Other Medical Devices Recalls

Firm discovered that an incorrect version of the Instructions for Use (IFU) containing language beyond the cleared 510(k) were inserted in the affected products. Firm is replacing these with the correct version of the IFU.

Dec 15, 2021 Other Medical Devices Nationwide View Details →

DREAMTOME 49-30MM/260CM Material Number: M00584010

Boston Scientific

Class I - Dangerous

Sterility of device is compromised due to a sterile barrier breach

Dec 22, 2021 Other Medical Devices Nationwide View Details →

(1)Traverse Rail Carrier E-System, wide 31017XX component to Liko overhead lift, (2)Traverse Rail Carrier 31025XX component to Liko overhead lift. Intended for to make safe lifting of a patient possible. Affected Devices: 3101704 TRAV RAIL CARR E-SYST STD 3102514 TR CARRIER SLIM/RAISED, LR 3101705 TRAV RAIL CARR ESYST WIDE 3102517 TR CARR. NORMAL/LOWER. LR 3102506 TR CARRIER WIDE/RAISED ML 3102519 TR CARR. LOW.LR 30MM/PAIR 3102511 TR CARRIER NORMAL, LR 3102531 TRAVERSE RL CARRIER STD/RAISED 3102512 TR CARRIER WIDE, LR 3102532 TRAVERSE RL CARRIER WD/RAISED 3102513 TR CARRIER SLIM, LR 3102562 TR CARRIER, PARALLEL/WIDE

Hill-Rom

Class I - Dangerous

Traverse rail carriage delivered with non-conforming screws are too short to ensure appropriate installation. There is potential that the screws are unable to secure the traverse rail appropriately and could loosen over time causing the rail system to fall, potentially causing injury to caregivers and/or patients

Jan 14, 2022 Other Medical Devices Nationwide View Details →

Dreamtome Cannulating Sphincterotome-DREAMTOME 44-20MM/450CM Material Number: M00584060

Boston Scientific

Class I - Dangerous

Sterility of device is compromised due to a sterile barrier breach

Dec 22, 2021 Other Medical Devices Nationwide View Details →

20544 Vitale Silver calcium Alginate Dressings 4x4, 10/box

CellEra

Class I - Dangerous

Firm discovered that an incorrect version of the Instructions for Use (IFU) containing language beyond the cleared 510(k) were inserted in the affected products. Firm is replacing these with the correct version of the IFU.

Dec 15, 2021 Other Medical Devices Nationwide View Details →

HYDRATOME RX 49-30MM/260CM Material Number: M00583010

Boston Scientific

Class I - Dangerous

Sterility of device is compromised due to a sterile barrier breach

Dec 22, 2021 Other Medical Devices Nationwide View Details →

20500 Vitale Silver calcium Alginate Dressing Ropes, 5/box

CellEra

Class I - Dangerous

Firm discovered that an incorrect version of the Instructions for Use (IFU) containing language beyond the cleared 510(k) were inserted in the affected products. Firm is replacing these with the correct version of the IFU.

Dec 15, 2021 Other Medical Devices Nationwide View Details →