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Medical Device Recalls in the United States

Monitor U.S. medical device recall enforcement reports from the FDA. Review product descriptions, recall reasons, classifications, dates, recalling firms and distribution information where the FDA provides them.

29,496medical device recall records

2,407FDA Class I records

8firms with 5+ records

Zimmer Biomet, Inc.784 records

Database records

Records — page 1128

29,496 detailed records are currently available in this category.

Medical DeviceDec 30, 2015

Rainbow Specialty & Health Products Dressit-X, Radiopaque D-545, NDC 11004-545-40, Dental recall — FDA Z-0477-2016

Rainbow Specialty & Health Products initiated a field action for Dressol-X and Dressit-X because the labeling does not currently list the percentage of drug components.

Class IIFDA: TerminatedRainbow Specialty & Health Products

Medical DeviceDec 30, 2015

Ameditech ProScreen 6 Panel Cassette w/Adult (AU), Item No recall — FDA Z-0525-2016

Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is…

Class IIIFDA: TerminatedAmeditech Inc.

Medical DeviceDec 30, 2015

Siemens Healthcare Diagnostics Reagent Management System (RMS) Dimension RxL Max w/o HM recall — FDA Z-0460-2016

Siemens has identified RMS refrigeration compressors that are missing the safety cover on the electrical termination block. The exposed electrical hazard on the electrical termination block…

Class IIFDA: TerminatedSiemens Healthcare Diagnostics Inc.

Medical DeviceDec 23, 2015

Myco Medical Supplies Unolok Blunt Fill Needle 18G x 1.5" Red, Sterile, Single use recall — FDA Z-0444-2016

Particulates: Complaints of rubber coring from the closure of injection vials.

Class IIFDA: TerminatedMyco Medical Supplies Inc.

Medical DeviceDec 23, 2015

bioMerieux MYLA CLINIC PATCH 3.2.0 CD Product Usage: MYLA is a computer application recall — FDA Z-0425-2016

MYLA software connected to a Laboratory Information System (LIS) and a VITEK 2 system has the potential to link a test result to an incorrect patient record with the same specimen ID.

Class IIFDA: TerminatedbioMerieux, Inc.

Medical DeviceDec 23, 2015

Beckman Coulter UniCel DxH 600 Coulter Cellular Analysis System, Software Version 3.0.2.0 recall — FDA Z-0433-2016

Beckman Coulter is recalling the DxH 800 Slidemaker Stainer Software version 3.0.2.0 and DxH 600 software version 1.1.1.0 because the software for the DxH systems allows the creation of…

Class IIFDA: TerminatedBeckman Coulter Inc.

Medical DeviceDec 23, 2015

Remel Oxoid Gentamicin Antimicrobial Susceptibility Testing Disc (CN10), REF# CT0024B recall — FDA Z-0443-2016

Antibiotic concentration may be insufficient which may result in incorrect test results.

Class IIFDA: TerminatedRemel Inc.

Medical DeviceDec 23, 2015

Philips Healthcare Ingenuity Core Computed Tomography X-ray system recall — FDA Z-0406-2016

During scans with specific protocol steps, the software unexpectedly sets the Axial ( 2 axis ) scan length to a different length than the user set in the plan.

Class IIFDA: TerminatedPhilips Electronics North America Corporation

Medical DeviceDec 23, 2015

Insulet OmniPod, Insulin Management System (OUS) recall — FDA Z-0394-2016

Pod's needle mechanism fails to deploy or there is a delay in the deployment of the needle mechanism.

Class IFDA: TerminatedInsulet Corporation

Medical DeviceDec 23, 2015

GE Medical Systems GE Healthcare Optima IGS 320 recall — FDA Z-0414-2016

GE Healthcare has recently become aware of a potential safety issue related to a non-recoverable loss of displayed imaging (loss of monitor video) involving Optima CL323i & Optima IGS 320…

Class IIFDA: TerminatedGE Medical Systems, LLC

Medical DeviceDec 23, 2015

bioMerieux MYLA MASTER DVD 3.2 CLI DL380 Product Usage: MYLA is a computer application recall — FDA Z-0426-2016

MYLA software connected to a Laboratory Information System (LIS) and a VITEK 2 system has the potential to link a test result to an incorrect patient record with the same specimen ID.

Class IIFDA: TerminatedbioMerieux, Inc.

Medical DeviceDec 23, 2015

Verathon GlideScope AVL Video Laryngoscope (AVL), Part Number AVL 3- 0574-0115 recall — FDA Z-0421-2016

Certain models and serial numbers of GlideScope GVL and AVL laryngoscope blades may separate, due to inadequate bonding of the silicone adhesive affixing the halves of the blade. The…

Class IIFDA: TerminatedVerathon, Inc.

Medical DeviceDec 23, 2015

Stryker Instruments Div. of Stryker Cournand Modified 2-PC 19G, 5.4cm or recall — FDA Z-0417-2016

The Guidewire Introducer Needle (0910-192-000) was shipped after the documented expiration date or with minimal time until expiration. There is a potential risk of a soft tissue infection…

Class IIFDA: TerminatedStryker Instruments Div. of Stryker Corporation

Medical DeviceDec 23, 2015

Elekta MOSAIQ Oncology Information System recall — FDA Z-0447-2016

First Databank (FDB) is a third party product incorporated into MOSAIQ. FDB routinely modifies drugs in their database to reflect market and formulary changes. In FDB Framework v2.0, those…

Class IIFDA: TerminatedElekta, Inc.

Medical DeviceDec 23, 2015

Summit Medical AbsorbENT, Sterile Compressed Absorbent Sponge, Nasal Pack, 8.9cm(L) x 3.0cm recall — FDA Z-0435-2016

Summit Medical is recalling Doyle P/F Nasal Pack w/Airway, string 8 cm x 3 cm x 1.5 cm, Catalog # RH-7413-10, Lot # 160889 & 161354 because the product does not have the split in the…

Class IIFDA: TerminatedSummit Medical, Inc.

Medical DeviceDec 23, 2015

bioMerieux MYLA CLI V3.X TO V4.1 ML350 SERVER Product Usage: MYLA is a computer application recall — FDA Z-0431-2016

MYLA software connected to a Laboratory Information System (LIS) and a VITEK 2 system has the potential to link a test result to an incorrect patient record with the same specimen ID.

Class IIFDA: TerminatedbioMerieux, Inc.

Medical DeviceDec 23, 2015

Medtronic MiniMed MiniMed 640G, 3.0mL mmol/L, 3.0mL mg/dL, Model No recall — FDA Z-0438-2016

The pump drive motors may experience a malfunction which would result in a pump error message alarm notifying you that insulin is no longer being delivered. Possible cause is either lack of…

Class IIFDA: TerminatedMedtronic MiniMed Inc.

Medical DeviceDec 23, 2015

Bestmed Digital Temple Thermometer labeled under: Bestmed, Good Neighbor recall — FDA Z-0412-2016

An incorrect calibration of the thermometer that causes the device to display inaccurate and frequently lower temperatures than the actual body temperature of the user.

Class IIFDA: TerminatedBestmed, LLC

Medical DeviceDec 23, 2015

bioMerieux MYLA CLI V3.X TO V4.1 DL380 SERVER Product Usage: MYLA is a computer application recall — FDA Z-0430-2016

MYLA software connected to a Laboratory Information System (LIS) and a VITEK 2 system has the potential to link a test result to an incorrect patient record with the same specimen ID.

Class IIFDA: TerminatedbioMerieux, Inc.

Medical DeviceDec 23, 2015

bioMerieux MYLA CLINIC PATCH 3.3.0 CD Product Usage: MYLA is a computer application recall — FDA Z-0427-2016

MYLA software connected to a Laboratory Information System (LIS) and a VITEK 2 system has the potential to link a test result to an incorrect patient record with the same specimen ID.

Class IIFDA: TerminatedbioMerieux, Inc.

Medical DeviceDec 23, 2015

Fujifilm Medical Systems Duodenoscope, Model Numbers ED-200XU, ED-200XT, ED-250XT, ED-310XU recall — FDA Z-0418-2016

A precautionary measure because the Duodenoscopes have been redesigned to incorporate a closed elevator wire channel that facilitates reprocessing.

Class IIFDA: TerminatedFujifilm Medical Systems U.S.A., Inc.

Medical DeviceDec 23, 2015

Cook VentriClear II Ventricular Drainage Catheter Set recall — FDA Z-0416-2016

Cook Medical initiated a voluntary recall of specific lot numbers of the VentriClear II Ventricular Drainage Catheter Set due to the device being sterilized twice, which may result in the…

Class IIFDA: TerminatedCook Inc.

Medical DeviceDec 23, 2015

Beckman Coulter UniCel DxH 600 Coulter Cellular Analysis System, Software Version 1.1.1.0 recall — FDA Z-0434-2016

Beckman Coulter is recalling the DxH 800 Slidemaker Stainer Software version 3.0.2.0 and DxH 600 software version 1.1.1.0 because the software for the DxH systems allows the creation of…

Class IIFDA: TerminatedBeckman Coulter Inc.

Medical DeviceDec 23, 2015

Medtronic MiniMed MiniMed 620G, 3.0mL mg/dL, Model No recall — FDA Z-0437-2016

The pump drive motors may experience a malfunction which would result in a pump error message alarm notifying you that insulin is no longer being delivered. Possible cause is either lack of…

Class IIFDA: TerminatedMedtronic MiniMed Inc.

How to use this medical device recall index

Medical device recall records can change as the FDA receives additional information. Check the official record identifier and current FDA information before making health or product-use decisions.

Recall Lookup USA keeps the last complete source record available when an official data service is temporarily unavailable. When a source provides only a few fields, we show only those known facts rather than padding the page with generic text.

What the database can and cannot tell you

This database is designed for discovery and reference. It can help you locate a relevant recall record, identify the recalling firm or NHTSA campaign, compare dates and classifications, and follow the official source. It is not a substitute for a VIN-specific NHTSA check, a manufacturer notice, medical advice or instructions issued by the recalling company.