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

7176–7200 of 39968

ModerateFDA (Devices)·Z-2088-2024·2024-05-29
Medline 20ML Non-Sterile Syringes Recalled for Non-Approved Configurations
Jiangsu Shenli Medical is recalling Medline 20ML non-sterile syringes (Model 91863) because certain piston syringe sizes and configurations were not cleared under the firm's FDA 510(k). The affected units were distributed nationwide.
Product
Brand Name: MEDLINE Product Name: SYR 20ML L/L YELLOW LIDO Model/Catalog Number: 91863 Product Description: NON-Sterile syringes without needles for single use Component: No
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2085-2024·2024-05-29
Medline Syringes Recalled: Device Configuration Outside FDA Clearance Scope
Medline is recalling 10ML non-sterile syringes (Model 91857) distributed nationwide because the device configurations fall outside the FDA-cleared range for this product.
Product
Brand Name: MEDLINE Product Name: SYR 10ML L/L GREEN CONT Model/Catalog Number: 91857 Product Description: NON-Sterile syringes without needles for single use Component: No
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2049-2024·2024-05-29
Medline non-sterile syringes recalled for manufacturing outside FDA clearance scope
Medline non-sterile syringes (Model 83084) are being recalled because they were manufactured in sizes and configurations outside the scope of FDA clearance.
Product
Brand Name: MEDLINE Product Name: SYR 3ML L/L Model/Catalog Number: 83084 Product Description: NON-Sterile syringes without needles for single use Component: No
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2045-2024·2024-05-29
MEDLINE SYR 60ML Non-Sterile Syringes Recalled for Clearance Violation
Jiangsu Shenli Medical is recalling 1,117,800 MEDLINE SYR 60ML non-sterile syringes (Model 83080) because certain syringe sizes and configurations exceed what was approved under the manufacturer's FDA 510(k) clearance.
Product
Brand Name: MEDLINE Product Name: SYR 60ML L/L Model/Catalog Number: 83080 Product Description: NON-Sterile syringes without needles for single use Component: No
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2064-2024·2024-05-29
Non-Sterile Syringes Recalled Outside FDA-Cleared Size and Configuration Range
Medline is recalling 820,400 non-sterile syringes (model 91832) because their sizes and configurations fall outside what was cleared by the FDA. The devices were not manufactured within the approved specifications.
Product
Brand Name: MEDLINE Product Name: SYR 10ML L/L BLUE Model/Catalog Number: 91832 Product Description: NON-Sterile syringes without needles for single use Component: No
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2056-2024·2024-05-29
MEDLINE Non-Sterile Syringes Model 91822 Recalled for Unapproved Configuration
MEDLINE non-sterile syringes (Model 91822) are recalled because their sizes and configurations fall outside the FDA-approved range under the manufacturer's 510(k) clearance. Approximately 12,000 units were distributed nationwide.
Product
Brand Name: MEDLINE Product Name: SYR 3ML L/L BLUE Model/Catalog Number: 91822 Product Description: NON-Sterile syringes without needles for single use Component: No
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2095-2024·2024-05-29
Medline non-sterile syringes recalled for out-of-range configuration variations
Medline's non-sterile syringes (Model 91877) are recalled because their sizes and configurations exceed what was approved under the firm's 510(k) clearance. The regulatory non-compliance affects 3,840 units distributed nationwide.
Product
Brand Name: MEDLINE Product Name: SYR CNTRL 10ML L/L YELLOW LIDO Model/Catalog Number: 91877 Product Description: NON-Sterile syringes without needles for single use Component: No
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2053-2024·2024-05-29
MEDLINE Piston Syringes Recalled for Out-of-Range Specifications
Jiangsu Shenli Medical Production recalled 1.7 million MEDLINE piston syringes because the devices' sizes and configurations exceed what was cleared by the FDA. The affected syringes were distributed nationwide across multiple states.
Product
Brand Name: MEDLINE Product Name: SYR 1ML TB Model/Catalog Number: 83089 Product Description: NON-Sterile syringes without needles for single use Component: No
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2116-2024·2024-05-29
GMAX 60ML Non-Sterile Syringes Recalled for Design Non-Compliance
Jiangsu Shenli Medical is recalling 1.59 million GMAX 60ML non-sterile syringes because the syringe sizes and configurations exceed what the FDA cleared the manufacturer to produce. The syringes were distributed nationwide.
Product
Brand Name: GMAX Product Name: SYR 60ML/LL syringe Model/Catalog Number: TS2260L-M Product Description: NON-Sterile syringes without needles for single use Component: No
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2075-2024·2024-05-29
Medline 20mL Non-Sterile Syringes Recalled for Configuration Non-Conformance
Medline syringes (Model 91845) distributed across six US states are recalled because their piston configurations don't match FDA-cleared design specifications. The recall affects approximately 40,800 units.
Product
Brand Name: MEDLINE Product Name: SYR 20ML L/L BLUE SALINE Model/Catalog Number: 91845 Product Description: NON-Sterile syringes without needles for single use Component: No
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2102-2024·2024-05-29
Wolf Medical 3 mL Syringes Recalled for Out-of-Specification Manufacturing
Jiangsu Shenli Medical is recalling 777,400 Wolf Medical 3 mL syringes (Model SYR03L) manufactured outside FDA clearance scope. Users should discontinue use of affected lot codes.
Product
Brand Name: Wolf Medical Product Name: 3 mL (cc) Luer Lock STERILE LATEX FREE NON PYROGENIC Model/Catalog Number: SYR03L Product Description: NON-Sterile syringes without needles for single use Component: No
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2122-2024·2024-05-29
GMAX Blue Syringes Recalled for Out-of-Range Design Configurations
Jiangsu Shenli Medical recalled 9,800 GMAX blue syringes because their sizes and configurations fall outside FDA's clearance range. Affected units were distributed nationwide to healthcare facilities and retailers.
Product
Brand Name: GMAX Product Name: SYR 10ML/LL Blue syringe Model/Catalog Number: TS2210B-M Product Description: NON-Sterile syringes without needles for single use Component: No
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2057-2024·2024-05-29
Non-sterile syringes recalled for configurations exceeding FDA clearance
Medline is recalling approximately 95,200 non-sterile 5mL syringes (Model 91825) distributed nationwide because syringe sizes and configurations exceed the scope of FDA 510(k) clearance.
Product
Brand Name: MEDLINE Product Name: SYR 5ML L/L RED Model/Catalog Number: 91825 Product Description: NON-Sterile syringes without needles for single use Component: No
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2071-2024·2024-05-29
Medline Non-Sterile Syringes Recalled for Unapproved Device Configurations
Jiangsu Shenli Medical is recalling 178,400 non-sterile syringes sold under the Medline brand because the device configurations exceed what was cleared under the firm's FDA 510(k) application.
Product
Brand Name: MEDLINE Product Name: SYR 20ML L/L YELLOW Model/Catalog Number: 91839 Product Description: NON-Sterile syringes without needles for single use Component: No
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1889-2024·2024-05-29
Cerene Cryotherapy Device recall: missing error code in troubleshooting table
Channel Medsystems is recalling the Cerene Cryotherapy Device because error code 003 is missing from the device's troubleshooting documentation, which could prevent clinicians from properly diagnosing errors during use.
Product
Brand Name: Cerene Cryotherapy Device Product Name: DEVICE, THERMAL ABLATION, ENDOMETRIAL Model/Catalog Number: FGS-7000 Product Description: The Cerene Cryotherapy Device is an endometrial ablation device that uses nitrous oxide (N2O) to freeze and ablate the endometrium to r
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2078-2024·2024-05-29
Medline Non-Sterile Syringes Recalled for Unapproved Configuration
Medline 10mL non-sterile syringes have been recalled because their piston size and configuration fall outside the range cleared by FDA. The recall affects 7,000 units distributed nationwide.
Product
Brand Name: MEDLINE Product Name: SYR 10ML L/L BLUE SALINE Model/Catalog Number: 91849 Product Description: NON-Sterile syringes without needles for single use Component: No
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2110-2024·2024-05-29
GMAX Syringes Recalled for Manufacturing Outside FDA-Cleared Specifications
Jiangsu Shenli Medical Production recalled 37,200 GMAX non-sterile syringes manufactured outside FDA-approved specifications. Affected units were distributed across CA, FL, GA, IL, TN, and VA.
Product
Brand Name: GMAX Product Name: SYR 6ML/LL syringe Model/Catalog Number: TS2206L-M Product Description: NON-Sterile syringes without needles for single use Component: No
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2069-2024·2024-05-29
MEDLINE Non-Sterile Syringes Recalled for Unapproved Sizes and Configuration
Medline non-sterile syringes are recalled because their piston sizes and configurations exceed those approved by the FDA. No injuries have been reported. Approximately 230,800 units were distributed nationwide across six states.
Product
Brand Name: MEDLINE Product Name: SYR 20ML L/L BLUE Model/Catalog Number: 91837 Product Description: NON-Sterile syringes without needles for single use Component: No
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2111-2024·2024-05-29
FDA Recalls GMAX Non-Sterile 10ML Syringes Due to Non-Compliant Manufacturing Specifications
GMAX non-sterile syringes are being recalled because their actual sizes and configurations exceed the range of specifications the manufacturer obtained FDA clearance for.
Product
Brand Name: GMAX Product Name: SYR 10ML/LL syringe Model/Catalog Number: TS2210L-M Product Description: NON-Sterile syringes without needles for single use Component: No
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2061-2024·2024-05-29
Medline Non-Sterile Syringes Recalled Due to Manufacturing Specification Mismatch
Medline non-sterile 5mL syringes (model 91829) are recalled because they were manufactured outside the scope of FDA-approved specifications. About 35,000 units are affected.
Product
Brand Name: MEDLINE Product Name: SYR 5ML L/L YELLOW Model/Catalog Number: 91829 Product Description: NON-Sterile syringes without needles for single use Component: No
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2066-2024·2024-05-29
Non-sterile Syringes Recalled for Unapproved Specifications
Jiangsu Shenli Medical Production is recalling approximately 749,400 non-sterile syringes (10ml) distributed under the Medline brand because their sizes and configurations were not cleared by FDA.
Product
Brand Name: MEDLINE Product Name: SYR 10ML L/L YELLOW Model/Catalog Number: 91834 Product Description: NON-Sterile syringes without needles for single use Component: No
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-1681-2024·2024-05-22
Cardiac Catheters Recalled Due to Polyurethane Delamination and Guidewire Advancement Issues
Boston Scientific is recalling 9,271 Expo 5F Selective Angiographic Catheters due to polyurethane delamination that can prevent guidewire advancement. The defect was found in certain batches with worldwide distribution.
Product
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AR2 (5PK), REF H74908526862; cardiac catheter
Category
Medical Device
Distribution
0 states
CriticalFDA (Devices)·Z-1671-2024·2024-05-22
Expo 5F Cardiac Catheters recalled due to polyurethane delamination
Boston Scientific recalled 2,314 Expo 5F cardiac catheters due to polyurethane delamination in the inner lining. The defect can prevent guidewire advancement during angiographic procedures.
Product
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO WR (SGL), REF H74908526501; cardiac catheter
Category
Medical Device
Distribution
0 states
CriticalFDA (Devices)·Z-1685-2024·2024-05-22
Boston Scientific cardiac catheters recalled for delaminating polyurethane and guidewire advancement failure
Boston Scientific is recalling Expo 5F Selective Angiographic Catheters due to complaints of guidewire advancement problems and polyurethane delamination in the catheter lining. Affected catheters are distributed worldwide.
Product
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL5 (5PK), REF H7490852624; cardiac catheter
Category
Medical Device
Distribution
0 states
CriticalFDA (Devices)·Z-1665-2024·2024-05-22
Expo Selective Angiographic Catheters Recalled for Material Delamination and Detachment
Boston Scientific recalls Expo 5F Selective Angiographic Catheters due to polyurethane layer delamination and material detachment that may prevent guidewire advancement during cardiac procedures. Affected batches 60443927 and 60495422 have been distributed worldwide.
Product
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK (SGL), REF H749085263001; cardiac catheter
Category
Medical Device
Distribution
0 states

How to read this listing

Filters

7176–7200 of 39968