American Contract Systems Inc. recalls Basic Biopsy Tray
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.
Basic Biopsy Tray; Item Number/Description: AKRB26D ROBOTIC, AMGL09AA GENERAL LAPAROSCOPY, ANLC35AD LAP CHOLE PACK - 205956, ANLP25AJ LAPROSCOPY PACK - 205958, FYLA38E LAPCHOLAPPY PACK, IHDA88AH DIVINCI GYN URO, IHLC11AE LAP GENERAL PACK, MHLP45AJ LAPAROSCOPY PACK - 206005, MHRB88AO ROBOTIC PACK - 242561, RCLC51C LAP CHOLE RCH 0246969, SMLC53C LAP CHOLE PACK, UDLC17AE DSC LAP CHOLE PACK - 206062, UIRU84AE ROBOTIC UROLOGY PACK (PS 060571)
Lot / code information
- UDI
- 191072229366
- Lot #
- 7350411 Bag
- Serial #
- 68236939; AMGL09AA
- UDI
- 191072207357
- Lot #
- 8459111 Bag
- Serial #
- 68678361 68678364; ANLC35AD
- UDI
- 191072211477
- Lot #
- 8021911 Bag
- Serial #
- n/a
- Lot #
- 8173811 Bag
- Serial #
- 17556328 17556374 17556376 17556393; ANLP25AJ
- UDI
- 191072236333
- Lot #
- 8306311 Bag
- Serial #
- 47862596 47862598; FYLA38E
- UDI
- 191072203519
- Lot #
- 8134111 Bag
- Serial #
- 17488260; IHDA88AH
- UDI
- 191072226303
- Lot #
- 8096211 Bag
- Serial #
- N/A
- Lot #
- 8150511 Bag
- Serial #
- 68277361; IHLC11AE
- UDI
- 191072226372
- Lot #
- 8107911 Bag
- Serial #
- N/A
- Lot #
- 8192711 Bag
- Serial #
- 68195543 68196275; MHLP45AJ
- UDI
- 191072236500
- Lot #
- 8527411 Bag
- Serial #
- 68873222; MHRB88AO
- UDI
- 191072236531
- Lot #
- 8322811 Bag
- Serial #
- 68596086; RCLC51C
- UDI
- 191072235930
- Lot #
- 8230311 Bag
- Serial #
- N/A; SMLC53C
- UDI
- 191072223029
- Lot #
- 8195611 Bag
- Serial #
- 68198164 68198213 68198222 68198228 68198229; UDLC17AE
- UDI
- 191072214072
- Lot #
- 8501711 Bag
- Serial #
- 17744347; UIRU84AE
- UDI
- 191072235565
- Lot #
- 8319311 Bag
- Serial #
- 68244060 * If "N/A" for bag
- Serial #
- , then whole
- Lot #
- is affected
Show 37 more code fieldsShow fewer
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 detailsHide
US Nationwide distribution in the states of SD, IA, MN, WA, IL.
Use of the product may cause temporary or medically reversible adverse health consequences.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-0171-2026
- FDA device classification · FDEOfficial FDA classification for this device type
- CFR regulation · 21 CFR 876.1500The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find American Contract Systems Inc.Search for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
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 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.
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