Medical device recalls
38750 federal recalls on file. Federal recalls for medical devices — surgical equipment, monitors, diagnostic tools, implants, home health devices. Sourced from the FDA.
- 2022-03-23FDA-DeviceBard Peripheral Vascular IncClass IISAFE-T PLUS LUMBAR PUNCTURE TRAY ADULT
Due to lumbar puncture tray manometer failure mode of leaking and mating issues.
- 2022-03-23FDA-DeviceBard Peripheral Vascular IncClass IIADULT LUMBAR PUNCTURE DRUG FREE TRAY 20G
Due to lumbar puncture tray manometer failure mode of leaking and mating issues.
- 2022-03-23FDA-DeviceBard Peripheral Vascular IncClass IILUMBAR PUNCTURE TRAY ADULT 20G X 3.5 DP
Due to lumbar puncture tray manometer failure mode of leaking and mating issues.
- 2022-03-23FDA-DeviceBard Peripheral Vascular IncClass IILUMBAR PUNCTURE TRAY PEDIATRIC 21G 2.5
Due to lumbar puncture tray manometer failure mode of leaking and mating issues.
- 2022-03-23FDA-DeviceBard Peripheral Vascular IncClass IISafe-T PLUS Pediatric/Infant Lumbar Puncture Tray, 22 g x 1.5" Spinal Needle with Manometer
Due to lumbar puncture tray manometer failure mode of leaking and mating issues.
- 2022-03-23FDA-DeviceSam Medical ProductsClass IISAM CHEST SEAL REF CS203-EN Combo LOT Y060321-09
Due to partially assembled valved dressing that has a hole within it instead of the intended non-valved dressing in the package resulting in that the dressing cannot be centered over the open chest wound and create an occlusive seal due to the hole being present.
- 2022-03-23FDA-DeviceMicrobiologics IncClass IIILYFO Disk
LYFO Disk Catalog #0983L is to contain Candida tropicalis. However, lot number 983-40-3 under Catalog #0983L, labeled as Candida tropicalis, is actually Yersinia entercolitica. This labeling error may cause a user's quality control to fail, resulting in testing needing to be repeated and delayed test results.
- 2022-03-23FDA-DeviceLivaNova Deutschland GmbHClass IIISorin Centrifugal Pump System, CP5, Drive Unit (Catalogue Item #60-01-04, UDI: 04033817900948) used in an HLM S5/C5 System configuration. A cardiopulmonary bypass speed control device.
One ferrite ring expected to be installed on centrifugal pump system power cable may not be present.
- 2022-03-23FDA-DeviceWright Medical Technology, Inc.Class IIWright Medical Technology, Inc. ORTHOLOC Non-Locking Screw 2mm x 8mm, REF 5201120008, non-sterile, a component of the ORTHOLOC 2.0/2.4 Plate System.
An incorrect screw is packaged in the product, which contains a locking screw instead of a non-locking screw.
- 2022-03-23FDA-DeviceMicrobiologics IncClass IIMycoplasma genitalium Control Panel (Inactivated Pellet)
Distributed product did not undergo proper release testing.
- 2022-03-23FDA-DeviceHill-Rom, Inc.Class II(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 CAR
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
- 2022-03-23FDA-DeviceMedtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)Class IILINQ II Insertable Cardiac Monitor
Devices may lose functionality due to susceptibility to moisture ingress.
- 2022-03-23FDA-DeviceBoston Scientific CorporationClass IIRX CHOLANGIOGRAM KIT - SINGLE Material Number: M00575240 M00575240 M00575280 M00575320 M00575360 M00575380 M00575400 M00575440 M00575480
Sterility of device is compromised due to a sterile barrier breach
- 2022-03-23FDA-DeviceBoston Scientific CorporationClass IIRX CHOLANGIOGRAM KIT Material Numbers: M00575241 M00575281 M00575321 M00575361 M00575381 M00575401 M00575441 M00575481
Sterility of device is compromised due to a sterile barrier breach
- 2022-03-23FDA-DeviceBoston Scientific CorporationClass IIJAGTOME RX 49-30-450-035 Material Number: M00573030
Sterility of device is compromised due to a sterile barrier breach
- 2022-03-23FDA-DeviceBoston Scientific CorporationClass IIJAGTOME RX 49-30-260-035 Material Number: M00573020
Sterility of device is compromised due to a sterile barrier breach
- 2022-03-23FDA-DeviceBoston Scientific CorporationClass IIJAGTOME RX 49-20-260-035 Material Number: M00573000
Sterility of device is compromised due to a sterile barrier breach
- 2022-03-23FDA-DeviceBoston Scientific CorporationClass IIJAGTOME RX 44-30-450-035 Material Number: M00573070
Sterility of device is compromised due to a sterile barrier breach
- 2022-03-23FDA-DeviceBoston Scientific CorporationClass IIJAGTOME RX 44-30-260-035 Material Number: M00573060
Sterility of device is compromised due to a sterile barrier breach
- 2022-03-23FDA-DeviceBoston Scientific CorporationClass IIJAGTOME RX 44-20-450-035 Material Number: M00573050
Sterility of device is compromised due to a sterile barrier breach
- 2022-03-23FDA-DeviceBoston Scientific CorporationClass IIJAGTOME RX 44-20-260-035 Material Number: M00573040
Sterility of device is compromised due to a sterile barrier breach
- 2022-03-23FDA-DeviceBoston Scientific CorporationClass IIJAGTOME RX 39-30-450-025 Material Number: M00573110
Sterility of device is compromised due to a sterile barrier breach
- 2022-03-23FDA-DeviceBoston Scientific CorporationClass IIJAGTOME RX 39-30-260-025 Material Number: M00573100
Sterility of device is compromised due to a sterile barrier breach
- 2022-03-23FDA-DeviceBoston Scientific CorporationClass IIJAGTOME RX 39-30-260-025 Material Number: M00573100
Sterility of device is compromised due to a sterile barrier breach
- 2022-03-23FDA-DeviceBoston Scientific CorporationClass IIJAGTOME RX 39-20-450-025 Material Number: M00573090
Sterility of device is compromised due to a sterile barrier breach
- 2022-03-23FDA-DeviceBoston Scientific CorporationClass IIJAGTOME RX 39-20-260-025 Material Number: M00573080
Sterility of device is compromised due to a sterile barrier breach
- 2022-03-23FDA-DeviceBoston Scientific CorporationClass IIJAGTOME REVOLUTION RX 39-30-260-025 Material Number: M00584260
Sterility of device is compromised due to a sterile barrier breach
- 2022-03-23FDA-DeviceBoston Scientific CorporationClass IIJAGTOME REVOLUTION RX 39-20-450-025 Material Number: M00584250
Sterility of device is compromised due to a sterile barrier breach
- 2022-03-23FDA-DeviceBoston Scientific CorporationClass IIJAGTOME REVOLUTION RX 39-20-260-025 Material Number: M00584240
Sterility of device is compromised due to a sterile barrier breach
- 2022-03-23FDA-DeviceBoston Scientific CorporationClass IIHYDRATOME RX 49-30MM/260CM Material Number: M00583010
Sterility of device is compromised due to a sterile barrier breach
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