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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.

28,535medical device recall records

2,363FDA Class I records

8firms with 5+ records

Zimmer Biomet, Inc.784 records

Database records

Records — page 1037

28,535 detailed records are currently available in this category.

Medical DeviceSep 21, 2016

ICU Medical Transpac IV Monitoring Kit with 2 SafeSet 84" Arterial Pressure Tubing recall — FDA Z-2810-2016

ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.

Class IIFDA: TerminatedICU Medical, Inc.

Medical DeviceSep 21, 2016

Stryker Howmedica Osteonics Supracondylar Nail T2 SCN 09x300 mm T2 Supracondylar Nail System recall — FDA Z-2791-2016

Stryker discovered that a Tibial Nail and femoral Nail were incorrectly labeled and distributed to the field.

Class IIFDA: TerminatedStryker Howmedica Osteonics Corp.

Medical DeviceSep 21, 2016

ICU Medical Transpac IV Bifurcated Kit with SafeSet Reservoir, 03 ml Squeeze Flush and recall — FDA Z-2807-2016

ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.

Class IIFDA: TerminatedICU Medical, Inc.

Medical DeviceSep 21, 2016

ICU Medical Transpac IV Monitoring Kit with 03 ml Squeeze Flush, SafeSet Reservoir, 2 recall — FDA Z-2826-2016

ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.

Class IIFDA: TerminatedICU Medical, Inc.

Medical DeviceSep 21, 2016

Siemens Healthcare Diagnostics RAPIDLab 1260 Blood Gas Analyzer Siemens Material Number recall — FDA Z-2802-2016

There is a potential for the first and/or last name of one patient to be printed with Patient ID and result data from a different patient, even though those fields have been turned Off for…

Class IIFDA: TerminatedSiemens Healthcare Diagnostics Inc.

Medical DeviceSep 21, 2016

ICU Medical Transpac IV Trifurcated Monitoring Kit with 84" SafeSet Reservoir, 03 ml Squeeze recall — FDA Z-2813-2016

ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.

Class IIFDA: TerminatedICU Medical, Inc.

Medical DeviceSep 21, 2016

ICU Medical Bifurcated SafeSet Kit with 03mL Flush Device, Item No. 46091-75 Product Usage recall — FDA Z-2820-2016

ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.

Class IIFDA: TerminatedICU Medical, Inc.

Medical DeviceSep 21, 2016

Siemens RAPIDPoint 500 Blood Gas Analyzer Siemens Material Number (SMN): 10492730, 10696855 recall — FDA Z-2799-2016

There is a potential for the first and/or last name of one patient to be printed with Patient ID and result data from a different patient, even though those fields have been turned Off for…

Class IIFDA: TerminatedSiemens Healthcare Diagnostics Inc.

Medical DeviceSep 21, 2016

ICU Medical Transpac IV Monitoring Kit with SafeSet 84" Arterial Pressure Tubing, Reservoir recall — FDA Z-2824-2016

ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.

Class IIFDA: TerminatedICU Medical, Inc.

Medical DeviceSep 21, 2016

ICU Medical Triple Line SafeSet Kit with 03mL Flush Device, Item No. 46076-27 Product Usage recall — FDA Z-2816-2016

ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.

Class IIFDA: TerminatedICU Medical, Inc.

Medical DeviceSep 21, 2016

Merge Healthcare RadSuite software. The firm name on the label is Merge Healthcare recall — FDA Z-2796-2016

Multiple studies were missing at a customer location that never made it to the archive before watermarking

Class IIFDA: TerminatedMerge Healthcare, Inc.

Medical DeviceSep 21, 2016

ICU Medical Transpac IV Trifurcated Monitoring Kit with SafeSet Reservoir and 2 Blood recall — FDA Z-2812-2016

ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.

Class IIFDA: TerminatedICU Medical, Inc.

Medical DeviceSep 21, 2016

Stryker Howmedica Osteonics Femoral Nail, A/R T2 Femur 011x280 mm T2 Femoral Nailing System recall — FDA Z-2792-2016

Stryker discovered that a Tibial Nail and femoral Nail were incorrectly labeled and distributed to the field.

Class IIFDA: TerminatedStryker Howmedica Osteonics Corp.

Medical DeviceSep 21, 2016

ICU Medical Transpac IV Trifurcated Monitoring Kit with SafeSet Reservoir, Port and 03 ml recall — FDA Z-2827-2016

ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.

Class IIFDA: TerminatedICU Medical, Inc.

Medical DeviceSep 21, 2016

Alere San Diego LDX Optical Check Cassettes (OCC) recall — FDA Z-2778-2016

Incorrect expiration date on the magnetic strip that does not match the labeled expiration date.

Class IIIFDA: TerminatedAlere San Diego, Inc.

Medical DeviceSep 21, 2016

Biosense Webster CARTO 3 EP Navigation System and Accessories, Product Codes: FG540000 and recall — FDA Z-2776-2016

Biosense Webster, Inc. is initiating a voluntary correction to re-install identified CARTO 3 Systems that were moved and installed in China without testing and approval by Biosense Webster…

Class IIFDA: TerminatedBiosense Webster, Inc.

Medical DeviceSep 21, 2016

Stryker Orthopaedics Patella Assembly Instrument, REF 3182-1000, Non-Sterile, NDC (01) recall — FDA Z-2789-2016

Upon failure of the press-fit, the clamping sub components and pins could disassociate from the Scorpio Patella Assembly Instrument.

Class IIFDA: TerminatedStryker Howmedica Osteonics Corp.

Medical DeviceSep 21, 2016

ICU Medical Transpac IV Monitoring Kit with 2 SafeSet Reservoir and 2 Blood Sampling Ports recall — FDA Z-2809-2016

ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.

Class IIFDA: TerminatedICU Medical, Inc.

Medical DeviceSep 21, 2016

Biomerieux France Chemin De L'Or VIDAS NT-pro-BNP Product Usage: VIDAS NTproBNP (PBNP) is an recall — FDA Z-2779-2016

Due to a packaging error; The kit does not contain the correct number of C1 or C2 control vials.

Class IIIFDA: TerminatedBiomerieux France Chemin De L'Or

Medical DeviceSep 21, 2016

ICU Medical Single Monitoring Kit with 30mL Flush Device, Item No. 46073-38 Product Usage recall — FDA Z-2814-2016

ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.

Class IIFDA: TerminatedICU Medical, Inc.

Medical DeviceSep 21, 2016

Clark Laboratories Trinity Biotech Captia Measles IgM, REF/Product Code 2326060,Test Kit for recall — FDA Z-2782-2016

The product lot failed to meet QC acceptance criteria during stability testing. The Calibrator OD was dropping causing the positive control to be invalid (running high out of range).

Class IIIFDA: TerminatedClark Laboratories, Inc. (dba, Trinity Biotech USA)

Medical DeviceSep 21, 2016

C.R. Bard Option-vf Urinary Catheter recall — FDA Z-2830-2016

During an FDA inspection it was found out that the Practical Foley Catheters to be potentially nonsterile.

Class IIFDA: TerminatedC.R. Bard, Inc.

Medical DeviceSep 21, 2016

Mentor Texas, LP Artoura Breast Tissue Expander 700 cc Product Usage: Tissue expanders can recall — FDA Z-2780-2016

The CPX4 Tissue Expander may have been packaged in the Artoura Tissue Expander box.

Class IIFDA: TerminatedMentor Texas, LP.

Medical DeviceSep 21, 2016

ICU Medical TP4 Kit with 10cc SafeSet Reservoir, Needleless Valve, Filter Millex and Admin recall — FDA Z-2825-2016

ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.

Class IIFDA: TerminatedICU Medical, 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.