Open, ClassifiedPosted Oct 16, 2025·Initiated Sep 4, 2025
Medical convenience kits
Item number/ Product description
AKGN82E GENERAL
AMCB08Y CHEST BREAST PACK
ANBP10AC BASIC PACK - 205939
ANIR77AM INTERVENTIONAL RADIOLOGY PACK - 205953
CFLA39G LAPAROTOMY PACK
CIBL33I BASIC LAP PACK
EVMN24E MINOR ESC
EVST48E STARTER
FDTA11AA T & A PACK
FHHY25P HYSTEROSCOPY PACK
HGML99G MAJOR LAP PACK
HGXR41H X-RAY PACK
HISU54M SET-UP PACK
IHAA19AP PK A A A
IHMP89K MINOR PROCEDURE PACK
IHPD14AM PK PEDIATRIC
LKVG10O VAG DELIVERY
LMAG20G VASCULAR PACK
LMLE46AA EXTREMITY LOWER PK
MIEN58A DTC GENERAL ENDOSCOPY PACK(PS 209468)
NUMB04H MAJOR BASIN SET 314666
OWBS11U BASIN SET - 206021
RCMS71B MIS SPECIALTY RCH
SFMB55X MINOR BASIN - 208293
STBA09F BASIN SET
TNBS21O BASIN SET 612833
UDBH37AX BASIC HEART PACK - 206044
UDMA50X MINOR ADULT - 206067
UICR54W ACS CRS PACK (PS055042)
UIPC89D PROCUREMENT PACK
UIPT13F PITCHER (PS 907953)
UISB96AB SMALL BACK TABLE SETUP (PS 907419)
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 been validated for exposure to multiple sterilization cycles. Therefore, product quality, safety, and effectiveness cannot be confirmed for product that was re-gassed.
Root cause: Nonconforming Material/Component
Recalling firm: American Contract Systems Inc.Type: General Surgery TrayDistribution: US Nationwide distribution in the states of SD, IA, MN, WA, IL.Recall #Z-0172-2026 Open, ClassifiedPosted Oct 16, 2025·Initiated Sep 4, 2025
Medical convenience kits
Item number/ Product description
AHLD15X LABOR DELIVERY PACK - 213387
AKDV96B VAGINAL DELIVERY
AKDV96B VAGINAL DELIVERY
EVBH28D BIRTHING ROOM PACK
UPVD01K VAGINAL DELIVERY 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 been validated for exposure to multiple sterilization cycles. Therefore, product quality, safety, and effectiveness cannot be confirmed for product that was re-gassed.
Root cause: Nonconforming Material/Component
Recalling firm: American Contract Systems Inc.Type: Labor And Delivery KitDistribution: US Nationwide distribution in the states of SD, IA, MN, WA, IL.Recall #Z-0173-2026 Open, ClassifiedPosted Oct 16, 2025·Initiated Sep 4, 2025
Medical convenience kits
Item Number/Description
BUCY78E CYSTO PACK
CMCP10X CYSTO PACK - 205972
IHCY10Y CYSTO PACK
MHCY35AE CYSTO PACK- 212487
PLBY52E CYSTO PACK
UDCY31Z CYSTO PACK - 206047
UICY28L MOR CYSTO 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 been validated for exposure to multiple sterilization cycles. Therefore, product quality, safety, and effectiveness cannot be confirmed for product that was re-gassed.
Root cause: Nonconforming Material/Component
Recalling firm: American Contract Systems Inc.Type: Endoscope Introducer KitDistribution: US Nationwide distribution in the states of SD, IA, MN, WA, IL.Recall #Z-0174-2026 Open, ClassifiedPosted Oct 16, 2025·Initiated Sep 4, 2025
Medical convenience kits
Item Number/Description
EVLH67F LEFT HEART CATH PACK
FDCL22R CATH LAB ANGIO
IHCC03X CATH CARDIAC PACK
TNCC02AD CARDIAC CATH TRINITY
UICC27AG CARDIAC CATH ANGIO PACK (PS 923077)
UIRD89AH RADIAL PACK (PS 56573)
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 been validated for exposure to multiple sterilization cycles. Therefore, product quality, safety, and effectiveness cannot be confirmed for product that was re-gassed.
Root cause: Nonconforming Material/Component
Recalling firm: American Contract Systems Inc.Type: Cardiac Catheterization KitDistribution: US Nationwide distribution in the states of SD, IA, MN, WA, IL.Recall #Z-0175-2026 Open, ClassifiedPosted Oct 16, 2025·Initiated Sep 4, 2025
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 PACK - 209533
UICD62AN CARDIOVASCUALR SUPPLY (PS 907285)
UICT16F CARDIO THORACIC DRAPE PACK (PS 907284)
UIVA75I VASCULAR 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 been validated for exposure to multiple sterilization cycles. Therefore, product quality, safety, and effectiveness cannot be confirmed for product that was re-gassed.
Root cause: Nonconforming Material/Component
Recalling firm: American Contract Systems Inc.Type: Cardiovascular Procedure KitDistribution: US Nationwide distribution in the states of SD, IA, MN, WA, IL.Recall #Z-0176-2026 Open, ClassifiedPosted Oct 16, 2025·Initiated Sep 4, 2025
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 been validated for exposure to multiple sterilization cycles. Therefore, product quality, safety, and effectiveness cannot be confirmed for product that was re-gassed.
Root cause: Nonconforming Material/Component
Recalling firm: American Contract Systems Inc.Type: Central Venous Catheter TrayDistribution: US Nationwide distribution in the states of SD, IA, MN, WA, IL.Recall #Z-0177-2026 Open, ClassifiedPosted Oct 16, 2025·Initiated Sep 4, 2025
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 been validated for exposure to multiple sterilization cycles. Therefore, product quality, safety, and effectiveness cannot be confirmed for product that was re-gassed.
Root cause: Nonconforming Material/Component
Recalling firm: American Contract Systems Inc.Type: Ear, Nose, And Throat Surgical TrayDistribution: US Nationwide distribution in the states of SD, IA, MN, WA, IL.Recall #Z-0178-2026 Open, ClassifiedPosted Oct 16, 2025·Initiated Sep 4, 2025
Medical convenience kits
Item Number/Description
RCGY52D GYN LAPAROSCOPY SPH 0246965
UIGN82M GYN (PS 907645)
UIHY16AE ASC HYSTEROSCOPY PACK (PS 020634)
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 been validated for exposure to multiple sterilization cycles. Therefore, product quality, safety, and effectiveness cannot be confirmed for product that was re-gassed.
Root cause: Nonconforming Material/Component
Recalling firm: American Contract Systems Inc.Type: Gynecological Laparoscopic KitDistribution: US Nationwide distribution in the states of SD, IA, MN, WA, IL.Recall #Z-0179-2026 Open, ClassifiedPosted Oct 16, 2025·Initiated Sep 4, 2025
Medical convenience kits
Item Number/Description
HSAN63N ANGIO PACK
IHAN02W ANGIOGRAPHY PACK
MHCA98AK CORONARY ANGIO PACK- 205991
RCAN45C ANGIO CUSTOM RCH
UDCO10F CVL CORONARY PACK 219224
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 been validated for exposure to multiple sterilization cycles. Therefore, product quality, safety, and effectiveness cannot be confirmed for product that was re-gassed.
Root cause: Nonconforming Material/Component
Recalling firm: American Contract Systems Inc.Type: Angiography/Angioplasty KitDistribution: US Nationwide distribution in the states of SD, IA, MN, WA, IL.Recall #Z-0180-2026 Open, ClassifiedPosted Oct 16, 2025·Initiated Sep 4, 2025
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 been validated for exposure to multiple sterilization cycles. Therefore, product quality, safety, and effectiveness cannot be confirmed for product that was re-gassed.
Root cause: Nonconforming Material/Component
Recalling firm: American Contract Systems Inc.Type: Cesarean Section TrayDistribution: US Nationwide distribution in the states of SD, IA, MN, WA, IL.Recall #Z-0181-2026 Open, ClassifiedPosted Oct 16, 2025·Initiated Sep 4, 2025
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 been validated for exposure to multiple sterilization cycles. Therefore, product quality, safety, and effectiveness cannot be confirmed for product that was re-gassed.
Root cause: Nonconforming Material/Component
Recalling firm: American Contract Systems Inc.Type: Radiology-Diagnostic KitDistribution: US Nationwide distribution in the states of SD, IA, MN, WA, IL.Recall #Z-0182-2026 Open, ClassifiedPosted Oct 16, 2025·Initiated Sep 4, 2025
Medical convenience kits
Item Number/Description
HSLM53AB SPINE PACK
MILM82A DTC LAMINECTOMY PACK (PS 209475)
RCNA47B NEURO ANGIO 0246971
SFLM54AB LAMINECTOMY PACK - 219659
UDLM94AA LAMINECTOMY PACK - 206064
UILM77AU LAMINECTOMY (PS 039500)
UINR44P NEURO IR PERIPHERAL (PS 64405)
UISH15AV SHUNT PACK (PS 039360)
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 been validated for exposure to multiple sterilization cycles. Therefore, product quality, safety, and effectiveness cannot be confirmed for product that was re-gassed.
Root cause: Nonconforming Material/Component
Recalling firm: American Contract Systems Inc.Type: Neurological TrayDistribution: US Nationwide distribution in the states of SD, IA, MN, WA, IL.Recall #Z-0183-2026 Open, ClassifiedPosted Oct 16, 2025·Initiated Sep 4, 2025
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
HJTO25C TOTAL HIP ACCESSORY PACK
HNEX60L EXTREMITY PACK
IAHD53C HAND PACK
IASH65A SHOULDER PACK
IHUE40AI UPPER EXTREMITY PK| STRL F G
ILTJ47AA TOTAL JOINT PACK
LMHP14Z ORIF HIP, ST LUKES METHODIS
LMSN44AE SPINAL PACK
MHHP25H HAND PACK - 206002
MHTH90AJ TOTAL HIP PACK - 206016
MWAH32P ANTERIOR HIP PACK
MWTK13AH TOTAL KNEE
PLOR89H ORTHO MINOR PACK
RCUE81B UPPER EXTREMITY RCH 0247031
TSTH54D TOTAL HIP TRAY
UDEX85Y DSC EXTREMITY - 206050
UDHD69U HAND PACK - 206055
UDKN68AH CUSTOM KNEE - 206061
UIHN18AW ACS HAND PACK (PS 020640)
UIHN18AX ACS HAND PACK (PS 020640)
UIKN28AR ASC KNEE PACK (PS 020641)
UISO44I SFCH SMALL ORTHO PACK (PS 143213)
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 been validated for exposure to multiple sterilization cycles. Therefore, product quality, safety, and effectiveness cannot be confirmed for product that was re-gassed.
Root cause: Nonconforming Material/Component
Recalling firm: American Contract Systems Inc.Type: Orthopedic TrayDistribution: US Nationwide distribution in the states of SD, IA, MN, WA, IL.Recall #Z-0184-2026 Open, ClassifiedPosted Oct 16, 2025·Initiated Sep 4, 2025
Medical convenience kits
Item Number/Description
BFCT04X CATARACT PACK - 205986
CMEY17AI EYE PACK - 213187
CMEY17AI EYE PACK - 213187
CMEY17AI EYE PACK - 213187
PERP25AQ PEI RETINAL PACK-206025
RFEY50AC EYE PACK-206026
UIVT47AS VITRECTOMY SUPPLY
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 been validated for exposure to multiple sterilization cycles. Therefore, product quality, safety, and effectiveness cannot be confirmed for product that was re-gassed.
Root cause: Nonconforming Material/Component
Recalling firm: American Contract Systems Inc.Type: Eye TrayDistribution: US Nationwide distribution in the states of SD, IA, MN, WA, IL.Recall #Z-0185-2026 Open, ClassifiedPosted Oct 16, 2025·Initiated Sep 4, 2025
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 been validated for exposure to multiple sterilization cycles. Therefore, product quality, safety, and effectiveness cannot be confirmed for product that was re-gassed.
Root cause: Nonconforming Material/Component
Recalling firm: American Contract Systems Inc.Type: Port Introducer KitDistribution: US Nationwide distribution in the states of SD, IA, MN, WA, IL.Recall #Z-0186-2026 Open, ClassifiedPosted Oct 16, 2025·Initiated Sep 4, 2025
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 been validated for exposure to multiple sterilization cycles. Therefore, product quality, safety, and effectiveness cannot be confirmed for product that was re-gassed.
Root cause: Nonconforming Material/Component
Recalling firm: American Contract Systems Inc.Type: D And C TrayDistribution: US Nationwide distribution in the states of SD, IA, MN, WA, IL.Recall #Z-0187-2026 Open, ClassifiedPosted Oct 16, 2025·Initiated Aug 29, 2025
CONTINU-FLO Solution Set, Non-Vented, two CLEARLINK Luer Activated Valves, Backcheck Valve, Plus 4-Way Stopcock Extension Set with two CLEARLINK Luer Activated Valve, Pfoduct code 2C6255
Reason: IV sets may leak.
Root cause: Process control
Recalling firm: Baxter Healthcare CorporationType: Stopcock, I.V. SetDistribution: US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV.Recall #Z-0189-2026
Open, ClassifiedPosted Oct 16, 2025·Initiated Aug 29, 2025
CLEARLINK System Solution Set, DUO-VENT, CLEARLINK Luer Activated Valve, 10 drops/mL, 92-inch (2.3 meters), Product code 2C8419
Reason: IV sets may leak.
Root cause: Process control
Recalling firm: Baxter Healthcare CorporationType: Stopcock, I.V. SetDistribution: US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV.Recall #Z-0190-2026
Open, ClassifiedPosted Oct 16, 2025·Initiated Aug 29, 2025
CLEARLINK SYSTEM Solution Set, Non-Vented, two CLEARLINK Luer Activated Valves, 10 drops/mL, 100-inch (2.5 meters), Product Code 2C8425
Reason: IV sets may leak.
Root cause: Process control
Recalling firm: Baxter Healthcare CorporationType: Stopcock, I.V. SetDistribution: US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV.Recall #Z-0191-2026
Open, ClassifiedPosted Oct 16, 2025·Initiated Aug 29, 2025
CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, two CLEARLINK Luer Activated Valves, Backcheck Valve, 10 drops/mL, 112-inch (2.8 meters), Product Code 2C8519
Reason: IV sets may leak.
Root cause: Process control
Recalling firm: Baxter Healthcare CorporationType: Stopcock, I.V. SetDistribution: US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV.Recall #Z-0192-2026