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

13276–13300 of 13802

HighFDA (Devices)·Z-2243-2021·2021-08-18
Merit Medical Prelude Introducer Sheath Recalled for Incorrect Dilator
Merit Medical is recalling 373 Prelude Short Sheath Introducer units from lot H2069291 due to potential incorrect dilators in some packages. The defect could affect device functionality in clinical procedures.
Product
MERITMEDICAL Prelude Short Sheath Introducer, REF: PSS-6F-4-018MT, 21G 6F(2.0 mm) 4 cm, Max Guide Wire 0.018" (0.46 mm), STERILE EO, Single Use, Rx Only, CE2797, UDI: (01)00884450015391
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-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-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-2252-2021·2021-08-18
Dutch Ophthalmic Vitrectomy Pack Contains Mismatched Infusion Line Gauge
Dutch Ophthalmic USA is recalling TDC Vitrectomy Pack VGPC 25g surgical kits. The packages are labeled as containing 25-gauge infusion lines but actually contain 23-gauge lines instead.
Product
The device is a 25-gauge infusion line that is part of 25-gauge surgical pack labeled TDC Vitrectomy Pack VGPC 25g, Product Number 8525.201.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2261-2021·2021-08-18
Arcos Modular Revision Hip System Cone Bodies Recalled for Device Failure Risk
Biomet, Inc. is recalling 21 units of Arcos Modular Revision Hip System Standard Cone Prox Bodies due to risk of fretting corrosion and device failure that may require surgical intervention.
Product
Arcos Modular Revision Hip System Standard Cone Prox Body, Size B, 60 MM Item Number: 11-301302
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2216-2021·2021-08-18
Hospital Bed Model 3005 Recalled for Distribution to Home Residents
Stryker's S3 MedSurg hospital bed was distributed to home residents instead of healthcare facilities. The devices are designed for professional operation, and untrained home users may not understand safety instructions.
Product
S3 MedSurg Bed - intended to support and transport patients within the Med/Surg and Critical Care hospital environments, Model Number: 3005, Part # 3005S3EX
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-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-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-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-2250-2021·2021-08-18
Exactech BIOLOX Delta Femoral Head Hip Prosthesis Recalled for Device Marking Mismatch
Exactech is recalling 29 BIOLOX delta femoral head hip prosthesis components due to a discrepancy between the product label and actual device marking. The mismatch could affect proper device identification and surgical placement.
Product
Exactech BIOLOX delta Femoral Head, 36m O.D., REF 170-36-00. Hip prosthesis component.
Category
Medical Device
Distribution
Distributed nationwide
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-2210-2021·2021-08-18
InTouch 2131 Medical Device Recalled for Distribution to Residential Users
Stryker's InTouch 2131 medical device, intended for healthcare facilities, was distributed to residential customers. Home users may not understand healthcare-specific instructions, creating a risk of improper use.
Product
InTouch 2131-intended to support a human patient in an acute care setting, Model Number: 2131000000, Part #1460000000¿¿¿¿¿¿¿
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-2241-2021·2021-08-18
Kaluza C Flow Cytometry Software Recalled for Potential Erroneous Results
The FDA is recalling Kaluza C Flow Cytometry Software versions 1.0, 1.1.1, and 1.1.2 due to software anomalies that may generate erroneous results affecting diagnostic interpretation.
Product
Kaluza C Flow Cytometry Software Versions: 1.0*, 1.1.1 and 1.1.2 Kits: C10574 - Kaluza C Single Perpetual License C10575 - Kaluza C Single User 1-year License C10576 - Kaluza C 10 User Network License C10577 - Kaluza C 5 User Network License C10578 - Kaluza C Single Perpet
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
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
HighFDA (Devices)·Z-2185-2021·2021-08-11
Abbott Activated Alanine Aminotransferase Reagent Recalled for Inaccurate Test Results
Abbott is recalling 1,603 units of its Activated Alanine Aminotransferase (A-ALT) lab reagent due to potential inaccuracies in test results. High bilirubin or high A-ALT samples may produce incorrect results affecting patient care.
Product
REF 8L92-22, Abbott Activated Alanine aminotransferase, for use with Architect, IVD, CE, UDI: (01) 00380740161859
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2180-2021·2021-08-11
TenderNeeds IUI Fertility Kits Distributed Without FDA Marketing Authorization
TenderNeeds Fertility PRO IUI home insemination kits were distributed without proper FDA marketing authorization. All lots sold before December 9, 2019, are affected.
Product
TenderNeeds Fertility PRO IUI Human Artificial Home Insemination Kits, SKU 133166055771
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2171-2021·2021-08-11
Stryker Nail Insertion Sleeve Recalled for Inner Diameter Mismatch
Stryker GmbH is recalling 242 Nail Insertion Sleeves (Catalog Number 18061406S, Lot K03CC4F) because the inner diameter does not match the dimension specified on the outer box label.
Product
Nail Insertion Sleeve, elastic T2 Tibia SPI ¿8-11 (SPI Elast. Sleeve 8-11), Catalog Number 18061406S
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2182-2021·2021-08-11
IntraCervical Insemination Kit Recalled for Lack of FDA Marketing Authorization
Tenderneeds Fertility LLC recalled its Deluxe IntraCervical Insemination Kit worldwide because the device was distributed without FDA marketing authorization. The device was sold prior to December 9, 2019.
Product
Deluxe IntraCervical Insemination (ICI) Kit (3), SKU 382903096046
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2169-2021·2021-08-11
Regard Newborn Heel Warmer Kit Recalled for Inadequate Safety Instructions
ROi CPS LLC is recalling the Regard NEWBORN KIT heel warmer (976 units in Missouri) due to incomplete safety instructions. Updated instructions now warn users to activate the device away from the infant's face and others.
Product
Regard NEWBORN KIT, LD00201M, Item Number: 830016013. Medical convenience kit which includes an infant heel warmer.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2170-2021·2021-08-11
Stryker Nail Insertion Sleeve Recalled for Incorrect Inner Diameter
Stryker is recalling Nail Insertion Sleeves with incorrect inner diameters that do not match the box label. The dimensional mismatch could affect proper fit during orthopedic surgical procedures.
Product
Nail Insertion Sleeve, elastic T2 Tibia SPI ¿8-13 (SPI Elast. Sleeve 8-13), Catalog Number 18061407S
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2201-2021·2021-08-11
In Vitro Diagnostic Reagent Recalled for Reagent Stability Deterioration
Stanbio Laboratory is recalling Synchron Beta-Hydroxybutyrate diagnostic reagent due to reagent deterioration causing quality control values to fall out of expected range.
Product
Synchron CX/DX/LX Beta-Hydroxybutyrate . in vitro diagnostic reagent.
Category
Medical Device
Distribution
Distributed nationwide

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13276–13300 of 13802