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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 1116

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

Medical DeviceFeb 10, 2016

Smith & Nephew, Inc., Endoscopy Div Biosure Ratchet Driver, Product No: 72201888 For recall — FDA Z-0700-2016

Driver does not meet specification, oversized. Driver may not be able to be fully inserted into the screw, or screw may become stuck on the driver.

Class IIFDA: TerminatedSmith & Nephew, Inc., Endoscopy Div.

Medical DeviceFeb 10, 2016

Philips Electronics INTEGRIS BH3000 recall — FDA Z-0720-2016

The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live images and still images can lead to still images being interpreted as live Images.

Class IIFDA: TerminatedPhilips Electronics North America Corporation

Medical DeviceFeb 10, 2016

Horiba Instruments ABX PENTRA Triglycerides CP ref recall — FDA Z-0742-2016

N-Acetylcysteine (NAC) present in the blood of patients treated for paracetamol overdose can interfere with the Trinder reaction that uses hydrogen peroxide catalytic on aminoantipyrine and…

Class IIFDA: TerminatedHoriba Instruments Inc.

Medical DeviceFeb 10, 2016

Philips Electronics INTEGRIS BH5000 recall — FDA Z-0723-2016

The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live images and still images can lead to still images being interpreted as live Images.

Class IIFDA: TerminatedPhilips Electronics North America Corporation

Medical DeviceFeb 10, 2016

Horiba Instruments ABX PENTRA Uric Acid CP ref recall — FDA Z-0743-2016

N-Acetylcysteine (NAC) present in the blood of patients treated for paracetamol overdose can interfere with the Trinder reaction that uses hydrogen peroxide catalytic on aminoantipyrine and…

Class IIFDA: TerminatedHoriba Instruments Inc.

Medical DeviceFeb 10, 2016

The Anspach Effort Synthes Small Electric Drive (SED) recall — FDA Z-0747-2016

The affected Small Electric Drive (SED) may operate solely in reverse mode, not operate in reverse mode when intended, not function, or unintentionally start.

Class IIFDA: TerminatedThe Anspach Effort, Inc.

Medical DeviceFeb 10, 2016

Philips Electronics INTEGRIS BV5000 recall — FDA Z-0725-2016

The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live images and still images can lead to still images being interpreted as live Images.

Class IIFDA: TerminatedPhilips Electronics North America Corporation

Medical DeviceFeb 10, 2016

Draeger Medical Emergency Transport Ventilator Oxylog 2000 Plus Ventilator recall — FDA Z-0691-2016

Drager became aware of situations where the error message "Poti unplugged" was generated causing acoustic and visual alarms, the breathing system releases pressure and the ventilation…

Class IFDA: TerminatedDraeger Medical, Inc.

Medical DeviceFeb 10, 2016

Draeger Medical Emergency Transport Ventilator Oxylog 3000 Ventilator and Oxylog 3000 plus recall — FDA Z-0692-2016

Drager became aware of situations where the error message "Poti unplugged" was generated causing acoustic and visual alarms, the breathing system releases pressure and the ventilation…

Class IFDA: TerminatedDraeger Medical, Inc.

Medical DeviceFeb 10, 2016

Smith & Nephew, Inc., Endoscopy Div Biosure Driver, Product No: 72201887 For delivery and recall — FDA Z-0699-2016

Driver does not meet specification, oversized. Driver may not be able to be fully inserted into the screw, or screw may become stuck on the driver.

Class IIFDA: TerminatedSmith & Nephew, Inc., Endoscopy Div.

Medical DeviceFeb 10, 2016

Siemens Healthcare Diagnostics ADVIA Chemistry XPT Systems, Software Version 1.0.3, SMN recall — FDA Z-0755-2016

Multiple Software issues. Auto Start-UP Fail, Calibration Interval Resets when a Reagent Blank is run, Control Definition screen assumes range defined is 2 SD, Laboratory Information System…

Class IIFDA: TerminatedSiemens Healthcare Diagnostics, Inc.

Medical DeviceFeb 10, 2016

Resmed Astral 100, 150 Model: 27001, 27003 In the US, Astral devices are primarily used as recall — FDA Z-0746-2016

Resmed Corporation is recalling Astral 100, 150 External Battery because of a start-up issue.

Class IIFDA: TerminatedResmed Corporation

Medical DeviceFeb 10, 2016

Owens & Minor Distribution MediChoice Cohesive Bandages, One (1) roll of cohesive bandage recall — FDA Z-0734-2016

MediChoice sterile cohesive bandages imported and sold under a private brand by Owens & Minor were tested and found to have microbial contamination.

Class IIFDA: TerminatedOwens & Minor Distribution, Inc.

Medical DeviceFeb 10, 2016

Horiba Instruments ABX PENTRA Lactic Acid CP ref recall — FDA Z-0741-2016

N-Acetylcysteine (NAC) present in the blood of patients treated for paracetamol overdose can interfere with the Trinder reaction that uses hydrogen peroxide catalytic on aminoantipyrine and…

Class IIFDA: TerminatedHoriba Instruments Inc.

Medical DeviceFeb 10, 2016

Philips Electronics Allura CV20 recall — FDA Z-0715-2016

The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live images and still images can lead to still images being interpreted as live Images.

Class IIFDA: TerminatedPhilips Electronics North America Corporation

Medical DeviceFeb 10, 2016

Philips Electronics INTEGRIS Allura 15-12 (mono) recall — FDA Z-0727-2016

The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live images and still images can lead to still images being interpreted as live Images.

Class IIFDA: TerminatedPhilips Electronics North America Corporation

Medical DeviceFeb 10, 2016

Philips Electronics INTEGRIS H3000 recall — FDA Z-0717-2016

The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live images and still images can lead to still images being interpreted as live Images.

Class IIFDA: TerminatedPhilips Electronics North America Corporation

Medical DeviceFeb 10, 2016

Horiba Instruments The ABX PENTRA Cholesterol CP ref recall — FDA Z-0738-2016

N-Acetylcysteine (NAC) present in the blood of patients treated for paracetamol overdose can interfere with the Trinder reaction that uses hydrogen peroxide catalytic on aminoantipyrine and…

Class IIFDA: TerminatedHoriba Instruments Inc.

Medical DeviceFeb 10, 2016

Philips Electronics INTEGRIS BN/BV3000 recall — FDA Z-0719-2016

The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live images and still images can lead to still images being interpreted as live Images.

Class IIFDA: TerminatedPhilips Electronics North America Corporation

Medical DeviceFeb 10, 2016

ACIST Medical Systems, BT2000 Automated Manifold Kit (SKU 014613) and CPT2000 (SKU 014623) recall — FDA Z-0744-2016

Reports related to ingress of air into the manifold.

Class IIFDA: TerminatedAcist Medical Systems

Medical DeviceFeb 10, 2016

Global Healthcare ET-20 Anesthesia Extension Tubes, 2.5 ml approximately, Sterile and recall — FDA Z-0696-2016

Firm was notified of a potential product defect related to kinking (flattening) of anesthesia extension tubes which may represent a potential health hazard.

Class IIFDA: TerminatedGlobal Healthcare Inc.

Medical DeviceFeb 10, 2016

Philips Electronics UNIQ FD; Model Numbers: 722028 The Philips UNIQ is intended for use on recall — FDA Z-0708-2016

The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live images and still images can lead to still images being interpreted as live Images.

Class IIFDA: TerminatedPhilips Electronics North America Corporation

Medical DeviceFeb 10, 2016

Philips Electronics INTEGRIS Allura 9 (biplane) recall — FDA Z-0726-2016

The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live images and still images can lead to still images being interpreted as live Images.

Class IIFDA: TerminatedPhilips Electronics North America Corporation

Medical DeviceFeb 10, 2016

Olympus TJF-Q180V flexible gastrointestinal Duodenoscope Product Usage: This instrument has recall — FDA Z-0757-2016

Olympus America Inc is conducting a voluntary removal/corrective action of all TJF-Q180V duodenoscopes in order to replace the forceps elevator mechanism Olympus is replacing the forceps…

Class IIFDA: TerminatedOlympus Corporation of the Americas

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.