FDA (Devices) recall action 97358

American Contract Systems Inc recalled 9 products on 2025-09-03

The FDA (Devices) publishes a recall like this one as 9 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 9 pages.

Products: 9
Announced: 2025-09-03
Critical: 0
Units: 43,200

Why these products were recalled

During an internal investigation, ACS determined that the rationale for sterilization of certain components was not justified and therefore, some components are not fit for further sterilization according to ACS procedures. As a result, ACS is unable to confirm product sterilization assurance requirements were met.

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

1–9 of 9

HighFDA (Devices)··2025-09-03
Cystoscopy and TUR packs recalled over unconfirmed sterilization assurance requirements
American Contract Systems cysto and TUR basin packs are recalled because the firm cannot confirm that product sterilization assurance requirements were met. 1,127 units are affected.
Product
AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) CYSTO, Model/Item Number ASCY24A; 2) CYSTO PACK, Model/Item Number BUCY78E; 3) CYSTO PACK, Model/Item Number LMCP22T; 4) TUR BASIN PACK, Model/Item Number LMTU31T; 5) CYSTO, Model/Item Number SA
Category
Distribution
2 states
HighFDA (Devices)··2025-09-03
Hysterectomy procedure packs recalled over unconfirmed sterilization assurance requirements
American Contract Systems robotic and vaginal hysterectomy packs are recalled because the firm cannot confirm that product sterilization assurance requirements were met. 50 units are affected.
Product
AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) ROBOT HYST PACK, MODEL/ITEM NUMBER GRRB10E; 2) VAG HYST PACK, MODEL/ITEM NUMBER SPVH62P.
Category
Distribution
2 states
HighFDA (Devices)··2025-09-03
Craniotomy and shunt packs recalled over unjustified sterilization of certain components
American Contract Systems craniotomy and shunt procedure packs are recalled because the firm cannot confirm that product sterilization assurance requirements were met. 204 units are affected.
Product
AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) SFCH CRANI PACK (PS 132432), MODEL/ITEM NUMBER UICR10W; 2) SFCH SHUNT PACK (PS 139798), MODEL/ITEM NUMBER UISH55V.
Category
Distribution
2 states
HighFDA (Devices)··2025-09-03
Labor and delivery packs recalled over unconfirmed product sterilization assurance
American Contract Systems Born on Arrival kits and Labor & Delivery packs are recalled because the firm cannot confirm that product sterilization assurance requirements were met. 781 units are affected.
Product
AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) BORN ON ARRIVAL KIT, Model/Item Number LLBN11C; 2) LABOR & DELIVERY PACK, Model/Item Number LLLD19I.
Category
Distribution
2 states
HighFDA (Devices)··2025-09-03
Hip and knee procedure packs recalled over unconfirmed sterilization assurance requirements
American Contract Systems anterior hip, total knee and hip prosthesis packs are recalled because the firm cannot confirm that product sterilization assurance requirements were met. 588 units are affected.
Product
AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) ANTERIOR HIP PACK, MODEL/ITEM NUMBER AMAH40N; 2)TOTAL KNEE DAN MYER, MODEL/ITEM NUMBER CCKM67F; 3)HIP PROTHESIS PACK, MODEL/ITEM NUMBER HSTH03N; 4)DTC ANTERIOR HIP PACK (PS 209459), MODEL/ITEM NUM
Category
Distribution
2 states
HighFDA (Devices)··2025-09-03
Lap chole and laparoscopy packs recalled over unmet sterilization assurance requirements
American Contract Systems lap chole and laparoscopy packs are recalled because the firm cannot confirm that product sterilization assurance requirements were met. 1,233 units are affected.
Product
AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) LAP CHOLE PACK, Model/Item Number CILC69L; 2) LAP CHOLE PACK, Model/Item Number HNLC80J; 3) LAP CHOLE PACK, Model/Item Number JKLC55H; 4) LAPAROSCOPY PACK, Model/Item Number LLLA21K; 5) GENERAL
Category
Distribution
2 states
HighFDA (Devices)··2025-09-03
Laparoscopy and pelviscopy packs recalled over unconfirmed sterilization assurance requirements
American Contract Systems laparoscopy and pelviscopy procedure packs are recalled because the firm cannot confirm that product sterilization assurance requirements were met. 1,094 units are affected.
Product
AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) LAPAROSCOPY PACK, MODEL/ITEM NUMBER EVLP61I; 2) PELVISCOPY, MODEL/ITEM NUMBER EVPV29G.
Category
Distribution
2 states
HighFDA (Devices)··2025-09-03
Heart and vascular packs recalled because sterilization rationale was not justified
American Contract Systems heart, vascular and off-pump CABG packs are recalled because the firm cannot confirm that product sterilization assurance requirements were met. 31,506 units are affected.
Product
AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) HEART PACK - 205947, MODEL/ITEM NUMBER ANCV78BC; 2) VASCULAR PACK - 232024, MODEL/ITEM NUMBER ANVA82AB; 3) OFF PUMP CABG PACK - 170316, MODEL/ITEM NUMBER BHOP48O; 4) OFF PUMP CABG PACK - 170316, M
Category
Distribution
2 states
HighFDA (Devices)··2025-09-03
Perfusion and laparoscopy packs recalled over unjustified sterilization of certain components
American Contract Systems supplement, kidney perfusion and lapchol/appy packs are recalled because the firm cannot confirm that product sterilization assurance requirements were met. 6,617 units are affected.
Product
AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) A-C SUPPLEMENT PACK - 205946, Model/Item Number ANCV67X; 2) KIDNEY PERFUSION PACK - 208439, Model/Item Number ANKP15AD; 3) LAPCHOLAPPY PACK, Model/Item Number FYLA38G; 4) CYSTO PACK, Model/Item N
Category
Distribution
2 states