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

13301–13325 of 13836

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-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-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-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-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-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-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-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-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-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-2230-2021·2021-08-18
Endoscope Grasper/Retriever Devices Mislabeled with Incorrect Catalog Numbers
Shent USA recalls grasper/retriever endoscopy devices that are mislabeled with incorrect catalog numbers. Units labeled as catalog #7208 may actually be #7226 and vice versa, potentially causing use of the wrong jaw size.
Product
Grasper/Retriever, Alligator Jaw, Rat Tooth 2.4 mm x 8 mm x 230 cm Catalog Number: 7226 Intended use: single use accessory devices used through the working channel of a GI endoscope
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-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-2283-2021·2021-08-18
Edwards PediaSat Oximetry Catheter Set: Potential Internal Leak Risk
Edwards Lifesciences is recalling Edwards PediaSat Oximetry Catheter Sets due to a potential for internal leaks that could affect proper device function.
Product
Edwards PediaSat Oximetry Catheter Set, REF: XT3515SJ, Exterior Diameter 5.5F, Usable Length 15 cm, Number of Lumens: 3, Rx Only, Sterile EO, UDI: (01)00690103197501 *NOT DISTRIBUTED WITHIN THE US
Category
Medical Device
Distribution
12 states
HighFDA (Devices)·Z-2211-2021·2021-08-18
Stryker Proform pressure ulcer support surface distributed to home users
Stryker Proform pressure ulcer support surfaces designed for healthcare facility use were distributed to residential customers. The device labeling is correct but home users may not understand professional-level instructions.
Product
Proform- support surface is used to assist in the prevention and treatment of all categories/stages of pressure ulcers, Model Number: 2710, Part #¿2710000027¿¿¿¿
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-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-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-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-2273-2021·2021-08-18
Biomet Hip Implant System Recalled Due to Potential Fretting Corrosion
Biomet is recalling the Arcos Modular Revision Hip System component due to potential inner taper fretting corrosion that could lead to device failure requiring surgery. No injuries have been reported.
Product
Arcos Modular Revision Hip System Standard Cone Prox Body, Size B, 80 MM Item Number: 11-301342
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2215-2021·2021-08-18
Support Surface Device Distributed to Home Patients Without Healthcare Professional Instructions
An Isolibrium Support Surface intended for healthcare facilities was distributed to home customers. While the labeling is correct, home users may not understand instructions intended for healthcare professionals.
Product
Isolibrium Support Surface - support surface assists in the prevention and treatment of all pressure injury stages (including stages 1, 2, 3, 4, Unstageable and Deep Tissue Pressure Injury, Model Number: 2972, Part # 2972000000
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2227-2021·2021-08-18
CIRRUS HD-OCT Model 6000 imaging devices recalled for missing FDA pre-market clearance
Carl Zeiss Meditec is recalling 914 CIRRUS HD-OCT Model 6000 imaging devices. The manufacturer failed to obtain FDA pre-market clearance before selling the devices.
Product
Chassis Label - "CIRRUS HD-OCT Rx-Only" Product Label Exterior RX - "CIRRUS HD-OCT Model 6000"
Category
Medical Device
Distribution
51 states
ModerateFDA (Devices)·Z-2209-2021·2021-08-18
Prime TC Transport Chair Recalled for Improper Residential Distribution
The Prime TC-transport chair, designed for healthcare facility use, was distributed to residential customers who may not understand the professional-level operating instructions. The recall addresses potential risk of improper use by home users.
Product
Prime TC-transport chair intended for medical purposes to assist a person in performing an activity that the person would find difficult to do or be unable to do Model Number: 1460, Part #1460000000¿¿¿¿¿¿¿
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2233-2021·2021-08-18
Medline Total Knee Surgical Kit Recalled for Expired Irrigation Component
Medline Industries is recalling Total Knee convenience kits that may contain an expired saline irrigation solution component. The expired component may not maintain proper sterility for surgical use.
Product
Medline Total Knee, convenience kit, REF DYNJ907129B, containing expired component NaCl 3000mL Irrigation Bag (exp. date 08/01/2020).
Category
Medical Device
Distribution
Distributed nationwide

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13301–13325 of 13836