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

40176–40200 of 40480

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
ModerateFDA (Devices)·Z-2086-2012·2012-08-01
Tripath PrepStain Upgrade Kit Recalled for Leaking Cones and Incorrect Instructions
Tripath Imaging is recalling PrepStain Upgrade Kits because some 1.2 DiTi Cones leak and the kits contain incorrect preventive maintenance instructions.
Product
PrepStain Upgrade Kit: 1.3.0.3/1.2 DiTi Cone. The PrepStain System is a liquid-based thin layer cell preparation process. The PrepStain System produces SurePath Slides that are intended for use in the screening and detection of cervical cancer, pre-cancerous lesions, atypical…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2085-2012·2012-08-01
Tripath PrepStain Kit 1.2 DiTi Cones Recalled for Leaking and Incorrect Instructions
Tripath Imaging is recalling 18 PrepStain Kit 1.2 DiTi Cones because some units are leaking and the kits contain incorrect preventive maintenance instructions.
Product
PrepStain Kit: 1.2 DiTi Cone. The PrepStain System is a liquid-based thin layer cell preparation process. The PrepStain System produces SurePath Slides that are intended for use in the screening and detection of cervical cancer, pre-cancerous lesions, atypical cells and all…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2080-2012·2012-08-01
Beekley Bella Blanket Mammography Coverlet Recalled for Imaging Artifacts
Beekley Corporation is recalling Bella Blanket Protective Coverlets used in mammography because they can cause imaging artifacts on results.
Product
Bella Blanket Protective Coverlet, for Mammography, 18cm x 25cm or 24cm x 30cm, Product Code: 311. The purpose of the product is to remove the cold by placing this sheet between the patients breast and the imaging receptor plate.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2088-2012·2012-08-01
Tripath PrepStain Kits Recalled for Leaking Cones and Incorrect Instructions
Tripath Imaging is recalling PrepStain kits because some 1.2 DiTi cones leak and the kits contain incorrect preventive maintenance instructions.
Product
PrepStain PM Kit, T-AG (Catalog 490588); PrepStain PM Kit Europe (Catalog 490671); PrepStain Prep Only PM Kit, T-AG (Catalog 490954); PrepStain PM Kit XLP, T-US-II (Catalog 490424); PrepStain Prep PM Kit XLP T-US-II (Catalog 491118); PrepStain Prep Only PM Kit XLP, T-US-II…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2087-2012·2012-08-01
Tripath PrepStain Slide Processor Recall for Leaking Cones and Incorrect Instructions
Tripath Imaging is recalling PrepStain Slide Processors because some 1.2 DiTi Cones leak and the kits contain incorrect preventive maintenance instructions.
Product
PrepStain Slide Processor. The PrepStain System is a liquid-based thin layer cell preparation process. The PrepStain System produces SurePath Slides that are intended for use in the screening and detection of cervical cancer, pre-cancerous lesions, atypical cells and all…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2081-2012·2012-08-01
Mallinckrodt Recalls Unsealed Handi-Fil Disposable Syringe Fill Tubes
Mallinckrodt Inc is recalling 75 cases of Handi-Fil Disposable Syringe Fill Tubes because ten packages were reported as not sealed.
Product
The Handi-Fil Disposable Syringe Fill Tube is a sterile plastic tube, approximately 10 inches in length, with a "J" shaped curve that projects upward approximately two inches. The Handi-Fil Disposable Syringe Fill Tube is used to transfer radiographic contrast media from a…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2054-2012·2012-08-01
Synthes Universal Spinal System Lamina Hooks Recalled for Incorrect Etching
Synthes (USA) Products LLC is recalling 12 units of Universal Spinal System Lamina Hooks because they are etched with the wrong part number.
Product
Universal Spinal System Lamina Hooks Synthes Medium TI Lamina Hook - Right 498.320 Non sterile LOT 6876785 Noncervical spinal fixation devices intended for posterior pedicle screw fixation, posterior hook fixation, or anterolateral fixation. Limited to skeletally mature…
Category
Medical Device
Distribution
Distributed nationwide

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40176–40200 of 40480