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 13802

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-2249-2021·2021-08-18
Bard Bone Marrow Aspiration Needles Recalled for Incomplete Packaging Seals
Bard Peripheral Vascular is recalling Illinois Bone Marrow Aspiration/Intraosseous Infusion Needles due to incomplete or open packaging seals that could compromise sterility. Approximately 1,200 devices are affected.
Product
TIN3018 Illinois Bone Marrow Aspiration/Intraosseous Infusion Needle 18G x 79mm TIN3015 Illinois Bone Marrow Aspiration/Intraosseous Infusion Needle 15G x 79mm
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-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-2254-2021·2021-08-18
Simpleware ScanIP Medical Software Recall: Incorrect Anatomical Orientation Display
Simpleware ScanIP medical software may display anatomical orientation tags incorrectly, potentially causing surgical planning errors. This FDA Class II recall affects versions from 2018–2021 distributed in the US and internationally.
Product
Simpleware ScanIP medical 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-2260-2021·2021-08-18
Biomet Arcos Hip Prosthesis Recalled Due to Device Failure Risk
Biomet is recalling certain Arcos Modular Revision Hip System components due to risk of device failure and fretting corrosion. Affected patients may require revision surgery.
Product
Arcos Modular Revision Hip System Standard Cone Prox Body, Size A, 60 MM Item Number: 11-301301
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-2220-2021·2021-08-18
Stretcher Chair Model 5050 Incorrectly Distributed to Residential Customers
Stryker's Model 5050 stretcher chair was distributed to residential customers despite being designed for healthcare professionals. Home users may not understand instructions intended for trained medical staff, creating a risk of misuse.
Product
Stretcher Chair-for use in all acute care hospitals and medical outpatient services Model Number: 5050¿¿¿¿ Part # 5050000000
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2229-2021·2021-08-18
Shent USA Grasper/Retriever Endoscopic Instruments Recalled for Mislabeling
Shent USA is recalling Grasper/Retriever endoscopic instruments (lot 020377208) due to mislabeling. Products bearing one catalog number may contain different devices with different jaw specifications, potentially resulting in wrong instrument selection.
Product
Grasper/Retriever, Alligator Jaw 2.4 mm x 5 mm x 230 cm Catalog Number: 7208 Intended use: single use accessory devices used through the working channel of a GI endoscope
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2267-2021·2021-08-18
Biomet Arcos Hip Implant Component Recalled for Potential Fretting Corrosion
Biomet is recalling 11 units of Arcos Modular Revision Hip System Standard Cone Prox Body components due to potential fretting corrosion at the inner taper joint that could cause device failure and require revision surgery.
Product
Arcos Modular Revision Hip System Standard Cone Prox Body, Size A, 70 MM Item Number: 11-301321
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2242-2021·2021-08-18
Smith & Nephew Orthopedic Nail May Detach During Surgery
Smith & Nephew is recalling an orthopedic surgical nail (BHR SQUARE HEADED, catalog #999908) that may detach during surgery. Forty-seven affected units have been distributed worldwide.
Product
smith&nephew BHR SQUARE HEADED NAIL, REF CATALOG NUMBER 999908. For use during orthopedic surgery.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2279-2021·2021-08-18
Edwards PediaSat Oximetry Catheter Kit Recalled for Internal Leak Risk
Edwards Lifesciences recalls PediaSat Oximetry Catheter Kits (REF: XT3515SP) due to potential for internal leaks that could affect oxygen saturation monitoring.
Product
Edwards PediaSat Oximetry Catheter Kit, REF: XT3515SP, Exterior Diameter 5.5F (1.83 mm), Usable Length 15 cm, Number of Lumens 3, Recommended Guidewire Size 0.025" (0.64 mm), Rx Only, Sterile EO, UDI: (01)00690103197532
Category
Medical Device
Distribution
12 states
HighFDA (Devices)·Z-2280-2021·2021-08-18
Edwards PediaSat Oximetry Catheter Kits Recalled for Potential Internal Leaks
Edwards Lifesciences is recalling PediaSat Oximetry Catheter Kits due to potential internal leaks within the devices. The recall involves 218 units distributed across multiple U.S. states and internationally.
Product
Edwards PediaSat Oximetry Catheter Kit, REF: XT358SJ, Usable Length 8 cm, Number of Lumens 3, Exterior Diameter 5.5F, Rx Only, Sterile EO, UDI: (01)00690103197495 *NOT DISTRIBUTED WITHIN THE US
Category
Medical Device
Distribution
12 states
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-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-2237-2021·2021-08-18
Advance Dx 100 Blood Collection Cards Recalled for Inaccurate Glucose Results
Advance Dx, Inc. is recalling Advance Dx 100 Blood Collection Cards due to inaccurate blood glucose test results. The recall affects 179,750 cards distributed in Maryland and North Carolina.
Product
Advance Dx 100 Blood Collection Card Quantity 25 REF CMT01 Advance Dx 100 Blood Collection Card and Foil Bags Quantity 500 Cards and Foil Bags REF CMT01/F02 IFU: Advance Dx 100 SSE(Serum Separating Extraction) Technology BLOOD COLLECTION INSTRUCTIONS
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-2246-2021·2021-08-18
Mislabeled Cutting Electrode May Contain Wrong Electrode Type
Richard Wolf's Cutting Electrode Bipo 24.5FR may be mislabeled and contain a BIVAP electrode instead. Affected lot 21002858 was distributed to healthcare facilities in five states.
Product
CUTTING ELECTRODE BIPO 24.5FR, REF 4653.1323
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2272-2021·2021-08-18
Hip Implant Component Recalled Due to Potential Fretting Corrosion and Device Failure
Biomet is recalling hip replacement components that could develop fretting corrosion and fail inside the body, potentially requiring revision surgery.
Product
Arcos Modular Revision Hip System High Offset Cone Prox Body, Size E, 70 MM Item Number: 11-301335
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2221-2021·2021-08-18
Stryker CUB Pediatric Crib distributed to home users instead of healthcare facilities
Stryker's CUB Pediatric Crib, designed for hospital use by healthcare professionals, was distributed to home users who may not understand the complex instructions and safety procedures required to operate pediatric medical equipment safely.
Product
CUB Pediatric Crib- intended to provide a pediatric patient support surface for medical purposes and to provide a method of transporting pediatric patients within a healthcare facility Model Number: FL19 Part #5050000000
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2225-2021·2021-08-18
MYLA Laboratory Software: Potential Test Result Alteration from Software Anomaly
BioMerieux is recalling MYLA microbiology software due to a software anomaly that could cause unwanted alterations to test results when using the BCI Connect scripting feature. 248 systems nationwide are affected.
Product
MYLA software. Used to manage microbiology test workflow from the reception of requests to the transmission of results by transferring, storing, and displaying medical device data.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2235-2021·2021-08-18
Cordis SABER PTA Balloon Catheter Recalled for Foreign Material Contamination
Cordis Corporation is recalling the SABER PTA Balloon Dilation Catheter due to potential contamination with foreign material from manufacturing. The contamination may transfer from the protective sheath to the balloon itself.
Product
Cordis SABER PTA Balloon Dilation Catheter, 4F, REF 48004010X
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-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-2271-2021·2021-08-18
Biomet Hip Replacement Component Recalled Over Corrosion and Device Failure Risk
Biomet is recalling Arcos Modular Revision Hip System components that may develop fretting corrosion in the inner taper, risking device failure and the need for revision surgery. Affected patients should contact their healthcare provider.
Product
Arcos Modular Revision Hip System High Offset Cone Prox Body, Size C, 70 MM Item Number: 11-301333
Category
Medical Device
Distribution
Distributed nationwide

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13251–13275 of 13802