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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.

29,496medical device recall records

2,407FDA Class I records

8firms with 5+ records

Zimmer Biomet, Inc.784 records

Database records

Records — page 1100

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

Medical DeviceMar 23, 2016

Zimmer Manufacturing B.V Product 43 consists of all product under product code: HSB and same recall — FDA Z-1141-2016

As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.

Class IIFDA: TerminatedZimmer Manufacturing B.V.

Medical DeviceMar 23, 2016

Zimmer Manufacturing B.V Product 4 consists of all products under product code HWC, and same recall — FDA Z-1102-2016

As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.

Class IIFDA: TerminatedZimmer Manufacturing B.V.

Medical DeviceMar 23, 2016

Zimmer Manufacturing B.V Product 16 consists of all product under poduct code: KWY and same recall — FDA Z-1114-2016

As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.

Class IIFDA: TerminatedZimmer Manufacturing B.V.

Medical DeviceMar 23, 2016

Zimmer Manufacturing B.V Product 46 consists of all product under product code: HWC and same recall — FDA Z-1144-2016

As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.

Class IIFDA: TerminatedZimmer Manufacturing B.V.

Medical DeviceMar 23, 2016

CORDIS AVANTI + CATHETER SHEATH INTRODUCER SYSTEM The product includes a Catheter Sheath recall — FDA Z-1174-2016

Incorrect cannula of the sheath introducer (smaller than intended).

Class IIFDA: TerminatedCordis Corporation

Medical DeviceMar 23, 2016

Zimmer Manufacturing B.V Product 69 consists of all product under product code: JDI and same recall — FDA Z-1167-2016

As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.

Class IIFDA: TerminatedZimmer Manufacturing B.V.

Medical DeviceMar 23, 2016

Zimmer Manufacturing B.V Product 30 consists of all product under product code: KTT and same recall — FDA Z-1128-2016

As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.

Class IIFDA: TerminatedZimmer Manufacturing B.V.

Medical DeviceMar 23, 2016

Zimmer Manufacturing B.V Product 60 consists of all product under product code: HSB and same recall — FDA Z-1158-2016

As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.

Class IIFDA: TerminatedZimmer Manufacturing B.V.

Medical DeviceMar 23, 2016

Zimmer Manufacturing B.V Product 53 consists of all product under: product code: JWH and recall — FDA Z-1151-2016

As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.

Class IIFDA: TerminatedZimmer Manufacturing B.V.

Medical DeviceMar 23, 2016

Zimmer Manufacturing B.V Product 63 consists of all product under product code: LPH and same recall — FDA Z-1161-2016

As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.

Class IIFDA: TerminatedZimmer Manufacturing B.V.

Medical DeviceMar 23, 2016

Zimmer Manufacturing B.V Product 70 consists of all product under product code: JDI and same recall — FDA Z-1168-2016

As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.

Class IIFDA: TerminatedZimmer Manufacturing B.V.

Medical DeviceMar 23, 2016

Collagen Matrix NuOSS Cancellous Intended for use in dental surgery recall — FDA Z-1096-2016

On 8/25/2015, Collagen Matrix, Inc discovered that one of the 171 units of NuOss Cancellous product shipped to a distributor may have included an incorrect size.

Class IIFDA: TerminatedCollagen Matrix Inc.

Medical DeviceMar 23, 2016

Zimmer Manufacturing B.V Product 66 consists of all product under product code: JDI and same recall — FDA Z-1164-2016

As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.

Class IIFDA: TerminatedZimmer Manufacturing B.V.

Medical DeviceMar 23, 2016

Zimmer Manufacturing B.V Product 20 consists of all prod oct under poduct code: KTT and same recall — FDA Z-1118-2016

As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.

Class IIFDA: TerminatedZimmer Manufacturing B.V.

Medical DeviceMar 23, 2016

Teleflex Medical Pilling Modular Verres Body/Obturator, Product Code 140880 recall — FDA Z-1178-2016

Packaging error in which customers who ordered product code 140880 (Verres cannula for use with a separately available needle tip) were incorrectly provided with product code 140878 (Verres…

Class IIFDA: TerminatedTeleflex Medical

Medical DeviceMar 23, 2016

Sorin Group USA Stockert Heater-Cooler 3T recall — FDA Z-1186-2016

On August 15, 2012, Sorin informed consignees via letter of changes made to create Version 12 of the Heater-Cooler 3T IFU. The revised IFU included enhancements to achieve water quality…

Class IIFDA: TerminatedSorin Group USA, Inc.

Medical DeviceMar 23, 2016

Steris Quick Connects. Steris Corporation. Model numbers: QKC1736E, QKC1736INT, QKC1737E recall — FDA Z-1180-2016

The firm discovered that one of the hysteroscope models listed for processing in four existing Quick Connects has one inlet port rather than two inlet ports as indicated in the Quick…

Class IIFDA: TerminatedSteris Corporation

Medical DeviceMar 23, 2016

Zimmer Manufacturing B.V Product 22 consists of all product under product code: JDI and same recall — FDA Z-1120-2016

As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.

Class IIFDA: TerminatedZimmer Manufacturing B.V.

Medical DeviceMar 23, 2016

Zimmer Manufacturing B.V Product 13 consists of all product under product code HWC , and recall — FDA Z-1111-2016

As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.

Class IIFDA: TerminatedZimmer Manufacturing B.V.

Medical DeviceMar 23, 2016

Zimmer Manufacturing B.V Product 71 consists of all product under product code: JDI and same recall — FDA Z-1169-2016

As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.

Class IIFDA: TerminatedZimmer Manufacturing B.V.

Medical DeviceMar 23, 2016

Zimmer Manufacturing B.V Product 40 consists of all product under product code: HSB and same recall — FDA Z-1138-2016

As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.

Class IIFDA: TerminatedZimmer Manufacturing B.V.

Medical DeviceMar 23, 2016

Zimmer Manufacturing B.V Product 47 consists of all product under product code: LPH and same recall — FDA Z-1145-2016

As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.

Class IIFDA: TerminatedZimmer Manufacturing B.V.

Medical DeviceMar 23, 2016

Zimmer Manufacturing B.V Product 49 consists of all product under product code: JWH and same recall — FDA Z-1147-2016

As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.

Class IIFDA: TerminatedZimmer Manufacturing B.V.

Medical DeviceMar 23, 2016

Covidien Medical Products (Shanghai) Short Percutaneous Antenna with Thermosphere" recall — FDA Z-1187-2016

Medtronic is voluntarily recalling specific item codes and production lots of Covidien Emprint" Percutaneous Antenna with Thermosphere" Technology due to the potential for the generator to…

Class IIFDA: TerminatedCovidien Medical Products (Shanghai) Manufacturing LLC

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.