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
Feb 20, 2013 14 x 11 x 6mm 7 deg 14 x 11 x 7mm 7 deg 14 x 11 x 8mm 7 deg 14 x 11 x 9... The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated b... Class II Spinal Solutions, LLC
Feb 20, 2013 Fang Screw 20mm Fang Plate 21mm Product Usage: Spinal Solutions distrib... The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated b... Class II Spinal Solutions, LLC
Feb 20, 2013 Set Screw, Item #BG3010 Product Usage: Spinal Solutions distributes a var... The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated b... Class II Spinal Solutions, LLC
Feb 20, 2013 45 mm Screw, Item #BG7045 Product Usage: Spinal Solutions distributes a v... The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated b... Class II Spinal Solutions, LLC
Feb 15, 2013 ABX Micros IM2, Part# M60CSB110EN04 and D00A00202 The IM2 Data Management ... Horiba Medical is recalling ABX Micros IM2 Data Management System because it may display incorrec... Class III Horiba Instruments, Inc dba Horiba Medical
Feb 12, 2013 Atrapro Antipruritic Hydrogel, 1.5 oz gel tube, 4 Net wt/ 1.5 oz.. RX only, ... Out of specification result - stability test failure of free available chlorine (FAC) which funct... Class II Oculus Innovative Sciences Inc
Feb 12, 2013 Synchron LXi 725 Clinical System; P/N 107405S Product Usage: The Access... Beckman Coulter is initiating a recall due to a defective newly released aluminum incubator belt ... Class II Beckman Coulter Inc.
Feb 12, 2013 UniCel DxC 600i Synchron Access Clinical System; P/N 107405S Product Usage... Beckman Coulter is initiating a recall due to a defective newly released aluminum incubator belt ... Class II Beckman Coulter Inc.
Feb 12, 2013 Access 2 Immunoassay System; P/N 107405S 2/12 The Access Immunoassay Syste... Beckman Coulter is initiating a recall due to a defective newly released aluminum incubator belt ... Class II Beckman Coulter Inc.
Feb 12, 2013 Access Immunoassay System; P/N 107405S Product Usage: The Access Immu... Beckman Coulter is initiating a recall due to a defective newly released aluminum incubator belt ... Class II Beckman Coulter Inc.
Feb 11, 2013 ANTI-BORRELIA (LYME) MICROPLATE EIA Kit, Catalog # 32507 Kit Lot Number 12096... Multiple incidents of low-reacting assay plates. Class II Innominata Dba Genbio
Jan 30, 2013 Pressure Monitoring sets with VAMP Plus closed blood sampling system model # ... The device is being recalled because the firm has received multiple complaints related to incorr... Class II Edwards Lifesciences, LLC
Jan 28, 2013 Varian Eclipse Treatment Planning System for Radiotherapy; Model Number: H48.... The calculation of dose dynamic plans containing different energy fields is incorrect when the Pe... Class II Varian Medical Systems, Inc. Oncology Systems
Jan 24, 2013 User Manual addendum, TORS for da Vinci Surgical System IS 1200, IS 2000 and... Change to User Manual to remove one indication for use and amend warnings to emphasize restrictio... Class II Intuitive Surgical, Inc.
Jan 21, 2013 Cardinal Health hCG Cassette Rapid Test, Part Number: B1077-22 (Mfg PN: 45821... Alere San Diego Inc. is recalling the Cardinal Health hCG Cassette Rapid Test because some of the... Class III Alere San Diego, Inc.
Jan 18, 2013 ACUSON S2000 Automated Breast Volume Scanner (ABVS); Model number 10042541 ... On some ACUSON S2000 ABVS systems, the inside of the transducer pod may contain sharp edges. Class II Siemens Medical Solutions USA, Inc.
Jan 17, 2013 SybronEndo Elements Obturation Unit; REF 973-0322; SN 91-1234; 2005-10; Sybr... A recall has been issued by SybronEndo because a Canadian Standards Association (CSA)-directed ca... Class II Ormco/Sybronendo
Jan 17, 2013 SybronEndo Replacement AC Power Cord, US Elements Obturation; REF 973-0334; ... A recall has been issued by SybronEndo because a Canadian Standards Association (CSA)-directed ca... Class II Ormco/Sybronendo
Jan 17, 2013 SIEMENS brand ARTISTE syngo RT Therapist (RTT) version 4.3, ARTISTE Model, Pa... Siemens became aware of a potential safety issue when using the "In-session resumption" feature o... Class II Siemens Medical Solutions USA, Inc
Jan 14, 2013 BREG Cold Therapy Combination Units containing Sterile Polar Pads. 02356 Rev ... The recall was initiated because Breg has determined that some Sterile Polar Pads products manufa... Class II Breg Inc
Jan 14, 2013 BREG Sterile Polar Pads; 02356 Rev M, PAD M/U XL STER, Mfg.Date: 112012. Mode... The recall was initiated because Breg has determined that some Sterile Polar Pads products manufa... Class II Breg Inc
Jan 11, 2013 Inspira AIR Balloon Dilation system. Size 7 x 24 mm, Syringe volume 6-8 cc. ... Labeling correction for all sizes of the Inspira AIR Balloon Dilation System to include additiona... Class II Acclarent, Inc.
Jan 11, 2013 Inspira AIR Balloon Dilation system. Size 16 x 40 mm, Syringe volume 12 cc. ... Labeling correction for all sizes of the Inspira AIR Balloon Dilation System to include additiona... Class II Acclarent, Inc.
Jan 11, 2013 Inspira AIR Balloon Dilation system. Size 14 x 40 mm, Syringe volume 12 cc. ... Labeling correction for all sizes of the Inspira AIR Balloon Dilation System to include additiona... Class II Acclarent, Inc.
Jan 11, 2013 Inspira AIR Balloon Dilation system. Size 12 x 40 mm, Syringe volume 12 cc. ... Labeling correction for all sizes of the Inspira AIR Balloon Dilation System to include additiona... Class II Acclarent, Inc.
Jan 11, 2013 Inspira AIR Balloon Dilation system. Size 8.5 x 24 mm, Syringe volume 12 cc.... Labeling correction for all sizes of the Inspira AIR Balloon Dilation System to include additiona... Class II Acclarent, Inc.
Jan 11, 2013 Inspira AIR Balloon Dilation system. Size 10 x 40 mm, Syringe volume 12 cc. ... Labeling correction for all sizes of the Inspira AIR Balloon Dilation System to include additiona... Class II Acclarent, Inc.
Jan 11, 2013 Inspira AIR Balloon Dilation system. Size 5 x 24 mm, Syringe volume 6-8 cc. ... Labeling correction for all sizes of the Inspira AIR Balloon Dilation System to include additiona... Class II Acclarent, Inc.
Dec 28, 2012 Creatinine, Part Numbers OSR6178, OSR6678 Product Usage: System reag... Beckman Coulter is including additional information and instructions in the Creatinine (OSR6x78) ... Class II Beckman Coulter Inc.
Dec 21, 2012 OPTIGEN Food 30; Catalog number: 85035. For allergen testing. Manufactur... There is no evidence that a visual inspection was performed on one tray of coverslips. Possibilit... Class III Hitachi Chemical Diagnostics Inc
Dec 20, 2012 ELEKTA MOSAIQ SW version below 2.41 Product Usage: The intended use of th... A potential safety risk with the MOSAIQ Oncology Information System that has been identified by... Class II Siemens Medical Solutions USA, Inc
Dec 20, 2012 FlowGate Balloon Guide Catheter; Manufactured by Concentric Medical, Mountai... Firm received complaints of resistance and possible collapse of the distal tip of the FlowGate Ba... Class II Concentric Medical Inc
Dec 20, 2012 CareFusion SmartSite Gravity Blood Set Model 42082E. Used to administer blo... CareFusion is recalling the SmartSite¿ Gravity Blood Set as a result of a potential for separatio... Class II Carefusion 303 Inc
Dec 20, 2012 AMO Sensar Intraocular Lenses (IOLs), Model AR40e, Sensar Foldable IOL with... Two production orders of these IOLs that contain mislabeled IOLs. Class II Abbott Medical Optics Inc (AMO)
Dec 17, 2012 Mizuho Orthopedic Table, model 5855, sub assembly 5855-901 Orthopedic Table S... Possible instability of Orthopedic Table Top. If the epoxy bond fails, the aluminum plug may mig... Class II Mizuho OSI
Dec 17, 2012 Medacta Quadra Trial Broach size 0 part # 01.10.10.045, for use with the Meda... The tip of the Quadra Trial Broach size 0, broke during a surgery. Class II Medacta Usa Inc
Dec 16, 2012 QuietCare-Networked product, Facility Server/model: QC101601; The QuietCa... Care Innovations detected a software anomaly: During the engineering investigation into the cause... Class II Intel-GE Care Innovations LLC
Dec 12, 2012 Sybron Endo Lightspeed: LSX Files, 25MM, Part Numbers: 835-2525; LSX Files, 2... The length markings on the Lightspeed LSX files were wrong. Class II Ormco/Sybronendo
Dec 11, 2012 GreenLight HPS (High Performance System) GreenLight XPS (Xcelerated Performa... During electrical recertification testing it was found that the Voltage Scaling Board was non-con... Class II AMS Innovative Center - San Jose
Dec 11, 2012 Aplio 500/400/300 Diagnostic Ultrasound System (TUS-500/400/300). Device Lis... Toshiba Medical Systems has received reports of startup issues with the Toshiba TUS-500 and TUS-... Class II Toshiba American Medical Systems Inc
Dec 3, 2012 Quidel, Sofia Influenza A + B FIA, Kit #20218 (25-Test Kit), in vitro diagnos... Quidel Corporation has initiated a voluntary recall of specific lots of the Sofia Influenza A+B F... Class II Quidel Corporation
Nov 28, 2012 Beckman Coulter AU5800 Clinical Chemistry Analyzer. An automated chemistry an... Due to a software data storage limitation which only occurs under certain conditions, measurement... Class II Beckman Coulter Inc.
Nov 15, 2012 Bausch and Lomb 27G sterile cannula packed in the Bausch and Lomb Amvisc 1.2%... Some disposable cannulas (with 4-digit lot numbers) provided with the Amvisc or Amvisc Plus OVD a... Class I Bausch and Lomb, Incorporated
Nov 15, 2012 EEG NeuroAmp, Model Number: CS 10090; CS 10137. Biofeedback and Relaxation EEG Info, Inc. is recalling the EEG Neuroamp device because they have identified a potential risk... Class II EEG Info
Nov 14, 2012 Toshiba TSX-30IC AQUlLlON ONE System, Computed Tomography X-Ray. This system ... Due to a problem with the control software of the x-ray high-voltage generator, if scanning is pe... Class II Toshiba American Medical Systems Inc
Nov 8, 2012 Toshiba Infinix-i X-Ray System. A radiographic and fluoroscopic x-ray system... Lost and incorrect images. When using the "F-Rec" fluoroscopy image acquisition recording option ... Class II Toshiba American Medical Systems Inc
Nov 5, 2012 Laparoscope, general; plastic surgery Used for general, abdominal, gynecol... Applied Medical is conducting a voluntary recall on a specific lot number of its 12x150mm Kii shi... Class II Applied Medical Resources Corp
Nov 5, 2012 The Access hLH assay is a paramagnetic particle, chemiluminescent immunoassay... Beckman Coulter Inc. (BEC) has demonstrated that real time stability testing of hLH Calibrator of... Class II Beckman Coulter Inc.
Nov 5, 2012 Varian brand ARIA Radiation Oncology, ARIA Oncology Information System Radiat... Varian Medical Systems has identified an anomaly with the ARIA Oncology Information System Radiat... Class II Varian Medical Systems, Inc. Oncology Systems
Nov 2, 2012 Rigid Tip Suction Wand Non sterile bulk devices (S112468N, S120196N, and S12... California Medical Laboratories, Inc. has identified an issue with the Rigid Tip Suction Wand. D... Class II California Medical Laboratories 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.