March 26, 2025Medical DevicesFDA
Oridion Medical 1987 Ltd. recalls Microstream Instructions for Use and Part Number used with - Product Description, REF: FilterLine H Set & VitaLine H
Hazard: 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.
March 26, 2025Medical DevicesFDA
CareFusion 303, Inc. recalls BD Pyxis: Anesthesia Station ES, REF: 327, MedStation ES, REF: 323, MedStation ES Tower, REF: 352, CII Safe ES, REF
Hazard: 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.
March 26, 2025Medical DevicesFDA
Waldemar Link GmbH & Co. KG (Mfg Site) recalls Modular Stem cylindrical, Tilastan¿, press-fit cementless, L= 80 mm, DIA = 13 mm, Product Code: 880-601/13
Hazard: 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.
March 26, 2025Medical DevicesFDA
Waldemar Link GmbH & Co. KG (Mfg Site) recalls Modular Stem cylindrical, Tilastan¿, press-fit cementless, L= 80 mm, DIA = 12 mm, Product Code: 880-601/12
Hazard: 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.
March 26, 2025Medical DevicesFDA
Waldemar Link GmbH & Co. KG (Mfg Site) recalls Modular Stem cylindrical, Tilastan¿, press-fit cementless, L= 80 mm, DIA = 11 mm, Product Code: 880-601/11
Hazard: 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.
March 26, 2025Medical DevicesFDA
Microbiologics Inc recalls Helix Elite" Inactivated Standard: Inactivated SARS-CoV-2 Whole Virus (Pellet), Multi-analyte, unassayed quality control
Hazard: The A549 human cell target (human cells for sample adequacy control) may give a late Ct value.
March 26, 2025Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls Proxima Drape labeled as ORTHO TRAUMA CDS, TOTAL KNEE AUX PACK, TOTAL HIP PACK, TOTAL HIP, TOTAL KNEE, SPINE. Sterile su
Hazard: Potential breach in pouch packaging which could lead to loss of sterility.
March 26, 2025Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls Proxima Drape labeled as UNIVERSAL DAVINCI ROBOTIC P. Sterile surgical drape.
Hazard: Potential breach in pouch packaging which could lead to loss of sterility.
March 26, 2025Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls Proxima Drape labeled as HEAD AND NECK OSIS, WILLIS SHOULDER PACK, EXTREMITY PACK-LF, TOTAL HIP PACK-LF, SHOULDER W/POUC
Hazard: Potential breach in pouch packaging which could lead to loss of sterility.
March 26, 2025Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls Proxima Drape labeled as FACE LIFT. Sterile surgical drape.
Hazard: Potential breach in pouch packaging which could lead to loss of sterility.
March 26, 2025Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls Proxima Drape labeled as MINOR PACK and LAPAROSCOPY. Sterile surgical drape.
Hazard: Potential breach in pouch packaging which could lead to loss of sterility.
March 26, 2025Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls Proxima Drape labeled as ENT-PLASTICS PACK. Sterile surgical drape.
Hazard: Potential breach in pouch packaging which could lead to loss of sterility.
March 26, 2025Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls Proxima 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 D
Hazard: Potential breach in pouch packaging which could lead to loss of sterility.
March 26, 2025Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls Proxima Drape labeled as DRAPE C-SECTION W/ WINDOW; SHEET, DRAPE, SPLIT, ST,10/CS; DRAPE,LAPROSCOPY,CHOLE,W/TROUGH,ST,8/
Hazard: Potential breach in pouch packaging which could lead to loss of sterility.
March 26, 2025Medical DevicesFDA
American Contract Systems Inc recalls VEIN TRAY, Model No UTVT21C UTVT21C02 UTVT21C-03
Hazard: ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
March 26, 2025Medical DevicesFDA
American Contract Systems Inc recalls THORACIC PACK , Model No UTTC82Y UTTC82AA-01
Hazard: ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
March 26, 2025Medical DevicesFDA
American Contract Systems Inc recalls SPINE LUMBAR PACK , Model No UTSL72AA UTSL72AB
Hazard: ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
March 26, 2025Medical DevicesFDA
American Contract Systems Inc recalls OPEN HEART A PACK , Model No UTOH19AI UTOH19AJ-01 UTOH19AJ-02
Hazard: ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
March 26, 2025Medical DevicesFDA
American Contract Systems Inc recalls MAJOR VASCULAR PACK , Model No UTMV78X-01 UTMV78Y UTMV78Y-01 UTMV78X-01 UTMV78Y-02
Hazard: ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
March 26, 2025Medical DevicesFDA
American Contract Systems Inc recalls GENERAL LAPAROSCOPIC PACK-LF , Model No UTGL53S-06 UTGL53S-07 UTGL53S-08
Hazard: ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
March 26, 2025Medical DevicesFDA
American Contract Systems Inc recalls AV FISTULA , Model No UTAV77T
Hazard: ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
March 26, 2025Medical DevicesFDA
American Contract Systems Inc recalls NEURO IR TRAY , Model No WENI56J
Hazard: ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
March 26, 2025Medical DevicesFDA
American Contract Systems Inc recalls DIAGNOSTIC NEURO IR TRAY , Model No WENE21
Hazard: ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
March 26, 2025Medical DevicesFDA
American Contract Systems Inc recalls CV BASIC PUMP PACK , Model No WECV23D
Hazard: ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
March 26, 2025Medical DevicesFDA
American Contract Systems Inc recalls LAPAROSCOPY PACK , Model No SFLA02A SFLA02B
Hazard: ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
March 26, 2025Medical DevicesFDA
American Contract Systems Inc recalls EAR PACK , Model No SFEA12A
Hazard: ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
March 26, 2025Medical DevicesFDA
American Contract Systems Inc recalls LACERATION TRAY , Model No SGLA07A SGLA07B-01 SGLA07B-02 SGLA07B
Hazard: ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
March 26, 2025Medical DevicesFDA
American Contract Systems Inc recalls LACERATION TRAY , Model No SGLA07A SGLA07B-01 SGLA07B-02 SGLA07B
Hazard: ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
March 26, 2025Medical DevicesFDA
American Contract Systems Inc recalls DELIVERY PACK , Model No SGDV22D-01 SGDV22E
Hazard: ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
March 26, 2025Medical DevicesFDA
American Contract Systems Inc recalls TOTAL HIP PACK , Model No SMTH06O SMTH06P
Hazard: ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.