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Browse Device Recalls

88 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 88 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Medical Device Recalls

Browse 88 FDA device recalls.

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DateProductReasonClassFirm
Apr 5, 2024 Brand Name: MEDLINE Product Name: SYR 10ML L/L BLUE Model/Catalog Number: 9... Piston syringes sizes and configurations are out of the range of devices cleared under the firm's... Class II Jiangsu Shenli Medical Production Co., Ltd.
Apr 5, 2024 Brand Name: MEDIGRATIVE Product Name: 100cc/ml disposable luer lock syringe ... Piston syringes sizes and configurations are out of the range of devices cleared under the firm's... Class II Jiangsu Shenli Medical Production Co., Ltd.
Apr 5, 2024 Brand Name: MEDLINE Product Name: SYR 1ML TB Model/Catalog Number: 83089 P... Piston syringes sizes and configurations are out of the range of devices cleared under the firm's... Class II Jiangsu Shenli Medical Production Co., Ltd.
Apr 5, 2024 Brand Name: MEDLINE Product Name: SYR 20ML L/S Model/Catalog Number: 83087 ... Piston syringes sizes and configurations are out of the range of devices cleared under the firm's... Class II Jiangsu Shenli Medical Production Co., Ltd.
Apr 5, 2024 Brand Name: MEDLINE Product Name: SYR 20ML L/L YELLOW LIDO Model/Catalog Nu... Piston syringes sizes and configurations are out of the range of devices cleared under the firm's... Class II Jiangsu Shenli Medical Production Co., Ltd.
Apr 5, 2024 Brand Name: MEDLINE Product Name: SYR 10ML L/S RED Model/Catalog Number: 91... Piston syringes sizes and configurations are out of the range of devices cleared under the firm's... Class II Jiangsu Shenli Medical Production Co., Ltd.
Apr 5, 2024 Brand Name: MEDLINE Product Name: SYR 30ML L/L Model/Catalog Number: 83078 ... Piston syringes sizes and configurations are out of the range of devices cleared under the firm's... Class II Jiangsu Shenli Medical Production Co., Ltd.
Apr 5, 2024 Brand Name: MEDLINE Product Name: SYR 5ML L/L RED Model/Catalog Number: 918... Piston syringes sizes and configurations are out of the range of devices cleared under the firm's... Class II Jiangsu Shenli Medical Production Co., Ltd.
Apr 5, 2024 Brand Name: MEDLINE Product Name: SYR CNTRL 10ML L/L BLUE Model/Catalog Num... Piston syringes sizes and configurations are out of the range of devices cleared under the firm's... Class II Jiangsu Shenli Medical Production Co., Ltd.
Apr 5, 2024 Brand Name: MEDLINE Product Name: SYR CNTRL 10ML L/L YELLOW LIDO Model/Cata... Piston syringes sizes and configurations are out of the range of devices cleared under the firm's... Class II Jiangsu Shenli Medical Production Co., Ltd.
Apr 5, 2024 Brand Name: MEDLINE Product Name: SYR 10ML L/L GREEN CONT Model/Catalog Num... Piston syringes sizes and configurations are out of the range of devices cleared under the firm's... Class II Jiangsu Shenli Medical Production Co., Ltd.
Apr 5, 2024 Brand Name: MEDLINE Product Name: SYR 10ML L/L RED CONT Model/Catalog Numbe... Piston syringes sizes and configurations are out of the range of devices cleared under the firm's... Class II Jiangsu Shenli Medical Production Co., Ltd.
Apr 5, 2024 Brand Name: MEDLINE Product Name: SYR 3ML L/L BLUE Model/Catalog Number: 91... Piston syringes sizes and configurations are out of the range of devices cleared under the firm's... Class II Jiangsu Shenli Medical Production Co., Ltd.
Apr 5, 2024 Brand Name: MEDLINE Product Name: SYR CNTRL 10ML L/L GREEN Model/Catalog Nu... Piston syringes sizes and configurations are out of the range of devices cleared under the firm's... Class II Jiangsu Shenli Medical Production Co., Ltd.
Apr 5, 2024 Brand Name: MEDLINE Product Name: SYR 10ML L/S Model/Catalog Number: 83081 ... Piston syringes sizes and configurations are out of the range of devices cleared under the firm's... Class II Jiangsu Shenli Medical Production Co., Ltd.
Apr 5, 2024 Brand Name: MEDLINE Product Name: SYR 20ML/L WHITE HEP FLUSH Model/Catalog ... Piston syringes sizes and configurations are out of the range of devices cleared under the firm's... Class II Jiangsu Shenli Medical Production Co., Ltd.
Apr 5, 2024 Brand Name: GMAX Product Name: SYR 10ML/LL syringe Model/Catalog Number: TS... Piston syringes sizes and configurations are out of the range of devices cleared under the firm's... Class II Jiangsu Shenli Medical Production Co., Ltd.
Apr 5, 2024 Brand Name: MEDLINE Product Name: SYR 10ML L/L RED HEPARIN Model/Catalog Nu... Piston syringes sizes and configurations are out of the range of devices cleared under the firm's... Class II Jiangsu Shenli Medical Production Co., Ltd.
Apr 5, 2024 Brand Name: MEDLINE Product Name: SYR 20ML/L PURPLE Model/Catalog Number: 9... Piston syringes sizes and configurations are out of the range of devices cleared under the firm's... Class II Jiangsu Shenli Medical Production Co., Ltd.
Apr 5, 2024 Brand Name: MEDLINE Product Name: SYR 20ML/L WHITE CONTRAST Model/Catalog N... Piston syringes sizes and configurations are out of the range of devices cleared under the firm's... Class II Jiangsu Shenli Medical Production Co., Ltd.
Apr 5, 2024 Brand Name: MEDLINE Product Name: SYR CNTR 10ML L/L YELLOW Model/Catalog Nu... Piston syringes sizes and configurations are out of the range of devices cleared under the firm's... Class II Jiangsu Shenli Medical Production Co., Ltd.
Apr 5, 2024 Brand Name: GMAX Product Name: SYR 10ML/LL Blue syringe Model/Catalog Numbe... Piston syringes sizes and configurations are out of the range of devices cleared under the firm's... Class II Jiangsu Shenli Medical Production Co., Ltd.
Apr 5, 2024 Brand Name: Wolf Medical Product Name: 6 mL (cc) Luer Lock STERILE LATEX FRE... Piston syringes sizes and configurations are out of the range of devices cleared under the firm's... Class II Jiangsu Shenli Medical Production Co., Ltd.
Apr 5, 2024 Brand Name: MEDLINE Product Name: SYR 10ML L/L YELLOW HEP/SALINE Model/Cata... Piston syringes sizes and configurations are out of the range of devices cleared under the firm's... Class II Jiangsu Shenli Medical Production Co., Ltd.
Apr 5, 2024 Brand Name: GMAX Product Name: SYR 10ML Control syringe Model/Catalog Numbe... Piston syringes sizes and configurations are out of the range of devices cleared under the firm's... Class II Jiangsu Shenli Medical Production Co., Ltd.
Apr 5, 2024 Brand Name: GMAX Product Name: SYR 60ML/LS syringe Model/Catalog Number: TS... Piston syringes sizes and configurations are out of the range of devices cleared under the firm's... Class II Jiangsu Shenli Medical Production Co., Ltd.
Apr 5, 2024 Brand Name: MEDLINE Product Name: SYR 5ML L/L WHITE Model/Catalog Number: 9... Piston syringes sizes and configurations are out of the range of devices cleared under the firm's... Class II Jiangsu Shenli Medical Production Co., Ltd.
Apr 5, 2024 Brand Name: MEDLINE Product Name: SYR 20ML L/L BLUE SALINE Model/Catalog Nu... Piston syringes sizes and configurations are out of the range of devices cleared under the firm's... Class II Jiangsu Shenli Medical Production Co., Ltd.
Apr 5, 2024 Brand Name: MEDLINE Product Name: SYR 20ML L/L GREEN Model/Catalog Number: ... Piston syringes sizes and configurations are out of the range of devices cleared under the firm's... Class II Jiangsu Shenli Medical Production Co., Ltd.
Apr 5, 2024 Brand Name: MEDLINE Product Name: SYR 20ML L/L YELLOW Model/Catalog Number:... Piston syringes sizes and configurations are out of the range of devices cleared under the firm's... Class II Jiangsu Shenli Medical Production Co., Ltd.
Apr 5, 2024 Brand Name: MEDLINE Product Name: SYR CNTRL 10ML L/L RED Model/Catalog Numb... Piston syringes sizes and configurations are out of the range of devices cleared under the firm's... Class II Jiangsu Shenli Medical Production Co., Ltd.
Apr 5, 2024 Brand Name: MEDLINE Product Name: SYR 60ML L/S Model/Catalog Number: 83079 ... Piston syringes sizes and configurations are out of the range of devices cleared under the firm's... Class II Jiangsu Shenli Medical Production Co., Ltd.
Apr 5, 2024 Brand Name: Wolf Medical Product Name: 12 mL (cc) Luer Lock STERILE LATEX FR... Piston syringes sizes and configurations are out of the range of devices cleared under the firm's... Class II Jiangsu Shenli Medical Production Co., Ltd.
Apr 5, 2024 Brand Name: GMAX Product Name: SYR 35ML/LL syringe Model/Catalog Number: TS... Piston syringes sizes and configurations are out of the range of devices cleared under the firm's... Class II Jiangsu Shenli Medical Production Co., Ltd.
Apr 5, 2024 Brand Name: MEDLINE Product Name: SYR 10ML L/L PURPLE Model/Catalog Number:... Piston syringes sizes and configurations are out of the range of devices cleared under the firm's... Class II Jiangsu Shenli Medical Production Co., Ltd.
Apr 5, 2024 Brand Name: MEDLINE Product Name: SYR 10ML L/L RED Model/Catalog Number: 91... Piston syringes sizes and configurations are out of the range of devices cleared under the firm's... Class II Jiangsu Shenli Medical Production Co., Ltd.
Apr 5, 2024 Brand Name: MEDLINE Product Name: SYR 10ML L/L GREEN Model/Catalog Number: ... Piston syringes sizes and configurations are out of the range of devices cleared under the firm's... Class II Jiangsu Shenli Medical Production Co., Ltd.
Apr 5, 2024 Brand Name: GMAX Product Name: SYR 5ML/LL syringe Model/Catalog Number: TS2... Piston syringes sizes and configurations are out of the range of devices cleared under the firm's... Class II Jiangsu Shenli Medical Production Co., Ltd.

Frequently Asked Questions

When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.

All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.

Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.