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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
Sep 8, 2011 Military Kit Portable Clinical Analyzer ; Abbott Point of Care, Princeton, N... 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-STAT1 Abaxis 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.
Sep 8, 2011 i-STAT1 Abaxis Analyzer; Abbott Point of Care, Princeton, NJ 08540 Model 2... 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 Fuso Analyzer 300F; Abbott Point of Care, Princeton, NJ 08540 Model 200. T... 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 6, 2011 Animas Vibe Insulin Infusion Pump. This product is indicated for continuou... Calibration factors in the pump overwritten during a programming step. The force sensor could sen... Class II Animas Corporation
Sep 1, 2011 The Brilliance 64 and Ingenuity CT are Computed Tomography X-Ray Systems inte... During a Field Test (a customer external evaluation period), the customer detected a problem in t... Class II Philips Medical Systems (Cleveland) Inc
Aug 19, 2011 OPTETRAK LOGIC TIBIAL INSERT POSTERIOR STABILIZED***Match Component Colors 6 ... Exactech, Inc. of Gainesville, FL is recalling their Optetrak Logic Posterior Stabilized Tibial I... Class II Exactech, Inc.
Aug 17, 2011 ColorSafe IV lines Catalog No.(Model No.) CS3000-R (76.7806), CS400-R... CODAN US Corporation is recalling the ColorSafe IV (intravenous) product lines because they were ... Class II Codan Us Corporation
Aug 12, 2011 CrossFT Punch, Product Number PFT-45M. Manufacturer: CONMED LINVATEC. The i... ConMed Linvatec recalled lot number #156920, PFT-45M, CrossFT Punch because there is a possibilit... Class II Linvatec Corp. dba ConMed Linvatec
Aug 12, 2011 Sunquest Laboratory SMART & Sunquest Laboratory SMART Select Product Usage... In GUI inquiry, searching by ID (CID) may return the wrong patient demographic data if the access... Class III Sunquest Information Systems, Inc.
Aug 8, 2011 Siemens syngo.plaza image processing system image processing radiological ... The firm became aware of an unintended behavior when using the syngo.plaza. The "Rename" function... Class II Siemens Medical Solutions USA, Inc
Aug 1, 2011 UniCel DxC 880i, 860i, 680i, and 660i Integrated Systems, Part Numbers: A6487... The recall was initiated because Beckman Coulter has confirmed that the UniCel Dxl and DxC Access... Class II Beckman Coulter Inc.
Aug 1, 2011 UniCel Dxl 600 Access Immunoassay System, Part Numbers: A30260, A71460, and A... The recall was initiated because Beckman Coulter has confirmed that the UniCel Dxl and DxC Access... Class II Beckman Coulter Inc.
Aug 1, 2011 UniCel Dxl 800 Access Immunoassay System, Part Numbers: 973100, A71456, and A... The recall was initiated because Beckman Coulter has confirmed that the UniCel Dxl and DxC Access... Class II Beckman Coulter Inc.
Jul 27, 2011 Access Immunoassay Systems Total T4 Calibrators, Part Number: 33805. The... A recall communication was initiated because Beckman has identified that Access Total T4 calibrat... Class II Beckman Coulter Inc.
Jul 25, 2011 GE, VCT for Discovery VCT, Discovery RX VCT, and Discovery PET/CT 690, Lights... Fastener bolts on the heat exchanger were not properly torqued and part of the heat exchanger can... Class II GE Healthcare, LLC
Jul 21, 2011 SL3 SOFT-TISSUE Laser (Model LR2002); Manuf: Discus Dental, LLC, 8550 Higuera... The firm is initiating this recall of the SL3 Soft Tissue Laser equipped with a fiber optic Unif... Class II Discus Dental LLC
Jul 20, 2011 GE Healthcare, CARESCAPE Monitor B850. Intended for use in multiple areas ... GE Healthcare has recently become aware of an issue associated with the CARESCAPE Monitor B850 wh... Class II GE Healthcare, LLC
Jul 9, 2011 Medpro Elastomeric Infusion Pump. AccuFlux, Model # CT-0020-100H. Pr... Please be aware that this is not a new recall. The firm has taken action; but, due to administrat... Class I First Medical Source LLC
Jul 8, 2011 Pointe Scientific Lactate Dehydrogenase (Liquid) Reagent Set Model Number(s... Pointe Scientific Lactate Dehydrogenase (Liquid) Reagent Set stability claim is not being met. Class II Medtest Holdings, Inc.
Jul 6, 2011 ILLICO Straight CP TI Rod, -5.5MM x 110M; REF#73601-110; Qty 1; LBL-005; REV.... The rods were incorrectly laser etched as ILLICO¿ Straight CP Tl Rods, 110mm, when they were in f... Class II Alphatec Spine, Inc.
Jul 6, 2011 Sigma Spectrum VOLUMETRIC INFUSION PUMP, with or without Master Drug Library,... Recall expansion; the infusion pumps have the potential to fail causing inaccurate flow condition... Class I Baxter Healthcare Corporation
Jul 5, 2011 Genesis Straight Esthetic 4.0 mm 1mm Cuff Abutment Part Number: G71200 Ge... Mislabeled: Genesis Straight Esthetic 5.0mm Contour ,3mm cuff labeled as Genesis Straight Estheti... Class II Keystone Dental Inc
Jul 5, 2011 Genesis Straight Esthetic 5.0 mm 3. mm Cuff Abutment Part Number: G71205 ... Mislabeled: Genesis Straight Esthetic 4.0mm Contour ,1mm cuff labeled as Genesis Straight Estheti... Class II Keystone Dental Inc
Jul 1, 2011 Catheter Irrigation Set labeled in part: ***24K Arthroscopy Outflow/Suction T... ConMed Linvatec recalled their 24k Arthroscopy Outflow/Suction Tubing Set (Product Number 24k100)... Class II Linvatec Corp. dba ConMed Linvatec
Jun 28, 2011 epoc Blood Analysis BGEM Test Cards for use with the epoc(R) Blood Analysis S... Customer reported problem while performing incoming QC of newly received lot of test cards. Liqu... Class II Epocal Inc
Jun 24, 2011 ***REF SC2101***eMax 2 Plus Console, Single Port, with Irrigation***SN G17307... The RPM of the Motor Handpiece may be less than 80,000 RPM. Class II The Anspach Effort, Inc.
Jun 24, 2011 ***REF SC2102***eMax 2 Plus Console, Single Port, no Irrigation***SN G1630788... The RPM of the Motor Handpiece may be less than 80,000 RPM. Class II The Anspach Effort, Inc.
Jun 24, 2011 ***REF SC2100***eMax 2 Plus Console***SN G 10307653002*** Product Usage: ... The RPM of the Motor Handpiece may be less than 80,000 RPM. Class II The Anspach Effort, Inc.
Jun 13, 2011 Z-800 Volumetric Infusion System. For intravenous infusion of parenteral f... Update Instruction For Use for Preventative Maintenance (PM) Schedule and addition of Odometer so... Class II Zyno Medical LLC
May 31, 2011 BioDerm Liberty 3.0 External Male Catheter Specialty Type with integral colle... On 06/08/2011, BioDerm, Inc. issued a voluntary recall of a component skin wipes for the BioDerm ... Class II BioDerm, Inc.
May 31, 2011 BioDerm Safe n' Dry 21006 (Component: SKIN-PREP Protective wipes). The rec... On 06/08/2011, BioDerm, Inc. issued a voluntary recall of a component (Smith and Nephew skin wipe... Class II BioDerm, Inc.
May 31, 2011 Varian High Energy Clinacs, High Energy Accelerator, Radiation Treatment Syst... Under certain conditions, photon beams in High Energy Clinacs may experience a gradual change in ... Class II Varian Medical Systems, Inc. Oncology Systems
May 31, 2011 BioDerm Liberty Pouch Clean & Dry External Male Catheter Specialty Type with ... On 06/08/2011, BioDerm, Inc. issued a voluntary recall of a component skin wipes for the BioDerm ... Class II BioDerm, Inc.
May 30, 2011 The product affected by this notice is sold under the trade name TomoTherapy... This field notice concerns two behaviors of the SharePlan (Multiple Fraction Groups and Depth Off... Class II RAYSEARCH LABORATORIES AB
May 24, 2011 Neptune¿ 2 Rover - ULTRA ~230V ~ 50 Hz 12A REF 0702-002-000, Rx Caution, con... Beginning May 24, 2011 Stryker Neptune 2 (N2) Waste Management Systems castors were replaced with... Class II Stryker Instruments Div. of Stryker Corporation
May 24, 2011 Neptune¿ 2 Rover - ULTRA ~120V ~ 60 Hz 12A REF 0702-001-000, Rx, Caution, co... Beginning May 24, 2011 Stryker Neptune 2 (N2) Waste Management Systems castors were replaced with... Class II Stryker Instruments Div. of Stryker Corporation
May 20, 2011 ***REF LS7700***Qty 1*** EC REP*** ConMed Linvatec Xenon Universal Light Source Linvatec Corporation dba ConMed Linvatec, Largo, FL initiated a recall of their products LS7700 X... Class II Linvatec Corp. dba ConMed Linvatec
May 20, 2011 ***REF LS7600***Qty 1*** EC REP*** ConMed Linvatec Xenon Light Source Linvatec Corporation dba ConMed Linvatec, Largo, FL initiated a recall of their products LS7700 X... Class II Linvatec Corp. dba ConMed Linvatec
May 16, 2011 GE Healthcare, Innova 3100 and Innova 4100 systems. The Digital Fluoroscop... GE Healthcare reported a potential safety issue due to temporary loss of X-Ray Imaging Modes dur... Class II GE Healthcare, LLC
May 12, 2011 DPM Central Station Mindray DS USA, Inc. 800 MacArthur Boulevard, Mahwah, NJ... There is a software anomaly with the DPM Central Monitoring System where the trend data of one pa... Class II Mindray DS USA, Inc. d.b.a. Mindray North America
May 10, 2011 Optima MR450w, Discovery MR450, Discovery MR750, Signa HDx, Signa HDxt, Signa... An error on the SR Viewer Reporting Tool in which edits can be made on a report and can be saved ... Class II GE Healthcare, LLC
May 6, 2011 Pneumatic Systems Operating Manual (part numbers 19-0005) utilized with the P... Anspach Effort, Inc. Palm Beach Gardens, FL initiated a correction of its medical Device labeling... Class II The Anspach Effort, Inc.
May 6, 2011 Cutting Bur Chart (part number 20-0019) utilized with the Electric and Pneuma... Anspach Effort, Inc. Palm Beach Gardens, FL initiated a correction of its medical Device labeling... Class II The Anspach Effort, Inc.
May 6, 2011 Product Catalog (part number 20-0020) utilized with the Electric and Pneumati... Anspach Effort, Inc. Palm Beach Gardens, FL initiated a correction of its medical Device labeling... Class II The Anspach Effort, Inc.
May 2, 2011 Lithium Thionyl non-rechargeable disposable battery pack P/N 350-0294-00 used... Braemar Inc., became aware of a battery related incident that occurred with an Able battery pack... Class II BRAEMAR, INC.
May 1, 2011 Cardiogenesis Corporation - Cardiogenesis Transmyocardial Laser. The devic... Following acquisition of Cardiogenesis, we began receiving complaints of sparks, burns, or smoke ... Class II Cardiogenesis Corporation
Apr 28, 2011 Sunquest Laboratory SMART & Sunquest Laboratory SMART Select In Online Entry (OEx) there are two scenarios where a Test result from one container may file to ... Class III Sunquest Information Systems, Inc.
Apr 25, 2011 IO FiX X-Post Reamer, Extremity Medical, www.extremitymedical.com; Customer S... Product Event Reports revealed a broken reamer experienced intra-operatively. Pre-drilling was n... Class II Extremity Medical LLC
Apr 13, 2011 IO Fix IntraOsseous Fixation System; Extremity Medical. www.extremitymedical... Product Event Reports revealed that lag screw passes through washer (e.g. X-Post) intra-operatively. Class II Extremity Medical LLC

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.