FDA (Devices) recall action 94520

Jiangsu Shenli Medical Production Co., Ltd. recalled 87 products on 2024-05-29

The FDA (Devices) publishes a recall like this one as 87 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 87 pages.

Products: 87
Announced: 2024-05-29
Critical: 0
Units: 108,025,840

Why these products were recalled

Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–25 of 87

HighFDA (Devices)··2024-05-29
GMAX Non-Sterile Syringes Recalled Due to Regulatory Non-Compliance
The FDA is recalling 98,700 GMAX non-sterile syringes (Model TS2212L-M) because their sizes and configurations exceed FDA-cleared specifications. Affected units were distributed in California, Florida, Georgia, Illinois, Tennessee, and Virginia.
Product
Brand Name: GMAX Product Name: SYR 12ML/LL syringe Model/Catalog Number: TS2212L-M Product Description: NON-Sterile syringes without needles for single use Component: No
Category
Distribution
6 states
ModerateFDA (Devices)··2024-05-29
Wolf Medical Syringes Recalled for Uncleared Size and Configuration Variants
Jiangsu Shenli Medical is recalling Wolf Medical 6 mL syringes because certain variants weren't cleared under the 510(k). Approximately 454,400 units distributed nationwide are affected.
Product
Brand Name: Wolf Medical Product Name: 6 mL (cc) Luer Lock STERILE LATEX FREE NON PYROGENIC Model/Catalog Number: SYR06L Product Description: NON-Sterile syringes without needles for single use Component: No
Category
Distribution
6 states
HighFDA (Devices)··2024-05-29
Medline Non-Sterile Syringes Recalled for Out-of-Specification Manufacturing
Medline brand non-sterile 5mL syringes (Model 91828) are being recalled because the piston syringe sizes and configurations exceed the manufacturer's FDA 510(k) clearance specifications. The recall affects 22,400 units distributed nationwide.
Product
Brand Name: MEDLINE Product Name: SYR 5ML L/L WHITE Model/Catalog Number: 91828 Product Description: NON-Sterile syringes without needles for single use Component: No
Category
Distribution
6 states
HighFDA (Devices)··2024-05-29
Medline Non-Sterile Syringes Recalled Due to Out-of-Specification Manufacturing
Jiangsu Shenli Medical Production Co., Ltd. is recalling 9,800 Medline non-sterile syringes (model 91852) manufactured in sizes and configurations outside the FDA-cleared range. Customers in six U.S. states should stop using and return the affected product.
Product
Brand Name: MEDLINE Product Name: SYR 5ML L/L YELLOW NITRO Model/Catalog Number: 91852 Product Description: NON-Sterile syringes without needles for single use Component: No
Category
Distribution
6 states
ModerateFDA (Devices)··2024-05-29
MEDLINE 20ML Non-Sterile Syringes Recalled for Configurations Outside FDA Clearance
MEDLINE non-sterile syringes (Model 91843) are being recalled because the product's sizes and configurations fall outside the scope of devices approved under the manufacturer's FDA 510(k) submission. The syringes were distributed nationwide across multiple U.S. states.
Product
Brand Name: MEDLINE Product Name: SYR 20ML/L PURPLE Model/Catalog Number: 91843 Product Description: NON-Sterile syringes without needles for single use Component: No
Category
Distribution
6 states
ModerateFDA (Devices)··2024-05-29
Medline Non-Sterile Syringes Recalled for Out-of-Range Sizes and Configurations
Medline non-sterile syringes (Model 91841) are recalled because certain size and configuration variants were not included in the FDA-cleared 510(k) specifications. These uncleared configurations should not have been distributed.
Product
Brand Name: MEDLINE Product Name: SYR 5ML L/L PURPLE Model/Catalog Number: 91841 Product Description: NON-Sterile syringes without needles for single use Component: No
Category
Distribution
6 states
HighFDA (Devices)··2024-05-29
GMAX SYR 5ML syringes recalled for unapproved piston configurations
FDA recalls 60,000 GMAX SYR 5ML/LL non-sterile syringes manufactured by Jiangsu Shenli Medical Production because the piston syringe sizes and configurations were not cleared under the firm's FDA 510(k) application.
Product
Brand Name: GMAX Product Name: SYR 5ML/LL syringe Model/Catalog Number: TS2205S-M Product Description: NON-Sterile syringes without needles for single use Component: No
Category
Distribution
6 states
ModerateFDA (Devices)··2024-05-29
Medline 10ML Syringes Recalled Due to Regulatory Specification Non-Compliance
Medline is recalling 10ML syringes in multiple lot codes because the device sizes fall outside the range cleared by the FDA for this product. The affected products were distributed to consumers in six states.
Product
Brand Name: MEDLINE Product Name: SYR 10ML L/L YELLOW CONT Model/Catalog Number: 91846 Product Description: NON-Sterile syringes without needles for single use Component: No
Category
Distribution
6 states
HighFDA (Devices)··2024-05-29
Non-Sterile Syringes Recalled for Manufacturing Beyond FDA-Cleared Scope
Jiangsu Shenli Medical recalled 3mL non-sterile syringes because they were manufactured outside the scope of FDA approval. The product was distributed nationwide across six U.S. states.
Product
Brand Name: MEDLINE Product Name: SYR 3ML L/L PURPLE Model/Catalog Number: 91840 Product Description: NON-Sterile syringes without needles for single use Component: No
Category
Distribution
6 states
ModerateFDA (Devices)··2024-05-29
Wolf Medical Syringes Recalled for Non-Compliance with FDA Clearance
Jiangsu Shenli Medical is recalling Wolf Medical 35 mL syringes because their piston sizes and configurations exceed the range cleared by the FDA 510(k) authorization.
Product
Brand Name: Wolf Medical Product Name: 35 mL (cc) Luer Lock STERILE LATEX FREE NON PYROGENIC Model/Catalog Number: SYR35L Product Description: NON-Sterile syringes without needles for single use Component: No
Category
Distribution
6 states
ModerateFDA (Devices)··2024-05-29
Medline Non-Sterile Syringes Recalled for Exceeding FDA-Cleared Specifications
Jiangsu Shenli Medical is recalling about 38.8 million Medline SYR 10ML L/L non-sterile syringes (Model 83082) because their sizes and configurations exceed FDA-cleared specifications. Nationwide distribution in CA, FL, GA, IL, TN, and VA.
Product
Brand Name: MEDLINE Product Name: SYR 10ML L/L Model/Catalog Number: 83082 Product Description: NON-Sterile syringes without needles for single use Component: No
Category
Distribution
6 states
HighFDA (Devices)··2024-05-29
Medline Non-Sterile Syringes Recalled for Configuration Outside FDA Clearance
Jiangsu Shenli is recalling Medline non-sterile 3mL syringes (Model 91820) nationwide because their configurations exceed FDA clearance scope. Users should discontinue use immediately.
Product
Brand Name: MEDLINE Product Name: SYR 3ML L/L RED Model/Catalog Number: 91820 Product Description: NON-Sterile syringes without needles for single use Component: No
Category
Distribution
6 states
HighFDA (Devices)··2024-05-29
Medline Non-Sterile Syringes Recalled for Out-of-Specification Configurations
Medline 3-mL non-sterile syringes are being recalled because their actual sizes and configurations fall outside the FDA-approved range for the manufacturer's 510(k) clearance. 20,000 units were distributed nationwide across six U.S. states.
Product
Brand Name: MEDLINE Product Name: SYR 3ML L/L GREEN Model/Catalog Number: 91821 Product Description: NON-Sterile syringes without needles for single use Component: No
Category
Distribution
6 states
HighFDA (Devices)··2024-05-29
Non-Sterile Syringes Recalled for Regulatory Non-Compliance and Design Deviation
Jiangsu Shenli Medical is recalling 7,000 MEDLINE non-sterile syringes because their sizes and configurations exceed FDA 510(k) approval. The syringes were distributed nationwide and may pose infection risks.
Product
Brand Name: MEDLINE Product Name: SYR 10ML/L BLUE CONTRAST Model/Catalog Number: 91848 Product Description: NON-Sterile syringes without needles for single use Component: No
Category
Distribution
6 states
ModerateFDA (Devices)··2024-05-29
GMAX SYR 60ML/LS Syringes Recalled for Non-Approved Specifications
Jiangsu Shenli Medical is recalling GMAX SYR 60ML/LS syringes (Model TS2260S-M) because the piston syringe sizes and configurations exceed what was approved by FDA in the company's 510(k) clearance.
Product
Brand Name: GMAX Product Name: SYR 60ML/LS syringe Model/Catalog Number: TS2260S-M Product Description: NON-Sterile syringes without needles for single use Component: No
Category
Distribution
6 states
ModerateFDA (Devices)··2024-05-29
FDA Recalls GMAX Syringes Due to Unapproved Configuration
Jiangsu Shenli is recalling GMAX 12ML syringes because the device sizes and configurations exceed what was cleared by FDA. Approximately 303,800 units were distributed nationwide.
Product
Brand Name: GMAX Product Name: SYR 12ML/LS syringe Model/Catalog Number: TS2212S-M Product Description: NON-Sterile syringes without needles for single use Component: No
Category
Distribution
6 states
ModerateFDA (Devices)··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
Distribution
6 states
HighFDA (Devices)··2024-05-29
GMAX SYR 60ML/LL Blue Syringes Recalled for Unapproved Specifications
Jiangsu Shenli Medical Production Co. is recalling GMAX SYR 60ML/LL blue syringes because the manufactured sizes and configurations fall outside the range cleared by the FDA. Approximately 116,160 units were distributed nationwide.
Product
Brand Name: GMAX Product Name: SYR 60ML/LL Blue syringe Model/Catalog Number: TS2260LB-M Product Description: NON-Sterile syringes without needles for single use Component: No
Category
Distribution
6 states
HighFDA (Devices)··2024-05-29
Non-Sterile Syringes Recalled Due to Manufacturing Specification Violation
Jiangsu Shenli Medical is recalling 754,600 non-sterile syringes because the piston syringe sizes and configurations exceed those cleared by the FDA. Affected units were distributed nationwide.
Product
Brand Name: MEDLINE Product Name: SYR 5ML L/S Model/Catalog Number: 83085 Product Description: NON-Sterile syringes without needles for single use Component: No
Category
Distribution
6 states
ModerateFDA (Devices)··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
Distribution
6 states
ModerateFDA (Devices)··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
Distribution
6 states
ModerateFDA (Devices)··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
Distribution
6 states
HighFDA (Devices)··2024-05-29
MEDLINE Non-Sterile Syringes Recalled: Sizes Outside FDA Clearance Range
MEDLINE non-sterile syringes (Model 91827) are recalled because piston sizes and configurations are outside the FDA clearance range. The manufacturer is recalling 44,800 units distributed in six U.S. states.
Product
Brand Name: MEDLINE Product Name: SYR 5ML L/L BLUE Model/Catalog Number: 91827 Product Description: NON-Sterile syringes without needles for single use Component: No
Category
Distribution
6 states
HighFDA (Devices)··2024-05-29
FDA Recalls Wolf Medical Disposable Syringes for Non-Conforming Configurations
Jiangsu Shenli Medical has recalled over 1 million Wolf Medical WOLF-PAK 1 mL disposable syringes because piston syringe sizes and configurations exceed those cleared under the company's 510(k) approval.
Product
Brand Name: Wolf Medical - WOLF-PAK Product Name: DISPOSABLE SYRINGE 1 mL (cc) Luer Lock STERILE LATEX FREE NON PYROGENIC Model/Catalog Number: SYR01L Serial Number: 850007185411 Product Description: NON-Sterile syringes without needles for single use Component: No
Category
Distribution
6 states
HighFDA (Devices)··2024-05-29
Medline Non-Sterile Syringes Recalled for Exceeding FDA Clearance Scope
Medline is recalling 2.1 million non-sterile syringes (Model 83081) because the piston syringe sizes and configurations exceed the FDA 510(k) clearance scope. Affected products were distributed in California, Florida, Georgia, Illinois, Tennessee, and Virginia.
Product
Brand Name: MEDLINE Product Name: SYR 10ML L/S Model/Catalog Number: 83081 Product Description: NON-Sterile syringes without needles for single use Component: No
Category
Distribution
6 states