Medical device recalls
38684 federal recalls on file. Federal recalls for medical devices — surgical equipment, monitors, diagnostic tools, implants, home health devices. Sourced from the FDA.
- 2025-03-26FDA-DeviceOridion Medical 1987 Ltd.Class IIMicrostream Instructions for Use and Part Number used with - Product Description, REF: FilterLine H Set & VitaLine H Set Infant/Neonatal, 006147 - MICROSTREAM FilterLine H Set Infant/Neonatal CO2 Sampling Line and Airway Adapter for Humid Environments, 006324; MICROSTREAM FilterLine H Set Long Infant/Neonatal CO2 Sampling Line and Airway Adapter for Humid Environments, 007738; MICROSTREAM VitaLine H Set Infant/Neonatal CO2 Sampling Line and Airway Adapter for Humid Environments, 01080
Neonatal-Infant and Adult-Pediatric CO2 Sampling Line/Airway Adapter/CO2 Oral-Nasal Filter Line/Intubated Filter (CO2) Line device users may experience difficulty/inability to disconnect adapter from endotracheal tube for procedures (e.g. suctioning), may cause treatment delay and/or unintended extubation, which could lead to respiratory failure, hypoxia, aspiration, and/or low oxygen saturation.
- 2025-03-26FDA-DeviceCareFusion 303, Inc.Class IIBD Pyxis: Anesthesia Station ES, REF: 327, MedStation ES, REF: 323, MedStation ES Tower, REF: 352, CII Safe ES, REF: 1116-00, CII Safe ES Desktop PC, REF: 1156-00, CII Safe ES Desktop PC, Wired SCNR, REF: 107-254-01, CII Safe ES Desktop PC, W-less SCNR, REF: 107-255-01, Used with Enterprise Server (ES), REF: 1115-00 with affected Enterprise Server software.
Sync timeout may occur between the server and automated dispensing device, due to a server software error which may occur if syncing a large amount of data that takes excessive time, which may cause the dispensing devices to become disconnected from the ES server; dispensing devices will not receive updated information, which may lead to incorrect therapy, and delay in accessing medication.
- 2025-03-26FDA-DeviceWaldemar Link GmbH & Co. KG (Mfg Site)Class IIModular Stem cylindrical, Tilastan¿, press-fit cementless, L= 80 mm, DIA = 13 mm, Product Code: 880-601/13
A problem was discovered during the scanning process of the outer carton label because of an incorrect GTIN on the label, which is a GTIN for a different product.
- 2025-03-26FDA-DeviceWaldemar Link GmbH & Co. KG (Mfg Site)Class IIModular Stem cylindrical, Tilastan¿, press-fit cementless, L= 80 mm, DIA = 12 mm, Product Code: 880-601/12
A problem was discovered during the scanning process of the outer carton label because of an incorrect GTIN on the label, which is a GTIN for a different product.
- 2025-03-26FDA-DeviceWaldemar Link GmbH & Co. KG (Mfg Site)Class IIModular Stem cylindrical, Tilastan¿, press-fit cementless, L= 80 mm, DIA = 11 mm, Product Code: 880-601/11
A problem was discovered during the scanning process of the outer carton label because of an incorrect GTIN on the label, which is a GTIN for a different product.
- 2025-03-26FDA-DeviceMicrobiologics IncClass IIHelix Elite" Inactivated Standard: Inactivated SARS-CoV-2 Whole Virus (Pellet), Multi-analyte, unassayed quality control material, Catalog Number HE0065N
The A549 human cell target (human cells for sample adequacy control) may give a late Ct value.
- 2025-03-26FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IIProxima Drape labeled as ORTHO TRAUMA CDS, TOTAL KNEE AUX PACK, TOTAL HIP PACK, TOTAL HIP, TOTAL KNEE, SPINE. Sterile surgical drape.
Potential breach in pouch packaging which could lead to loss of sterility.
- 2025-03-26FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IIProxima Drape labeled as UNIVERSAL DAVINCI ROBOTIC P. Sterile surgical drape.
Potential breach in pouch packaging which could lead to loss of sterility.
- 2025-03-26FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IIProxima Drape labeled as HEAD AND NECK OSIS, WILLIS SHOULDER PACK, EXTREMITY PACK-LF, TOTAL HIP PACK-LF, SHOULDER W/POUCH-LF, VEIN PACK. Sterile surgical drape.
Potential breach in pouch packaging which could lead to loss of sterility.
- 2025-03-26FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IIProxima Drape labeled as FACE LIFT. Sterile surgical drape.
Potential breach in pouch packaging which could lead to loss of sterility.
- 2025-03-26FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IIProxima Drape labeled as MINOR PACK and LAPAROSCOPY. Sterile surgical drape.
Potential breach in pouch packaging which could lead to loss of sterility.
- 2025-03-26FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IIProxima Drape labeled as ENT-PLASTICS PACK. Sterile surgical drape.
Potential breach in pouch packaging which could lead to loss of sterility.
- 2025-03-26FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IIProxima Drape labeled as PACK,BASIC,SIRUS,V,5/CS; PACK,BASIC IV,SIRUS,5/CS; PACK,SET UP,NO DRAPE,12/CS; PACK,SET UP,NO DRAPE,12/CS; PACK,SET UP,NO DRAPE,12/CS; PACK,SET UP,NO DRAPE,12/CS; PACK,SET UP,NO DRAPE,12/CS; PACK,UNIVERSAL II,SIRUS,7/CS; PACK,LAPAROTOMY,NO GOWN,10/CS; PACK,CYSTOSCOPY,PK VI,14/CS; PACK,CYSTOSCOPY,PK VI,14/CS; PACK,OB III,GRADUATED UNDERBUTTOCK,6/CS; PACK,LAVH,AURORA,4/CS. Sterile surgical drape.
Potential breach in pouch packaging which could lead to loss of sterility.
- 2025-03-26FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IIProxima Drape labeled as DRAPE C-SECTION W/ WINDOW; SHEET, DRAPE, SPLIT, ST,10/CS; DRAPE,LAPROSCOPY,CHOLE,W/TROUGH,ST,8/CS; DRAPE,LAPROSCOPY,CHOLE,W/TROUGH,ST,8/CS; DRAPE,ABDOMINAL,MAJOR,ST,8/CS; DRAPE,ABDOMINAL,MAJOR,ST,8/CS; DRAPE,SPLIT,CVMAX,6/CS; DRAPE,ORTHOMAX ,BAR,6/CS; DRAPE,FEMORAL,RADIAL,5/CS; DRAPE,C-SECTION,FEN,CLR SCREEN,WIRE,7/CS; DRAPE,HAND,ULTRAGARD,18/CS; DRAPE,HAND,ULTRAGARD,18/CS; DRAPE,U,ORTHOMAX,6/CS; DRAPE,SPLIT,77X120",10/CS; DRAPE,ROBOTIC,W/LEGGING,W/POUCH,5/CS; DRAPE,ROBO
Potential breach in pouch packaging which could lead to loss of sterility.
- 2025-03-26FDA-DeviceAmerican Contract Systems IncClass IIVEIN TRAY, Model No UTVT21C UTVT21C02 UTVT21C-03
ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
- 2025-03-26FDA-DeviceAmerican Contract Systems IncClass IITHORACIC PACK , Model No UTTC82Y UTTC82AA-01
ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
- 2025-03-26FDA-DeviceAmerican Contract Systems IncClass IISPINE LUMBAR PACK , Model No UTSL72AA UTSL72AB
ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
- 2025-03-26FDA-DeviceAmerican Contract Systems IncClass IIOPEN HEART A PACK , Model No UTOH19AI UTOH19AJ-01 UTOH19AJ-02
ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
- 2025-03-26FDA-DeviceAmerican Contract Systems IncClass IIMAJOR VASCULAR PACK , Model No UTMV78X-01 UTMV78Y UTMV78Y-01 UTMV78X-01 UTMV78Y-02
ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
- 2025-03-26FDA-DeviceAmerican Contract Systems IncClass IIGENERAL LAPAROSCOPIC PACK-LF , Model No UTGL53S-06 UTGL53S-07 UTGL53S-08
ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
- 2025-03-26FDA-DeviceAmerican Contract Systems IncClass IIAV FISTULA , Model No UTAV77T
ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
- 2025-03-26FDA-DeviceAmerican Contract Systems IncClass IINEURO IR TRAY , Model No WENI56J
ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
- 2025-03-26FDA-DeviceAmerican Contract Systems IncClass IIDIAGNOSTIC NEURO IR TRAY , Model No WENE21
ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
- 2025-03-26FDA-DeviceAmerican Contract Systems IncClass IICV BASIC PUMP PACK , Model No WECV23D
ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
- 2025-03-26FDA-DeviceAmerican Contract Systems IncClass IILAPAROSCOPY PACK , Model No SFLA02A SFLA02B
ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
- 2025-03-26FDA-DeviceAmerican Contract Systems IncClass IIEAR PACK , Model No SFEA12A
ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
- 2025-03-26FDA-DeviceAmerican Contract Systems IncClass IILACERATION TRAY , Model No SGLA07A SGLA07B-01 SGLA07B-02 SGLA07B
ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
- 2025-03-26FDA-DeviceAmerican Contract Systems IncClass IILACERATION TRAY , Model No SGLA07A SGLA07B-01 SGLA07B-02 SGLA07B
ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
- 2025-03-26FDA-DeviceAmerican Contract Systems IncClass IIDELIVERY PACK , Model No SGDV22D-01 SGDV22E
ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
- 2025-03-26FDA-DeviceAmerican Contract Systems IncClass IITOTAL HIP PACK , Model No SMTH06O SMTH06P
ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
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