Browse Device Recalls

35,290 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 35,290 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 35,290 FDA device recalls, Class II.

Clear
DateProductReasonClassFirm
Apr 8, 2024 Medline Convenience kits labeled as: 1) SYR CONTROL PAD 12ML L/L, Pack Num... Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... Class II MEDLINE INDUSTRIES, LP - Northfield
Apr 8, 2024 Medline procedural kits labeled as: 1) FETAL SURGERY-LF, Pack Number CDS84... Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... Class II MEDLINE INDUSTRIES, LP - Northfield
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: 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: 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 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 IPS e.max ZirCAD CER/in. Prime A2 C17/5 -A zirconium oxide block for the fabr... Defective blocks may show cracks after sintering If cracks are unnoticed, restorations may fract... Class II IVOCLAR VIVADENT AG
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: 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 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 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 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 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: 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: 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: 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 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 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 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 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: 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: 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: 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 CARESCAPE Canvas Smart Display, Model Numbers: a) 5514418, b) 5514418 / ... GE HealthCare has become aware of the potential for loss of monitoring on CARESCAPE Canvas 1000, ... Class II GE Healthcare Finland Oy
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: 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: 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: 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 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 IPS e.max ZirCAD CER/in. Prime C2 C17/5- A zirconium oxide block for the fabr... Defective blocks may show cracks after sintering If cracks are unnoticed, restorations may fract... Class II IVOCLAR VIVADENT AG
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 CARESCAPE Canvas 1000, Model Numbers: a) 5865770; b) 5865770-01040169; c)... GE HealthCare has become aware of the potential for loss of monitoring on CARESCAPE Canvas 1000, ... Class II GE Healthcare Finland Oy
Apr 5, 2024 CARESCAPE B850 Model Numbers: a) MBC303, Model Numbers: 1) 2078633-001, ... GE HealthCare has become aware of the potential for loss of monitoring on CARESCAPE Canvas 1000, ... Class II GE Healthcare Finland Oy
Apr 5, 2024 CARESCAPE B650: Model Numbers: a) MBB313, Model Numbers: 1) 2095801-001,... GE HealthCare has become aware of the potential for loss of monitoring on CARESCAPE Canvas 1000, ... Class II GE Healthcare Finland Oy
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: 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/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 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 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 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 IPS e.max ZirCAD CER/in. Prime B1 C17/5 -A zirconium oxide block for the fabr... Defective blocks may show cracks after sintering If cracks are unnoticed, restorations may fract... Class II IVOCLAR VIVADENT AG
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 CARESCAPE Canvas Smart Display, Model Numbers: a) 5700023, b) 5700023-02, ... GE HealthCare has become aware of the potential for loss of monitoring on CARESCAPE Canvas 1000, ... Class II GE Healthcare Finland Oy
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 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 IPS e.max ZirCAD CER/in. Prime A1 C17/5 - A zirconium oxide block for the fab... Defective blocks may show cracks after sintering If cracks are unnoticed, restorations may fract... Class II IVOCLAR VIVADENT AG
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: 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: 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: 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.