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

40051–40075 of 40356

ModerateFDA (Devices)·Z-2127-2012·2012-08-08
GE OEC Medical Systems Recalls UroView 2800 Imaging Devices
GE OEC Medical Systems is recalling UroView 2800 and other imaging devices due to hard disk drive issues. The recall covers 82 units distributed worldwide.
Product
UroView 2800; MDL number A349855. Product Usage: Designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical, and interventional procedures. Clinical application may include but are not limited to urologic and endoscopic procedures. The…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2116-2012·2012-08-08
Exactech Recalls Equinoxe Shoulder Arthroplasty Devices Due to Labeling Error
Exactech is recalling Equinoxe shoulder arthroplasty devices and related components because the labeling incorrectly states a ten-year shelf life instead of the qualified five-year shelf life.
Product
Equinoxe Fixed Angle Replicator Plate Intended for Primary and Reverse Total Shoulder Arthroplasty.
Category
Medical Device
Distribution
27 states
ModerateFDA (Devices)·Z-2118-2012·2012-08-08
Exactech Recalls Shoulder and Spine Devices Due to Labeling Error
Exactech is recalling Equinoxe and Octane-C devices because labeling incorrectly states a ten-year shelf life for parts qualified for five years.
Product
Equinoxe Reverse Shoulder Fracture Adapter Tray Screw Intended for Primary and Reverse Total Shoulder Arthroplasty.
Category
Medical Device
Distribution
27 states
ModerateFDA (Devices)·Z-2115-2012·2012-08-08
Exactech Recalls Shoulder Arthroplasty Devices Due to Labeling Error
Exactech is recalling Equinoxe shoulder arthroplasty devices because the labeling incorrectly states a ten-year shelf life instead of the qualified five-year shelf life.
Product
Equinoxe Anatomic Replicator Plate Intended for Primary and Reverse Total Shoulder Arthroplasty
Category
Medical Device
Distribution
27 states
ModerateFDA (Devices)·Z-2112-2012·2012-08-08
Beekley Altus Floral Skin Markers Recalled for Separation Defect
Beekley Corporation is recalling 6,420 units of Altus Floral Skin Markers because the marker may separate from the backing material.
Product
Beekley Altus Floral Skin Markers -Order Number: 754 Product Usage: designed for Digital Mammography-Disposable skin markers for marking areas of concern or pain
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-2124-2012·2012-08-08
Iris Diagnostics Recalls Urine Chemistry Control Material Due to Inaccurate Results
Iris Diagnostics is recalling IRISpec CA/CB urine chemistry control material because nitrite results were incorrectly negative.
Product
IRISpec" CA/CB two-part urine chemistry control twin set, Iris Diagnostics part number 800-0074. Intended Use: IRISpec CA/CB is an assayed QC material for monitoring of the urine chemistry analytes and devices as listed on the package insert. For in vitro diagnostic (IVD)…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2065-2012·2012-08-01
GE OEC 8800 Flexview X-ray System Recalled for Safety Issues
GE OEC Medical Systems is recalling OEC 8800 Flexview x-ray systems due to intermittent safety issues including navigation tracking inaccuracy and system lock-up.
Product
OEC 8800 Flexview, 892.1650 Image-intensified fluoroscopic x-ray system Product Usage: The 8800 Flexview is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical, and interventional procedures. Clinical applications may include…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2024-2012·2012-08-01
Respironics Trilogy Ventilators Recalled for Faulty Power Supply Component
Respironics is recalling 173 Trilogy 100, 200, and 202 ventilators due to a potential faulty component in the power supply.
Product
Respironics Trilogy 100, 200, and 202 Ventilators The Respironics Trilogy systems provides continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. Trilogy 100 is intended for pediatric through adult patients weighing at…
Category
Medical Device
Distribution
16 states
SevereFDA (Devices)·Z-2040-2012·2012-08-01
GE OEC 6800 Miniview X-ray System Recalled for Safety Issues
GE OEC Medical Systems is recalling 1,933 OEC 6800 Miniview fluoroscopic x-ray systems due to intermittent safety issues, including navigation tracking inaccuracy and system lock-ups.
Product
OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and…
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-2082-2012·2012-08-01
Hill-Rom Recalls Affinity Four Birthing Beds Due to Fall Risk
Hill-Rom is recalling 12,726 Affinity Four Birthing Beds because bed movement during labor may cause patient or caregiver falls.
Product
Affinity Four Birthing Bed P3700 Product Usage: The Affinity, Four Birthing Bed is intended to be used as birthing beds for women of child bearing age in an LDR (Labor, Delivery, Recovery ) or LDRP (Labor, Delivery, Recovery, Postpartum) setting within the acute care Labor…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2076-2012·2012-08-01
CareFusion Alaris PC Unit Model 8015 Recalled for Power Supply Board Error
CareFusion 303, Inc. is recalling Alaris PC unit model 8015 devices because a power supply board component causes startup error codes and alarms.
Product
Alaris PC unit model 8015 Product Usage: The device is labeled for prescription use only.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2077-2012·2012-08-01
Anspach Effort Recalls Sterile Bone Cutting Burrs Due to Breakage Risk
The Anspach Effort, Inc. is recalling specific sterile bone cutting burrs because the cutter may come apart during use.
Product
.***ANSPACH***Sterile. REF SHD-4820DS***QTY: 1, 4.8 mm x 2mm Twist Drill with Depth Stop. Use with SHORT-HD Attachment ***RX Only Product Usage: Cutting and shaping bone including bones of the spine and cranium.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2038-2012·2012-08-01
GE OEC 9800 C-arm Systems Recalled for Power Supply Defect
GE OEC Medical Systems is recalling 8,214 OEC 9800 C-arm systems worldwide because the vertical lift column power supply is defective and subject to early life failure.
Product
OEC 9800; OEC FluoroTrak 9800 Plus; OEC 9800 Plus; OEC 9800 MD Motorized C-arm System, 892.1650 Image-intensified fluoroscopic x-ray system. The OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional…
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2083-2012·2012-08-01
Philips and Neusoft Recall NeuViz 16 CT Scanners Due to Detached Oil Accumulator
Philips and Neusoft are recalling 15 NeuViz 16 CT scanners because a screw failure caused the oil accumulator to detach from the X-ray tube.
Product
NeuViz 16 Multi-Slice CT Scanner System is a computed Tomography X-ray system, and has a Part number 989605858501. The device is labeled in part: "***Neusoft***NeuViz16 MULTI-SLICE CT SCANNER SYSTEM***MANUFACTURED FOR NEUSOFT MEDICAL SYSTEMS CO., LTD***MANUFACTURED BY PHILIPS…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2068-2012·2012-08-01
Ortho-Clinical Diagnostics Recalls VITROS 5600 Integrated System Software
Ortho-Clinical Diagnostics is recalling VITROS 5600 Integrated System Software due to a defect that prevents proper quality verification when reagent lots are switched.
Product
VITROS 5600 Integrated System Software For use in the in-vitro quantitative, semi quantitative, and qualitative measurement of variety of analytes of clinical interest.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2073-2012·2012-08-01
Siemens Linear Accelerators Recalled for Potential Radiation Dosing Error
Siemens is recalling 18 ARTISTE and ONCOR linear accelerators due to a rare software issue that could cause radiation beams to be delivered twice.
Product
ARTISTE or ONCOR Digital Linear Accelerators with syngo RT Therapist version 4.2/MOSAIQ OIS Systems and Multiple-X, Manufactured by SIEMENS AG. The ARTISTE and ONCOR family of Linear Accelerators are used to deliver X-ray photon and electron radiation for the therapeutic…
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-2055-2012·2012-08-01
Terumo Advanced Perfusion System 1 Recalled for Drive Motor Failure
Terumo CVS is recalling 992 Advanced Perfusion System 1 units due to drive motor failures that trigger alarms. The potential hazards depend on the specific medical application.
Product
System 1 Base 100/120V The Terumo¿ Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2066-2012·2012-08-01
Ortho-Clinical Diagnostics Recalls VITROS 5,1 FS System Software
Ortho-Clinical Diagnostics is recalling VITROS 5,1 FS System Software versions 2.6.1 and below because the software may fail to verify quality assessments when reagent lots are switched.
Product
VITROS 5,1 FS System Software For use in the in-vitro quantitative, semi quantitative, and qualitative measurement of variety of analytes of clinical interest.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2074-2012·2012-08-01
BridgePoint Medical Recalls Stingray Catheters Due to Sterility Concerns
BridgePoint Medical is voluntarily recalling Stingray Catheters because a faulty pouch seal may have compromised sterility assurance. No adverse clinical events have been reported.
Product
BridgePoint Medical, Stingray Catheter, REF M - 1000, Sterilized with Ethylene Oxide Gas, Prescription Only, Manufacturer BridgePoint Medical Inc. 13355 10th Ave N, Suite 110, Plymouth, MN 55441. Stingray" Catheters are intended to facilitate the intraluminal placement of…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2075-2012·2012-08-01
Hospira LifeShield Burette Set Recalled Due to Sticking Float Valve
Hospira is recalling 4,420 LifeShield Latex-Free 100 mL Burette Sets because the float valve may stick to the burette wall and fail to open or close properly.
Product
Hospira LifeShield Latex-Free 100 mL Burette Set, Convertible Pin, 77 inch with 2 Prepierced Injection Sites and Option-Lok Microdrip Soluset with Calibrated Burette and Precision Drip Chamber; an Rx sterile medical device used to administer fluids; 20 individually wrapped sets…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2058-2012·2012-08-01
Westone Recalls Oto Ease Ear Lubricant Due to Microbial Contamination
Westone Laboratories is recalling all Oto Ease ear lubricant products due to potential microbial contamination. The product is used to ease the insertion of hearing aids and earmolds.
Product
Oto Ease by Westone, labeled as a bacteria free, greaseless lubricant. Sold in 0.5 oz consumer sized semi transparent flexible plastic bottles. Product Usage: The product is used as a patient lubricant which eases insertion of earmolds and hearing instruments such as…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2056-2012·2012-08-01
Terumo Advanced Perfusion System 1 Recalled for Drive Motor Failure
Terumo CVS is recalling 640 Advanced Perfusion System 1 units worldwide due to drive motor failures in the Sarns Centrifugal System.
Product
System 1 Base 220/240V The Terumo¿ Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2089-2012·2012-08-01
Stryker Recalls ABG II Modular Hip Stems for Corrosion Risk
Stryker is recalling ABG II Modular Hip Stems to update instructions due to a reported rate of less than one percent for revisions associated with fretting and corrosion.
Product
ABG II Modular Hip Stem Stryker Howmedica Osteonics Corp. Mahwah, NJ 07430 Stryker Ireland Carrigtwohill Industrial Estate, Carrigtwohill County Cork, Ireland. The ABG II Modular range of implants is constituted of 8 right stems and 8 left stems. The necks are made of GADS…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2067-2012·2012-08-01
Ortho-Clinical Diagnostics Recalls VITROS 4600 Chemistry System Software
Ortho-Clinical Diagnostics is recalling VITROS 4600 Chemistry System Software due to a defect that prevents proper quality assessment verification when reagent lots are switched.
Product
VITROS 4600 Chemistry System Software For use in the in-vitro quantitative, semi quantitative, and qualitative measurement of variety of analytes of clinical interest.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2090-2012·2012-08-01
Stryker Recalls Rejuvenate Modular Hip Stems and Necks
Stryker is recalling Rejuvenate Modular Hip System stems and necks due to a reported rate of less than one percent for revisions associated with fretting or corrosion.
Product
Rejuvenate Modular Stems Stryker Ireland Carrigtwohill Industrial Estate Carrigtwohill County Cork, Ireland Rejuvenate Modular Necks Stryker Howmedica Osteonics Corp. Mahwah, NJ 07430. Stem Bodies Rejuvenate Modular consists of 6 modular stems bodies in sizes 7-12. The…
Category
Medical Device
Distribution
Distributed nationwide

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40051–40075 of 40356