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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.

28,992medical device recall records

2,381FDA Class I records

8firms with 5+ records

Zimmer Biomet, Inc.784 records

Database records

Records — page 1078

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

Medical DeviceMay 25, 2016

Zimmer universal locking system (ULS) 3.5 mm cortical screw selftapping 18 mm length recall — FDA Z-1675-2016

A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws.

Class IIFDA: TerminatedZimmer Manufacturing B.V.

Medical DeviceMay 25, 2016

Zimmer Manufacturing B.V Hgp ii acetabular cup bone screw selftap 6.5x15mm 00662406515 Hgp recall — FDA Z-1683-2016

A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws.

Class IIFDA: TerminatedZimmer Manufacturing B.V.

Medical DeviceMay 25, 2016

Zimmer Plates and Screws (ZPS) 2.7 mm Cortical Screw SelfTapping, 14 mm Length 47482701401 recall — FDA Z-1674-2016

A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws.

Class IIFDA: TerminatedZimmer Manufacturing B.V.

Medical DeviceMay 25, 2016

Zimmer Manufacturing B.V Herbert Cannulated Bone Screw System, Bone Screw, 6.5 mm Dia., 45 recall — FDA Z-1680-2016

A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws.

Class IIFDA: TerminatedZimmer Manufacturing B.V.

Medical DeviceMay 25, 2016

Diamedix Is-Mumps IgG Test Kit Diamedix Is-Mumps IgG Test Kit is an EIA procedure intended recall — FDA Z-1685-2016

A gel-like substance was found in kit component, sample diluent , that could potentially compromise product performance.

Class IIFDA: TerminatedDiamedix Corporation

Medical DeviceMay 25, 2016

Zimmer Plates and Screws (ZPS) 3.5 mm Cortical Screw SelfTapping, 10 mm Length 47483501001 recall — FDA Z-1673-2016

A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws.

Class IIFDA: TerminatedZimmer Manufacturing B.V.

Medical DeviceMay 25, 2016

Zimmer Manufacturing B.V Mini MagnaFx Cannulated Screw Fixation System Small Cannulated Bone recall — FDA Z-1679-2016

A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws.

Class IIFDA: TerminatedZimmer Manufacturing B.V.

Medical DeviceMay 25, 2016

Becton Dickinson & Company 1) 24 G x 0.75 in. BD Angiocath" Autoguard" shielded IV catheter recall — FDA Z-1690-2016

The device may have a defect in the catheter. In some instances this defect could result in catheter separation or breakage.

Class IIFDA: TerminatedBecton Dickinson & Company

Medical DeviceMay 25, 2016

Zimmer Manufacturing B.V Periarticular plating system, cancellous bone screw, partially recall — FDA Z-1676-2016

A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws.

Class IIFDA: TerminatedZimmer Manufacturing B.V.

Medical DeviceMay 18, 2016

Biomerieux Vitek 2 Gram Positive Susceptibility Test Cards (AST-P640 REF 418579), 20 recall — FDA Z-1641-2016

Product insert fails to identify performance limitation related to EUCAST breakpoints for Teicolplanin.

Class IFDA: TerminatedBiomerieux Inc.

Medical DeviceMay 18, 2016

St Jude Medical Ellipse ICD recall — FDA Z-1632-2016

St. Jude Medical is recalling the Ellipse ICD (Implantable Cardioverter Defibrillator) due to the potential inability to deliver high voltage therapy.

Class IIFDA: TerminatedSt Jude Medical Inc.

Medical DeviceMay 18, 2016

Siemens Healthcare Diagnostics Dimension Vista Blood Urea Nitrogen (BUN) Flex reagent recall — FDA Z-1622-2016

Siemens Healthcare Diagnostics has determined that Dimension Vista Blood Urea Nitrogen (BUN) lots 15215AE, 15243BB, 15264BA, 15299BB, 15300BA and 15341AC may exhibit inaccurate patient…

Class IIFDA: TerminatedSiemens Healthcare Diagnostics, Inc.

Medical DeviceMay 18, 2016

Siemens Healthcare Diagnostics Dimension Assays: Triglycerides (TGL) recall — FDA Z-1661-2016

Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyrone) interference with Trinder and Trinder-like reaction assays. Siemens has confirmed that…

Class IIFDA: TerminatedSiemens Healthcare Diagnostics, Inc.

Medical DeviceMay 18, 2016

Siemens Healthcare Diagnostics ADVIA CHEMISTRY GLUCOSE OXIDASE ASSAY AND ADVIA Chemistry recall — FDA Z-1655-2016

Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyrone) interference with Trinder and Trinder-like reaction assays. Siemens has confirmed that…

Class IIFDA: TerminatedSiemens Healthcare Diagnostics, Inc.

Medical DeviceMay 18, 2016

Siemens Healthcare Diagnostics Dimension clinical chemistry system, Sirolimus (SIRO) Flex recall — FDA Z-1633-2016

Siemens Healthcare Diagnostics has received customer complaints regarding QC shifts and imprecision after one day when using Dimension SIRO lot EB6064. They have confirmed SIRO lot # EB6064…

Class IIFDA: TerminatedSiemens Healthcare Diagnostics, Inc.

Medical DeviceMay 18, 2016

Baxter Healthcare GEM(TM), FLOWCOUPLER(R), 2.5 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF recall — FDA Z-1628-2016

Instructions for use booklet may puncture the outer Tyvek lid.

Class IIFDA: TerminatedBaxter Healthcare Corp.

Medical DeviceMay 18, 2016

Siemens Healthcare Diagnostics Dimension Assays: ENZYMATIC CREATININE recall — FDA Z-1660-2016

Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyrone) interference with Trinder and Trinder-like reaction assays. Siemens has confirmed that…

Class IIFDA: TerminatedSiemens Healthcare Diagnostics, Inc.

Medical DeviceMay 18, 2016

Covidien Given Imaging Bravo pH capsule delivery device, 5-pack recall — FDA Z-1619-2016

Potential of an allergic reaction in a patient with nickel sensitivity.

Class IIFDA: TerminatedCovidien LLC

Medical DeviceMay 18, 2016

Medtronic Battery Pack Used with the Capnostream"20 and Capnostream"20p Patient Monitor recall — FDA Z-1577-2016

Medtronic Respiratory & Monitoring Solutions Announces a Voluntary Recall of a Battery Pack Used with the Capnostream"20 and Capnostream"20p Patient Monitor Due to the Battery Pack Might…

Class IFDA: TerminatedMedtronic

Medical DeviceMay 18, 2016

Biomerieux Vitek 2 Gram Positive Susceptibility Test Cards (AST-P645 REF 419602), 20 recall — FDA Z-1646-2016

Product insert fails to identify performance limitation related to EUCAST breakpoints for Teicolplanin.

Class IFDA: TerminatedBiomerieux Inc.

Medical DeviceMay 18, 2016

Biomerieux Vitek 2 Gram Positive Susceptibility Test Cards (AST-P639 REF 418662), 20 recall — FDA Z-1640-2016

Product insert fails to identify performance limitation related to EUCAST breakpoints for Teicolplanin.

Class IFDA: TerminatedBiomerieux Inc.

Medical DeviceMay 18, 2016

Siemens Healthcare Diagnostics Dimension Assays: Direct HDL Cholesterol (AHDL) recall — FDA Z-1659-2016

Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyrone) interference with Trinder and Trinder-like reaction assays. Siemens has confirmed that…

Class IIFDA: TerminatedSiemens Healthcare Diagnostics, Inc.

Medical DeviceMay 18, 2016

Stryker CinchLock SS Knotless Anchor with Inserter recall — FDA Z-1634-2016

Stryker Endoscopy is recalling the CinchLock SS Knotless Anchor with Inserter and the CinchLock Flex Anchor with Inserter after 13 reports of s of an internal wire breaking upon deployment…

Class IIFDA: TerminatedStryker Corporation

Medical DeviceMay 18, 2016

Atlas Spine Torque Limiting Handle 6N-m, P/N 70089 Model # ITN-001-000 Used to rotate recall — FDA Z-1616-2016

The device was not appropriately set to mitigate the risk of implant fracture upon rotation inside the disc space.

Class IIFDA: TerminatedAtlas Spine, 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.