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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.

29,496medical device recall records

2,407FDA Class I records

8firms with 5+ records

Zimmer Biomet, Inc.784 records

Database records

Records — page 1145

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

Medical DeviceSep 30, 2015

Siemens RAPIDPoint 500 Measurement Cartridge Lactate (750 tests) Part Number: 10491449 recall — FDA Z-2813-2015

RAPIDPoint 500 measurement cartridge serial numbers 2517102517 through 2519000012, negative sodium bias on both QC and patient results

Class IIFDA: TerminatedSiemens Healthcare Diagnostics Inc.

Medical DeviceSep 30, 2015

OrthoPediatrics 3.5mm Non Locking Cortical Screw, in the PediLoc Tibial Plate System Part recall — FDA Z-2796-2015

The 00-0903-2510, 3.5mm x 10mm Non Locking Cortical Screw, Lot # 150192-J package may contain a different screw. The screw in the package is a 00-0903-2526, 3.5mm x 26mm, and is etched…

Class IIFDA: TerminatedOrthoPediatrics Corp

Medical DeviceSep 30, 2015

GE Healthcare Lightspeed 16 CT recall — FDA Z-2801-2015

Potential for expulsion of the Power Supply on Lightspeed CT scanner or Discovery ST PET CT or Discovery LS PET CT scanner.

Class IIFDA: TerminatedGE Healthcare

Medical DeviceSep 30, 2015

Stryker Howmedica Osteonics Trident 10 degrees X3 Insert 36 mm ID Catalog #623-10-36I Hip recall — FDA Z-2810-2015

it was discovered that item 623-10-36I Lot 3Y0KHP, although meeting all device specifications, was determined to be unacceptable due to a documentation issue. However the parts were…

Class IIFDA: TerminatedStryker Howmedica Osteonics Corp.

Medical DeviceSep 30, 2015

GE Healthcare PET Discovery LS recall — FDA Z-2802-2015

Potential for expulsion of the Power Supply on Lightspeed CT scanner or Discovery ST PET CT or Discovery LS PET CT scanner.

Class IIFDA: TerminatedGE Healthcare

Medical DeviceSep 30, 2015

Terumo Custom Cardiovascular Procedure Kit Tubing Pack P/N: 66041-1 Terumo Cardiovascular recall — FDA Z-2786-2015

Custom Cardiovascular Procedure Kits contain recalled component Medivators HPH700 High Performance Hemoconcentrators

Class IIFDA: TerminatedTerumo Cardiovascular Systems Corp

Medical DeviceSep 30, 2015

Terumo Custom Cardiovascular Procedure Kit X-Coated Perfusion Pack with FX25RE P/N: 7928-03 recall — FDA Z-2788-2015

Custom Cardiovascular Procedure Kits contain recalled component Medivators HPH700 High Performance Hemoconcentrators

Class IIFDA: TerminatedTerumo Cardiovascular Systems Corp

Medical DeviceSep 30, 2015

Terumo Custom Cardiovascular Procedure Kit X-Coated Pediatric Pack P/N: 74039-02 Terumo recall — FDA Z-2789-2015

Custom Cardiovascular Procedure Kits contain recalled component Medivators HPH700 High Performance Hemoconcentrators

Class IIFDA: TerminatedTerumo Cardiovascular Systems Corp

Medical DeviceSep 30, 2015

Synthes Cranial Flap Tube Clamp and Crimping Device Product Usage: The Synthes Cranial Flap recall — FDA Z-2811-2015

The Synthes Cranial Flap Tube Clamp and Crimping Device for Cranial Tube Clamp had been labeled MR Safe although they do not have the testing protocols currently required to designate them…

Class IIFDA: TerminatedSynthes (USA) Products LLC

Medical DeviceSep 30, 2015

GE Healthcare PET Discovery ST 16 recall — FDA Z-2803-2015

Potential for expulsion of the Power Supply on Lightspeed CT scanner or Discovery ST PET CT or Discovery LS PET CT scanner.

Class IIFDA: TerminatedGE Healthcare

Medical DeviceSep 30, 2015

Fujifilm Processor EPX 2500 High Definition Endoscopy recall — FDA Z-2806-2015

The EPX-2500 Operation Manual and sales brochure incorrectly identify that the ED-530XT endoscope is meant to be used with the EPX-2500 Processor. The Operation Manual and sales brochure…

Class IIFDA: TerminatedFujifilm Medical Systems U.S.A., Inc.

Medical DeviceSep 30, 2015

Terumo Custom Cardiovascular Procedure Kit X-Coated PED/Adult Main Pack P/N: 75185 Terumo recall — FDA Z-2791-2015

Custom Cardiovascular Procedure Kits contain recalled component Medivators HPH700 High Performance Hemoconcentrators

Class IIFDA: TerminatedTerumo Cardiovascular Systems Corp

Medical DeviceSep 30, 2015

Resource Optimization & Innovation Regard Custom Surgical Pack, Item Number: 800208002 recall — FDA Z-2799-2015

Surgical kits contain a surgical scrub product which may be chemically contaminated and lack sterility assurance.

Class IIFDA: TerminatedResource Optimization & Innovation LLC

Medical DeviceSep 30, 2015

Terumo Custom Cardiovascular Procedure Kit X-Coated Perfusion Pack P/N: 74077-01 Terumo recall — FDA Z-2790-2015

Custom Cardiovascular Procedure Kits contain recalled component Medivators HPH700 High Performance Hemoconcentrators

Class IIFDA: TerminatedTerumo Cardiovascular Systems Corp

Medical DeviceSep 30, 2015

Terumo Custom Cardiovascular Procedure Kit X-Coated PED/Adult Main Pack P/N: 75529 Terumo recall — FDA Z-2792-2015

Custom Cardiovascular Procedure Kits contain recalled component Medivators HPH700 High Performance Hemoconcentrators

Class IIFDA: TerminatedTerumo Cardiovascular Systems Corp

Medical DeviceSep 30, 2015

Brainlab AG Disposable Reflective Marker Spheres The Disposable Reflective Marker Spheres recall — FDA Z-2795-2015

Disposable Reflective Marker Spheres (DRMS) for Brainlab Image Guided Surgery (IGS) Systems: DRMS spheres may separate at the mid-point where the two halves of the sphere are sealed…

Class IIFDA: TerminatedBrainlab AG

Medical DeviceSep 30, 2015

Siemens RAPIDPoint 500 Measurement Cartridge Lactate (100) tests Part Number: 10844813 recall — FDA Z-2816-2015

RAPIDPoint 500 measurement cartridge serial numbers 2517102517 through 2519000012, negative sodium bias on both QC and patient results

Class IIFDA: TerminatedSiemens Healthcare Diagnostics Inc.

Medical DeviceSep 30, 2015

Edwards Lifesciences ThruPort Knot Pusher recall — FDA Z-2780-2015

The configuration of the slot at the tip of the knot pusher may inhibit intended ease of use. Fraying or splitting of the suture could occur, which could compromise the integrity of the…

Class IIFDA: TerminatedEdwards Lifesciences, LLC

Medical DeviceSep 30, 2015

Fujifilm Medical Systems U.S.A Fujinon/Fujifilm Processor EPX 2500 Operation Manual recall — FDA Z-2805-2015

The EPX-2500 Operation Manual and sales brochure incorrectly identify that the ED-530XT endoscope is meant to be used with the EPX-2500 Processor. The Operation Manual and sales brochure…

Class IIFDA: TerminatedFujifilm Medical Systems U.S.A., Inc.

Medical DeviceSep 30, 2015

Siemens Medical Solutions USA ARTISTE, ONCOR Avantgarde, ONCOR Impression Plus, ONCOR recall — FDA Z-2812-2015

A software fix has been released to prevent automatic movement resulting in a collision safety risk for patients.

Class IIFDA: TerminatedSiemens Medical Solutions USA, Inc.

Medical DeviceSep 30, 2015

Terumo Custom Cardiovascular Procedure Kit X-Coated Adult Pak P/N: 73124 Terumo recall — FDA Z-2787-2015

Custom Cardiovascular Procedure Kits contain recalled component Medivators HPH700 High Performance Hemoconcentrators

Class IIFDA: TerminatedTerumo Cardiovascular Systems Corp

Medical DeviceSep 30, 2015

Leica Microsystems The Leica ASP6025 Tissue Processor recall — FDA Z-2804-2015

The ASP6025 Tissue Processor instrument is incorrectly getting into a state of bottle empty during retort filling, after passing the fill lever sensor 2 and prior to reaching level sensor…

Class IIFDA: TerminatedLeica Microsystems, Inc.

Medical DeviceSep 30, 2015

Siemens RAPIDPoint 500 Measurement Cartridge Lactate (400) tests Part Number: 10491448 recall — FDA Z-2814-2015

RAPIDPoint 500 measurement cartridge serial numbers 2517102517 through 2519000012, negative sodium bias on both QC and patient results

Class IIFDA: TerminatedSiemens Healthcare Diagnostics Inc.

Medical DeviceSep 30, 2015

Becton, Dickinson and Company, BD Biosciences CD4 (SK3), FITC; Contains CD4 FITC with recall — FDA Z-2817-2015

CD4 FITC label contains an error in the Spanish small text - it states CD8 FITC.

Class IIIFDA: TerminatedBecton, Dickinson and Company, BD Biosciences

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.