Open, ClassifiedPosted Mar 14, 2025·Initiated Feb 6, 2025
AV FISTULA
, Model No UTAV77T
Reason: ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
Root cause: Process control
Recalling firm: American Contract Systems IncType: Cardiovascular Procedure KitDistribution: US Nationwide distribution in the state of OH.Recall #Z-1356-2025 Open, ClassifiedPosted Mar 14, 2025·Initiated Feb 6, 2025
GENERAL LAPAROSCOPIC PACK-LF
, Model No UTGL53S-06
UTGL53S-07
UTGL53S-08
Reason: ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
Root cause: Process control
Recalling firm: American Contract Systems IncType: General Surgery TrayDistribution: US Nationwide distribution in the state of OH.Recall #Z-1357-2025 Open, ClassifiedPosted Mar 14, 2025·Initiated Feb 6, 2025
MAJOR VASCULAR PACK
, Model No UTMV78X-01
UTMV78Y
UTMV78Y-01
UTMV78X-01
UTMV78Y-02
Reason: ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
Root cause: Process control
Recalling firm: American Contract Systems IncType: Cardiovascular Procedure KitDistribution: US Nationwide distribution in the state of OH.Recall #Z-1358-2025 Open, ClassifiedPosted Mar 14, 2025·Initiated Feb 6, 2025
OPEN HEART A PACK
, Model No UTOH19AI
UTOH19AJ-01
UTOH19AJ-02
Reason: ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
Root cause: Process control
Recalling firm: American Contract Systems IncType: Cardiovascular Procedure KitDistribution: US Nationwide distribution in the state of OH.Recall #Z-1359-2025 Open, ClassifiedPosted Mar 14, 2025·Initiated Feb 6, 2025
SPINE LUMBAR PACK
, Model No UTSL72AA
UTSL72AB
Reason: ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
Root cause: Process control
Recalling firm: American Contract Systems IncType: Neurological TrayDistribution: US Nationwide distribution in the state of OH.Recall #Z-1360-2025 Open, ClassifiedPosted Mar 14, 2025·Initiated Feb 6, 2025
THORACIC PACK
, Model No UTTC82Y
UTTC82AA-01
Reason: ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
Root cause: Process control
Recalling firm: American Contract Systems IncType: Cardiovascular Procedure KitDistribution: US Nationwide distribution in the state of OH.Recall #Z-1361-2025 Open, ClassifiedPosted Mar 14, 2025·Initiated Feb 6, 2025
VEIN TRAY, Model No UTVT21C
UTVT21C02
UTVT21C-03
Reason: ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
Root cause: Process control
Recalling firm: American Contract Systems IncType: Cardiovascular Procedure KitDistribution: US Nationwide distribution in the state of OH.Recall #Z-1362-2025 Open, ClassifiedPosted Mar 14, 2025·Initiated Feb 13, 2025
Proxima 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,ROBOTIC,W/LEGGING,W/POUCH,5/CS. Sterile surgical drape.
Reason: Potential breach in pouch packaging which could lead to loss of sterility.
Root cause: Packaging process control
Recalling firm: MEDLINE INDUSTRIES, LP - NorthfieldType: Drape, Surgical, ExemptDistribution: US Nationwide distribution.Recall #Z-1363-2025
Open, ClassifiedPosted Mar 14, 2025·Initiated Feb 13, 2025
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 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.
Reason: Potential breach in pouch packaging which could lead to loss of sterility.
Root cause: Packaging process control
Recalling firm: MEDLINE INDUSTRIES, LP - NorthfieldType: General Surgery TrayDistribution: US Nationwide distribution.Recall #Z-1364-2025
Open, ClassifiedPosted Mar 14, 2025·Initiated Feb 13, 2025
Proxima Drape labeled as ENT-PLASTICS PACK. Sterile surgical drape.
Reason: Potential breach in pouch packaging which could lead to loss of sterility.
Root cause: Packaging process control
Recalling firm: MEDLINE INDUSTRIES, LP - NorthfieldType: Ear, Nose, And Throat Surgical TrayDistribution: US Nationwide distribution.Recall #Z-1365-2025
Open, ClassifiedPosted Mar 14, 2025·Initiated Feb 13, 2025
Proxima Drape labeled as MINOR PACK and LAPAROSCOPY. Sterile surgical drape.
Reason: Potential breach in pouch packaging which could lead to loss of sterility.
Root cause: Packaging process control
Recalling firm: MEDLINE INDUSTRIES, LP - NorthfieldType: Laparoscopy KitDistribution: US Nationwide distribution.Recall #Z-1366-2025
Open, ClassifiedPosted Mar 14, 2025·Initiated Feb 13, 2025
Proxima Drape labeled as FACE LIFT. Sterile surgical drape.
Reason: Potential breach in pouch packaging which could lead to loss of sterility.
Root cause: Packaging process control
Recalling firm: MEDLINE INDUSTRIES, LP - NorthfieldType: Plastic Surgery And Accessories KitDistribution: US Nationwide distribution.Recall #Z-1367-2025
Open, ClassifiedPosted Mar 14, 2025·Initiated Feb 13, 2025
Proxima 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.
Reason: Potential breach in pouch packaging which could lead to loss of sterility.
Root cause: Packaging process control
Recalling firm: MEDLINE INDUSTRIES, LP - NorthfieldType: General Surgery TrayDistribution: US Nationwide distribution.Recall #Z-1368-2025
Open, ClassifiedPosted Mar 14, 2025·Initiated Feb 13, 2025
Proxima Drape labeled as UNIVERSAL DAVINCI ROBOTIC P. Sterile surgical drape.
Reason: Potential breach in pouch packaging which could lead to loss of sterility.
Root cause: Packaging process control
Recalling firm: MEDLINE INDUSTRIES, LP - NorthfieldType: Gynecological Laparoscopic KitDistribution: US Nationwide distribution.Recall #Z-1369-2025
Open, ClassifiedPosted Mar 14, 2025·Initiated Feb 13, 2025
Proxima Drape labeled as ORTHO TRAUMA CDS, TOTAL KNEE AUX PACK, TOTAL HIP PACK, TOTAL HIP, TOTAL KNEE, SPINE. Sterile surgical drape.
Reason: Potential breach in pouch packaging which could lead to loss of sterility.
Root cause: Packaging process control
Recalling firm: MEDLINE INDUSTRIES, LP - NorthfieldType: Orthopedic TrayDistribution: US Nationwide distribution.Recall #Z-1370-2025
Open, ClassifiedPosted Mar 14, 2025·Initiated Feb 20, 2025
Helix Elite" Inactivated Standard: Inactivated SARS-CoV-2 Whole Virus (Pellet), Multi-analyte, unassayed quality control material, Catalog Number HE0065N
Reason: The A549 human cell target (human cells for sample adequacy control) may give a late Ct value.
Root cause: Process control
Recalling firm: Microbiologics IncType: Multi-Analyte Controls UnassayedDistribution: US Nationwide distribution in the states of TX. UK.Recall #Z-1371-2025
Open, ClassifiedPosted Mar 13, 2025·Initiated Feb 18, 2025
BD Alaris Systems Manager , REF 9601 Infusion Safety Management Software
Reason: Software issue that may result in outdated automated programming request(APR) being sent to the progressive care unit (PCU).
Root cause: Under Investigation by firm
Recalling firm: CareFusion 303, Inc.Type: Infusion Safety Management SoftwareDistribution: US: AZ, CA, DC, FL, GA, IL, IN, MI, MO, NC, NJ, NY, OH, OR, PA, SC, TX, UT, VA, WA, WI
OUS: NoneRecall #Z-1304-2025
Open, ClassifiedPosted Mar 13, 2025·Initiated Feb 18, 2025
BD Care Coordination Engine (CCE) Infusion Adapter, Safety Management Software
Reason: Software issue that may result in outdated automated programming request(APR) being sent to the progressive care unit (PCU).
Root cause: Under Investigation by firm
Recalling firm: CareFusion 303, Inc.Type: Infusion Safety Management SoftwareDistribution: US: AZ, CA, DC, FL, GA, IL, IN, MI, MO, NC, NJ, NY, OH, OR, PA, SC, TX, UT, VA, WA, WI
OUS: NoneRecall #Z-1305-2025
Open, ClassifiedPosted Mar 13, 2025·Initiated Feb 5, 2025
Aortic Root Cannula:
1. DLP Aortic Root Cannula
A. CANNULA 11012 AR FLOWGUARD 12GA, model no
11012
B. CANNULA 11014 AR FLOWGUARD 14GA, model no.
11014
2. MiAR Cannula:
A. CANNULA 11012L AR FLOWGUARD LONG 12GA, model no
11012L
B. CANNULA 11014L AR FLOWGUARD 14FR LONG, model no.
11014L
3. DLP Aortic Root Cannula with Vent Line
A. CANNULA 21012 AR VENT FLOW 12GA, model no.
21012
B. CANNULA 21014 AR VENT FLOW 14GA, model no.
21014
Reason: Unexpected loose material in the male luer used in the aortic root cannula has been identified. Potential harms when identified prior to use - procedure delay. Potential harm if not identified and used - stroke (reversible and irreversible).
Root cause: Process control
Recalling firm: Medtronic Perfusion SystemsType: Catheter, Cannula And Tubing, Vascular, Cardiopulmonary BypassDistribution: Domestic distribution nationwide. International distribution to the following countries: Albania
Algeria
Argentina
Armenia
Australia
Austria
Azerbaijan
Bahrain
Bangladesh
Belarus
Belgium
Bosnia And Herzegovina
Botswana
Brazil
Bulgaria
Canada
Canary Islands
Cayman Islands
Chile
China
Colombia
Costa Rica
Croatia
Cyprus
Czech Republic
Denmark
Ecuador
Egypt
Estonia
Finland
France
Georgia
Germany
Greece
Guatemala
Hong Kong
Hungary
India
Indonesia
Iran
Iraq
Ireland
Israel
Italy
Japan
Jordan
Kazakhstan
Kuwait
Latvia
Lebanon
Lithuania
Luxembourg
Malaysia
Moldova, Republic Of
Montenegro
Morocco
Namibia
Nepal
Netherlands
New Zealand
North Macedonia
NorthernIreland
Norway
Oman
Pakistan
Panama
Peru
Philippines
Poland
Portugal
Puerto Rico
Qatar
Reunion
Romania
Russia
Saudi Arabia
Senegal
Serbia
Singapore
Slovakia
Slovenia
South Africa
South Korea
Spain
Suriname
Sweden
Switzerland
Taiwan
Thailand
Turkey
Ukraine
United Arab Emirates
United Kingdom
Viet Nam
YemenRecall #Z-1306-2025
Open, ClassifiedPosted Mar 13, 2025·Initiated Jan 16, 2025
Brand Name: Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors
Product Name: Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
Model/Catalog Number: CP22V-VT
Software Version: N/A
Reason: Their is a potential of fluid leakage from the centrifugal blood pump pump during the priming procedure or during clinical procedures.
Root cause: Process control
Recalling firm: Spectrum Medical IncType: Pump, Blood, Cardiopulmonary Bypass, Non-Roller TypeDistribution: US Nationwide distribution including in the states of Alabama, Arizona, Arkansas, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Illinois, Kansas, Kentucky, Louisiana, Maryland, Massachusetts, Minnesota, Mississippi, Missouri, New York, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, and Washington.Recall #Z-1327-2025