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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 1117

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

Medical DeviceFeb 10, 2016

Philips Electronics Allura Xper FD20 Biplane OR Table recall — FDA Z-0712-2016

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 Cardiovascular Allura Centron recall — FDA Z-0716-2016

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 Allura Xper FD20; Model Numbers: 722028 722012 722006 Dedicated vascular recall — FDA Z-0707-2016

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

bioMerieux BacT/ALERT FA, bioM¿rieux, Inc., Product Usage: BacT/ALERT Culture Bottles are recall — FDA Z-0750-2016

Bottles may have been exposed to non-normal shipping conditions which may lead to media degradation and impact growth performance.

Class IIFDA: TerminatedbioMerieux, Inc.

Medical DeviceFeb 10, 2016

Owens & Minor Distribution MediChoice Cohesive Bandages, One (1) roll of cohesive bandage recall — FDA Z-0733-2016

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

Radiometer AQURE System recall — FDA Z-0748-2016

The AQURE System has a design error regarding sample type in which sample type may be specified for some results and left blank for other results. The fact that the sample type field is…

Class IIFDA: TerminatedRadiometer America Inc.

Medical DeviceFeb 10, 2016

Mindray DS USA, Inc. dba Mindray Panorama Patient Monitoring Network recall — FDA Z-0701-2016

An issue with the Panorama Central Station may cause the system to spontaneously restart. This may occur after about 49 days of continuous operation. On restart, monitoring will be lost for…

Class IIFDA: TerminatedMindray DS USA, Inc. dba Mindray North America

Medical DeviceFeb 10, 2016

Philips Electronics INTEGRIS HM3000 recall — FDA Z-0718-2016

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 V5000 recall — FDA Z-0724-2016

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 BV3000 MONO recall — FDA Z-0730-2016

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 Allura Xper FD20 OR Table recall — FDA Z-0710-2016

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 Medical Systems DS/US Proton Feature with Pinnacle3 Software Version 10.0.0 and recall — FDA Z-0745-2016

In DS/US proton planning, there is a correction factor used internally to the dose engine that is calculating improperly in some cases. This can result in an incorrect dose calculation.

Class IIFDA: TerminatedPhilips Medical Systems

Medical DeviceFeb 10, 2016

BioMerieux SA API ZYM Bx2 (Ref 70493) Product Usage: ZYM B reagent is an additional test recall — FDA Z-0756-2016

Discrepant identification results related to API identification strips. These discrepant identification results are due to false negative results on the tests of the strips linked to the…

Class IIFDA: TerminatedBioMerieux SA

Medical DeviceFeb 10, 2016

Owens & Minor Distribution MediChoice Cohesive Bandages, One (1) roll of cohesive bandage recall — FDA Z-0735-2016

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

Philips Electronics Allura Xper FD20/15 recall — FDA Z-0706-2016

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 Allura Xper FD20/20 recall — FDA Z-0713-2016

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 Enzymatic Creatinine CP ref recall — FDA Z-0739-2016

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

Siemens Healthcare Diagnostics ADVIA Centaur PSA Assay recall — FDA Z-0754-2016

PSA assay is not meeting the High Dose Hook Effect expectation in the Instructions for Use (IFU).

Class IIFDA: TerminatedSiemens Healthcare Diagnostics, Inc.

Medical DeviceFeb 10, 2016

Philips Electronics UNIQ FD OR table; Model Number 722035 The Philips UNIQ is intended for recall — FDA Z-0709-2016

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 3, 2016

Fresenius Liberty Cycler-Peritoneal Dialysis Cycler Model: 180111 and RTLR180111 recall — FDA Z-0693-2016

The door latch may not fully close and the door may open unexpectedly. The door may make physical contact with anything near the door of the machine, including the patient. May cause…

Class IIFDA: TerminatedFresenius Medical Care Renal Therapies Group, LLC

Medical DeviceFeb 3, 2016

Phadia Ab EliA SmDP Well, Article Number 14-5624-01 Product Usage: EliA SmDP is intended for recall — FDA Z-0697-2016

All equivocal and positive results (greater or equal 7 EliA U/ml) on EliA SmDP well lot 0018 may be incorrect and must be considered invalid. Patient samples in complaint investigations…

Class IIFDA: TerminatedPhadia Ab

Medical DeviceFeb 3, 2016

Globalmed Logistix Lipogems SPA Aspiration Cannulae, intended for aspiration of adipose recall — FDA Z-0690-2016

The cannulae may bend during procedure.

Class IIFDA: TerminatedGlobalmed Logistix

Medical DeviceFeb 3, 2016

Cook Medical Zilver 518RX Vascular Stent with Rapid Exchange Delivery System recall — FDA Z-0689-2016

Manufacturing of the joint between the inner catheter and stylet of the delivery system does not consistently meet specifications, and the joint may separate during deployment. Failure of…

Class IIFDA: TerminatedCook Medical Inc.

Medical DeviceFeb 3, 2016

Bio-Rad Laboratories D-10 Rack Loader; Model Number 220-0600; Hematology: The D-10 is a recall — FDA Z-0695-2016

On a rare occasion, there is a potential to assign a patient result to an incorrect sample ID when running in D10 Rack Loader configuration.

Class IIFDA: TerminatedBio-Rad Laboratories, 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.