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.

29,496medical device recall records

2,407FDA Class I records

8firms with 5+ records

Zimmer Biomet, Inc.784 records

Database records

Records — page 1101

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

Medical DeviceMar 23, 2016

Zimmer Manufacturing B.V Product 26 consists of all product under product code: JWH and same recall — FDA Z-1124-2016

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 41 consists of all product under product code: KTT and same recall — FDA Z-1139-2016

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 32 consists of all product under product code: HWC and same recall — FDA Z-1130-2016

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 9 consists of all product under HRS, and same usage: Item recall — FDA Z-1107-2016

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

CHG Hospital Beds The Spirit TM Select bed is a Med-Surg bed intended to support and recall — FDA Z-1176-2016

It was identified that in some situations the bed exit alarm may not function as intended. The software code for the bed exit system has the potential to auto-reset erroneously. In some…

Class IIFDA: TerminatedCHG Hospital Beds Inc.

Medical DeviceMar 23, 2016

Zimmer Manufacturing B.V Product 50 consists of all product under product code: JWH and same recall — FDA Z-1148-2016

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 39 consists of all product under product code: JDI and same recall — FDA Z-1137-2016

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 57 consists of all product code: JDI and same usage: Item recall — FDA Z-1155-2016

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 11 consists of all product under product code JDI , and recall — FDA Z-1109-2016

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 33 consists of all product under product code: JDI and same recall — FDA Z-1131-2016

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 38 consists of all product under product code: HSB and same recall — FDA Z-1136-2016

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

Sekisui Diagnostics P.E.I Sekure Chemistry Sekisui Diagnostics Acetaminophen L3K Assay recall — FDA Z-1171-2016

Crystal formation in the Color Reagent (R2) when left on board automated analyzers causing samples to under recover

Class IIFDA: TerminatedSekisui Diagnostics P.E.I. Inc.

Medical DeviceMar 23, 2016

Zimmer Manufacturing B.V Product 58 consists of all product under product code: HRS and same recall — FDA Z-1156-2016

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 55 consists of all product under product code: HSB and same recall — FDA Z-1153-2016

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 Puritan Bennett 980 Ventilator System, PB980 Ventilator (980xxxxxxxx) recall — FDA Z-1181-2016

Graphical user interface (GUI) unresponsive to touch and Loss of primary ventilation under certain circumstances. Covidien Respiratory and Monitoring Solutions, now a part of Medtronic,…

Class IIFDA: TerminatedCovidien LP (formerly Nellcor Puritan Bennett Inc.)

Medical DeviceMar 23, 2016

Zimmer Manufacturing B.V Product 6 consists of all products under product code HWC, and same recall — FDA Z-1104-2016

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 2 consists of all products product code LPH, and same recall — FDA Z-1100-2016

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 61 consists of all product under product code: JWH and same recall — FDA Z-1159-2016

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 68 consists of all product under product code: JDI and same recall — FDA Z-1166-2016

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 21 consists of all product under product code: JDI and same recall — FDA Z-1119-2016

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

Siemens Syngo Dynamics-a Picture Archiving and Communication System (PACS) Model Numbers recall — FDA Z-1183-2016

Siemens' conducting a recall due to a potential issue when using the measurement package of the VA10 version of syngo Dynamics.

Class IIFDA: TerminatedSiemens Medical Solutions USA, Inc.

Medical DeviceMar 23, 2016

Zimmer Manufacturing B.V Product 23 consists of all product code: JDI and same usage: Item recall — FDA Z-1121-2016

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 44 consists of all product under product code: HWC and same recall — FDA Z-1142-2016

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

Stryker Medical Division of Stryker Prime Series Stretchers recall — FDA Z-1184-2016

The hydraulic jack assemblies (PN: 0753-002-101, 0753-002-070, 0753-002-001, and 0753-002-001) were manufactured using the incorrect oil. The oil used does not contain the same wear…

Class IIFDA: TerminatedStryker Medical Division of Stryker Corporation

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.