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-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-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-2224-2021·2021-08-18
Codman Raney Scalp Clips recalled for compromised sterile barrier packaging
Integra LifeSciences is recalling Codman Raney Scalp Clips (lot numbers W2102045, W2102046, W2102048, W2102049) due to wrinkles in the packaging that may compromise the sterile barrier.
Product
CODMAN RANEY SCALP CLIPS-Disposable cylindrical clips designed to provide hemostasis to the scalp wound edge. Part Number: 201037
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-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
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-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-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-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
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-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-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
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-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-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-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-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
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
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-2179-2021·2021-08-11
Sterile Home Artificial Insemination Kits Recalled for Missing FDA Marketing Authorization
Tenderneeds Fertility LLC is recalling sterile home artificial insemination semen kits distributed worldwide prior to December 9, 2019, due to lack of required FDA marketing authorization.
Product
2 X Sterile Human Home Artificial Insemination Semen Kit (Human), SKU 143298592960
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2198-2021·2021-08-11
Straumann SCS Screwdriver Recalled for Incorrect Tip Configuration
Straumann USA LLC is recalling 130 units of the Straumann SCS Screwdriver (Article 046.401) due to an incorrect tip configuration that prevents proper engagement with screw heads during dental surgery, creating a potential injury risk.
Product
Straumann SCS Screwdriver, driver, for ratchet, short, L 21mm, stainless steel Article Number: 046.401. dental surgical instrument.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2183-2021·2021-08-11
Artificial insemination kits recalled for lack of FDA authorization
Tenderneeds Fertility LLC is recalling artificial insemination kits that were distributed without proper FDA marketing authorization. All lots sold before December 9, 2019 are affected.
Product
2 Complete ICI Human At Home Donor Artificial Insemination Kits Tenderneeds, SKU unknown
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2174-2021·2021-08-11
AMIA Automated Peritoneal Dialysis System User Guide Contains Incorrect Operating Instructions
The AMIA Sharesource User Guide for the AMIA Automated Peritoneal Dialysis System incorrectly describes the Ultrafiltration Limit setting, potentially causing patients to misunderstand when therapy should end. Approximately 5,101 affected units have been distributed worldwide.
Product
Kaguya Automated Peritoneal Dialysis System
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2176-2021·2021-08-11
Home Artificial Insemination Kit Recalled for Lack of Marketing Authorization
Tenderneeds Fertility LLC is recalling home artificial insemination kits that were distributed without proper FDA authorization. The device was sold worldwide prior to December 9, 2019.
Product
Home Artificial Insemination Kit Human IUI ICI Pregnancy & Ovulation Tests, SKU midiuikt
Category
Medical Device
Distribution
0 states

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13276–13300 of 13802