Medical Device Recalls

39,072 Records

FDA medical device enforcement reports

1,565 results found for sterilization Page 7 of 63
American Contract Systems Inc
Class II Ongoing
TOTAL HIP PACK , Model No SMTH06O SMTH06P
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.
Z-1347-2025 March 26, 2025 Tiffin, OH
American Contract Systems Inc
Class II Ongoing
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.
Z-1357-2025 March 26, 2025 Tiffin, OH
American Contract Systems Inc
Class II Ongoing
LABOR & DELIVERY PPS , Model No LLLD64O LLLD64O-01 LLLD64O-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.
Z-1344-2025 March 26, 2025 Tiffin, OH
American Contract Systems Inc
Class II Ongoing
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.
Z-1360-2025 March 26, 2025 Tiffin, OH
American Contract Systems Inc
Class II Ongoing
GENERAL ANGIO PACK , Model Nos LLAP75G LLAP75G-01 LLAP75G-02 LLAP75G-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.
Z-1340-2025 March 26, 2025 Tiffin, OH
American Contract Systems Inc
Class II Ongoing
LACERATION TRAY , Model No SGLA07A SGLA07B-01 SGLA07B-02 SGLA07B
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.
Z-1350-2025 March 26, 2025 Tiffin, OH
American Contract Systems Inc
Class II Ongoing
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.
Z-1358-2025 March 26, 2025 Tiffin, OH
American Contract Systems Inc
Class II Ongoing
DELIVERY PACK , Model No SGDV22D-01 SGDV22E
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.
Z-1348-2025 March 26, 2025 Tiffin, OH
American Contract Systems Inc
Class II Ongoing
LAPAROSCOPY PACK, Model No. CALS41F, CALS41F-01, CALS41G
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.
Z-1331-2025 March 26, 2025 Tiffin, OH
American Contract Systems Inc
Class II Ongoing
NEURO IR TRAY , Model No WENI56J
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.
Z-1355-2025 March 26, 2025 Tiffin, OH
American Contract Systems Inc
Class II Ongoing
CRANI PACK, Model/Catalog Number WECR41D, medical procedure kit.
Reason: During an internal investigation, ACS was unable to confirm that the CODMAN component achieved the required Sterility Assurance Level and therefore is not suitable for sterilizatio...
Z-1406-2025 March 26, 2025 Tiffin, OH
American Contract Systems Inc
Class II Ongoing
DIAGNOSTIC NEURO IR TRAY , Model No WENE21
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.
Z-1354-2025 March 26, 2025 Tiffin, OH
American Contract Systems Inc
Class II Ongoing
LABOR & DELIVERY PACK, Model Nos LLLD19H
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.
Z-1338-2025 March 26, 2025 Tiffin, OH
American Contract Systems Inc
Class II Ongoing
CV BASIC PUMP PACK , Model No WECV23D
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.
Z-1353-2025 March 26, 2025 Tiffin, OH
American Contract Systems Inc
Class II Ongoing
CENTRAL LINE PICC , Model No LLCL44H LLCL44H-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.
Z-1343-2025 March 26, 2025 Tiffin, OH
American Contract Systems Inc
Class II Ongoing
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.
Z-1361-2025 March 26, 2025 Tiffin, OH
American Contract Systems Inc
Class II Ongoing
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.
Z-1359-2025 March 26, 2025 Tiffin, OH
American Contract Systems Inc
Class II Ongoing
LACERATION TRAY , Model No SGLA07A SGLA07B-01 SGLA07B-02 SGLA07B
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.
Z-1349-2025 March 26, 2025 Tiffin, OH
American Contract Systems Inc
Class II Ongoing
CYSTO PACK , Model N. HKCY31A
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.
Z-1335-2025 March 26, 2025 Tiffin, OH
American Contract Systems Inc
Class II Ongoing
HIP SCOPE, Model Nos. CCHS21B CCHS21B-01 CCHS21B-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.
Z-1333-2025 March 26, 2025 Tiffin, OH
American Contract Systems Inc
Class II Ongoing
LAPAROSCOPY PACK , Model No SFLA02A SFLA02B
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.
Z-1352-2025 March 26, 2025 Tiffin, OH
American Contract Systems Inc
Class II Ongoing
LAPAROSCOPY PACK, Model Nos LLLA21J LLLA21J-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.
Z-1337-2025 March 26, 2025 Tiffin, OH
American Contract Systems Inc
Class II Ongoing
DR DIULUS INJECTION PACK, Model Nos. CCDU12C CCDU12D CCDU12D-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.
Z-1332-2025 March 26, 2025 Tiffin, OH
American Contract Systems Inc
Class II Ongoing
EAR PACK , Model No SFEA12A
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.
Z-1351-2025 March 26, 2025 Tiffin, OH
American Contract Systems Inc
Class II Ongoing
CYSTO , Model No SACY80R
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.
Z-1346-2025 March 26, 2025 Tiffin, OH