of FlowTriever Retrieval/ Asp... | The hemostasis valve of aspiration guide catheter devices may fail to seal resulting in a loss of... | Class II | INARI MEDICAL |
| Mar 20, 2020 | Utak NR Trace Elements Serum Control, 5 ml, REF 66816. The responsible firm ... | The product has an incorrect reference value for cadmium and an incorrect expected range. | Class III | Utak Laboratories Inc |
| Mar 17, 2020 | Epix latis GRASPER, 5mm x 45 cm, REF: C4140, Qty: 10, Sterile R, CE, Rx ONLY,... | There may be a slightly protruding rivet on the distal end of the laparoscopic grasper which has ... | Class II | Applied Medical Resources Corp |
| Mar 17, 2020 | Epix latis GRASPER, 5 mm x 35 cm, REF C4130, Qty: 10, Sterile R, CE, Rx ONLY... | There may be a slightly protruding rivet on the distal end of the laparoscopic grasper which has ... | Class II | Applied Medical Resources Corp |
| Mar 17, 2020 | Clip Applier Kit, REF: K2887, UDI: (01)30607915139132(17)220822(30)1(10) | There may be a slightly protruding rivet on the distal end of the laparoscopic grasper which has ... | Class II | Applied Medical Resources Corp |
| Mar 17, 2020 | DR. THAMES - LAP CHOLE, REF: K0880, UDI: (01)30607915139620 | There may be a slightly protruding rivet on the distal end of the laparoscopic grasper which has ... | Class II | Applied Medical Resources Corp |
| Mar 5, 2020 | Philips V60 Ventilators with Power Management PCBA part number 1055906 | Solder connection failure on Power Management printed circuit board assembly of ventilators may c... | Class II | Respironics California, LLC |
| Mar 3, 2020 | Infinix-8000C with Catheterization Table CAT-850B or CAT-860B - Product Usage... | Bolts holding the longitudinal movement of catheterization tables may be loose, which may lead to... | Class II | Canon Medical System, USA, INC. |
| Mar 3, 2020 | Infinix-8000V with Catheterization Table CAT-850B or CAT-860B - Product Usage... | Bolts holding the longitudinal movement of catheterization tables may be loose, which may lead to... | Class II | Canon Medical System, USA, INC. |
| Mar 3, 2020 | Infinix-8000F with Catheterization Table CAT-850B or CAT-860B - Product Usage... | Bolts holding the longitudinal movement of catheterization tables may be loose, which may lead to... | Class II | Canon Medical System, USA, INC. |
| Feb 28, 2020 | Merlin PCS 3650 Software Upgrade Kit, REF 3330 St. Jude Medical The Merlin... | Internal testing of software identified software anomaly scenarios where if non-applicable shock ... | Class II | Abbott |
| Feb 26, 2020 | The CapsoCam Plus (SV-3); Device Common Name: System, Imaging, Gastrointestin... | Ingestible video capsule system has capsule with incorrect capture mode which will not record dat... | Class II | Capso Vision, Inc. |
| Feb 25, 2020 | Acutus Medical AcQGuide Mini Fixed-Curve Introducer with AcQCros QX Integrate... | It has been determined that the manufacturing process may have left foreign material particulates... | Class II | Acutus Medical Inc |
| Feb 25, 2020 | Acutus Medical AcQGuide Flex Steerable Introducer with AcQcross QX Integrated... | It has been determined that the manufacturing process may have left foreign material particulates... | Class II | Acutus Medical Inc |
| Feb 25, 2020 | Rhythm Xience Flextra Steerable Introducer with Lancer Integrated Dilator/Tra... | It has been determined that the manufacturing process may have left foreign material particulates... | Class II | Acutus Medical Inc |
| Feb 25, 2020 | Nexus Universal with OptiBond Universal, Universal Adhesive Resin Cement, Tri... | An issue within production process used to package trial kits let to the inclusion of the incorr... | Class II | Kerr/Pentron, DBA Kerr Corporation and Pentron ... |
| Feb 25, 2020 | Rhythm Xience Guider Catheter Introducer with Lancer Intergrated Dilator/Tran... | It has been determined that the manufacturing process may have left foreign material particulates... | Class II | Acutus Medical Inc |
| Feb 17, 2020 | AB HiResolution Bionic Ear System, HiRes Ultra 3D CI, HiFocus SlimJ Electrode... | hearing performance degradation due to body-fluid entering the device. | Class II | Advanced Bionics, 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.