Home › Medical Device Recalls

FDA public records

Medical Device Recalls in the United States

Monitor U.S. medical device recall enforcement reports from the FDA. Review product descriptions, recall reasons, classifications, dates, recalling firms and distribution information where the FDA provides them.

23,781medical device recall records

2,201FDA Class I records

8firms with 5+ records

Zimmer Biomet, Inc.751 records

Database records

Records — page 365

23,781 detailed records are currently available in this category.

Medical DeviceMay 10, 2023

Linkbio LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 13 MM X 50 MM Item Number recall — FDA Z-1532-2023

Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the…

Class IIFDA: OngoingLinkbio Corp.

Medical DeviceMay 10, 2023

Linkbio LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 9 MM X 55 MM Item Number recall — FDA Z-1549-2023

Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the…

Class IIFDA: OngoingLinkbio Corp.

Medical DeviceMay 10, 2023

Siemens Healthcare Diagnostics ADVIA Centaur Cortisol 50T (Material Number 10994924), ADVIA recall — FDA Z-1505-2023

There is a negative bias with urine patient samples and urine cortisol Quality Control (QC) results intermittently out of range low.

Class IIFDA: OngoingSiemens Healthcare Diagnostics, Inc.

Medical DeviceMay 10, 2023

Linkbio LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 8 MM X 45 MM Item Number recall — FDA Z-1536-2023

Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the…

Class IIFDA: OngoingLinkbio Corp.

Medical DeviceMay 10, 2023

Linkbio LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 8 MM X 55 MM Item Number recall — FDA Z-1538-2023

Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the…

Class IIFDA: OngoingLinkbio Corp.

Medical DeviceMay 10, 2023

Linkbio LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 13 MM X 55 MM Item Number recall — FDA Z-1551-2023

Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the…

Class IIFDA: OngoingLinkbio Corp.

Medical DeviceMay 10, 2023

Inpeco S.A Input Output Module (IOM) FLX-201-Laboratory Automation system Brand names of the recall — FDA Z-1559-2023

Firmware versions have the potential to mis-associate sample IDs leading to incorrect results or delayed sodium, potassium, and chloride patient results. Falsely increased or decreased…

Class IIFDA: OngoingInpeco S.A.

Medical DeviceMay 10, 2023

ASO WALGREENS BANDAGES, item number 196568, 110 CT VALUE PACK, 24 BOXES/MASTER recall — FDA Z-1499-2023

The adhesive bandage contains 0.1% benzalkonium chloride impregnated in the pad and is not disclosed on the labeling.

Class IIFDA: OngoingASO LLC

Medical DeviceMay 10, 2023

Linkbio LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 11 MM X 45 MM Item Number recall — FDA Z-1544-2023

Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the…

Class IIFDA: OngoingLinkbio Corp.

Medical DeviceMay 10, 2023

Linkbio LINK SLED Knee System: ENDO MODEL SLED TIBIAL COMP 11 MM X 45 MM Item Number recall — FDA Z-1528-2023

Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the…

Class IIFDA: OngoingLinkbio Corp.

Medical DeviceMay 10, 2023

Linkbio LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 9MM X 45MM Item Number: 15-2028/02 recall — FDA Z-1512-2023

Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the…

Class IIFDA: OngoingLinkbio Corp.

Medical DeviceMay 10, 2023

Inpeco S.A Vesmatic Cube 80 Interface Module (VMC)-Laboratory Automation system Brand names recall — FDA Z-1562-2023

Firmware versions have the potential to mis-associate sample IDs leading to incorrect results or delayed sodium, potassium, and chloride patient results. Falsely increased or decreased…

Class IIFDA: OngoingInpeco S.A.

Medical DeviceMay 10, 2023

Linkbio LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 11 MM X 50 MM Item Number recall — FDA Z-1547-2023

Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the…

Class IIFDA: OngoingLinkbio Corp.

Medical DeviceMay 10, 2023

Linkbio LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 13MM X 55MM Item Number: 15-2028/12 recall — FDA Z-1522-2023

Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the…

Class IIFDA: OngoingLinkbio Corp.

Medical DeviceMay 10, 2023

Linkbio LINK SLED Knee System: ENDO MODEL SLED TIBIAL COMP 9 MM X 45 MM Item Number recall — FDA Z-1527-2023

Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the…

Class IIFDA: OngoingLinkbio Corp.

Medical DeviceMay 10, 2023

GE Healthcare Centricity PACS-IW with Universal Viewer, Model/Catalog Numbers: a) recall — FDA Z-1500-2023

GE HealthCare has become aware of an issue where information from two different patients can be mismatched when correcting patient or study information.

Class IIFDA: OngoingGE Healthcare

Medical DeviceMay 10, 2023

GE Healthcare Centricity Universal Viewer, Centricity Universal Viewer 6.0, Model/Catalog recall — FDA Z-1501-2023

GE HealthCare has become aware of an issue where information from two different patients can be mismatched when correcting patient or study information.

Class IIFDA: OngoingGE Healthcare

Medical DeviceMay 10, 2023

Inpeco S.A PVT Interface Module (PVT)-Laboratory Automation system Brand names of the same recall — FDA Z-1561-2023

Firmware versions have the potential to mis-associate sample IDs leading to incorrect results or delayed sodium, potassium, and chloride patient results. Falsely increased or decreased…

Class IIFDA: OngoingInpeco S.A.

Medical DeviceMay 10, 2023

Steris Lighting and Visualization Systems, Sterile Light handle Cover LB44 -Sterilizable recall — FDA Z-1476-2023

Light handle covers may separate from the light handle (detach and fall off) during use, this could result in a procedure delay and/or impact the sterile field which could result in an…

Class IIFDA: OngoingSteris Corporation

Medical DeviceMay 10, 2023

Inpeco S.A Alinity h Interface Module (HSQ)-Laboratory Automation system Brand names of the recall — FDA Z-1563-2023

Firmware versions have the potential to mis-associate sample IDs leading to incorrect results or delayed sodium, potassium, and chloride patient results. Falsely increased or decreased…

Class IIFDA: OngoingInpeco S.A.

Medical DeviceMay 10, 2023

Beaver Visitec International CryoTreQ- Aa disposable handheld instrument intended for recall — FDA Z-1497-2023

Device suddenly and forcefully disassembled after cryotherapy, potential for long-term or permanent impairment of a patient or user if a CryoTreq device suddenly or forcefully disassembles…

Class IIFDA: OngoingBeaver Visitec International, Inc.

Medical DeviceMay 10, 2023

Linkbio LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 13 MM X 45 MM Item Number recall — FDA Z-1545-2023

Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the…

Class IIFDA: OngoingLinkbio Corp.

Medical DeviceMay 10, 2023

Linkbio LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 9X58MM Item Number: 15-2028/14 recall — FDA Z-1524-2023

Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the…

Class IIFDA: OngoingLinkbio Corp.

Medical DeviceMay 10, 2023

Linkbio LINK SLED Knee System POREX ENDO SLED KNEE FEM COMP, LARGE Item Number: 15-2220/60 recall — FDA Z-1542-2023

Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the…

Class IIFDA: OngoingLinkbio Corp.

How to use this medical device recall index

Medical device recall records can change as the FDA receives additional information. Check the official record identifier and current FDA information before making health or product-use decisions.

Recall Lookup USA keeps the last complete source record available when an official data service is temporarily unavailable. When a source provides only a few fields, we show only those known facts rather than padding the page with generic text.

What the database can and cannot tell you

This database is designed for discovery and reference. It can help you locate a relevant recall record, identify the recalling firm or NHTSA campaign, compare dates and classifications, and follow the official source. It is not a substitute for a VIN-specific NHTSA check, a manufacturer notice, medical advice or instructions issued by the recalling company.