Class II — the FDA judged the product may cause temporary or medically reversible harm, with a remote chance of serious harm.
This is the FDA's risk judgment for this recall. It describes the potential of the product as a category — it does not establish that any specific unit harmed anyone. Most recalls are Class II or III.
Custom procedural convenience kits and trays, gastroenterological & urological, labeled as: a) LAP KIDNEY MODULE, kit number AGKD50L; b) ROBOTIC PROSTATE PACK - 264852, kit number ANPR34S; c) LAP CHOLE - 213388, kit number BFLC02AD; d) GENERAL LAPAROSCOPY PACK, kit number GUGE09I; e) LAP CHOLE PACK, kit number HNLC80I; f) Lap Chole Ovarian Appy, kit number JSLC06I; g) LAP CHOLE, ST LUKES, kit number LMLP08Z; h) ROBOTIC PACK - 242561, kit number MHRB88AJ; i) KIT, GENERAL LAPAROSCOPY, kit number MMLP40F; j) KIT, MAJOR LAPAROTOMY, kit number MMML26F; k) LAP CHOLE - LAP HERNIA PACK - 282807, kit number OWLC07K; l) GENERAL LAPAROSCOPY SAH, kit number SAGL57H; m) ROBOTIC PACK SAH, kit number SARB30K; n) ROBOTIC PACK SAH, kit number SARB30L; o) ROBOTIC PACK SAH, kit number SARB30M; p) LAP CHOLE PACK, kit number SMLC53; q) ROBOTICS PACK, kit number SNRP85D; r) ROBOTIC PACK, kit number SSRO22C; s) ROBOTIC PACK, kit number SSRO22D; t) TPK DAVINCI PROSTATE SYSTEM, kit number TPDV16; u) ASC LAP CHOLE PACK (PS 42279), kit number UICH53Y; v) GENERAL LAPAROSCOPIC PACK, kit number WVGL60E
Why it was recalled
During an internal investigation, ACS identified that several components were "piggybacked" to ACS trays and subjected to the ACS sterilization process. There is no supporting documentation stating the "piggybacked" components were assessed to determine if they were suitable for exposure to elevated temperatures for an extended period of time and further exposure to sterilization. As a result, the piggybacked components may (1) have a loss/lack of functionality, (2) loss of drug efficacy, if applicable, and (3) may have had higher than specified EO residuals.
Is your unit affected?
The recall covers only the specific lots or serial numbers the FDA listed. Enter the lot or serial number from your product's label and we'll check it against that list.
A match means your unit may be covered — stop and call your pharmacist before doing anything. No match suggests it isn't covered, but confirm anyway: code formats vary and lists can be incomplete. Your unit not being listed does not guarantee it is safe, and being listed does not mean you have been harmed.
Show the FDA's listed lot / code information
a) AGKD50L, UDI/DI 00191072141156, Lot Numbers: 905231, exp. 4/5/2024; 638221, exp. 12/28/2023; 689221, exp. 5/21/2023; b) ANPR34S, UDI/DI 00191072171351, Lot Numbers: 721221, exp. 10/6/2023; 879231, exp. 5/1/2024; 896231, exp. 4/14/2024; 927231, exp. 3/14/2024; 956231, exp. 2/13/2024; 645221, exp. 12/21/2023; c) BFLC02AD, UDI/DI 00191072169075, Lot Numbers: 654221, exp. 12/12/2023; 647221, exp. 12/19/2023; 987231, exp. 1/13/2024; UDI/DI 00191072188830, Lot Numbers: 946231, exp. 2/23/2024; 896231, exp. 4/14/2024; d) GUGE09I, UDI/DI none, Lot Numbers: 768221, exp. 8/20/2023; e) HNLC80I, UDI/DI 00191072146267, Lot Numbers: 797221, exp. 7/22/2023; 679221, exp. 11/17/2023; 995231, exp. 1/25/2024; 911231, exp. 3/30/2024; f) JSLC06I, UDI/DI 00191072126061, Lot Numbers: 839221, exp. 6/10/2023; 766221, exp. 8/22/2023; g) LMLP08Z, UDI/DI none, Lot Numbers: 661221, exp. 12/5/2023; 987231, exp. 1/13/2024; 942231, exp. 2/27/2024; 893231, exp. 4/17/2024; h) MHRB88AJ, UDI/DI none, Lot Numbers: 735221, exp. 9/22/2023; 710221, exp. 10/17/2023; 997231, exp. 1/3/2024; 959231, exp. 2/10/2024; 904231, exp. 4/6/2024; i) MMLP40F, UDI/DI none, Lot Numbers: 933231, exp. 3/8/2024; 879231, exp. 5/1/2024; j) MMML26F, UDI/DI none, Lot Numbers: 989231, exp. 1/11/2024; 896231, exp. 4/14/2024; k) OWLC07K, UDI/DI none, Lot Numbers: 682221, exp. 11/14/2023; 646221, exp. 12/20/2023; 982231, exp. 1/18/2024; 928231, exp. 3/13/2024; l) SAGL57H, UDI/DI none, Lot Numbers: 687221, exp. 11/9/2023; 790221, exp. 7/29/2023; m) SARB30K, UDI/DI none, Lot Numbers: 845221, exp. 6/4/2023; 888221, exp. 4/22/2023; n) SARB30L, UDI/DI none, Lot Numbers: 752221, exp. 9/5/2023; o) SARB30M, UDI/DI none, Lot Numbers: 658221, exp. 12/8/2023; 700221, exp. 10/27/2023; 792221, exp. 7/27/2023; 949231, exp. 2/20/2024; 983231, exp. 1/17/2024; p) SMLC53, UDI/DI 00191072188465, Lot Numbers: 969231, exp. 1/31/2024; q) SNRP85D, UDI/DI none, Lot Numbers: 666221, exp. 11/30/2023; 720221, exp. 10/7/2023; 793221, exp. 7/26/2023; 853221, exp. 5/27/2023; 965231, exp. 2/4/2024; r) SSRO22C, UDI/DI none, Lot Numbers: 891221, exp. 04/19/2023; s) SSRO22D, UDI/DI none, Lot Numbers: 660221, exp. 5/31/2023; 698221, exp. 10/29/2023; 756221, exp. 9/1/2023; 804221, exp. 7/15/2023; 840221, exp. 6/9/2023; 933231, exp. 8/31/2023; 987231, exp. 1/13/2024; t) TPDV16, UDI/DI 00191072128904, Lot Numbers: 856221, exp. 5/24/2023; 744221, exp. 9/13/2023; 675221, exp. 11/21/2023; 932231, exp. 3/9/2024; u) UICH53Y, UDI/DI none, Lot Numbers: 897231, exp. 4/13/2024; 882231, exp. 4/28/2024; v) WVGL60E, UDI/DI 00191072144034, Lot Numbers: 766221, exp. 8/22/2023; 694221, exp. 11/2/2023; 952231, exp. 2/17/2024;
Recall status
Ongoing — the recall is still being carried out.
Where it was distributed
US Nationwide distribution.
Recall record
- Recalling firm
- American Contract Systems, Inc.
- Product type
- Devices
- Recall number
- Z-0822-2024
- Voluntary / mandated
- Voluntary: Firm initiated
- Initial notification
- Origin
- Temple Terrace, FL
- Recall initiated
- 2023-11-29
What to do
Check the lot/code above against your product. To confirm this record and read the FDA's full notice, see the FDA recall page. Before changing anything you take or use, ask your pharmacist or prescriber — this page does not tell you to start or stop any drug or device.
Also available: structured data (JSON-LD) · recall record (JSON)
What this is — and is not
A recall is a recorded FDA enforcement action — the FDA logged that a firm is removing or correcting a product. It does not establish that any specific unit harmed anyone, and causation is not established by a recall. The class above is the FDA's risk judgment for the product category, not a finding about your unit. This page informs and compares; it is not medical advice and never tells you to start or stop a drug or device.
To report a problem you experienced, use
FDA MedWatch.
Verify this record at FDA recalls ·
Recall Z-0822-2024 · Source: openFDA enforcement.