Reason: Instructions for use for a foot plating system is being updated to remove the second option of requirements for sterilization which was 3 minutes exposure time at 134-137-degrees C...
Reason: Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. These products have not...
Reason: Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. These products have not...
Reason: Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. These products have not...
Z-0183-2026October 22, 2025Grimes, IA
American Contract Systems Inc.
Class IIOngoing
Medical convenience kits Item Number/Description UICL44P ADULT CENTRAL LINE INSERTION SUPPLY KIT UICL44R ADULT CENTRAL LINE INSERTION SUPPLY KIT
Reason: Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. These products have not...
Z-0177-2026October 22, 2025Grimes, IA
American Contract Systems Inc.
Class IIOngoing
Medical convenience kits Item Number/Description FHCP08Y C SECTION PK HICS50I C-SECTION PACK HSCB90B C-SECTION BASIN PACK
Reason: Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. These products have not...
Z-0181-2026October 22, 2025Grimes, IA
American Contract Systems Inc.
Class IIOngoing
Medical convenience kits IHDC30R D AND C PACK
Reason: Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. These products have not...
Z-0187-2026October 22, 2025Grimes, IA
American Contract Systems Inc.
Class IIOngoing
Medical convenience kits Item Number/Description ANCV78BC HEART PACK - 205947 HGCV05K CV SET UP PACK MHPP97AR PACEMAKER PACK- 206010 UDBH37AW BASIC HEART PACK - 206044 UHPP82AH PERIPHERAL PAC...
Reason: Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. These products have not...
Reason: Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. These products have not...
Z-0179-2026October 22, 2025Grimes, IA
American Contract Systems Inc.
Class IIOngoing
Medical convenience kits Item Number/Description RCEN25B ENT SDSC 0246972 RCHN27D HEAD AND NECK RCH 0246951
Reason: Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. These products have not...
Z-0178-2026October 22, 2025Grimes, IA
American Contract Systems Inc.
Class IIOngoing
Medical convenience kits Item Number/Description LKRA40G RADIOLOGY PACK
Reason: Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. These products have not...
Z-0182-2026October 22, 2025Grimes, IA
American Contract Systems Inc.
Class IIOngoing
Medical convenience kits Item Number/Description ANSH14AF SHOULDER PACK - 205962 EVAH76H ANTERIOR HIP PACK FDSA15M SHOULDER ARTHROSCOPY GRTS90G TOTAL SHPULDER PACK HGHI26G HIP PINNING PACK ...
Reason: Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. These products have not...
Reason: Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. These products have not...
Z-0185-2026October 22, 2025Grimes, IA
American Contract Systems Inc.
Class IIOngoing
Basic Biopsy Tray, Item Number NMBP44L
Reason: Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. These products have not...
Z-0170-2026October 22, 2025Grimes, IA
American Contract Systems Inc.
Class IIOngoing
Medical convenience kits Item number/ Product description AKGN82E GENERAL AMCB08Y CHEST BREAST PACK ANBP10AC BASIC PACK - 205939 ANIR77AM INTERVENTIONAL RADIOLOGY PACK - 205953 CFLA39G LAPARO...
Reason: Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. These products have not...
Z-0172-2026October 22, 2025Grimes, IA
American Contract Systems Inc.
Class IIOngoing
Medical convenience kits UDPG88W PICC G-TUBE PACK-230209
Reason: Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. These products have not...
Reason: Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. These products have not...
Reason: Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. These products have not...
Reason: Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. These products have not...
Z-0174-2026October 22, 2025Grimes, IA
Medline Industries, LP
Class IOngoing
Sterile Medline Convenience Kits: 1) EXTREMITY PACK, Model Number: DYNJ45701B
Reason: Convenience kits labeled as sterile have not gone through the sterilization process.
Z-2593-2025October 8, 2025Northfield, IL
Medline Industries, LP
Class IOngoing
Sterile Medline Convenience Kits: 1) MAJOR PACK L-F, Model Number: DYNJ0382730O; 2) LB BASIC CUSTOM PACK, Model Number: DYNJ61038B
Reason: Convenience kits labeled as sterile have not gone through the sterilization process.
Z-2592-2025October 8, 2025Northfield, IL
CooperVision, Inc.
Class IIOngoing
MyDay Toric, stenfilcon A) Contact Lens. Model/Catalog Number: MyDay Toric. 54% water content, Toric, cast moulded Silicone Hydrogel, In-monomer tinted, contact lens, for Daily Disposable Wear. Bli...
Reason: One lot manufactured with an invalid sterilization cycle.
Z-2606-2025October 1, 2025West Henrietta, NY
CooperVision, Inc.
Class IIOngoing
Sofmed Breathables, (stenfilcon A) contact lens. Model Number: Softmed Breathables. 54% water content, Toric, cast moulded Silicone Hydrogel, In-monomer tinted, contact lens, for Daily Disposable W...
Reason: One lot manufactured with an invalid sterilization cycle.
Z-2607-2025October 1, 2025West Henrietta, NY
CooperVision, Inc.
Class IIOngoing
Voyant 1-Day Premium Toric, (stenfilcon A) contact lens. Model Number: Voyant 1-Day Premium Toric. 54% water content, Toric, cast moulded Silicone Hydrogel, In-monomer tinted, contact lens, for Dai...
Reason: One lot manufactured with an invalid sterilization cycle.
Z-2608-2025October 1, 2025West Henrietta, NY
Encore Medical, LP
Class IIOngoing
Brand Name: DJO SURGICAL Product Name: FA S Altivate Reverse Glenoid Tray Model/Catalog Number: None Software Version: NA Product Description: Enovis" shoulder devices are intended for treatment o...
Reason: Their is a potential that the reamer may kick or bind up during or immediately prior to use.