FDA (Devices) recall action 97659

American Contract Systems Inc. recalled 18 products on 2025-10-22

The FDA (Devices) publishes a recall like this one as 18 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 18 pages.

Products: 18
Announced: 2025-10-22
Critical: 0
Units: 583,794

Why these products were recalled

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.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–18 of 18

HighFDA (Devices)··2025-10-22
Cardiac catheterization packs recalled after being sterilized more than once
American Contract Systems is recalling cardiac catheterization and cath lab convenience packs that were re-gassed after a sterilization nonconformance.
Product
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)
Category
Distribution
5 states
HighFDA (Devices)··2025-10-22
Dilation and curettage packs recalled after being sterilized more than once
American Contract Systems is recalling D and C convenience packs that were re-gassed after a sterilization nonconformance, without validation for multiple cycles.
Product
Medical convenience kits IHDC30R D AND C PACK
Category
Distribution
5 states
HighFDA (Devices)··2025-10-22
Radiology procedure packs recalled after being sterilized more than once
American Contract Systems is recalling radiology convenience packs that were re-gassed after a sterilization nonconformance, without validation for multiple cycles.
Product
Medical convenience kits Item Number/Description LKRA40G RADIOLOGY PACK
Category
Distribution
5 states
HighFDA (Devices)··2025-10-22
Central line insertion kits recalled after being sterilized more than once
American Contract Systems is recalling 32,433 adult central line insertion supply kits that were re-gassed after a nonconformance, without validation for multiple sterilization cycles.
Product
Medical convenience kits Item Number/Description UICL44P ADULT CENTRAL LINE INSERTION SUPPLY KIT UICL44R ADULT CENTRAL LINE INSERTION SUPPLY KIT
Category
Distribution
5 states
HighFDA (Devices)··2025-10-22
General and laparotomy packs recalled after being sterilized more than once
American Contract Systems is recalling general, chest, laparotomy and interventional radiology convenience packs that were re-gassed after a sterilization nonconformance.
Product
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
Category
Distribution
5 states
HighFDA (Devices)··2025-10-22
Cardiovascular procedure packs recalled after being sterilized more than once
American Contract Systems is recalling cardiovascular convenience kits that were re-gassed after a sterilization nonconformance, without validation for multiple cycles.
Product
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
Category
Distribution
5 states
HighFDA (Devices)··2025-10-22
Head and neck procedure packs recalled after being sterilized more than once
American Contract Systems is recalling ENT and head and neck convenience packs that were re-gassed after a sterilization nonconformance, without validation for multiple cycles.
Product
Medical convenience kits Item Number/Description RCEN25B ENT SDSC 0246972 RCHN27D HEAD AND NECK RCH 0246951
Category
Distribution
5 states
HighFDA (Devices)··2025-10-22
PICC and gastrostomy tube packs recalled after being sterilized more than once
American Contract Systems is recalling PICC G-Tube convenience packs that were re-gassed after a sterilization nonconformance, without validation for multiple cycles.
Product
Medical convenience kits UDPG88W PICC G-TUBE PACK-230209
Category
Distribution
5 states
HighFDA (Devices)··2025-10-22
Caesarean section packs recalled after being sterilized more than once
American Contract Systems is recalling C-section convenience packs that were re-gassed after a sterilization nonconformance, without validation for multiple cycles.
Product
Medical convenience kits Item Number/Description FHCP08Y C SECTION PK HICS50I C-SECTION PACK HSCB90B C-SECTION BASIN PACK
Category
Distribution
5 states
HighFDA (Devices)··2025-10-22
Orthopedic procedure packs recalled after being sterilized more than once
American Contract Systems is recalling shoulder, hip and extremity convenience kits that were re-gassed after a sterilization nonconformance, without validation for multiple cycles.
Product
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 IAS
Category
Distribution
5 states
HighFDA (Devices)··2025-10-22
Spine and laminectomy packs recalled after being sterilized more than once
American Contract Systems is recalling spine, laminectomy and neuro angio convenience kits that were re-gassed after a sterilization nonconformance, without validation for multiple cycles.
Product
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
Category
Distribution
5 states
HighFDA (Devices)··2025-10-22
Gynecology procedure packs recalled after being sterilized more than once
American Contract Systems is recalling gynecology, laparoscopy and hysteroscopy convenience kits that were re-gassed after a sterilization nonconformance, without validation for multiple cycles.
Product
Medical convenience kits Item Number/Description RCGY52D GYN LAPAROSCOPY SPH 0246965 UIGN82M GYN (PS 907645) UIHY16AE ASC HYSTEROSCOPY PACK (PS 020634)
Category
Distribution
5 states
HighFDA (Devices)··2025-10-22
Cystoscopy procedure packs recalled after being sterilized more than once
American Contract Systems is recalling cysto convenience packs that were re-gassed after a sterilization nonconformance, without validation for multiple cycles.
Product
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
Category
Distribution
5 states
HighFDA (Devices)··2025-10-22
Basic biopsy trays recalled after entire lot was sterilized more than once
American Contract Systems is recalling a Basic Biopsy Tray lot that was re-gassed after a sterilization nonconformance, without validation for multiple cycles.
Product
Basic Biopsy Tray, Item Number NMBP44L
Category
Distribution
5 states
HighFDA (Devices)··2025-10-22
Angiography procedure packs recalled after being sterilized more than once
American Contract Systems is recalling angiography and coronary convenience packs that were re-gassed after a sterilization nonconformance, without validation for multiple cycles.
Product
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
Category
Distribution
5 states
HighFDA (Devices)··2025-10-22
Eye and cataract packs recalled after being sterilized more than once
American Contract Systems is recalling cataract, eye, retinal and vitrectomy convenience packs that were re-gassed after a sterilization nonconformance.
Product
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
Category
Distribution
5 states
HighFDA (Devices)··2025-10-22
Biopsy and laparoscopy packs recalled after being sterilized more than once
American Contract Systems is recalling biopsy and laparoscopy convenience kits that were re-gassed after a sterilization nonconformance, without validation for multiple cycles.
Product
Basic Biopsy Tray; Item Number/Description: AKRB26D ROBOTIC, AMGL09AA GENERAL LAPAROSCOPY, ANLC35AD LAP CHOLE PACK - 205956, ANLP25AJ LAPROSCOPY PACK - 205958, FYLA38E LAPCHOLAPPY PACK, IHDA88AH DIVINCI GYN URO, IHLC11AE LAP GENERAL PACK, MHLP45AJ LAPAROSCOPY PAC
Category
Distribution
5 states
HighFDA (Devices)··2025-10-22
Labor and delivery packs recalled after being sterilized more than once
American Contract Systems is recalling labor, delivery and birthing room convenience kits that were re-gassed after a sterilization nonconformance, without validation for multiple cycles.
Product
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
Category
Distribution
5 states