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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.

28,992medical device recall records

2,381FDA Class I records

8firms with 5+ records

Zimmer Biomet, Inc.784 records

Database records

Records — page 1097

28,992 detailed records are currently available in this category.

Medical DeviceMar 30, 2016

Covidien Dover PREC PRM 18FR SILVER FLY TY Item Code: PP18XSD Castile soap towelettes are recall — FDA Z-1229-2016

Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria

Class IIFDA: TerminatedCovidien LLC

Medical DeviceMar 30, 2016

Qiagen Sciences QFT TB Antigen Tube recall — FDA Z-1230-2016

Potential for obtaining a false positive result due to the possibility of endotoxin presence.

Class IIFDA: TerminatedQiagen Sciences LLC

Medical DeviceMar 30, 2016

QiG Group Algostim LLC, Algovita Implanted Pulse Generator stimulator, Model 2412 recall — FDA Z-1193-2016

The implantable pulse generator (IPG) model 2408 had suboptimal performance establishing a connection to the external devices unless they were brought into close proximity (as close as 5…

Class IIFDA: TerminatedQiG Group LLC

Medical DeviceMar 30, 2016

Covidien Dover CATCH KIT SOAP Item Code: 5205 Castile soap towelettes are used to clean the recall — FDA Z-1196-2016

Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria

Class IIFDA: TerminatedCovidien LLC

Medical DeviceMar 30, 2016

Covidien Dover PRECSION PRM 14FR SIL FLY Item Code: ¿ PP14SD ¿¿ Castile soap towelettes are recall — FDA Z-1220-2016

Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria

Class IIFDA: TerminatedCovidien LLC

Medical DeviceMar 30, 2016

Covidien Dover MIDSTREAM KIT CASTILE SOAP Item Code: 2090SA Castile soap towelettes are used recall — FDA Z-1201-2016

Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria

Class IIFDA: TerminatedCovidien LLC

Medical DeviceMar 30, 2016

Nidek RT-5100 (Epic 5100) Refractor and RT 3100 Refractor: Product Usage: Instrument recall — FDA Z-1245-2016

There has been a reoccurrence of an issue on the RT 5100 and RT 3100 Refractor of the Near Point Chart Arm lowering spontaneously with potential for slight injury to face or nose of patient.

Class IIFDA: TerminatedNidek Inc.

Medical DeviceMar 30, 2016

Covidien Dover MIDSTREAM KIT CASTILE SOAP Item Code: 2040SA Castile soap towelettes are used recall — FDA Z-1200-2016

Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria

Class IIFDA: TerminatedCovidien LLC

Medical DeviceMar 23, 2016

Zimmer Manufacturing B.V Product 25 consists of all product under product code: LPH and same recall — FDA Z-1123-2016

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 48 consists of all product under product code: JWH and same recall — FDA Z-1146-2016

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 12 consists of all product under product code JDI , and recall — FDA Z-1110-2016

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 31 consists of all product under product code: KTT and same recall — FDA Z-1129-2016

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 29 consists of all product under product code: LPHand same recall — FDA Z-1127-2016

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

McKesson Horizon Medical Imaging (HMI) products versions 4.6.1 to including 11.9 and recall — FDA Z-1182-2016

McKesson has identified a design deficiency where under rare circumstances, imported images/studies may re-use a non-unique image directory. This issue may cause incorrect images to be…

Class IIFDA: TerminatedMckesson Medical Immaging

Medical DeviceMar 23, 2016

Zimmer Manufacturing B.V Product 52 consists of product code: HWC and same usage: Item no recall — FDA Z-1150-2016

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 18 consists of all product under product code: HWC and same recall — FDA Z-1116-2016

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

Roche Diagnostics Operations Accu-Chek Inform II Base Unit as a part of the Accu-Chek Inform recall — FDA Z-1172-2016

Accu-Chek Inform II Base Unit might produce physical transmission errors in the form of data loss in the communication between the meter and the Data Management Systems (DMS). The issue can…

Class IIFDA: TerminatedRoche Diagnostics Operations, Inc.

Medical DeviceMar 23, 2016

Richard Wolf Medical Instruments The Vesa 75/100 adaptation with rotation is an accessory to recall — FDA Z-1188-2016

Supplier of the "VESA 75 / 100 adaptation with rotation", which is part of their monitor mounts and support arms may be missing riveting.

Class IIFDA: TerminatedRichard Wolf Medical Instruments Corp.

Medical DeviceMar 23, 2016

Zimmer Manufacturing B.V Product 5 consists of all products under product code HWC, and same recall — FDA Z-1103-2016

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 28 consists of all product under product code: JDI and same recall — FDA Z-1126-2016

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 51 consists of all product under product code: JWH and same recall — FDA Z-1149-2016

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 36 consists of all product under product code: HSB and same recall — FDA Z-1134-2016

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 17 consists of all product under product code: LPH and same recall — FDA Z-1115-2016

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 45 consists of all product under product code: JWH and same recall — FDA Z-1143-2016

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.

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.