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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 1036

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

Medical DeviceSep 28, 2016

AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model No recall — FDA Z-2864-2016

Abbott Medical Optics is recalling Intraocular Lenses (IOLs) because they were not being checked prior to release and this may result in the release of mislabeled IOLs.

Class IIFDA: TerminatedAbbott Medical Optics Inc. (AMO)

Medical DeviceSep 21, 2016

ICU Medical Monitoring Kit with 30mL Flush Device, Item No. 46076-15 Product Usage: The recall — FDA Z-2815-2016

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

Ortho-Clinical Diagnostics The VITROS Chemistry Products Calibrator Kit 31, Lot 3155 used in recall — FDA Z-2804-2016

There is an incorrect value (data/calibration mathematics) on ADDs. This incorrect value will prevent a successful calibration of the assay.

Class IIIFDA: TerminatedOrtho-Clinical Diagnostics

Medical DeviceSep 21, 2016

Integra Meshed Dermal Regeneration Template 5 cmx 5 cm (2 in x 2in) Rx Only Meshed Integra recall — FDA Z-2777-2016

Integra's post QA release review of historical product release test results for Meshed IDRT products identified the Peel Strength test average result was incorrectly calculated for a single…

Class IIFDA: TerminatedIntegra LifeSciences Corporation

Medical DeviceSep 21, 2016

ICU Medical Transpac IV Monitoring Kit with SafeSet 84inch Arterial Pressure Tubing recall — FDA Z-2805-2016

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 405 Blood Gas Analyzer nBili Siemens Material Number (SMN): 10282093 recall — FDA Z-2798-2016

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 Monitoring Kit with TP4, 30 ml Squeeze Flush and Needleless Valve, Item No. recall — FDA Z-2823-2016

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

C.R. Bard Option-vm Urinary Catheter recall — FDA Z-2831-2016

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

ICU Medical Transpac IV Monitoring Kit with 2 SafeSet Blood Sampling Ports, 60" TUBING recall — FDA Z-2808-2016

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

Howmedica Osteonics AccuLIF PL 8-12mm x 11mm x 27mm x 8 Cage, Rx only, Sterile R, Legal The recall — FDA Z-2787-2016

Since Stryker acquired the AccuLIF product in March of 2014, there have been Product Inquires (PIs) related to the PL implant confirming to have a reduction of height > 1 mm. The current…

Class IIFDA: TerminatedHowmedica Osteonics Corp.

Medical DeviceSep 21, 2016

ICU Medical Transpac IV Monitoring Kit with SafeSet Reservoir and Blood Sampling Port, 24" recall — FDA Z-2811-2016

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 Monitoring Kit with 03mL Flush Device, Item No. 46080-57 Product Usage: The recall — FDA Z-2818-2016

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 1265 Blood Gas Analyzer Siemens Material Number recall — FDA Z-2803-2016

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 Kit With Safeset Reservoir And 2 Blood Sampling Ports recall — FDA Z-2806-2016

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

Arrow International Cather, Ultrasound, Intravascular The VPS Stylet and Console are recall — FDA Z-2772-2016

Notification of component molding abnormality by supplier used to package certain Arrow Select Kit (ASK) products.

Class IIFDA: TerminatedArrow International Inc.

Medical DeviceSep 21, 2016

ICU Medical Pediatric Kit with 30mL Flush Device, Item No. 46099-10 Product Usage: The recall — FDA Z-2821-2016

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 SafeSet Kit with 30 mL Flush Device, Item No. 46083-42 Product Usage: The recall — FDA Z-2819-2016

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 5 Port OFF Manifold with Transpac IV, Item No. 46100-29 Usage: The Transpac recall — FDA Z-2822-2016

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

Arrow International Catheter, Intravascular, Therapeutic, Long Term Greater than 30 days recall — FDA Z-2771-2016

Notification of component molding abnormality by supplier used to package certain Arrow Select Kit (ASK) products.

Class IIFDA: TerminatedArrow International Inc.

Medical DeviceSep 21, 2016

Siemens Medical Solutions USA Syngo.Plaza VB 10 A, image processing system (PACS) intended recall — FDA Z-2794-2016

Siemens is releasing a Customer Advisory Notice to explain meaning of a suffix o.p. that shows on some DICOM images on area, distance or perimeter values. This suffix stands for on…

Class IIFDA: TerminatedSiemens Medical Solutions USA, Inc.

Medical DeviceSep 21, 2016

ICU Medical Monitoring Kit with TP4, 30 ml Squeeze Flush Device, 10 cc Contamination Syringe recall — FDA Z-2828-2016

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

Hospira MedNet Medication Management Suite software, version 6.1, List Numbers 16037-64-02 recall — FDA Z-2790-2016

Hospira MedNet 6.1 software, in combination with the SapphirePlus 13.1x infusion pump, may result in incorrect bolus amount calculations for drugs whose concentrations are listed in Million…

Class IIFDA: TerminatedHospira Inc., A Pfizer Company

Medical DeviceSep 21, 2016

Circulatory Technology The Bigger-Better-Bladder, TM 2 With 3/8"ID tubing, 72" long tubing recall — FDA Z-2832-2016

The seal between the balloon and the housing may leak.

Class IIFDA: TerminatedCirculatory Technology Inc.

Medical DeviceSep 21, 2016

Mentor Texas, LP CPX4 Breast Tissue Expander 650 cc : Product Usage: Tissue expanders can be recall — FDA Z-2781-2016

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

Class IIFDA: TerminatedMentor Texas, LP.

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.