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

26201–26225 of 27686

HighFDA (Devices)·Z-1931-2013·2013-08-14
Mitsubishi VERO Linear Accelerator Software Recall for Data Storage Error
Mitsubishi Heavy Industries is recalling VERO Linear Accelerator Systems due to a software anomaly that may save treatment records to the wrong location.
Product
MHI-TM2000 Linear Accelerator System, Software Version 3.0.0 revision 13 or earlier; Proprietary and Trade Name: MHI-TM2000/ VERO (TM); Common Name: Medical Linear Accelerator. MHI-TM2000 Linear Accelerator System is intended for radiation therapy of lesions, tumors and…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1891-2013·2013-08-14
ASO Recalls HEB Wound Closure Adhesive Surgical Tape Strips Due to Sterility Concerns
ASO, LLC is recalling HEB Wound Closure Adhesive Surgical Tape Strips because the manufacturer cannot confirm the product's sterility.
Product
HEB Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 in. Sterile latex free UPC # 041220302536 Used to secure, close and support small cuts and wounds.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1880-2013·2013-08-14
Stryker Recalls Sonopet Ultrasonic Aspirator Consoles Due to Corrosion
Stryker is recalling 215 Sonopet Ultrasonic Aspirator Consoles because corrosion on a power supply component may cause the irrigation pump to stop working.
Product
Sonopet Ultrasonic Aspirator Console 5450-852-000 (Console 230V) Product Usage: The Sonopet Console is indicated for use in surgical procedures where fragmentation, emulsification, and aspiration of soft and hard tissue is desirable, including neurosurgery, gastrointestinal…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1886-2013·2013-08-14
Siemens IMMULITE Rapid TSH Recalled for Rare TSH Variant Detection Failure
Siemens Healthcare Diagnostics is recalling IMMULITE Systems Rapid TSH tests because they fail to detect a rare TSH variant identified in a small patient cluster.
Product
IMMULITE Systems Rapid TSH (REF LKRT1 - 100T, LKRT5 - 500 T, L2KRT2 - 200T, L2KRT6 - 600T). Intended to quantitatively measure human thyroid stimulating hormone (TSH, thyrotropin).
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1890-2013·2013-08-14
ASO Recalls Duane Reade Wound Closure Adhesive Surgical Tape Strips
ASO, LLC is recalling Duane Reade Wound Closure Adhesive Surgical Tape Strips because the manufacturer cannot confirm the products are sterile.
Product
Duane Reade (DR) Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 in. Sterile latex free UPC # 639194043885 Used to secure, close and support small cuts and wounds.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1885-2013·2013-08-14
Siemens IMMULITE TSH Assay Recalled for Rare Variant Detection Failure
Siemens Healthcare Diagnostics is recalling IMMULITE Systems Third Generation TSH assays because a rare TSH variant is not detected.
Product
IMMULITE Systems Third Generation TSH (REF LKTS1 - 100T, LKTS5 - 500T, L2KTS2 - 200T, L2KTS6 - 600T). Intended to quantitatively measure human thyroid stimulating hormone (TSH, thyrotropin).
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1928-2013·2013-08-14
Smith & Nephew Recalls R3 XLPE Acetabular Liners Due to Packaging Error
Smith & Nephew is recalling 53 units of R3 XLPE acetabular liners because some 60 mm and 62 mm liners may be laser etched and packaged with incorrect size labels.
Product
R3 (TM) XLPE ACETABULAR LINER UHMWPE, 20o OVERHANG, 36 MM ID, 62 MM OD, QTY: (1), STERILE H2O2, REF 71335762. Orthopaedic.
Category
Medical Device
Distribution
13 states
HighFDA (Devices)·Z-1926-2013·2013-08-14
SpineFrontier Recalls Rev E PedFuse Return Screw Inserters Due to Loose Set Screw
SpineFrontier, Inc. is recalling eight Rev E PedFuse Return Screw Inserters because a set screw can loosen, causing the collar and locking sleeve to slide off the instrument.
Product
Rev E PedFuse Return Screw Inserter, Part Number: 11-80030 Screw inserters are instruments which capture, hold and drive pedicle screw assemblies. There is a capturing feature that engages and holds the screw in place. There is also a feature used to lock the screw to the…
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1894-2013·2013-08-14
ASO Recalls Premier Value Wound Closure Adhesive Tape Due to Sterility Concerns
ASO, LLC is recalling Premier Value Wound Closure Adhesive Surgical Tape Strips because the manufacturer could not confirm the product's sterility.
Product
Premier Value Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 in. Sterile latex free UPC # 040986021558 Used to secure, close and support small cuts and wounds.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1896-2013·2013-08-14
ASO Recalls Walgreens Wound Closure Adhesive Surgical Tape Strips
ASO, LLC is recalling specific lots of Walgreens wound closure adhesive surgical tape strips because the manufacturer could not confirm the products were sterile.
Product
Walgreens ("W" and "Well at Walgreens") Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 in. Sterile latex free UPC # ("W") 311917111728 item # 479241 UPC # ("Well at Walgreens") 311917143354 item # 156744 Used to secure, close and support small cuts…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1878-2013·2013-08-14
Stryker Sonopet Ultrasonic Aspirator Console Recall for Corrosion Defect
Stryker is recalling 215 Sonopet Ultrasonic Aspirator Consoles because corrosion on a power supply component may cause the irrigation pump to stop working during surgery.
Product
Sonopet Ultrasonic Aspirator Console (Console 110V with Pedal & Pole) Product Usage: The Sonopet Console is indicated for use in surgical procedures where fragmentation, emulsification, and aspiration of soft and hard tissue is desirable, including neurosurgery…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1879-2013·2013-08-14
Stryker Sonopet Ultrasonic Aspirator Console Recalled for Corrosion
Stryker is recalling 215 Sonopet Ultrasonic Aspirator Consoles because corrosion on a power supply component may cause the irrigation pump to stop working.
Product
Sonopet Ultrasonic Aspirator Console 5450-851-000(Console 100V) Product Usage: The Sonopet Console is indicated for use in surgical procedures where fragmentation, emulsification, and aspiration of soft and hard tissue is desirable, including neurosurgery…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0833-2013·2013-08-14
Ventana BenchMark ULTRA Staining Platform Recalled for Fluid Overflow Risk
Ventana Medical Systems is recalling 1,735 BenchMark ULTRA automated staining platforms due to a potential waste fluid overflow that could cause electrical shorting.
Product
VENTANA (a member of the Roche Group) BenchMark ULTRA; REF/MU 750-600; Research Use Only Product Usage: Research Use Only-The DISCOVERY ULTRA Advanced Staining System is intended to automatically stain histological or cytological specimens on microscope slides with…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1932-2013·2013-08-14
SpineFrontier T-Handle Strike Plate Separation Recall
SpineFrontier, Inc. is recalling 11 T-Handles because the strike plate loosened and separated during an operation.
Product
T-Handle, Strike Plate, Push Connection, Part Number: SI50023 Rev A T-handles are silicone handled instruments that have a quick release end. The silicone T-handle has an impactor cap on the proximal end of the handle which is designed to be struck with a mallet. T-handles…
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-1924-2013·2013-08-14
Siemens Recalls Dimension Tacrolimus Flex Reagent Cartridges Due to Low Recovery
Siemens Healthcare Diagnostics is recalling specific lots of Dimension Tacrolimus Flex reagent cartridges and calibrators because they may produce falsely low test results, potentially affecting medication dosing for transplant patients.
Product
Dimension Tacrolimus Flex reagent cartridge (DF107) and Dimension TACR CAL (DC107) Product Usage: The TACR method is an in vitro diagnostic test intended to quantitatively measure Tacrolimus in human whole blood on the Dimension clinical chemistry system. Measurements of…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1883-2013·2013-08-14
Siemens Dimension EXL TSH Reagent Cartridge Recall for Rare Variant Detection
Siemens Healthcare Diagnostics is recalling Dimension EXL TSH reagent cartridges because they fail to detect a rare TSH variant found in a small patient cluster.
Product
Dimension EXL LOCI Module TSHL Flex Reagent Cartridge (REF RF612). Intended to quantitatively measure human thyroid stimulating hormone (TSH, thyrotropin).
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1881-2013·2013-08-14
Siemens ADVIA Centaur TSH3 Ultra ReadyPack Recalled for Rare TSH Variant Detection Failure
Siemens Healthcare Diagnostics is recalling ADVIA Centaur Systems TSH3 Ultra ReadyPacks because a rare variant of TSH is not detected by the test.
Product
ADVIA Centaur Systems TSH3 Ultra ReadyPack ((REF 06491072 - 100 Tests, REF 06491080 - 500 Tests, REF 04862625 - 2500T). Intended to quantitatively measure human thyroid stimulating hormone (TSH, thyrotropin).
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1892-2013·2013-08-14
ASO Leader Wound Closure Adhesive Surgical Tape Strips Recalled for Sterility Concerns
ASO, LLC is recalling Leader Wound Closure Adhesive Surgical Tape Strips because the company cannot confirm the products are sterile.
Product
Leader Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 in. Sterile latex free UPC # 096295114706 Used to secure, close and support small cuts and wounds.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1893-2013·2013-08-14
Meijer Wound Closure Adhesive Surgical Tape Strips Recalled for Sterility Concerns
ASO, LLC is recalling Meijer Wound Closure Adhesive Surgical Tape Strips because the manufacturer could not confirm the product's sterility.
Product
Meijer Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 in. Sterile latex free UPC # 719283595973 Used to secure, close and support small cuts and wounds.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1923-2013·2013-08-14
BD Vacutainer Luer Adapter Recalled for Potential Blood Leakage and Low Draw Volume
Becton Dickinson is recalling BD Vacutainer Multiple Sample and Direct Draw Luer Adapters due to potential blood leakage and low draw volume.
Product
BD Vacutainer Multiple Sample and Direct Draw Luer Adapter BD Franklin Lakes, NJ 07417 USA A sterile non-invasive device used to connect venous access devices such as needles, blood collection sets, ad infusion sets to blood collection tubes.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1895-2013·2013-08-14
TopCare Wound Closure Adhesive Surgical Tape Strips Recalled for Sterility Concerns
ASO, LLC is recalling TopCare Wound Closure Adhesive Surgical Tape Strips because the manufacturer cannot confirm the product's sterility.
Product
TopCare Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 in. Sterile latex free UPC # 036800165854 Used to secure, close and support small cuts and wounds.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0834-2013·2013-08-14
Ventana Discovery Ultra Staining Systems Recalled for Waste Fluid Overflow Risk
Ventana Medical Systems is recalling 54 Discovery Ultra automated staining systems because waste fluid drainage may become restricted, leading to overflow and potential fluid migration.
Product
VENTANA (a member of the Roche Group) DISCOVERY ULTRA; REF/MU 750-601; Research Use Only Product Usage: Research Use Only-The DISCOVERY ULTRA Advanced Staining System is intended to automatically stain histological or cytological specimens on microscope slides with…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1889-2013·2013-08-14
ASO Recalls Wound Closure Tape Strips Due to Sterility Concerns
ASO, LLC is recalling Discount Drug Mart wound closure adhesive tape strips because the company cannot confirm the product is sterile.
Product
Discount Drug Mart Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 in. Sterile latex free UPC # 093351120374 Used to secure, close and support small cuts and wounds.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1888-2013·2013-08-14
CVS Pharmacy Wound Closure Adhesive Surgical Tape Strips Recalled for Sterility Concerns
ASO, LLC is recalling CVS Pharmacy Wound Closure Adhesive Surgical Tape Strips because the manufacturer cannot confirm the product's sterility.
Product
CVS Pharmacy Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 in. Sterile latex free UPC # 050428102909 item # 409170 Used to secure, close and support small cuts and wounds.
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-1820-2013·2013-08-07
DePuy LPS Lower Extremity Dovetail Intercalary Component Recall for Fracture Risk
DePuy Orthopaedics is recalling LPS Lower Extremity Dovetail Intercalary components due to a potential for fracture under certain physiological loads.
Product
LPS Lower Extremity Dovetail Intercalary component. Intended for use in replacement of the mid-shaft portion of the femur.
Category
Medical Device
Distribution
17 states

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26201–26225 of 27686