Browse Device Recalls

4,606 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 4,606 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 4,606 FDA device recalls in CA.

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DateProductReasonClassFirm
May 22, 2012 CYTO-STAT tetraCHROME CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5, Part Number 6607013.... The recall was initiated because Beckman Coulter has determined that the specimen and prepared sa... Class II Beckman Coulter Inc.
May 22, 2012 Alere Triage CardioProfiler Panel PN 97100CP Used for the quantitative det... Certain lots of the affected products may have significantly decreased precision relative to the ... Class I Alere San Diego, Inc.
May 21, 2012 Formula Shaver Handpiece (with buttons); Formula 180 Shaver Handpiece (with ... Stryker Endoscopy determined that there may not have been adequate determination of required rout... Class II Stryker Endoscopy
May 14, 2012 Alere Triage Tox+MTD Drug Screen, PN 94400 Product Usage: The Alere Triag... A recall was initiated because Alere San Diego has confirmed that the Triage TOX Drug Screen may ... Class II Alere San Diego, Inc.
May 12, 2012 BriteField illuminated Suction Device; Model numbers 8Fr, 10Fr and 12Fr, Kit... Invuity is notifying customers to return all obsolete BriteField Illuminated Suction Devices from... Class II Invuity, Inc.
May 11, 2012 ACUSON SC2000 volume imaging ultrasound systems at software versions VA16C, V... In some cases, the system is unable to capture a clip or image during a routine scan. Class II Siemens Medical Solutions USA, Inc.
May 11, 2012 Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 131HF7P. ... The device is being recalled because the firm received multiple complaints related to passage of ... Class II Edwards Lifesciences, LLC
May 11, 2012 Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 141F7. F... The device is being recalled because the firm received multiple complaints related to passage of ... Class II Edwards Lifesciences, LLC
May 11, 2012 Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 151F7. F... The device is being recalled because the firm received multiple complaints related to passage of ... Class II Edwards Lifesciences, LLC
May 11, 2012 Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 141HF7P. ... The device is being recalled because the firm received multiple complaints related to passage of ... Class II Edwards Lifesciences, LLC
May 11, 2012 Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 141HF7J. ... The device is being recalled because the firm received multiple complaints related to passage of ... Class II Edwards Lifesciences, LLC
May 11, 2012 Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 131HF7J. ... The device is being recalled because the firm received multiple complaints related to passage of ... Class II Edwards Lifesciences, LLC
May 11, 2012 Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model TS057HF7. ... The device is being recalled because the firm received multiple complaints related to passage of ... Class II Edwards Lifesciences, LLC
May 11, 2012 Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 131F7P. ... The device is being recalled because the firm received multiple complaints related to passage of ... Class II Edwards Lifesciences, LLC
May 11, 2012 Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 131HVF7P. ... The device is being recalled because the firm received multiple complaints related to passage of ... Class II Edwards Lifesciences, LLC
May 11, 2012 Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 131F7J. ... The device is being recalled because the firm received multiple complaints related to passage of ... Class II Edwards Lifesciences, LLC
May 11, 2012 Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 151HF7. ... The device is being recalled because the firm received multiple complaints related to passage of ... Class II Edwards Lifesciences, LLC
May 8, 2012 ON-Q pump with ONDEMAND bolus button, ON-Q C-bloc with ONDEMAND; ON-Q C-bloc ... It was determined that in a small quantity of ON-Q pumps with ONDEMAND, the bolus button may not ... Class I I-Flow Corporation
Apr 27, 2012 Patient Side Cart Battery Box used in conjunction with the da Vinci A surgica... Patient Side Cart battery boxes may overheat in rare charging conditions, causing battery bulging. Class II Intuitive Surgical, Inc.
Apr 24, 2012 The brand name of the device is Damon 3MX Bicuspid Bracket, an orthodontic br... The firm initiated the recall as a result of a misidentification of the brackets. Damon 3MX Bicus... Class III Ormco/Sybronendo
Apr 17, 2012 High Pressure Stopcock (3-Way, Luer Lock, Off). Product Usage: For IV. The firm initiated the recall due to a molding defect in a high pressure stopcock where a small ... Class II ICU Medical, Inc.
Apr 17, 2012 Cardiac Catheterization Waste Management System w/1000mL Waste Bag, 2 Fluid A... The firm initiated the recall due to a molding defect in a high pressure stopcock where a small ... Class II ICU Medical, Inc.
Apr 17, 2012 94" (239cm) 20 Drop Admin Set w/High Pressure 4-Way (300 psi) Stopcock, Rota... The firm initiated the recall due to a molding defect in a high pressure stopcock where a small ... Class II ICU Medical, Inc.
Apr 17, 2012 Flush Kit w 3 Way Off Stopcock Product Usage: Flush Kit The firm initiated the recall due to a molding defect in a high pressure stopcock where a small ... Class II ICU Medical, Inc.
Apr 11, 2012 AutoMate 1250 and AutoMate 2550, Part Numbers ODL25125 and ODL25255. The A... The recall was initiated because Beckman Coulter has confirmed customer reports of secondary tube... Class II Beckman Coulter Inc.
Apr 3, 2012 Unicel DxH 800 Coulter Cellular Analysis System, Part Number 629029. The U... Beckman Coulter is recalling the UniCel DxH 800 Coulter Cellular Analysis System because the NRBC... Class II Beckman Coulter Inc.
Mar 27, 2012 MC-500 Multicolor Laser Photocoagulator; Indicated for use in retinal phot... The spot size control of the scan delivery unit of the MC-500 Multicolor Laser Photocoagulator ma... Class II Nidek Inc
Mar 27, 2012 PASCAL and PASCAL Streamline (532 nm.577 nm); Treats the patient's eye. When using the "Favorites" function for saved settings, there is potential for a mismatch between... Class II Topcon Medical Laser Systems, Inc
Mar 13, 2012 STERRAD 200 System Carriage, P/N 10208. Used as a tool to expedite loading... Advanced Sterilization Products (ASP) is recalling the STERRAD 200 System Carriage because it can... Class II Advanced Sterilization Products
Mar 8, 2012 BLOM-SINGER indwelling TEP Occluder, catalog IN2004-TO The Blom-Singer Ind... Helix Medical LLC is recalling the BLOM-SINGER indwelling TEP Occluder due to an invalid expirati... Class III Helix Medical LLC
Feb 28, 2012 Presage ST2 Assay, catalog numbers BC-1065 and BC-1065E. The Critical Diag... The recall was initiated because Critical Diagnostics has confirmed that it is possible to obtain... Class III Critical Diagnostics
Feb 22, 2012 TX1 Tissue Removal System Console. Model: TX1 TX1 Tissue Removal System is a... Two reasons for recall. 1. Incorrect pressure relief valve installed inside console, leading t... Class II American Optisurgical Inc
Feb 21, 2012 Toshiba Ultra-Short Magnetic Resonance Imaging System, EXCELART Vantage. MRT-... The firm recalled due to a potentail problem with the position of the hold in the lug teminals on... Class II Toshiba American Medical Systems Inc
Feb 12, 2012 The Symbionic Leg is an integrated prosthetic leg for transfemoral and knee d... OSSUR initiated this recall of the Symbionic Leg because it may have a possible defect in a small... Class II Ossur Americas, Inc.
Feb 6, 2012 VerifyNow System, part #85005-6H Product Usage: The VerifyNow P2Y12 assay... The recall was initiated by Accumetrics because of a field correction to the VerifyNow System; sp... Class II Accumetrics Inc
Feb 6, 2012 VerifyNow P2Y12 Assay, Part Number: 85064, All reagent lots. Product Usage... The recall was initiated by Accumetrics because of a field correction to the VerifyNow System; sp... Class II Accumetrics Inc
Jan 27, 2012 IMMAGE Immunochemistry Systems Rheumatoid Factor (RF) Reagent, PN 447070 T... The recall was initiated because Beckman Coulter has confirmed customer reports of QC shifts, lot... Class II Beckman Coulter Inc.
Jan 20, 2012 Active Renin IRMA Kit, Part Number DSL25100 Product Usage: The Renin IRMA... The recall was initiated because Beckman Coulter has confirmed that the Active Renin IRMA Test Ki... Class II Beckman Coulter Inc.
Jan 20, 2012 COULTER PrepPlus, Part Number: 286600 Product Usage: The COULTER PrepPlus... The recall was initiated because Beckman Coulter has confirmed that the Coulter PrepPlus may expe... Class II Beckman Coulter Inc.
Jan 19, 2012 MEE-1000A Neuromaster, Model No. Accessories: MS-110B (Electric Stimulation),... The MEE-1000A Neuromaster had defective printed circuit boards (PCBs). Gas arrestors on these boa... Class II Nihon Kohden America Inc
Dec 15, 2011 Synchron Systems Synchron Calibrator Multi Calibrator Diskettes, Part Number ... The recall was initiated because Beckman Coulter has confirmed a mislabeling error, some Synchron... Class III Beckman Coulter Inc.
Dec 13, 2011 UniCel DxH Slidemaker Stainer Stainer Floor Cabinet, PN A96152. The DxH Sl... The recall was initiated because Beckman Coulter has confirmed that the DxH Slidemaker Stainer Fl... Class II Beckman Coulter Inc.
Dec 13, 2011 UniCel DxH Slidemaker Stainer Instrument System, PN 775222. The DxH Slidem... The recall was initiated because Beckman Coulter has confirmed that the DxH Slidemaker Stainer Fl... Class II Beckman Coulter Inc.
Dec 12, 2011 Vector TAS Modular Driver, a manual driver for Vector TAS dental screws. The Instructions For Use (IFUs) for Vector TAS Modular Driver for some foreign language sections ... Class II Ormco/Sybronendo
Nov 30, 2011 Brand Name: RX Accunet Embolic Protection System Common Name: RX Accunet EPS... The recall was initiated because Abbot Vascular has discovered that the identified lots of the RX... Class II Abbott Vascular
Nov 30, 2011 TSX-IOI: AQUILION 32/64; System, X-Ray, Tomography, Computed. Designed to ... The firm initiated this recall due to a potential software issue. The DLP (Dose Length Product) ... Class II Toshiba American Medical Systems Inc
Oct 28, 2011 R-30H , Diagnostic X-Ray Beam-Limiting Device. In combination with any of ... Shimadzu is recalling Diagnostic X-ray Beam-Limiting Device, Mobile x-ray system and Diagnostic x... Class II Shimadzu Medical Systems
Oct 28, 2011 0.7/1.2JG326D-265 Product Usage: The device is a mobile X-ray system i... Shimadzu is recalling Diagnostic X-ray Beam-Limiting Device, Mobile x-ray system and Diagnostic x... Class II Shimadzu Medical Systems
Oct 28, 2011 R-20J , Diagnostic X-Ray Beam-Limiting Device. In combination with any of ... Shimadzu is recalling Diagnostic X-ray Beam-Limiting Device, Mobile x-ray system and Diagnostic x... Class II Shimadzu Medical Systems
Oct 28, 2011 0.4/0.7JG326D-265AX/AT Product Usage: The device is a mobile X-ray sys... Shimadzu is recalling Diagnostic X-ray Beam-Limiting Device, Mobile x-ray system and Diagnostic x... Class II Shimadzu Medical Systems

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.