Latest U.S. Recalls — FDA & NHTSA Records

Latest records

Latest recalls — page 573

The newest recall records with useful source details are listed here.

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

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: 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

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 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

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

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

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

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 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

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 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

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 ENDO MODEL SLED TIBIAL COMP 9 MM X 55 MM Item Number recall — FDA Z-1533-2023

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 50 MM Item Number recall — FDA Z-1537-2023

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 13 MM X 55 MM Item Number recall — FDA Z-1535-2023

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

Baxter Healthcare Hill-Rom pro+ mattress, product codes (REF): a) 20877002S, b) 20877003S recall — FDA Z-1482-2023

There is a potential for mattress cover damage (delamination) which may result in fluid absorption in the mattress (fluid ingress).

Class IIFDA: OngoingBaxter Healthcare Corporation

Medical DeviceMay 10, 2023

Inpeco S.A Storage and Retrieval Module (SRM)-Laboratory Automation system Brand names of recall — FDA Z-1560-2023

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: ALL POLY TIBIAL COMPONENT 7MM X 45MM Item Number: 15-2028/01 recall — FDA Z-1511-2023

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 SLED KNEE FEM COMP, SMALL Item Number: 15-2020/40 recall — FDA Z-1507-2023

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 11X58MM Item Number: 15-2028/15 recall — FDA Z-1525-2023

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 8 MM X 50 MM Item Number recall — FDA Z-1553-2023

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 55MM Item Number: 15-2028/10 recall — FDA Z-1520-2023

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 50 MM Item Number recall — FDA Z-1531-2023

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.

Browse by month

Recent recall archives

Browse recent months with enough recall history for useful comparison.

Full archive →