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 deaths or serious injuries are reported, 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

13251–13275 of 13836

HighFDA (Devices)·Z-2217-2021·2021-08-18
TruRize Clinical Chair distributed to home users who may misuse it
Stryker's TruRize Clinical Chair was distributed to residential customers despite being designed for healthcare facility use only. Home users may not understand safety instructions intended for trained professionals.
Product
TruRize Clinical Chair - support structure that places human occupants in upright, seated, recline, supine, and trend positions, Model Number: 3333, Part #¿3333000000
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2253-2021·2021-08-18
Medical imaging software displays anatomical orientation tags incorrectly
Simpleware ScanIP medical imaging software contains a bug where anatomical orientation tags display incorrectly. This could lead to operator misunderstanding and errors during image resampling and realignment.
Product
Simpleware ScanIP software. For transfer of imaging information from a medical scanner to an output file, and for simulating/evaluating surgical treatment options.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2248-2021·2021-08-18
Bard Jamshidi Evolve Bone Marrow Needle Recall Due to Open Packaging
Bard recalls Jamshidi Evolve bone marrow needles due to incomplete packaging seals that could compromise sterility. The recall affects 560 devices distributed in the U.S. and internationally.
Product
EJM4011 Jamshidi Evolve" Bone Marrow Biopsy/Aspiration Needle with Specimen Cradle. 11G x 10cm
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2219-2021·2021-08-18
Michael Graves Stryker Highback Chair distributed to home users instead of healthcare facilities
Stryker Medical Division recalled its Michael Graves Highback Chair (Model 4853) after it was distributed to residential customers instead of healthcare facilities. Home users may not understand safety instructions written for trained medical professionals.
Product
Michael Graves with Stryker Highback Chair-intended for pediatric and adult person guest and patient seating use in an indoor medical setting, Model Number 4853, Part #4853000000 ¿
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2213-2021·2021-08-18
Stryker IsoGel Air Medical Device Distributed to Home Users Instead of Healthcare Facilities
Stryker has recalled 3 IsoGel Air pressure ulcer support surfaces that were distributed to home users when designed for use only in healthcare facilities. Home users may not understand the professional healthcare instructions required for proper use.
Product
IsoGel Air - support surface assists in the prevention and treatment of all pressure ulcers stages, Model Number 2860, Part 2860000999
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2269-2021·2021-08-18
Hip implant component recalled due to potential corrosion and failure risk
Biomet is recalling 11 units of a hip replacement component that could experience inner taper corrosion and failure, potentially requiring surgical intervention. No injuries have been reported.
Product
Arcos Modular Revision Hip System Standard Cone Prox Body, Size E, 70 MM Item Number:11-301325
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2277-2021·2021-08-18
Spectrum Medical Quantum Standard Heat Exchanger Sterilization Defect Recall
QURA S.R.L. is recalling 1088 units of Spectrum Medical Quantum Standard heat exchangers that may not be adequately sterilized. The devices also lack required 510(k) clearance for US distribution.
Product
Spectrum Medical Quantum Standard heat exchanger
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2218-2021·2021-08-18
Symmetry Plus Treatment Recliner distributed to home users instead of healthcare facilities
A medical treatment recliner designed for healthcare facilities was distributed to home consumers. Home users may not understand the specialized instructions intended for healthcare professionals, creating a potential safety risk.
Product
Symmetry Plus Treatment Recliner - general hospital use as a convenient seating surface for patients or guests to sit, Model Number 3500, Part # 3500000710
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2266-2021·2021-08-18
Hip Implant Component Failure Risk From Inner Taper Fretting Corrosion
Biomet's Arcos hip implant replacement components may develop inner taper fretting corrosion, leading to device failure requiring surgical intervention. Seven units nationwide are affected.
Product
Arcos Modular Revision Hip System High Offset Cone Prox Body, Size E, 60 MM Item Number: 11-301315
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2214-2021·2021-08-18
S3 MedSurg hospital beds recalled from residential sale due to misuse risk
Stryker's S3 MedSurg hospital beds designed for healthcare facilities were distributed to home customers. The device labeling is correct but home users may not understand professional-use instructions, posing a risk of improper operation.
Product
S3 MedSurg Bed - intended to support and transport patients within the Med/Surg and Critical Care hospital environments, Model Number 3002, Part 3002S3CUSTOM, 3002S3EX, 3002S3PATRIOT
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2212-2021·2021-08-18
Medical device designed for healthcare professionals distributed to untrained home users
Stryker's ComfortGel pressure injury treatment device was distributed to residential customers for home use, though it was designed for trained healthcare professionals. Home users may not understand the complex instructions intended for professional use.
Product
ComfortGel - assists in the prevention and treatment of all pressure injury stages, Model Number 2850, Part # 2850000999, 2850000001, 2850000009
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2226-2021·2021-08-18
In Vitro Diagnostic Test Produces Incorrect Antibiotic Susceptibility Results
Biomerieux's ETEST IMIPENEM RELEBACTAM diagnostic test produces major errors when testing Pseudomonas aeruginosa, incorrectly identifying resistant strains as susceptible. Approximately 1,431 units distributed worldwide.
Product
ETEST IMIPENEM RELEBACTAM. in vitro diagnostic
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2207-2021·2021-08-18
Stryker Prime Fifth Wheel Stretcher distributed to residential customers instead of healthcare facilities
A medical stretcher designed for healthcare professionals was distributed to residential customers. The device labeling is appropriate for healthcare settings, but home users may not understand or follow the professional-use instructions.
Product
Prime Fifth Wheel Stretcher-stretcher may be used for minor procedures and short-term stay (treatment and recovery, Model 1105, Part Numbers 1105000026 and 1105000000X
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2264-2021·2021-08-18
Hip Implant Component Recalled for Fretting Corrosion Risk
Biomet is recalling 33 units of the Arcos Modular Revision Hip System due to potential inner taper fretting corrosion that could lead to device failure and require surgical intervention.
Product
Arcos Modular Revision Hip System High Offset Cone Prox Body, Size B, 60 MM Item Number: 11-301312
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2262-2021·2021-08-18
Hip Replacement Component Recalled for Potential Device Failure Risk
Biomet is recalling 81 units of a hip replacement component due to potential device failure that could require additional surgery. The affected device is the Arcos Modular Revision Hip System High Offset Cone Prox Body, Size A.
Product
Arcos Modular Revision Hip System High Offset Cone Prox Body, Size A, 50 MM Item Number: 11-301310
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2281-2021·2021-08-18
Edwards PediaSat Oximetry Catheters Recalled for Potential Internal Leaks
Edwards Lifesciences is recalling Edwards PediaSat Oximetry Catheter Sets due to a potential for internal leaks within the catheters. The recall affects 178 units distributed across multiple US states and international locations.
Product
Edwards PediaSat Oximetry Catheter Set, REF: XT358SP, Exterior Diameter 5.5F (1.83 mm), Usable Length 9 cm, Number of Lumens: 3, Recommended Guidewire Size: GW: 0.025" (0.64 mm), Rx Only, Sterile EO, UDI: (01)00690103197525 *NOT DISTRIBUTED WITHIN THE US
Category
Medical Device
Distribution
12 states
HighFDA (Devices)·Z-2222-2021·2021-08-18
Stryker Electric Hospital Beds Recalled for Unintended Home Use
Stryker recalled 9 Electric MedSurg Bed FL23 units intended for healthcare facilities but distributed to residential customers. Professional-level instructions may not be understood by untrained home users.
Product
Electric MedSurg Bed FL23 - AC-powered adjustable hospital bed with four built-in electric DC motors and remote controls that is intended for medical purposes, Model Number: FL23, Part #FL23SE
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2206-2021·2021-08-18
Stryker Surgistool Model 830 distributed to home users instead of healthcare professionals
Stryker Medical recalls a surgical support tool that was distributed to home consumers but is intended only for healthcare professionals. The device labeling is correct, but home users may lack training to use it safely.
Product
Surgistool-intended to support a healthcare professional during surgical procedures Model 830, Part Number 0830000000
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2205-2021·2021-08-18
Transport Stretcher 747 distributed to home users without professional training
Stryker's Transport Stretcher 747, designed for healthcare facilities, was distributed to home users who may not understand its intended-use instructions. The recall addresses risks from improper use by untrained consumers.
Product
Transport Stretcher 747 - a non-powered, wheeled device designed to support patients in a horizontal position, Part Number 0747000000
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2239-2021·2021-08-18
Cardiac Sheath Introducer Devices Recalled Due to Size Mislabeling
Merit Medical Systems recalls 760 units of Prelude SNAP Splittable Sheath Introducer (7F) due to packaging errors where devices are labeled as 10F instead of the correct 7F size.
Product
Prelude SNAP Splittable Sheath Introducer, REF: PLS-1007, size 7F, Standard Length: 13 cm, CE0344, STERILE EO, Rx Only, UDI:(01) 00884450467985. For the introduction of various types of pacing leads and catheters to the heart and coronary venous system.
Category
Medical Device
Distribution
29 states
HighFDA (Devices)·Z-2268-2021·2021-08-18
Arcos Hip System Cones Recalled for Potential Inner Taper Corrosion
Biomet recalled 11 Arcos Modular Revision Hip System proximal cones due to potential inner taper fretting corrosion and device failure that could require surgical intervention. Affected units distributed nationwide.
Product
Arcos Modular Revision Hip System Standard Cone Prox Body, Size B, 70 MM Item Number: 11-301322
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2258-2021·2021-08-18
ACCESS SARS-CoV-2 Antigen Extraction Solution recalled for potential false positive results
Beckman Coulter is recalling ACCESS SARS-CoV-2 Antigen Extraction Solution nationwide because the assay test may generate false positive results, leading to incorrect diagnosis.
Product
ACCESS SARS-CoV-2 ANTIGEN EXTRACTION SOLUTION, CONTENTS: 6 x 6.0 mL EXTRACTION SOLN, IVD, Rx Only, UDI: (01)15099590743017
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2231-2021·2021-08-18
Medline Shoulder CDS Kits Recalled Due to Expired Irrigation Component
Medline Industries is recalling 286 Shoulder CDS convenience kits that may contain an expired NaCl irrigation component. Users should stop using the kits and contact the manufacturer for return instructions.
Product
Medline Shoulder CDS convenience kits, REF DYNJ902837D and REF DYNJ902837F, containing expired component NaCl 3000mL Irrigation Bag (exp. date 08/01/2020).
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2228-2021·2021-08-18
Medtronic StimLoc Burr Hole Cover Recalled for Excess Nylon Flash on Clip
Medtronic is recalling StimLoc Burr Hole Cover neurosurgical devices and related components due to excess nylon flash on the clip. The defect could affect device function during implantation or use.
Product
Medtronic StimLoc Burr Hole Cover, Part Numbers: a) 3387S-40 b) 3389S-28 c) 3389S-40 d) 3391S-40 e) 3550S-01 f) 924256 g) DB-5000
Category
Medical Device
Distribution
46 states
HighFDA (Devices)·Z-2282-2021·2021-08-18
Edwards PediaSat Oximetry Catheter Set recalled for potential internal leaks
Edwards Lifesciences is recalling its PediaSat Oximetry Catheter Set due to potential for internal leaks within the device.
Product
Edwards PediaSat Oximetry Catheter Set, REF: XT358KTP, Exterior Diameter 5.5F, Usable Length 8 cm, Number of Lumens: 3, Recommended Guidewire Size: GW: 0.025" (0.64 mm), Rx Only, Sterile EO, UDI: (01)00690103197556
Category
Medical Device
Distribution
12 states

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13251–13275 of 13836