Recalls

All US Product Recalls

Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.

How to read this listing

Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means the agency’s own highest classification or reported deaths or serious injuries, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.

The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.

Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.

Agency

All agencies FDA (Food)FDA (Drugs)FDA (Devices)USDA FSIS CPSC NHTSA EPA

34751–34775 of 40325

LowFDA (Devices)·Z-2644-2014·2014-09-24
BioFire Defense Recalls JBAIDS Instrument System Software Version 3.5.0.72
BioFire Defense is recalling JBAIDS Instrument System Software version 3.5.0.72 because the wrong version may have been installed on the devices.
Product
JBAIDS Instrument System Software version 3.5.0.72. The JBAIDS instrument is a portable thermocycler and real-time fluorimeter capable of simultaneous and rapid identification of multiple biological warfare and clinical pathogens from a variety of biological specimens. The…
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-2650-2014·2014-09-24
Stago IVD Liquid Anti-Xa Recalled for Barcode Misreading
Diagnostica Stago is recalling 514 Liquid Anti-Xa kits due to customer complaints about barcode misreading on analyzers.
Product
Stago IVD, Liquid Anti-Xa, NDC 3607450003116. The STA - Liquid Anti-Xa kits are intended for use with STA-R, STA Compact and STA Satellite Analyzers for the quantitative determination of the plasma levels of unfractionated (UFH) and low molecular weight (LMWH) heparins by…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2626-2014·2014-09-17
Stryker Recalls Aria Implant Inserters Due to Product Fracturing Complaints
Stryker Spine is recalling 64 units of Aria Standard and Specialty Implant Inserters due to complaints of product fracturing. The devices are used for spinal fusion procedures.
Product
Stryker Aria Implant Inserter, REF 48758500, This instrument is part of the Aria product brand. It is used for Implant insertion into the disc space. The Aria Inserter PEEK Spacer System offers implants that are interbody fusion devices intended for use as an aid in spinal…
Category
Medical Device
Distribution
24 states
SevereFDA (Devices)·Z-2627-2014·2014-09-17
Stryker Recalls Aria Inserter Devices Due to Product Fracturing
Stryker Spine is recalling 57 units of Aria Standard and Specialty Implant Inserters because of complaints that the instruments fractured.
Product
Specialty Aria Inserter, REF IS3021ARI, Non-Sterile, This instrument is part of the Aria product brand. It is used for Implant insertion into the disc space. The Aria Inserter PEEK Spacer System offers implants that are interbody fusion devices intended for use as an aid in…
Category
Medical Device
Distribution
24 states
SevereFDA (Devices)·Z-2608-2014·2014-09-17
Wright Medical Recalls CLAW II Straight Plates Due to Incorrect Raw Material
Wright Medical Technology is recalling 50 units of CLAW II Straight Plates because they were manufactured from an incorrect raw material.
Product
CLAW II STRAIGHT PLATE ORTHOLOC 3DSi, LENGTH 20mm x 25mm, REF 40242025, 1 EACH, Rx ONLY, NON STERILE Orthopedic
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2617-2014·2014-09-17
GE Healthcare Recalls CARESCAPE Respiratory Modules Due to O2 Sensor Failure
GE Healthcare is recalling 748 CARESCAPE respiratory modules and Airway Gas Options due to a potential O2 sensor component failure.
Product
CARESCAPE Respiratory Modules E-sCO, E-sCOV, E-sCAiO, E-sCAiOV, E-sCAiOE, E-sCAiOVE; the Airway Gas Option N-CAiO and respective service exchange units. The affected modules could be in use with any of the following GE host devices: -CARESCAPE respiratory modules with…
Category
Medical Device
Distribution
18 states
HighFDA (Devices)·Z-2609-2014·2014-09-17
Ab Sciex API 3200MD System Recalled for Incorrect Diagnostic Data
Ab Sciex is recalling six API 3200MD LC/MS/MS systems because the MultiQuant 3.0 software may provide incorrect data for patient diagnosis.
Product
AB SCIEX API 3200MD" LC/MS/MS System with software: MultiQuantMD 3.0In vitro diagnostic to identify inorganic or organic compounds (e.g., lead, mercury, and drugs) in human specimens Part Number 5024543.
Category
Medical Device
Distribution
5 states
HighFDA (Devices)·Z-2614-2014·2014-09-17
Baxter Recalls Buretrol Solution Sets Due to Chamber Separation
Baxter Healthcare is voluntarily recalling specific lots of Buretrol Solution Sets because the burette chamber may separate from the drip chamber.
Product
***Baxter***BURETROL Solution Set***105" (2.7 m) 150 mL Burette***Drip Chamber Filter Valve***3 Luer Activated Valves***Male Luer Lock Adapter***with Retractable Collar***Fluid path is Sterile, Nonpyrogenic. ****Indications for Use: For the administration of fluids from a…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2611-2014·2014-09-17
Illumina Worklist Manager Software Recalled for Performance Failure
Illumina Inc is recalling 35 units of Illumina Worklist Manager software v1.0.15 because it fails to perform as intended.
Product
Illumina Worklist Manager (IWM) (software v1.0.15), a component of Illumina MiSeqDx Platform. Product Usage: The Illumina MiSeqDx is a sequencing instrument that measures fluorescence signals of labeled nucleotides through the use of instrument specific reagents and flow…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2601-2014·2014-09-17
Wright Medical Recalls CLAW II 2 Hole Plate OrthoLoc 3DSi Orthopedic Plates
Wright Medical Technology is recalling 497 CLAW II 2 Hole Plate OrthoLoc 3DSi orthopedic plates because they were manufactured from an incorrect raw material.
Product
CLAW II 2 HOLE PLATE ORTHOLOC 3DSi, LENGTH 15mm, REF 40240215, 1 EACH, Rx ONLY, NON STERILE Orthopedic
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2605-2014·2014-09-17
Wright Medical Recalls CLAW II Straight Plate OrthoLoc 3DSi Orthopedic Devices
Wright Medical Technology is recalling 66 units of CLAW II Straight Plate OrthoLoc 3DSi orthopedic devices because they were manufactured from an incorrect raw material.
Product
CLAW II STRAIGHT PLATE ORTHOLOC 3DSi, LENGTH 20mm x 20mm, REF 40242020, 1 EACH, Rx ONLY, NON STERILE Orthopedic
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2603-2014·2014-09-17
Wright Medical Recalls CLAW II Orthopedic Plates Due to Incorrect Material
Wright Medical Technology is recalling 400 CLAW II 2 Hole Plate Ortholoc 3DSi units because they were manufactured from an incorrect raw material.
Product
CLAW II 2 HOLE PLATE ORTHOLOC 3DSi, LENGTH 25mm, REF 40240225, 1 EACH, Rx ONLY, NON STERILE Orthopedic
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2610-2014·2014-09-17
Ethicon Recalls PROXIMATE Skin Staplers Due to Unformed Staple Risk
Ethicon Endo-Surgery Inc is recalling PROXIMATE skin staplers because a non-conforming component may cause the device to fire an unformed staple.
Product
PROXIMATE Skin Stapler. PROXIMATE RH Rotating-Head Skin Stapler (Model PRR35), PROXIMATE PX Fixed-Head Skin Stapler (Model PXR35), Bulk/Non-Sterile PROXIMATE RH Rotating-Head Skin Stapler (Model CK 117), and Bulk/Non-Sterile PROXIMATE PX Fixed-Head Skin Stapler (Model CK…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2604-2014·2014-09-17
Wright Medical Recalls CLAW II Orthopedic Plates Due to Incorrect Raw Material
Wright Medical Technology is recalling 178 CLAW II 2 Hole Plate Ortholoc 3DSi units because they were manufactured from an incorrect raw material.
Product
CLAW II 2 HOLE PLATE ORTHOLOC 3DSi, LENGTH 30mm, REF 40240230, 1 EACH, Rx ONLY, NON STERILE Orthopedic
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2616-2014·2014-09-17
Pioneer Surgical Technology Recalls Streamline MIS Spinal Fixation System Fixed Rod Holders
Pioneer Surgical Technology is recalling nine Streamline MIS Spinal Fixation System Fixed Rod Holders because they failed to lock onto the spinal rod.
Product
Streamline MIS Spinal Fixation System Fixed Rod Holder NON STERILE, Rx only The Streamline MIS Spinal Fixation System is intended for posterior, noncervical pedicle fixation, T1-S2. Pedicle screw fixation is limited to skeletally mature patients and is intended to be used as…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2599-2014·2014-09-17
Wright Medical Recalls Orthopedic Claw Plates Due to Incorrect Raw Material
Wright Medical Technology is recalling specific orthopedic claw plates because they were manufactured from an incorrect raw material.
Product
CLAW PLATE 20mm INTERAXIS CHARLOTTE F&A SYSTEM, REF 40S20020, 1 EACH, Rx ONLY, NON STERILE Orthopedic
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2597-2014·2014-09-17
Radiometer America Recalls RADIANCE Clinical Data Processing Software Versions 2.4X to 2.6X
Radiometer America Inc. is voluntarily recalling RADIANCE software versions 2.4X, 2.5X, and 2.6X. The recall is classified as Class II by the FDA.
Product
RADIANCE v. 2.4X, 2.5X and 2.6X Product Usage: RADIANCE is a data processing application for clinical use intended to monitor, collect, store, retrieve and process laboratory data. RADIANCE is also intended to control clinical analyzers providing laboratory data.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2600-2014·2014-09-17
Wright Medical Recalls 3.5mm Claw Plates Due to Incorrect Raw Material
Wright Medical Technology is recalling 9 units of CLAW 3.5mm plates because they were manufactured from an incorrect raw material.
Product
CLAW 3.5mm PLATE CHARLOTTE F&A SYSTEM, SIZE 30mm, 2 HOLE, USE WITH 3.5mm CLAW SCREW, REF 4013-0130, 1 EACH, Rx ONLY, NON STERILE Orthopedic
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2625-2014·2014-09-17
Life Force Chamber Recalled for Lack of FDA Approval
Life Force of Tampa, LLC is recalling 10 Life Force Chambers because the product is marketed as a medical device without FDA premarket approval.
Product
Life Force Chamber Product Usage:The product is intended for restful contemplation and spirituality.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2607-2014·2014-09-17
Wright Medical Recalls CLAW II Straight Plate OrthoLoc 3DSi Orthopedic Plates
Wright Medical Technology is recalling 18 units of CLAW II Straight Plate OrthoLoc 3DSi orthopedic plates because they were manufactured from an incorrect raw material.
Product
CLAW II STRAIGHT PLATE ORTHOLOC 3DSi, LENGTH 25mm x 25mm, REF 40242525, 1 EACH, Rx ONLY, NON STERILE Orthopedic
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2292-2014·2014-09-17
Siemens Medical Imaging Systems Recalled for Potential Radiation Overexposure
Siemens is recalling 192 Luminos dRF, Ysio, and Uroskop Omnia systems because a software malfunction may cause longer radiation exposure than required.
Product
Siemens Luminos dRF, Ysio or Uroskop Omnia systems. The Axiom Luminos dRF is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic studies.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2615-2014·2014-09-17
Baxter Recalls Buretrol Solution Sets Due to Chamber Separation
Baxter Healthcare is voluntarily recalling specific lots of Buretrol Solution Sets because the burette chamber may separate from the drip chamber.
Product
***Baxter***Non-DEHP***BURETROL Solution Set 105" (2.7 m), 150 mL Burette***Drip Chamber Filter Valve 3 Luer Activated Valves***Male Luer Lock Adapter***with Retractable Collar***Fluid path is Sterile, Nonpyrogenic.***Indications for Use: For the administration of fluids from…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2623-2014·2014-09-17
Medtronic Recalls Hancock Apical Left Ventricle Connectors Due to Production Discontinuation
Medtronic is recalling two units of the Hancock Apical Left Ventricle Connector because the company has decided to discontinue production and distribution of this low-volume product.
Product
Hancock Apical Left Ventricle Connector, Model No. H174Axx, Catalog No. 0174ACP012. Used use in conjunction with Hancock Conduit Model 105 to provide an alternate method for relief of left ventricular hypertension.
Category
Medical Device
Distribution
2 states
ModerateFDA (Devices)·Z-2613-2014·2014-09-17
Baxter Recalls Buretrol Solution Sets Due to Chamber Separation
Baxter Healthcare is voluntarily recalling specific lots of Buretrol Solution Sets because the burette chamber may separate from the drip chamber.
Product
***Baxter***Buretrol Solution Set***105" (2.7 m)***150 mL Burette***Drip Chamber Filter Valve***3 Injection Sites Male Luer Lock Adapter with***Retractable Collar***Fluid path is Sterile, Nonpyrogenic***Indications for Use: For the administration of fluids from a container into…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2624-2014·2014-09-17
Integra Container Lids Recalled for Lack of FDA Clearance
Integra York PA, Inc. is recalling 84 container lids that were distributed without FDA clearance.
Product
Integra Container Lid, ¿¿ Size, Red; Container Lid, ¿¿ Size, Blue; Container Lid, ¿¿ Size, Red; Container Lid, ¿¿ Size, Gold; Container Lid, ¿¿ Size, Green; Container Lid, Full Size, Blue; Container Lid, Full Size, Red Catalogue Numbers: 730422, 730521, 730522, 730523, 730524…
Category
Medical Device
Distribution
0 states

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34751–34775 of 40325