Latest U.S. Recalls — FDA & NHTSA Records

Latest records

Latest recalls — page 1364

The newest recall records with useful source details are listed here.

Medical DeviceSep 19, 2018

SPS Sterilization Boston Scientific Wallstent Endoprosthesis Tracheobronchial Transhepatic recall — FDA Z-3035-2018

The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization process used does not have adequate support for the extended shelf life.

Class IIFDA: TerminatedSPS Sterilization, Inc.

Medical DeviceSep 19, 2018

Zimmer Biomet Affixus Hip Fracture Nail Right 130 13 mm x 400 mm, Item Number: 814513400 recall — FDA Z-3138-2018

The set screw is not able to advance or reverse from the original position in the nail.

Class IIFDA: TerminatedZimmer Biomet, Inc.

Medical DeviceSep 19, 2018

Zimmer Biomet Affixus Hip Fracture Nail Left 130 13 mm x 420 mm, Item Number: 814613420 recall — FDA Z-3171-2018

The set screw is not able to advance or reverse from the original position in the nail.

Class IIFDA: TerminatedZimmer Biomet, Inc.

Medical DeviceSep 19, 2018

Zimmer Biomet Affixus Hip Fracture Nail Right 125 13 mm x 300 mm, Item Number: 814313300 recall — FDA Z-3069-2018

The set screw is not able to advance or reverse from the original position in the nail.

Class IIFDA: TerminatedZimmer Biomet, Inc.

Medical DeviceSep 19, 2018

Zimmer Biomet Affixus Hip Fracture Nail Left 130 13 mm x 340 mm, Item Number: 814613340 recall — FDA Z-3167-2018

The set screw is not able to advance or reverse from the original position in the nail.

Class IIFDA: TerminatedZimmer Biomet, Inc.

Medical DeviceSep 19, 2018

Beaver Accu-Temp High Temperature Cautery, 2 inch Shaft with Fine Tip, Model Number 8445000 recall — FDA Z-3045-2018

A small number of devices in this lot may have a melted cap and a hole formed through the packaging. The risk is potentially the product will no longer be sterile for use and may cause harm…

Class IIFDA: TerminatedBeaver Visitec

Medical DeviceSep 19, 2018

Zimmer Biomet Affixus Hip Fracture Nail Right 125 11 mm x 300 mm, Item Number: 814311300 recall — FDA Z-3057-2018

The set screw is not able to advance or reverse from the original position in the nail.

Class IIFDA: TerminatedZimmer Biomet, Inc.

Medical DeviceSep 19, 2018

Zimmer Biomet Affixus Hip Fracture Nail 125 11 mm x 180 mm, Item Number: 814311180 recall — FDA Z-3055-2018

The set screw is not able to advance or reverse from the original position in the nail.

Class IIFDA: TerminatedZimmer Biomet, Inc.

Medical DeviceSep 19, 2018

Zimmer Biomet Affixus Hip Fracture Nail Right 125 13 mm x 180 mm, Item Number: 814313180 recall — FDA Z-3066-2018

The set screw is not able to advance or reverse from the original position in the nail.

Class IIFDA: TerminatedZimmer Biomet, Inc.

Medical DeviceSep 19, 2018

Zimmer Biomet Affixus Hip Fracture Nail Left 125 13 mm x 420 mm, Item Number: 814413420 recall — FDA Z-3106-2018

The set screw is not able to advance or reverse from the original position in the nail.

Class IIFDA: TerminatedZimmer Biomet, Inc.

Medical DeviceSep 19, 2018

Zimmer Biomet Affixus Hip Fracture Nail Left 130 11 mm x 460 mm, Item Number: 814611460 recall — FDA Z-3162-2018

The set screw is not able to advance or reverse from the original position in the nail.

Class IIFDA: TerminatedZimmer Biomet, Inc.

Medical DeviceSep 19, 2018

Zimmer Biomet Affixus Hip Fracture Nail Left 125 13 mm x 260 mm, Item Number: 814413260 recall — FDA Z-3098-2018

The set screw is not able to advance or reverse from the original position in the nail.

Class IIFDA: TerminatedZimmer Biomet, Inc.

Medical DeviceSep 19, 2018

Zimmer Biomet Affixus Hip Fracture Nail Left 125 9 mm x 360 mm, Item Number: 814409360 recall — FDA Z-3083-2018

The set screw is not able to advance or reverse from the original position in the nail.

Class IIFDA: TerminatedZimmer Biomet, Inc.

Medical DeviceSep 19, 2018

Zimmer Biomet Affixus Hip Fracture Nail 125 9 mm x 180 mm, Item Number: 814309180 recall — FDA Z-3047-2018

The set screw is not able to advance or reverse from the original position in the nail.

Class IIFDA: TerminatedZimmer Biomet, Inc.

Medical DeviceSep 19, 2018

Zimmer Biomet Affixus Hip Fracture Nail Right 130 15 mm x 360 mm, Item Number: 814515360 recall — FDA Z-3143-2018

The set screw is not able to advance or reverse from the original position in the nail.

Class IIFDA: TerminatedZimmer Biomet, Inc.

Medical DeviceSep 19, 2018

Ortho-Clinical Diagnostics VITROS Chemistry Products Cl- Slides, Product Code 844 5207 recall — FDA Z-3043-2018

The slides do not meet the maximum allowable interference (MAI) claims for triglyceride interference when using serum samples. Triglyceride interference on the Cl- Slide was observed around…

Class IIIFDA: TerminatedOrtho-Clinical Diagnostics

Medical DeviceSep 19, 2018

Zimmer Biomet Affixus Hip Fracture Nail Left 130 13 mm x 280 mm, Item Number: 814613280 recall — FDA Z-3164-2018

The set screw is not able to advance or reverse from the original position in the nail.

Class IIFDA: TerminatedZimmer Biomet, Inc.

Medical DeviceSep 19, 2018

Zimmer Biomet Affixus Hip Fracture Nail Right 130 9 mm x 380 mm, Item Number: 814509380 recall — FDA Z-3115-2018

The set screw is not able to advance or reverse from the original position in the nail.

Class IIFDA: TerminatedZimmer Biomet, Inc.

Medical DeviceSep 19, 2018

Zimmer Biomet Affixus Hip Fracture Nail Left 125 9 mm x 300 mm, Item Number: 814409300 recall — FDA Z-3080-2018

The set screw is not able to advance or reverse from the original position in the nail.

Class IIFDA: TerminatedZimmer Biomet, Inc.

Medical DeviceSep 19, 2018

SPS Sterilization Edwards Lifesciences Thin-Flex Single Stage Venous Drainage Cannula, 34F recall — FDA Z-3030-2018

The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization process used does not have adequate support for the extended shelf life.

Class IIFDA: TerminatedSPS Sterilization, Inc.

Medical DeviceSep 19, 2018

Zimmer Biomet Affixus Hip Fracture Nail Right 130 9 mm x 360 mm, Item Number: 814509360 recall — FDA Z-3114-2018

The set screw is not able to advance or reverse from the original position in the nail.

Class IIFDA: TerminatedZimmer Biomet, Inc.

Medical DeviceSep 19, 2018

Zimmer Biomet Affixus Hip Fracture Nail Left 130 11 mm x 400 mm, Item Number: 814611400 recall — FDA Z-3159-2018

The set screw is not able to advance or reverse from the original position in the nail.

Class IIFDA: TerminatedZimmer Biomet, Inc.

Medical DeviceSep 19, 2018

Zimmer Biomet Affixus Hip Fracture Nail Right 130 15 mm x 400 mm, Item Number: 814515400 recall — FDA Z-3144-2018

The set screw is not able to advance or reverse from the original position in the nail.

Class IIFDA: TerminatedZimmer Biomet, Inc.

Medical DeviceSep 19, 2018

Zimmer Biomet Affixus Hip Fracture Nail Left 130 11 mm x 360 mm, Item Number: 814611360 recall — FDA Z-3157-2018

The set screw is not able to advance or reverse from the original position in the nail.

Class IIFDA: TerminatedZimmer Biomet, Inc.

Browse by month

Recent recall archives

Browse recent months with enough recall history for useful comparison.

Full archive →