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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 5ML L/L PURPLE NITRO 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 3ML 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: GMAX Product Name: SYR 3ML/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.
Apr 5, 2024 Brand Name: MEDLINE Product Name: SYR 10ML L/L Model/Catalog Number: 83082 ... 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 WHITE SALINE 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 10ML L/L YELLOW CONT 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/L RED LIDO 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/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: MEDLINE Product Name: SYR 3ML L/L GREEN 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 WHITE 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 5ML 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: 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.
Apr 5, 2024 Brand Name: MEDLINE Product Name: SYR 10ML 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: Wolf Medical - WOLF-PAK Product Name: DISPOSABLE SYRINGE 1 mL (c... 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 12ML/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 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 20ML 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: MEDLINE Product Name: SYR 10ML L/L CONTROL 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 30ML L/L Model/Catalog Number: 83078 Pr... Piston syringes sizes and configurations are out of the range of devices cleared under the firm's... Not Yet Classified Jiangsu Shenli Medical Production Co., Ltd.
Apr 5, 2024 Brand Name: MEDLINE Product Name: SYR 5ML L/L BLUE 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 30ML/LS Model/Catalog Number: 83077 ... 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 BLUE CONTRAST 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 3ML 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 5ML L/L YELLOW NITRO 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 3ML L/S Model/Catalog Number: 83083 ... 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: 35 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: MEDLINE Product Name: SYR 10ML L/S 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: GMAX Product Name: SYR 20ML/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 5ML L/L RED NITRO 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 5ML 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: GMAX Product Name: SYR 20ML/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: Wolf Medical Product Name: 60 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 12ML/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: Wolf Medical Product Name: 3 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 WHITE 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 60ML/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 5ML L/L GREEN 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 5ML L/S Model/Catalog Number: 83085 ... 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: 20 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 10ML/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 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: GMAX Product Name: SYR 30ML/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 BLUE LIDO 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 3ML L/L Model/Catalog Number: 83084 ... 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 6ML/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.
Apr 5, 2024 Brand Name: MEDLINE Product Name: SYR 10ML L/S WHITE LIDO 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 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 20ML L/L Model/Catalog Number: 83088 ... 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 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 60ML L/L Model/Catalog Number: 83080 ... 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.