Food, drugs, devices › American Contract Systems, Inc.
Device recall: 1) ACS Spine Pack 2) ACS Lumbar/Back Set Up Tray
American Contract Systems, Inc. (Kansas City, MO) initiated this device recall on 22 Mar 2022; FDA lists 5 product records under event 89868, classified Class II.
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. 88% of the 839 device enforcement events initiated in 2022 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., Kansas City, MO.
Reason for recall
"Product was sterilized with a higher than specification EO concentration."
Distribution
"US Nationwide distribution in the states of IL, MO, NE, and TX."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1036-2022 | 1) ACS Spine Pack 2) ACS Lumbar/Back Set Up Tray | 72 packs | Class II | Ongoing | 18 May 2022 |
| Z-1037-2022 | 1) ACS Arthroscopy Kit 2) ACS Knee Kit 3) ACS Hand Pack | 114 packs | Class II | Ongoing | 18 May 2022 |
| Z-1038-2022 | ACS IR - Angio Pack | 24 packs | Class II | Ongoing | 18 May 2022 |
| Z-1039-2022 | ACS Lap Chole Pack | 20 packs | Class II | Ongoing | 18 May 2022 |
| Z-1040-2022 | ACS Cath Lab Pack | 10 packs | Class II | Ongoing | 18 May 2022 |
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: "Product was sterilized with a higher than specification EO concentration."
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 Nationwide distribution in the states of IL, MO, NE, and TX."
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.