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

26251–26275 of 27722

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
HighFDA (Devices)·Z-1847-2013·2013-08-07
Hospira Symbiq Infusion System Recalled for Secondary Audio Signal Failure
Hospira Inc. is recalling 2,791 Symbiq Infusion Systems because the secondary audio signal fails to activate. The devices were distributed across 22 US states.
Product
The Hospira Symbiq Infusion System is intended for the delivery of fluids, solutions, drugs, agents, nutritionals, electrolytes, blood and blood products via parenteral, enteral, intravenous, intra-arterial, subcutaneous, epidural, or irrigation routes of administration.
Category
Medical Device
Distribution
22 states
HighFDA (Devices)·Z-1848-2013·2013-08-07
Siemens Luminos dRF Fluoroscopic X-Ray System Recalled for Software Error
Siemens is recalling four Luminos dRF Fluoroscopic X-Ray systems due to a software error that may cause the table to tilt and collide with the floor.
Product
Siemens Luminos dRF Fluoroscopic X-Ray system Fluoroscopic X-Ray system
Category
Medical Device
Distribution
4 states
HighFDA (Devices)·Z-1837-2013·2013-08-07
Omnicycle Elite Medical Exercise Equipment Recalled for Firmware Anomaly
Accelerated Care Plus is recalling 1,001 Omnicycle Elite units due to a firmware anomaly that may cause the equipment to operate at an incorrect speed in reverse mode.
Product
Omnicycle Elite; US Importer and Distributor: Accelerated Care Plus, Reno NV. Manufactured by Medica Medizintechnik GmbH, Hochdorf, Germany. The product is indicated for powered exercise equipment intended for medical purposes.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1821-2013·2013-08-07
Synthes Synapse SD Drill Guide Recalled for Incorrect Etching
Synthes USA HQ, Inc. is recalling two Synapse SD Drill Guides with incorrect etching. The error could lead to the use of the wrong drill size during surgery.
Product
Synthes Synapse SD Drill Guide, Part Number SD389.477, Lot Number 6913900 Indicated for Hooks, Plate/Rods, Rods and Screws when intended to promote fusion of the cervical spine fusion of the cervical spine and occipitocervical junction (occiput-T3), the plate/rod, rod, hook…
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1817-2013·2013-08-07
Sotera Wireless Recalls ViSi Mobile Monitor Due to Blister Wound Risk
Sotera Wireless is recalling 90 ViSi Mobile Monitoring Systems because the chest sensor may cause blister wounds.
Product
ViSi Mobile Monitor, Catalog No. 92-10010 The ViSi Mobile Monitoring System is intended for use by clinicians and medically qualified personnel for single or multi-parameter vital signs monitoring of adult patients.
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-1832-2013·2013-08-07
Exactech Articulated Driver Recalled for Potential Disassembly During Use
Exactech, Inc. is recalling 57 Articulated Driver units because the cross pin may shift out of position, potentially leading to instrument disassembly during orthopedic surgery.
Product
Exactech Articulated Driver A nonpowered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery.
Category
Medical Device
Distribution
7 states
HighFDA (Devices)·Z-1818-2013·2013-08-07
Sotera Wireless Recalls ViSi Mobile Chest Sensors for Blister Risk
Sotera Wireless is recalling 75 ViSi Mobile Chest Sensors because they may cause blister wounds on patients.
Product
ViSi Mobile Chest Sensor (3 lead-wire ECG, AAMI), Catalog No. 93-10014 The ViSi Mobile Monitoring System is intended for use by clinicians and medically qualified personnel for single or multi-parameter vital signs monitoring of adult patients.
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-1836-2013·2013-08-07
St. Jude Medical Recalls Eon Mini Implantable Pulse Generators
St. Jude Medical is recalling 34,617 Eon Mini implantable pulse generators worldwide due to a battery weld issue that can cause loss of pain relief.
Product
Eon Mini - 3788 (IPG), Eon Mini system is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs including unilateral or bilateral pain associated with the following: failed back, surgery syndrome, intractable low back and leg pain.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1813-2013·2013-08-07
Heartware HVAD Pump Implant Kit Recalled for Electrostatic Discharge Risk
HeartWare Inc is recalling HVAD Pump Implant Kits due to a potential electrostatic discharge (ESD) hazard. The recall covers 76 units in the US and 82 internationally.
Product
Heartware HVAD Pump Implant Kit (Heartware Ventricular Assist Device)
Category
Medical Device
Distribution
29 states

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26251–26275 of 27722