Skip to content
RecallWatchMedical Device Safety
Class IIOngoingZ-0172-2026

American Contract Systems Inc. recalls Medical convenience kits Item number/ Product description AKGN82E GENERAL AMCB08Y…

American Contract Systems Inc.Grimes, IA, United StatesReported Oct 22, 2025 · 8 months ago
Legal News Analyst ·

Reason for recall

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.

Affected product

Check your device

Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.

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 T & A PACK FHHY25P HYSTEROSCOPY PACK HGML99G MAJOR LAP PACK HGXR41H X-RAY PACK HISU54M SET-UP PACK IHAA19AP PK A A A IHMP89K MINOR PROCEDURE PACK IHPD14AM PK PEDIATRIC LKVG10O VAG DELIVERY LMAG20G VASCULAR PACK LMLE46AA EXTREMITY LOWER PK MIEN58A DTC GENERAL ENDOSCOPY PACK(PS 209468) NUMB04H MAJOR BASIN SET 314666 OWBS11U BASIN SET - 206021 RCMS71B MIS SPECIALTY RCH SFMB55X MINOR BASIN - 208293 STBA09F BASIN SET TNBS21O BASIN SET 612833 UDBH37AX BASIC HEART PACK - 206044 UDMA50X MINOR ADULT - 206067 UICR54W ACS CRS PACK (PS055042) UIPC89D PROCUREMENT PACK UIPT13F PITCHER (PS 907953) UISB96AB SMALL BACK TABLE SETUP (PS 907419)

Lot / code information

UDI
191072229281
Lot #
7352211 Bag
Serial #
47384448; AMCB08Y
UDI
191072185082
Lot #
8069911 Bag
Serial #
68117042; ANBP10AC
UDI
191072214300
Lot #
8125811 Bag
Serial #
17487164 17488117; ANIR77AM
UDI
191072236692
Show 97 more code fields
Lot #
8394711 Bag
Serial #
58588193 58588194 68563615 68663621; CFLA39G
UDI
191072203496
Lot #
8484911 Bag
Serial #
68642706; CIBL33I
UDI
191072186409
Lot #
8044011 Bag
Serial #
N/A; EVMN24E
UDI
191072215093
Lot #
8184711 Bag
Serial #
68198257; EVST48E
UDI
191072224064
Lot #
7366711 Bag
Serial #
68194868; FDTA11AA
UDI
191072159236
Lot #
8522811 Bag
Serial #
47864258; FHHY25P
UDI
191072157256
Lot #
8031711 Bag
Serial #
68152897; HGML99G
UDI
191072212580
Lot #
8316911 Bag
Serial #
68244067; HGXR41H
UDI
191072212672
Lot #
8285311 Bag
Serial #
N/A; HISU54M
UDI
191072212399
Lot #
7969611 Bag
Serial #
17427513; IHAA19AP
UDI
191072224187
Lot #
8035011 Bag
Serial #
68048038; IHMP89K
UDI
191072159960
Lot #
8024811 Bag
Serial #
68154486; IHPD14AM
UDI
191072227232
Lot #
8180911 Bag
Serial #
68200149; LKVG10O
UDI
191072158666
Lot #
7957411 Bag
Serial #
N/A; LMAG20G
UDI
191072158680
Lot #
7964411 Bag
Serial #
N/A; LMLE46AA
UDI
191072237880
Lot #
8500811 Bag
Serial #
68642780; MIEN58A
UDI
191072231444
Lot #
8118411 Bag
Serial #
N/A; NUMB04H
UDI
191072202895
Lot #
7993111 Bag
Serial #
N/A; OWBS11U
UDI
191072214843
Lot #
8069411 Bag
Serial #
47507802 47508002 47508012; RCMS71B
UDI
191072226150
Lot #
7950311 Bag
Serial #
N/A; SFMB55X
UDI
191072217851
Lot #
7971211 Bag
Serial #
N/A; SFMB55Y
UDI
191072229991
Lot #
8096711 Bag
Serial #
N/A
Lot #
8179711 Bag
Serial #
17556181 17557278; STBA09F
UDI
191072208798
Lot #
8079711 Bag
Serial #
17506128; TNBS21O
UDI
191072199775
Lot #
8115211 Bag
Serial #
N/A
Lot #
8432911 Bag
Serial #
N/A; UDBH37AX
UDI
191072238740
Lot #
8454211 Bag
Serial #
68703044; UDMA50X
UDI
191072172587
Lot #
8084711 Bag
Serial #
17390548
Lot #
8183611 Bag
Serial #
17554620; UICR54W
UDI
191072228932
Lot #
8142811 Bag
Serial #
N/A; UIPC89D
UDI
191072205742
Lot #
7956111 Bag
Serial #
N/A; UIPT13F
UDI
191072107121
Lot #
8049111 Bag
Serial #
68047422; UISB96AB
UDI
191072205797
Lot #
8147011 Bag
Serial #
N/A * If "N/A" for bag
Serial #
, then whole
Lot #
is affected

What the firm is doing

Firm notified affected distributors who received affected product via email on 9/4/25. An updated letter was provided on 9/9/25, which better clarified product codes and impacted lot numbers and bag serial numbers. Consignees were instructed to immediately discontinue use and discard impacted trays. Distribution partners were provided with a customer letter for further distribution to end users.

DistributionShow details

US Nationwide distribution in the states of SD, IA, MN, WA, IL.

Class IIWhat this means

Use of the product may cause temporary or medically reversible adverse health consequences.

Sources & references

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.

Taylor Coteus
Legal News Analyst

Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.

More Class II recalls