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Browse Device Recalls

209 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 209 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 209 FDA device recalls in 2011.

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DateProductReasonClassFirm
Oct 28, 2011 0.7/1.3U163CS-36 In combination with below systems MobileArt Evolution, Mob... Shimadzu is recalling Diagnostic X-ray Beam-Limiting Device, Mobile x-ray system and Diagnostic x... Class II Shimadzu Medical Systems
Oct 28, 2011 0.7U163CS-36 In combination with below systems MUX-100H, MUX-100D, MobileAr... Shimadzu is recalling Diagnostic X-ray Beam-Limiting Device, Mobile x-ray system and Diagnostic x... Class II Shimadzu Medical Systems
Oct 21, 2011 GE Healthcare, Innova 2100IQ, Innova 3100IQ, Innova 4100IQ, Cardiovascula... As part of GE Innova IQ table introduction, a label was designed to be affixed on the front Cover... Class II GE Healthcare, LLC
Oct 19, 2011 Pointe Scientific Liquid Creatine Kinase Reagent Set Device is a kit compris... Linear performance information in product insert does not match that listed in the approved prema... Class III Medtest Holdings, Inc.
Oct 19, 2011 CADstream software Product Usage: CADstream is an image processing syst... Customers may experience an issue with the software study preferences when changes are made to th... Class II Merge Healthcare, Inc.
Oct 19, 2011 Philips Healthcare Practix Convenio Mobile X-ray system Worldwide Distribu... When the system is switched off or when the tube arm is parked in the down position (X-ray genera... Class II Philips Healthcare Inc.
Oct 17, 2011 da Vinci Si Surgical System IS3000 with the da Vinci Surgeon Console which co... Improper restraints during transportation of the da Vinci system could cause the HRSV Monitor to ... Class II Intuitive Surgical, Inc.
Oct 17, 2011 OPTETRAK LOGIC Proximal Tibial Spacer & Screws (2) 2.5 LT BLUE Size 2.5, 8mm*... Exactech, Inc. of Gainesville, FL recalled their Optetrak Proximal Tibial Spacer after the device... Class II Exactech, Inc.
Oct 17, 2011 SoftLab with SA INST versions: 3.1.6.12, 4.0.1.26-4.0.1.32, 4.0.2.21-4.0.2.51... On 10/17/2011 SCC Soft Computer, Clearwater, FL initiated a correction on SoftLab with SA INST ve... Class II SCC Soft Computer
Oct 13, 2011 UniCel DxC 660i, 680i, 860i, 880i SYNCHRON Access Clinical Systems, Part Nu... The recall was initiated because Beckman Coulter has received seven reports of a software anomaly... Class II Beckman Coulter Inc.
Oct 13, 2011 Thyroidectomy Indication for the da Vinci Surgical Systems; Product Usage:... Promotional literature for use of the da Vinci system for thyroidectomy, which had not been appro... Class II Intuitive Surgical, Inc.
Oct 13, 2011 UniCel DxI 800 Access Immunoassay Systems, Part Numbers: Dxl 800: 937100; D... The recall was initiated because Beckman Coulter has received seven reports of a software anomaly... Class II Beckman Coulter Inc.
Oct 13, 2011 UniCel DxI 600 Access Immunoassay Systems, Part Numbers: Dxl 600: A30260; ... The recall was initiated because Beckman Coulter has received seven reports of a software anomaly... Class II Beckman Coulter Inc.
Oct 11, 2011 Integra Mozaik Putty 2.5cc, 5 cc, 10 cc Product Usage: The product is... The Instructions for Use {HIFU} {Putty Part Number 7700713001 and Strip Part Number 770151300 l f... Class II Integra LifeSciences Corp.
Oct 11, 2011 Integra Mozaik Strip 10 cc Product Usage: The product is a bone graft ... The Instructions for Use {IFU} {Putty Part Number 7700713001 and Strip Part Number 770151300l for... Class II Integra LifeSciences Corp.
Oct 11, 2011 Access Total T3 Reagent, PN: 33830 The Access Total T3 assay is used for t... A recall was initiated because Beckman Coulter has identified a negative bias in test results whe... Class III Beckman Coulter Inc.
Oct 10, 2011 SharePlan 1.1, aka t-RayAutoplan version 1.2.1 (build number 1.3.1.10). Manu... This notice concerns behavior of the SharePlan that may be unexpected and not clearly described i... Class II RAYSEARCH LABORATORIES AB
Oct 6, 2011 Navitrack System - OS Knee Universal, Orthopedic Stereotaxic Instrument CAS ... Zimmer CAS voluntarily conducted a retrospective recall of the Navitrack System - OS Knee Univers... Class II Orthosoft, Inc. dba Zimmer CAS
Oct 6, 2011 GE Healthcare, Xeleris 2 Processing & Review Workstation. The display, pro... GE Healthcare has become aware of a software issue in your Xeleris 2.1 workstation (that is used ... Class II GE Healthcare, LLC
Sep 30, 2011 CMS-5284 Custom Myelogram Tray containing 2 oz. bottle PVP Prep Solution P... The firm saw on the FDA web site a recall by the manufacturer of the Povidone Iodine Prep Solutio... Class I Custom Medical Specialties, Inc.
Sep 30, 2011 CMS-8495-R5 Custom Vein Tray containing 4 oz. bottle PVP Prep Solution Pro... The firm saw on the FDA web site a recall by the manufacturer of the Povidone Iodine Prep Solutio... Class I Custom Medical Specialties, Inc.
Sep 30, 2011 CMS-8325-R2 Abington Radiology Drainage Pack and CMS-8325-R3 Abington Radiolo... The firm saw on the FDA web site a recall by the manufacturer of the Povidone Iodine Prep Solutio... Class I Custom Medical Specialties, Inc.
Sep 30, 2011 CMS-4975 HSG Tray containing 4 oz. bottle PVP Prep Solution Product Usage:... The firm saw on the FDA web site a recall by the manufacturer of the Povidone Iodine Prep Solutio... Class I Custom Medical Specialties, Inc.
Sep 30, 2011 CMS-8162-R1 Fox Chase Specials Pack containing 2 oz. bottle PVP Prep Solution... The firm saw on the FDA web site a recall by the manufacturer of the Povidone Iodine Prep Solutio... Class I Custom Medical Specialties, Inc.
Sep 30, 2011 CMS-4501-R1 Custom HSG Tray containing 2 oz. PVP Prep Bottle Product Usag... The firm saw on the FDA web site a recall by the manufacturer of the Povidone Iodine Prep Solutio... Class I Custom Medical Specialties, Inc.
Sep 30, 2011 BR980-9600 Hysteroscopy Sterile Procedure Kit containing 2 oz. bottle PVP Pre... The firm saw on the FDA web site a recall by the manufacturer of the Povidone Iodine Prep Solutio... Class I Custom Medical Specialties, Inc.
Sep 30, 2011 CMS-2981-R3 Arthrogram Tray containing 2 oz. bottle PVP Prep Solution CMS-... The firm saw on the FDA web site a recall by the manufacturer due to no microbial testing in plac... Class II Custom Medical Specialties, Inc.
Sep 30, 2011 CMS-8412-R2 Custom Cysto Pack containing 2 oz. bottle of PVP Prep Solution ... The firm saw on the FDA web site a recall by the manufacturer due to no microbial testing in plac... Class II Custom Medical Specialties, Inc.
Sep 30, 2011 CMS-8457 Hysteroscopic Sterilization Pack containing 4 oz. bottle PVP Prep ... The firm saw on the FDA web site a recall by the manufacturer of the Povidone Iodine Prep Solutio... Class I Custom Medical Specialties, Inc.
Sep 30, 2011 CMS-4219-R2 Custom Laser Pack containing 2 oz bottles PVP Prep Solution Th... The firm saw on the FDA web site a recall by the manufacturer due to no microbial testing in plac... Class II Custom Medical Specialties, Inc.
Sep 30, 2011 CMS-2586 Custom Amnio Tray containing 2 oz. bottle PVP Prep Solution Produ... The firm saw on the FDA web site a recall by the manufacturer of the Povidone Iodine Prep Solutio... Class I Custom Medical Specialties, Inc.
Sep 30, 2011 CMS-4316 Custom Vein Tray containing 4 oz. bottle PVP Prep Solution Produc... The firm saw on the FDA web site a recall by the manufacturer of the Povidone Iodine Prep Solutio... Class I Custom Medical Specialties, Inc.
Sep 30, 2011 CMS-2890 Custom Needle Local Tray containing PVP Prep Pad The PV contained... The firm saw on the FDA web site a recall by the manufacturer due to no microbial testing in plac... Class II Custom Medical Specialties, Inc.
Sep 30, 2011 GE Healthcare, CARESCAPE Monitor B650. The CARESCAPE Monitor B650 is a mul... GE Healthcare has become aware of potential issues associated with the CARESCAPE Monitor B650. ... Class II GE Healthcare, LLC
Sep 30, 2011 CMS-4873 Custom CT Biopsy Tray, CMS-4873-R1 Custom CT Biopsy Tray containing ... The firm saw on the FDA web site a recall by the manufacturer of the Povidone Iodine Prep Solutio... Class I Custom Medical Specialties, Inc.
Sep 30, 2011 CMS-8450-R1 Custom Vein Tray containing 4 oz. bottle PVP Prep Solution Pro... The firm saw on the FDA web site a recall by the manufacturer of the Povidone Iodine Prep Solutio... Class I Custom Medical Specialties, Inc.
Sep 23, 2011 UltraFlow HPC Flow Directed Micro Catheter, Model # 105-5065. Product Usag... The recall was initiated because ev3 Neurovascular has identified one lot of UltraFlow Flow Direc... Class II Micro Therapeutics Inc, Dba Ev3 Neurovascular
Sep 23, 2011 Tip Cover Accessory, 8 MM, MCS, box of 10 Product Usage: The disposable T... Clarification of existing labeling and related cautions for the tip cover accessory of the da Vin... Class II Intuitive Surgical, Inc.
Sep 23, 2011 Marathon Flow Directed Micro Catheter, Model #105-5055. Product Usage: The... The recall was initiated because ev3 Neurovascular has identified one lot of UltraFlow Flow Direc... Class II Micro Therapeutics Inc, Dba Ev3 Neurovascular
Sep 23, 2011 Product is labeled in part: "***OPTETRAK***TIBIAL TRAY***TRAPEZOID CEMENTED*... Exactech, Inc. Gainesville, FL is recalling their Optetrak Cemented Trapezoid Tibial Tray, Size 1... Class II Exactech, Inc.
Sep 23, 2011 Product is labeled in part: "***OPTETRAK RBK***TIBIAL TRAY***FINNED, CEMENT... Exactech, Inc. Gainesville, FL is recalling their Optetrak Cemented Trapezoid Tibial Tray, Size 1... Class II Exactech, Inc.
Sep 20, 2011 Pentron Clinical Metrex Research; Pinnacle Cure Sleeve, a protective barrier ... The firm initiated the recall due to a labeling error. The boxes labeled as Pinnacle Cure Sleeve ... Class II Metrex Research, LLC.
Sep 19, 2011 Cannula 8MM Regular. Provides the means of introduction and placement of a... Clarification of existing labeling information and operating procedures. Class II Intuitive Surgical, Inc.
Sep 19, 2011 .***ANSPACH***Sterile. REF SHD-4820DS***QTY: 1, 4.8 mm x 2mm Twist Drill with... Anspach Effort, Inc. Palm Beach Gardens, FL is recalling their Single Use Sterile Bone Cutting B... Class II The Anspach Effort, Inc.
Sep 19, 2011 Flush Port (used in almost all da Vinci instruments) Assists in cleaning t... Clarification of existing labeling information and operating procedures. Class II Intuitive Surgical, Inc.
Sep 19, 2011 da Vinci Si Surgeon Console. Intended to assist in the accurate Control of... Clarification of existing labeling information and operating procedures. Class II Intuitive Surgical, Inc.
Sep 12, 2011 Respironics SealFlex Single Port Ribbed Mask (Infant). For general use in ... The mask inside the package has been identified as "Neonatal" in size and not "Infant" as the lab... Class I Engineered Medical Systems,Inc
Sep 9, 2011 Anspach Single Use Sterile Bone Cutting Burs and Irrigation Clips. Rx Only Recall was initiated due to the observation of separation between clear layers of the pouch durin... Class II The Anspach Effort, Inc.
Sep 8, 2011 iStat1 Analyzer Abbott Point of Care, Princeton, NJ 08540 Model 200. The ... Some i-Stat Analyzers become uncomfortably hot to touch in the are of the battery. This is a reca... Class II Abbott Point Of Care Inc.
Sep 8, 2011 i-Stat Portable Clinical Analyzer; Abbott Point of Care, Princeton, NJ 08540 ... Some i-Stat Analyzers become uncomfortably hot to touch in the are of the battery. This is a reca... Class II Abbott Point Of Care 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.