Home › Medical Device Recalls

FDA public records

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.

26,628medical device recall records

2,311FDA Class I records

8firms with 5+ records

Zimmer Biomet, Inc.778 records

Database records

Records — page 776

26,628 detailed records are currently available in this category.

Medical DeviceOct 24, 2018

Zimmer Biomet Affixus Hip Fracture Nail Left 125 13 mm x 360 mm, Item Number 814413360 recall — FDA Z-0156-2019

There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.

Class IIFDA: TerminatedZimmer Biomet, Inc.

Medical DeviceOct 24, 2018

Carl Zeiss Meditec AG, Goeschwitzer Strasse 51-52 07745 Jena, Germany, IOLMaster 700, REF recall — FDA Z-0108-2019

Calibration setting was incorrectly entered during manufacturing causing the optical coherence tomography (OCT) to obtain the incorrect two-dimensional images of ocular structures of the…

Class IIFDA: TerminatedCarl Zeiss Meditec AG

Medical DeviceOct 24, 2018

OriGen Biomedical Reinforced Dual Lumen Cannula, 13Fr., REF: VV13F, Sterile EO recall — FDA Z-0179-2019

These catheters may have the following deficiencies: 1) barium sulfate omission, and 2) actual catheter tip length is one centimeter shorter than printed on the tip

Class IIFDA: TerminatedOriGen Biomedical, Inc.

Medical DeviceOct 24, 2018

Zimmer Biomet Affixus Hip Fracture Nail Right 130 9 mm x 320 mm, Item Number 814509320 recall — FDA Z-0157-2019

There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.

Class IIFDA: TerminatedZimmer Biomet, Inc.

Medical DeviceOct 24, 2018

Zimmer Biomet Affixus Hip Fracture Nail 125 9 mm x 180 mm, Item Number 814309180 Product recall — FDA Z-0122-2019

There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.

Class IIFDA: TerminatedZimmer Biomet, Inc.

Medical DeviceOct 24, 2018

Zimmer Biomet Affixus Hip Fracture Nail Right 125 11 mm x 380 mm, Item Number 814311380 recall — FDA Z-0134-2019

There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.

Class IIFDA: TerminatedZimmer Biomet, Inc.

Medical DeviceOct 24, 2018

Zimmer Biomet Affixus Hip Fracture Nail Right 125 11 mm x 360 mm, Item Number 814311360 recall — FDA Z-0133-2019

There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.

Class IIFDA: TerminatedZimmer Biomet, Inc.

Medical DeviceOct 24, 2018

Zimmer Biomet Affixus Hip Fracture Nail Right 125 11 mm x 340 mm, Item Number 814311340 recall — FDA Z-0132-2019

There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.

Class IIFDA: TerminatedZimmer Biomet, Inc.

Medical DeviceOct 24, 2018

Mindray BeneVision Distributed Monitoring System (DMS), Part No. 115-034413-00 recall — FDA Z-0170-2019

The firm has identified performance anomalies with the device caused when more than 64 TD60 telemetry transmitters have been connected to a central station. The anomaly causes some ECG…

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

Medical DeviceOct 24, 2018

Zimmer Biomet Affixus Hip Fracture Nail Right 125 9 mm x 380 mm, Item Number 814309380 recall — FDA Z-0128-2019

There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.

Class IIFDA: TerminatedZimmer Biomet, Inc.

Medical DeviceOct 24, 2018

Siemens Healthcare Diagnostics Atellica Sample Handler Connect (SMN 11069018) recall — FDA Z-0190-2019

Atellica Solution system software (SW) version 1.13 and lower, five (5) behavioral issues were identified: 1. Reagent Lock may not work as intended with Primary Reagent ReadyPacks and…

Class IIFDA: TerminatedSiemens Healthcare Diagnostics, Inc.

Medical DeviceOct 24, 2018

Zimmer Biomet Affixus Hip Fracture Nail Left 125 11 mm x 320 mm, Item Number 814411320 recall — FDA Z-0151-2019

There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.

Class IIFDA: TerminatedZimmer Biomet, Inc.

Medical DeviceOct 24, 2018

A M Systems Disposable Smooth Interior Tubing Material: Polyethylene EVA copolymer recall — FDA Z-0120-2019

Some of the Disposable Smooth Interior Tubing may pull apart when stretched.

Class IIFDA: TerminatedA M Systems Inc.

Medical DeviceOct 24, 2018

OriGen Biomedical Reinforced Dual Lumen Cannula, 23Fr., REF: VV23F, Sterile EO Indications recall — FDA Z-0182-2019

These catheters may have the following deficiencies: 1) barium sulfate omission, and 2) actual catheter tip length is one centimeter shorter than printed on the tip

Class IIFDA: TerminatedOriGen Biomedical, Inc.

Medical DeviceOct 24, 2018

Siemens Healthcare Diagnostics Atellica CH 930 Analyzer (SMN 11067000) recall — FDA Z-0194-2019

Atellica Solution system software (SW) version 1.13 and lower, five (5) behavioral issues were identified: 1. Reagent Lock may not work as intended with Primary Reagent ReadyPacks and…

Class IIFDA: TerminatedSiemens Healthcare Diagnostics, Inc.

Medical DeviceOct 24, 2018

Thoratec CentriMag Motor, Model: 102956, a component of the Thoratec CentriMag Blood Pumping recall — FDA Z-0103-2019

Reports of circulatory support system motor stopping. Motor stop can be attributed to a break of a wire or short circuit between wires within the electrical cable where the cable exits the…

Class IIFDA: TerminatedThoratec Switzerland GMBH

Medical DeviceOct 24, 2018

Zimmer Biomet Affixus Hip Fracture Nail Left 125 13 mm x 340 mm, Item Number 814413340 recall — FDA Z-0155-2019

There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.

Class IIFDA: TerminatedZimmer Biomet, Inc.

Medical DeviceOct 24, 2018

Life Technologies Gibco GlutaMAX Supplement, for In-Vitro Diagnostic Use SKU 35050061 recall — FDA Z-0174-2019

Leaky bottles due to a defect in the bottle cap compromising the sterility of the product

Class IIFDA: TerminatedLife Technologies, Corp.

Medical DeviceOct 24, 2018

OriGen Biomedical Reinforced Dual Lumen Cannula, 13Fr., REF: VV13F, Sterile EO recall — FDA Z-0102-2019

The catheter failed the endotoxin testing.

Class IIFDA: TerminatedOriGen Biomedical, Inc.

Medical DeviceOct 24, 2018

Siemens Healthcare Diagnostics Atellica IM 1300 Analyzer (SMN 11066001) recall — FDA Z-0192-2019

Atellica Solution system software (SW) version 1.13 and lower, five (5) behavioral issues were identified: 1. Reagent Lock may not work as intended with Primary Reagent ReadyPacks and…

Class IIFDA: TerminatedSiemens Healthcare Diagnostics, Inc.

Medical DeviceOct 24, 2018

GE Medical Systems GE Healthcare MRI Systems, Software Version 11.x, sold under the recall — FDA Z-0110-2019

The latest on-site software version may not have been reinstalled at some sites after service activities were performed resulting in images possibly flipped left/right and/or there can be…

Class IIFDA: TerminatedGE Medical Systems, LLC

Medical DeviceOct 24, 2018

Zimmer Biomet Affixus Hip Fracture Nail Right 125 13 mm x 440 mm, Item Number 814313440 recall — FDA Z-0144-2019

There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.

Class IIFDA: TerminatedZimmer Biomet, Inc.

Medical DeviceOct 24, 2018

GE Medical Systems GE Healthcare MRI Systems, Software Version 12.x, sold under the recall — FDA Z-0111-2019

The latest on-site software version may not have been reinstalled at some sites after service activities were performed resulting in images possibly flipped left/right and/or there can be…

Class IIFDA: TerminatedGE Medical Systems, LLC

Medical DeviceOct 24, 2018

Zimmer Biomet Affixus Hip Fracture Nail Left 130 11 mm x 400 mm, Item Number 814611400 recall — FDA Z-0167-2019

There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.

Class IIFDA: TerminatedZimmer Biomet, 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.