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.

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DateProductReasonClassFirm
Apr 26, 2021 Atec Insignia Anterior Cervical Plate System, REF 136-0238 Insignia, ACP, 2-L... There is a potential for the screw blocking mechanism on the anterior cervical plate system to ... Class II Alphatec Spine, Inc.
Apr 26, 2021 Atec Insignia Anterior Cervical Plate System, REF 136-0478 Insignia, ACP, 4-L... There is a potential for the screw blocking mechanism on the anterior cervical plate system to ... Class II Alphatec Spine, Inc.
Apr 26, 2021 Atec Insignia Anterior Cervical Plate System, REF 136-0356 Insignia, ACP, 3-L... There is a potential for the screw blocking mechanism on the anterior cervical plate system to ... Class II Alphatec Spine, Inc.
Apr 26, 2021 Atec Insignia Anterior Cervical Plate System, REF 136-0482 Insignia, ACP, 4-L... There is a potential for the screw blocking mechanism on the anterior cervical plate system to ... Class II Alphatec Spine, Inc.
Apr 26, 2021 Atec Insignia Anterior Cervical Plate System, REF 136-0242 Insignia, ACP, 2-L... There is a potential for the screw blocking mechanism on the anterior cervical plate system to ... Class II Alphatec Spine, Inc.
Apr 26, 2021 Atec Insignia Anterior Cervical Plate System, REF 136-0358 Insignia, ACP, 3-L... There is a potential for the screw blocking mechanism on the anterior cervical plate system to ... Class II Alphatec Spine, Inc.
Apr 26, 2021 Atec Insignia Anterior Cervical Plate System, REF 136-0244 Insignia, ACP, 2-L... There is a potential for the screw blocking mechanism on the anterior cervical plate system to ... Class II Alphatec Spine, Inc.
Apr 26, 2021 Atec Insignia Anterior Cervical Plate System, REF 136-0119, Insignia, ACP, 1-... There is a potential for the screw blocking mechanism on the anterior cervical plate system to ... Class II Alphatec Spine, Inc.
Apr 26, 2021 Atec Insignia Anterior Cervical Plate System, REF 136-0116, Insignia, ACP, 1-... There is a potential for the screw blocking mechanism on the anterior cervical plate system to ... Class II Alphatec Spine, Inc.
Apr 26, 2021 Atec Insignia Anterior Cervical Plate System, REF 136-0117, Insignia, ACP, 1-... There is a potential for the screw blocking mechanism on the anterior cervical plate system to ... Class II Alphatec Spine, Inc.
Apr 26, 2021 Atec Insignia Anterior Cervical Plate System, REF 136-0232 Insignia, ACP, 2-L... There is a potential for the screw blocking mechanism on the anterior cervical plate system to ... Class II Alphatec Spine, Inc.
Apr 26, 2021 Atec Insignia Anterior Cervical Plate System, REF 136-0250 Insignia, ACP, 2-L... There is a potential for the screw blocking mechanism on the anterior cervical plate system to ... Class II Alphatec Spine, Inc.
Apr 26, 2021 Atec Insignia Anterior Cervical Plate System, REF 136-0360 Insignia, ACP, 3-L... There is a potential for the screw blocking mechanism on the anterior cervical plate system to ... Class II Alphatec Spine, Inc.
Apr 26, 2021 Atec Insignia Anterior Cervical Plate System, REF 136-0234 Insignia, ACP, 2-L... There is a potential for the screw blocking mechanism on the anterior cervical plate system to ... Class II Alphatec Spine, Inc.
Apr 26, 2021 Atec Insignia Anterior Cervical Plate System, REF 136-0121, Insignia, ACP, 1-... There is a potential for the screw blocking mechanism on the anterior cervical plate system to ... Class II Alphatec Spine, Inc.
Apr 26, 2021 Atec Insignia Anterior Cervical Plate System, REF 136-0350 Insignia, ACP, 3-L... There is a potential for the screw blocking mechanism on the anterior cervical plate system to ... Class II Alphatec Spine, Inc.
Apr 26, 2021 Atec Insignia Anterior Cervical Plate System, REF 136-0364 Insignia, ACP, 3-L... There is a potential for the screw blocking mechanism on the anterior cervical plate system to ... Class II Alphatec Spine, Inc.
Apr 26, 2021 Atec Insignia Anterior Cervical Plate System, REF 136-0240 Insignia, ACP, 2-L... There is a potential for the screw blocking mechanism on the anterior cervical plate system to ... Class II Alphatec Spine, Inc.
Apr 26, 2021 Atec Insignia Anterior Cervical Plate System, REF 136-0118, Insignia, ACP, 1-... There is a potential for the screw blocking mechanism on the anterior cervical plate system to ... Class II Alphatec Spine, Inc.
Apr 26, 2021 Atec Insignia Anterior Cervical Plate System, REF 136-0362 Insignia, ACP, 3-L... There is a potential for the screw blocking mechanism on the anterior cervical plate system to ... Class II Alphatec Spine, Inc.
Apr 26, 2021 Atec Insignia Anterior Cervical Plate System, REF 136-0124, Insignia, ACP, 1-... There is a potential for the screw blocking mechanism on the anterior cervical plate system to ... Class II Alphatec Spine, Inc.
Apr 26, 2021 Atec Insignia Anterior Cervical Plate System, REF 136-0236 Insignia, ACP, 2-L... There is a potential for the screw blocking mechanism on the anterior cervical plate system to ... Class II Alphatec Spine, Inc.
Apr 26, 2021 Atec Insignia Anterior Cervical Plate System, REF 136-0474 Insignia, ACP, 4-L... There is a potential for the screw blocking mechanism on the anterior cervical plate system to ... Class II Alphatec Spine, Inc.
Apr 26, 2021 Atec Insignia Anterior Cervical Plate System, REF 136-0120, Insignia, ACP, 1-... There is a potential for the screw blocking mechanism on the anterior cervical plate system to ... Class II Alphatec Spine, Inc.
Apr 26, 2021 Atec Insignia Anterior Cervical Plate System, REF 136-0122, Insignia, ACP, 1-... There is a potential for the screw blocking mechanism on the anterior cervical plate system to ... Class II Alphatec Spine, Inc.
Apr 26, 2021 Atec Insignia Anterior Cervical Plate System, REF 136-0352 Insignia, ACP, 3-L... There is a potential for the screw blocking mechanism on the anterior cervical plate system to ... Class II Alphatec Spine, Inc.
Apr 26, 2021 Atec Insignia Anterior Cervical Plate System, REF 136-0248 Insignia, ACP, 2-L... There is a potential for the screw blocking mechanism on the anterior cervical plate system to ... Class II Alphatec Spine, Inc.
Apr 26, 2021 Atec Insignia Anterior Cervical Plate System, REF 136-0354 Insignia, ACP, 3-L... There is a potential for the screw blocking mechanism on the anterior cervical plate system to ... Class II Alphatec Spine, Inc.
Apr 23, 2021 Sapi Med sterile disposable colorectal anoscopes and proctoscopes. REF/Pro... Due to issue with product sterility. Sterilization service provider had falsified records. Class II Adler MicroMed, Inc.
Apr 21, 2021 VIA Microcatheter VIA 27 REF VIA-27-154-01 - Product Usage: is a single lumen... Due to inadvertently shipping to U.S. customers with international labeling which has some differ... Class III MICROVENTION INC.
Apr 21, 2021 VIA Microcatheter VIA 17 REF VIA-17-154-01 - Product Usage: is a single lumen... Due to inadvertently shipping to U.S. customers with international labeling which has some differ... Class III MICROVENTION INC.
Apr 21, 2021 VIA Microcatheter VIA 21 REF VIA-21-154-01 - Product Usage: is a single lumen... Due to inadvertently shipping to U.S. customers with international labeling which has some differ... Class III MICROVENTION INC.
Apr 16, 2021 Quickslide GramPro 1 Automated Gram Stanier is a microscope slide stainer. Instruments were assembled and serviced using a defective lot of tubing, which is part of the pum... Class II Hardy Diagnostics
Apr 14, 2021 Access SARS-CoV-2 Antigen, REF C68668, UDI: (01)15099590742713, 3.30 mL/R1a, ... specimens collected in transport media may result is false negative results when stored in certai... Class II Beckman Coulter Inc.
Apr 9, 2021 COVID-19 Self-Test Kit *** INNOVA *** 7T Due to distributing test kits to customers who were not part of a clinical investigation. Class I INNOVA MEDICAL GROUP, INC.
Apr 9, 2021 For In Vitro Diagnostic Use Only *** 25T 888 SARS-CoV-2 Antigen *** SARS-CoV-... Due to distributing test kits to customers who were not part of a clinical investigation. Class I INNOVA MEDICAL GROUP, INC.
Apr 9, 2021 COVID-19 Self-Test Kit *** INNOVA *** 3T Due to distributing test kits to customers who were not part of a clinical investigation. Class I INNOVA MEDICAL GROUP, INC.
Mar 26, 2021 Alaris Pump Module, Model 8100, serviced/repaired by Infusion Pump Repair wit... Bezel repair parts used, not by the original manufacturer, to service and repair infusion pump mo... Class I Infusion Pump Repair
Mar 24, 2021 Aftermarket Alaris Infusion Pump Module Model 8100 Front Bezel, installed by ... Aftermarket front bezel components were installed during service/repair, not by the original manu... Class I Pacific Medical Group Inc.
Mar 23, 2021 Bioseal, Chest Tube Insertion Tray, containing ChloraPREP Applicator 3 mL, RE... Pre-op skin prep component ChloraPrep included within kits may allow the growth of Aspergillus pe... Class II Bioseal Corporation
Mar 23, 2021 Bioseal, Central Line Dressing Kit, containing ChloraPREP Applicator 3 mL, RE... Pre-op skin prep component ChloraPrep included within kits may allow the growth of Aspergillus pe... Class II Bioseal Corporation
Mar 23, 2021 Bioseal, Central Line Dressing Kit, containing ChloraPREP Applicator 3 mL, RE... Pre-op skin prep component ChloraPrep included within kits may allow the growth of Aspergillus pe... Class II Bioseal Corporation
Mar 16, 2021 REF CH2020 20mL Syringe w/Spinning Spiros, Red Cap - Product Usage: provides ... Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios... Class II ICU Medical, Inc.
Mar 16, 2021 REF 011-CH3967 Admin Set w/ClaveTM, SpirosTM - Product Usage: provides access... Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios... Class II ICU Medical, Inc.
Mar 16, 2021 REF CH3034 5" (13 cm) Bag Spike Adapter w/Spiros" w/Red Cap, Vented Cap - Pr... Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios... Class II ICU Medical, Inc.
Mar 16, 2021 REF Spinning Spiros Closed Male Luer - Product Usage: provides access for th... Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios... Class II ICU Medical, Inc.
Mar 16, 2021 REF CL4151 45" (114 cm) Appx 1.7 ml, Smallbore Ext Set w/Spiros w/Red Cap, A... Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios... Class II ICU Medical, Inc.
Mar 16, 2021 REF CH3625 5" (13 cm) Appx 0.50 ml, Smallbore Trifuse Ext Set w/3 ChemoClave ... Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios... Class II ICU Medical, Inc.
Mar 16, 2021 REF K7040-001 Spinning Spiros Closed Male Luer - Product Usage: provides acce... Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios... Class II ICU Medical, Inc.
Mar 16, 2021 REF 20130-01 Spinning Spiros Closed Male Luer, Red Cap - Product Usage: prov... Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios... Class II ICU Medical, 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.