Medical Device Recalls

This is our largest category by volume. The FDA tracks recalls for an enormous range of medical devices: implants, pacemakers, insulin pumps, surgical tools, blood glucose monitors, X-ray machines, prosthetics, contact lenses, and home health equipment, among many others. We have records dating back to 2005 and add new ones as the FDA publishes them.

Device recalls can happen because of software bugs, manufacturing defects, bacterial contamination, incorrect labeling, or design flaws that lead to inaccurate results or equipment failure. Class I recalls are the most serious and mean the device could cause injury or death.

38,428 total recalls
0 this month

Showing 5501–5520 of 38,428 recalls

April 5, 2024· Jiangsu Shenli Medical Production Co., Ltd.

Recalled Item: GMAX Product Name: SYR 60ML/LL Blue syringe Model/Catalog

The Issue: Piston syringes sizes and configurations are out of

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
April 5, 2024· Jiangsu Shenli Medical Production Co., Ltd.

Recalled Item: MEDLINE Product Name: SYR 10ML L/L RED LIDO

The Issue: Piston syringes sizes and configurations are out of

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
April 5, 2024· Jiangsu Shenli Medical Production Co., Ltd.

Recalled Item: MEDLINE Product Name: SYR 10ML L/L YELLOW CONT

The Issue: Piston syringes sizes and configurations are out of

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
April 5, 2024· Jiangsu Shenli Medical Production Co., Ltd.

Recalled Item: MEDLINE Product Name: SYR 20ML L/L WHITE SALINE

The Issue: Piston syringes sizes and configurations are out of

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
April 5, 2024· Jiangsu Shenli Medical Production Co., Ltd.

Recalled Item: MEDLINE Product Name: SYR 10ML L/L Model/Catalog Number:

The Issue: Piston syringes sizes and configurations are out of

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
April 5, 2024· Jiangsu Shenli Medical Production Co., Ltd.

Recalled Item: GMAX Product Name: SYR 3ML/LL syringe Model/Catalog Number:

The Issue: Piston syringes sizes and configurations are out of

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
April 5, 2024· Jiangsu Shenli Medical Production Co., Ltd.

Recalled Item: MEDLINE Product Name: SYR 3ML L/L RED Model/Catalog

The Issue: Piston syringes sizes and configurations are out of

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
April 5, 2024· Jiangsu Shenli Medical Production Co., Ltd.

Recalled Item: MEDLINE Product Name: SYR 5ML L/L PURPLE NITRO

The Issue: Piston syringes sizes and configurations are out of

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
April 5, 2024· Wishbone Medical, Inc.

Recalled Item: WishFIX Growth Control Plating System

The Issue: The products in this lot are incorrectly packed

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
April 5, 2024· Randox Laboratories Ltd.

Recalled Item: Evidence MultiSTAT with software v 3.7-Analyzer intended for the qualitative

The Issue: Foam gasket on the Evidence MultiSTAT chip heater

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class III — Low RiskOngoing
April 5, 2024· IVOCLAR VIVADENT AG

Recalled Item: IPS e.max ZirCAD CER/in. Prime A3 C17/5 -A zirconium oxide

The Issue: Defective blocks may show cracks after sintering If

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
April 5, 2024· IVOCLAR VIVADENT AG

Recalled Item: IPS e.max ZirCAD CER/in. Prime C2 C17/5- A zirconium oxide

The Issue: Defective blocks may show cracks after sintering If

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
April 5, 2024· IVOCLAR VIVADENT AG

Recalled Item: IPS e.max ZirCAD CER/in. Prime BL1 C17/3- A zirconium oxide

The Issue: Defective blocks may show cracks after sintering If

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
April 5, 2024· IVOCLAR VIVADENT AG

Recalled Item: IPS e.max ZirCAD CER/in. Prime A2 C17/5 -A zirconium oxide

The Issue: Defective blocks may show cracks after sintering If

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
April 5, 2024· IVOCLAR VIVADENT AG

Recalled Item: IPS e.max ZirCAD CER/in. Prime B1 C17/5 -A zirconium oxide

The Issue: Defective blocks may show cracks after sintering If

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
April 5, 2024· IVOCLAR VIVADENT AG

Recalled Item: IPS e.max ZirCAD CER/in. Prime A1 C17/5 - A zirconium

The Issue: Defective blocks may show cracks after sintering If

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
April 4, 2024· Philips Medical Systems Nederland B.V.

Recalled Item: Philips IntelliSpace Cardiovascular software

The Issue: Study data is not able to be archived,

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
April 4, 2024· Stryker Leibinger GmbH & Co. KG

Recalled Item: 8000-021-002

The Issue: Unreleased software was installed on customer systems resulting

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
April 4, 2024· Macherey Nagel Gmbh & Co. Kg

Recalled Item: Reagent Test Strips for Blood

The Issue: The reason for the recall is one of

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
April 3, 2024· Olympus Corporation of the Americas

Recalled Item: InstaClear Lens Sheath. The InstaClear lens cleaner system and versatile

The Issue: for distal end of the sheath to

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing