Browse Device Recalls

2,260 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,260 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 2,260 FDA device recalls in 2021.

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DateProductReasonClassFirm
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 EPIQ Diagnostic Ultrasound Systems: Software Versions 5.0, 5.0.1 and 5.0.2... Due to a software defect that can intermittently cause the system to lock-up which exiting Review... Class II Philips Ultrasound Inc
Aug 6, 2021 Affiniti Diagnostic Ultrasound Systems: Software Versions 5.0, 5.0.1 and 5... Due to a software defect that can intermittently cause the system to lock-up which exiting Review... Class II Philips Ultrasound Inc
Aug 6, 2021 NORMOFLO Irrigation Fluid Warmer Models H-1100 and H-1129 There is potential for harmful levels of aluminum leaching when using lower flow rates with certa... Class I Smiths Medical ASD 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 NORMOFLO Irrigation Warming administration set (disposable), Models IR-40, IR... There is potential for harmful levels of aluminum leaching when using lower flow rates with certa... Class I Smiths Medical ASD 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 Medtronic HVAD Pump Implant Kits There is more force required to slide the driveline cover (boot cover) away from the connector af... Class II Heartware, 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 Centricity PACS-IW with Universal Viewer - Product Usage: Is a device that di... Image acquisition failures and synchronization failure with the Centricity Enterprise Archive Class II GE Healthcare, LLC
Aug 6, 2021 NAMIC Stopcocks: (1) NAMIC STOPCOCK, 200 psi (14 bar), REF 70015002, UPN H... Potential for sterile barrier breach. Microscopic pinholes within the sterile pouch could potent... Class II Medline Industries 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 Centricity Universal Viewer and Viewer 6.0 - Product Usage: Is a device that ... Image acquisition failures and synchronization failure with the Centricity Enterprise Archive Class II GE Healthcare, LLC
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 Catalog A902416, SureStep" Foley Tray, Silicone, Urine Meter, StatLock" Stabi... There is potential for packaging defects that may impact the sterile barrier. Class II C.R. Bard Inc
Aug 5, 2021 Catalog A300316A, SureStep" Foley Tray, Bardex" I.C., Complete Care", Drainag... There is potential for packaging defects that may impact the sterile barrier. Class II C.R. Bard Inc
Aug 5, 2021 Catalog A399400A, SureStep" Foley Tray, Add-a-Foley, Complete Care", Drainage... There is potential for packaging defects that may impact the sterile barrier. Class II C.R. Bard 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 5, 2021 Catalog A319516AM, SureStep" Foley Tray, Lubri-Sil" I.C., Temperature Sensing... There is potential for packaging defects that may impact the sterile barrier. Class II C.R. Bard Inc
Aug 5, 2021 Bone Marrow Transplantation biopsy needle Sterility assurance may be compromised. Class II M.D.L. S.r.l.
Aug 5, 2021 Catalog A303416A, SureStep" Foley Tray, Lubri-Sil" I.C., Temperature Sensing ... There is potential for packaging defects that may impact the sterile barrier. Class II C.R. Bard Inc
Aug 5, 2021 Aspirated Cyto-Histological Biopsy needle Sterility assurance may be compromised. Class II M.D.L. S.r.l.
Aug 5, 2021 Catalog A902916, SureStep" Foley Tray, Lubricath", Urine Meter, StatLock" Sta... There is potential for packaging defects that may impact the sterile barrier. Class II C.R. Bard Inc
Aug 5, 2021 Catalog A300314A, SureStep" Foley Tray, Bardex" I.C., Complete Care", Drainag... There is potential for packaging defects that may impact the sterile barrier. Class II C.R. Bard Inc
Aug 5, 2021 General Manual surgical instrument Sterility assurance may be compromised. Class II M.D.L. S.r.l.
Aug 5, 2021 Catalog A800365, SureStep" Foley Tray, Bard LubricathTM Foley Catheter Tray There is potential for packaging defects that may impact the sterile barrier. Class II C.R. Bard Inc
Aug 5, 2021 Catalog A800361, SureStep" Foley Tray, Bard LubricathTM Foley Catheter Tray There is potential for packaging defects that may impact the sterile barrier. Class II C.R. Bard Inc
Aug 5, 2021 Catalog A943216, SureStep" Foley Tray, Lubricath", Urine Meter, StatLock" Sta... There is potential for packaging defects that may impact the sterile barrier. Class II C.R. Bard Inc
Aug 5, 2021 Catalog A303316A, SureStep" Foley Tray, Bardex" I.C., Complete Care", Urine M... There is potential for packaging defects that may impact the sterile barrier. Class II C.R. Bard Inc
Aug 5, 2021 Catalog A300318A, SureStep" Foley Tray, Bardex" I.C., Complete Care", Drainag... There is potential for packaging defects that may impact the sterile barrier. Class II C.R. Bard Inc
Aug 5, 2021 Catalog A303318A, SureStep" Foley Tray, Bardex" I.C., Complete Care", Urine M... There is potential for packaging defects that may impact the sterile barrier. Class II C.R. Bard Inc
Aug 5, 2021 AMSORB PLUS PREFILLED G-CAN 1.0L; Carbon dioxide absorbent canister; Product ... Some devices may be associated with high and unexpected resistance to gas flow during clinical us... Class I Armstrong Medical Services Limited
Aug 5, 2021 Catalog A119216M, SureStep" Foley Tray, Lubri-Sil", Urine Meter, Temperature ... There is potential for packaging defects that may impact the sterile barrier. Class II C.R. Bard Inc
Aug 5, 2021 Catalog A800061, SureStep" Foley Tray, Bard LubricathTM Foley Catheter Tray There is potential for packaging defects that may impact the sterile barrier. Class II C.R. Bard 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.