Food, drugs, devices › American Contract Systems Inc
Device recall: AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) HEART PACK - 205947, MODEL/ITEM NUMBER ANCV78
FDA enforcement event 97358 is a device recall by American Contract Systems Inc of Tiffin, OH, initiated 14 Jul 2025 and classified Class II, with 9 product records.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 85% of the 945 device enforcement events initiated in 2025 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated. American Contract Systems Inc has 22 enforcement events on this register, with a median of 4 product records per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
American Contract Systems Inc, Tiffin, OH.
Reason for recall
"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."
Distribution
"US distribution to states of: IL and LA"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2464-2025 | 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, MODEL/ITEM NUMBER BHOP48P; 5) PEDIATRIC OPEN… | 31506 units | Class II | Ongoing | 3 Sep 2025 |
| Z-2465-2025 | 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 LAPAROSCOPY MPH, Model/Item Number MPGL15G; | 1233 units | Class II | Ongoing | 3 Sep 2025 |
| Z-2466-2025 | 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 SACY80S; 6) UROLOGY PACK, Model/Item Number SPUR64F. | 1127 units | Class II | Ongoing | 3 Sep 2025 |
| Z-2467-2025 | 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 Number HSCY13M; 5) PICC DRESSING CHANGE KIT,… | 6617 units | Class II | Ongoing | 3 Sep 2025 |
| Z-2468-2025 | 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. | 204 units | Class II | Ongoing | 3 Sep 2025 |
| Z-2469-2025 | 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. | 781 units | Class II | Ongoing | 3 Sep 2025 |
| Z-2470-2025 | AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) LAPAROSCOPY PACK, MODEL/ITEM NUMBER EVLP61I; 2) PELVISCOPY, MODEL/ITEM NUMBER EVPV29G. | 1094 units | Class II | Ongoing | 3 Sep 2025 |
| Z-2471-2025 | 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. | 50 units | Class II | Ongoing | 3 Sep 2025 |
| Z-2472-2025 | 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 NUMBER MIAH65B; 5)DR WHIDD0N TOTAL HIP CPP,… | 588 units | Class II | Ongoing | 3 Sep 2025 |
Context
Other enforcement events for American Contract Systems Inc
All 22 events for American Contract Systems Inc
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "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."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "US distribution to states of: IL and LA"
Is the recall still ongoing?
FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.