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Browse Device Recalls

530 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 530 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 530 FDA device recalls.

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DateProductReasonClassFirm
Jan 11, 2016 Product 7 consists of all products under product code HWC, and same usage: ... As a result of the insufficient sealer calibration data for product packaged in firm's Building I... Class II Zimmer Manufacturing B.V.
Jan 11, 2016 Product 27 consists of all product under product code: HSB and same usage: ... As a result of the insufficient sealer calibration data for product packaged in firm's Building I... Class II Zimmer Manufacturing B.V.
Jan 11, 2016 Product 37 consists of all product under product code: HSB and same usage: ... As a result of the insufficient sealer calibration data for product packaged in firm's Building I... Class II Zimmer Manufacturing B.V.
Jan 11, 2016 Product 64 consists of all product under product code: JDI and same usage: I... As a result of the insufficient sealer calibration data for product packaged in firm's Building I... Class II Zimmer Manufacturing B.V.
Jan 11, 2016 Product 1 consists of all product under , product code: JWH and same usage: ... As a result of the insufficient sealer calibration data for product packaged in firm's Building I... Class II Zimmer Manufacturing B.V.
Jan 11, 2016 Product 54 consists of all product under product code: JWH and same usage: I... As a result of the insufficient sealer calibration data for product packaged in firm's Building I... Class II Zimmer Manufacturing B.V.
Jan 11, 2016 Product 67 consists of all product under product code: JDI and same usage: I... As a result of the insufficient sealer calibration data for product packaged in firm's Building I... Class II Zimmer Manufacturing B.V.
Jan 11, 2016 Product 35 consists of all product under product code: JWH and same usage: ... As a result of the insufficient sealer calibration data for product packaged in firm's Building I... Class II Zimmer Manufacturing B.V.
Jan 11, 2016 Product 19 consists of all product code: JDI and same usage: Item no: 7653... As a result of the insufficient sealer calibration data for product packaged in firm's Building I... Class II Zimmer Manufacturing B.V.
Jan 11, 2016 Product 62 consists of all product under product code: LPH and same usage: I... As a result of the insufficient sealer calibration data for product packaged in firm's Building I... Class II Zimmer Manufacturing B.V.
Jan 11, 2016 Product 14 consists of all product under product code HSB , and same usage:... As a result of the insufficient sealer calibration data for product packaged in firm's Building I... Class II Zimmer Manufacturing B.V.
Jan 11, 2016 Product 65 consists of all product under product code: KTT and same usage: I... As a result of the insufficient sealer calibration data for product packaged in firm's Building I... Class II Zimmer Manufacturing B.V.
Jan 11, 2016 Product 10consists of all product under product code HWC, and same usage: It... As a result of the insufficient sealer calibration data for product packaged in firm's Building I... Class II Zimmer Manufacturing B.V.
Jan 11, 2016 Product 59 consists of all product under product code: JWH and same usage: I... As a result of the insufficient sealer calibration data for product packaged in firm's Building I... Class II Zimmer Manufacturing B.V.
Jan 11, 2016 Product 34 consists of all product under product code: JWH and same usage: ... As a result of the insufficient sealer calibration data for product packaged in firm's Building I... Class II Zimmer Manufacturing B.V.
Jan 11, 2016 Product 45 consists of all product under product code: JWH and same usage: ... As a result of the insufficient sealer calibration data for product packaged in firm's Building I... Class II Zimmer Manufacturing B.V.
Jan 11, 2016 Product 17 consists of all product under product code: LPH and same usage: ... As a result of the insufficient sealer calibration data for product packaged in firm's Building I... Class II Zimmer Manufacturing B.V.
Jan 11, 2016 Product 36 consists of all product under product code: HSB and same usage: ... As a result of the insufficient sealer calibration data for product packaged in firm's Building I... Class II Zimmer Manufacturing B.V.
Jan 11, 2016 Product 51 consists of all product under product code: JWH and same usage: ... As a result of the insufficient sealer calibration data for product packaged in firm's Building I... Class II Zimmer Manufacturing B.V.
Jan 11, 2016 Product 28 consists of all product under product code: JDI and same usage: I... As a result of the insufficient sealer calibration data for product packaged in firm's Building I... Class II Zimmer Manufacturing B.V.
Jan 11, 2016 Product 5 consists of all products under product code HWC, and same usage: ... As a result of the insufficient sealer calibration data for product packaged in firm's Building I... Class II Zimmer Manufacturing B.V.
Jan 11, 2016 Product 18 consists of all product under product code: HWC and same usage: ... As a result of the insufficient sealer calibration data for product packaged in firm's Building I... Class II Zimmer Manufacturing B.V.
Jan 11, 2016 Product 52 consists of product code: HWC and same usage: Item no: 52500453... As a result of the insufficient sealer calibration data for product packaged in firm's Building I... Class II Zimmer Manufacturing B.V.
Jan 11, 2016 Product 29 consists of all product under product code: LPHand same usage: I... As a result of the insufficient sealer calibration data for product packaged in firm's Building I... Class II Zimmer Manufacturing B.V.
Jan 11, 2016 Product 31 consists of all product under product code: KTT and same usage: ... As a result of the insufficient sealer calibration data for product packaged in firm's Building I... Class II Zimmer Manufacturing B.V.
Jan 11, 2016 Product 12 consists of all product under product code JDI , and same usage: ... As a result of the insufficient sealer calibration data for product packaged in firm's Building I... Class II Zimmer Manufacturing B.V.
Jan 11, 2016 Product 48 consists of all product under product code: JWH and same usage: ... As a result of the insufficient sealer calibration data for product packaged in firm's Building I... Class II Zimmer Manufacturing B.V.
Jan 11, 2016 Product 25 consists of all product under product code: LPH and same usage: I... As a result of the insufficient sealer calibration data for product packaged in firm's Building I... Class II Zimmer Manufacturing B.V.
Dec 23, 2015 Moog Curlin Infusion, Ambulatory Infusion Pump The Curlin Ambulatory Infusi... Moog is recalling Curlin 4000, 6000, and PainSmart Infusion Pumps manufactured or serviced by MMD... Class II MOOG Medical Devices Group
Nov 12, 2015 Digital Temple Thermometer labeled under: Bestmed, Good Neighbor (Amerisource... An incorrect calibration of the thermometer that causes the device to display inaccurate and freq... Class II Bestmed, LLC
Nov 11, 2015 Siemens Acute Care BHCG TestPak-an in vitro diagnostic product intended to be... Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems Class II Siemens Healthcare Diagnostics Inc
Nov 11, 2015 Siemens Acute Care BHCG CalPak-in vitro diagnostic product intended to be use... Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems Class II Siemens Healthcare Diagnostics Inc
Nov 11, 2015 Siemens Acute Care CCRP CalPak-in vitro diagnostic product intended to be use... Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems Class II Siemens Healthcare Diagnostics Inc
Nov 11, 2015 Siemens Acute Care" CCRP TestPak-in vitro diagnostic product intended to be u... Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems Class II Siemens Healthcare Diagnostics Inc
Nov 5, 2015 Altrus Thermal Tissue Fusion Energy Sources, Catalog Numbers: 1) 60-9500-120 ... Miscalibration of the Energy Source monitoring function, which may incorrectly sense the handpiec... Class II ConMed Corporation
Nov 3, 2015 Dimension Vista System B2 Microglobulin Flex reagent cartridge and urine sta... Siemens Healthcare Diagnostics has confirmed an increase in the rate of Abnormal Assay errors a... Class II Siemens Healthcare Diagnostics, Inc.
Oct 7, 2015 ADVIA Chemistry XPT Systems, Software Version 1.0.3, SMN 11127538 Clinical... Multiple Software issues. Auto Start-UP Fail, Calibration Interval Resets when a Reagent Blank is... Class II Siemens Healthcare Diagnostics, Inc.
Aug 28, 2015 ADVIA Chemistry XPT Chemistry Systems, Siemens Material Number (SMN) 1072303... ISE module may produce discrepant, unflagged results for Sodium, Potassium or Chloride when the r... Class II Siemens Healthcare Diagnostics, Inc.
Jul 14, 2015 cobas b 123 Fluid Pack COOX REF 05169992001 200 Product Usage: The cobas ... Low PO2 results. QC failures of the PO2 parameter, affecting primarily Levels 1 and 2, caused b... Class II Roche Diagnostics Operations, Inc.
Jul 14, 2015 cobas b 123 Fluid Pack COOX REF 05170036001 400 Product Usage: The cobas ... Low PO2 results. QC failures of the PO2 parameter, affecting primarily Levels 1 and 2, caused b... Class II Roche Diagnostics Operations, Inc.
May 1, 2015 Integra¿ Long Epidural Steroid Injection Needle (Tuohy Needle), 20 gauge x 5 ... Integra LifeSciences Corp. d.b.a. Integra Pain Management Announces Voluntary Recall of Tuohy Nee... Class II Integra LifeSciences Corp. d.b.a. Integra Pain ...
Mar 30, 2015 Integra Long Epidural Steroid Injection Needle (Tuohy Needle), 18 Gauge x 5 i... A single lot of 18 Gauge, 3.5 inch Tuohy Needles were incorrectly packaged and labeled as 18 Gaug... Class II Integra LifeSciences Corp. d.b.a. Integra Pain ...
Feb 24, 2015 QuikLYTE Dilution Check: used to monitor and adjust for the dilution ratio on... A positive bias beyond 5% resulting in a dilution check failure or an unnecessary dilution check ... Class II Siemens Healthcare Diagnostics, Inc.
Feb 17, 2015 EOS, Digital radiography system used in general radiographic examinations. When performing calibration, an alert message on the spectral filtration of the X-ray beam may be... Class II Eos Imaging Inc
Jan 19, 2015 ADVIA Chemistry Systems Drug Calibrator I; For in vitro diagnostic use in the... Incorrect calibrator lot values were assigned for ADVIA Chemistry Systems Drug Calibrator I, lot ... Class II Siemens Healthcare Diagnostics, Inc.
Jan 12, 2015 Servo-I ventilator system CO2 analyzer. Part number 65 23 588. A calibration problem was detected in a specific number of the Servo-I ventilator system CO2 anal... Class II Maquet Cardiovascular Us Sales, Llc
Dec 8, 2014 ABL90 FLEX analyzer; Model number 393-090. A portable, automated analyzer th... The ABL90 analyzer does not always use the most recent calibration data to calculate patient resu... Class II Radiometer America Inc
Nov 24, 2014 Dimension Vista Myoglobin Calibrator (MYO CAL), Lot 4FD085 Product usage:... Dimension Vista Myoglobin Calibrator (MYO CAL) may produce a positive shift in MYO QC and Patient... Class II Siemens Healthcare Diagnostics, Inc.
Nov 19, 2014 VITROS 5600 Integrated System, Catalog Number 6802413, IVD --- Ortho Clinical... Software Anomaly: the firm has identified an anomaly with VITROS System Software Version 3.1 and ... Class II Ortho-Clinical Diagnostics
Nov 19, 2014 VITROS 4600 Chemistry System (VITROS 5,1 FS System family member), Catalog Nu... Software Anomaly: the firm has identified an anomaly with VITROS System Software Version 3.1 and ... Class II Ortho-Clinical Diagnostics

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.