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

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
ModerateFDA (Devices)··2024-05-29
Medline non-sterile syringes recalled for exceeding cleared device specifications
Jiangsu Shenli is recalling Medline 20mL non-sterile syringes (Model 91836, 133,600 units) because certain lot configurations exceed the scope of FDA-cleared specifications. Affected units were distributed across six U.S. states.
Product
Brand Name: MEDLINE Product Name: SYR 20ML L/L GREEN Model/Catalog Number: 91836 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
ModerateFDA (Devices)··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
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
HighFDA (Devices)··2024-05-29
MEDLINE 5ML Syringes Recalled for Non-Compliance with FDA Clearance
Jiangsu Shenli Medical is recalling MEDLINE non-sterile 5ML syringes (Model 91826) because certain sizes and configurations exceed the range cleared by the FDA. The company is notifying customers and arranging product retrieval.
Product
Brand Name: MEDLINE Product Name: SYR 5ML L/L GREEN Model/Catalog Number: 91826 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
ModerateFDA (Devices)··2024-05-29
Medline non-sterile syringes recalled for exceeding 510(k) clearance scope
Jiangsu Shenli Medical recalled 18,900 Medline non-sterile syringes (Model 91842) because their sizes and configurations exceed the FDA's approved scope under the firm's 510(k) clearance.
Product
Brand Name: MEDLINE Product Name: SYR 10ML L/L PURPLE Model/Catalog Number: 91842 Product Description: NON-Sterile syringes without needles for single use Component: No
Category
Distribution
6 states
ModerateFDA (Devices)··2024-05-29
FDA Recalls Medline Syringes Manufactured Outside Approved Specifications
Jiangsu Shenli Medical Production Co. is recalling 9,800 Medline non-sterile syringes (Model 91866, Lot 63722070002) because the devices were manufactured in sizes and configurations outside the firm's FDA-cleared scope.
Product
Brand Name: MEDLINE Product Name: SYR 5ML L/L RED NITRO Model/Catalog Number: 91866 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 Offering Configurations Outside FDA Approved Clearance Scope
Medline non-sterile syringes are being recalled because configurations and sizes sold exceeded the FDA's approved 510(k) scope. Approximately 502,250 units were distributed nationwide.
Product
Brand Name: MEDLINE Product Name: SYR 30ML/LS Model/Catalog Number: 83077 Product Description: NON-Sterile syringes without needles for single use Component: No
Category
Distribution
6 states
ModerateFDA (Devices)··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
Distribution
6 states
ModerateFDA (Devices)··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
Distribution
6 states
ModerateFDA (Devices)··2024-05-29
Medline 10ml Syringes Recalled for Exceeding FDA Clearance Range
Jiangsu Shenli Medical is recalling 39,200 Medline non-sterile syringes (Model 91850) because the device sizes and configurations exceed the range approved by the FDA's 510(k) clearance. No illnesses or injuries have been reported.
Product
Brand Name: MEDLINE Product Name: SYR 10ML L/L RED LIDO Model/Catalog Number: 91850 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 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
Distribution
6 states
HighFDA (Devices)··2024-05-29
Medline Non-Sterile Syringes Recalled for Exceeding Approved Specifications
Jiangsu Shenli Medical Production Co., Ltd. is recalling Medline brand 10ML non-sterile syringes (Model 91874) because piston sizes and configurations exceed the range approved under the firm's FDA 510(k) clearance.
Product
Brand Name: MEDLINE Product Name: SYR 10ML L/S RED Model/Catalog Number: 91874 Product Description: NON-Sterile syringes without needles for single use Component: No
Category
Distribution
6 states
ModerateFDA (Devices)··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
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
ModerateFDA (Devices)··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
Distribution
6 states
ModerateFDA (Devices)··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
Distribution
6 states
ModerateFDA (Devices)··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
Distribution
6 states
ModerateFDA (Devices)··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
Distribution
6 states
HighFDA (Devices)··2024-05-29
Medline Non-Sterile Syringes Recalled for Non-Compliant Manufacturing Specifications
Medline non-sterile syringes (Model 91858) are recalled for manufacturing outside FDA-cleared specifications. The recall covers 50,400 units distributed nationwide.
Product
Brand Name: MEDLINE Product Name: SYR 20ML L/L WHITE SALINE Model/Catalog Number: 91858 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
Jiangsu Shenli Medical is recalling Medline non-sterile syringes (Model 91862, Lot 63722030001) because sizes and configurations exceed FDA-cleared specifications. The recall affects 400 units distributed in California, Florida, Georgia, Illinois, Tennessee, and Virginia.
Product
Brand Name: MEDLINE Product Name: SYR 20ML/L WHITE HEP FLUSH Model/Catalog Number: 91862 Product Description: NON-Sterile syringes without needles for single use Component: No
Category
Distribution
6 states