Reported Oct 22, 2025 · Ongoing
Basic Biopsy Tray; Item Number/Description: AKRB26D ROBOTIC, AMGL09AA GENERAL LAPAROSCOPY, ANLC35AD LAP CHOLE PACK -…
American Contract Systems Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: American Contract Systems Inc. · 1601 Se Gateway Dr Ste 120 · Grimes, IA · 50111-5223
Is this the product you have?
- Basic Biopsy Tray
- Item Number/Description
AKRB26D ROBOTICAMGL09AA GENERAL LAPAROSCOPYANLC35AD LAP CHOLE PACK - 205956ANLP25AJ LAPROSCOPY PACK - 205958FYLA38E LAPCHOLAPPY PACKIHDA88AH DIVINCI GYN UROIHLC11AE LAP GENERAL PACKMHLP45AJ LAPAROSCOPY PACK - 206005MHRB88AO ROBOTIC PACK - 242561RCLC51C LAP CHOLE RCH 0246969SMLC53C LAP CHOLE PACKUDLC17AE DSC LAP CHOLE PACK - 206062UIRU84AE ROBOTIC UROLOGY PACK (PS 060571)
- Lot codes and dates
13 of 13 products
Products covered by this recall # Barcodes Product as published 1 191072229366AKRB26D UDI-DI 191072229366 Lot 7350411 Bag Serial Number 68236939 2 191072207357AMGL09AA UDI-DI 191072207357 Lot 8459111 Bag Serial Numbers 68678361 68678364 3 191072211477ANLC35AD UDI-DI 191072211477 LOT 8021911 Bag Serial Number n/a Lot 8173811 Bag Serial Numbers 17556328 17556374 17556376 17556393 4 191072236333ANLP25AJ UDI-DI 191072236333 Lot 8306311 Bag Serial Numbers 47862596 47862598 5 191072203519FYLA38E UDI-DI 191072203519 Lot 8134111 Bag Serial Number 17488260 6 191072226303IHDA88AH UDI-DI 191072226303 Lot 8096211 Bag serial number N/A Lot 8150511 Bag Serial number 68277361 7 191072226372IHLC11AE UDI-DI 191072226372 Lot 8107911 Bag Serial Number N/A Lot 8192711 Bag Serial Numbers 68195543 68196275 8 191072236500MHLP45AJ UDI-DI 191072236500 Lot 8527411 Bag serial number 68873222 9 191072236531MHRB88AO UDI-DI 191072236531 Lot 8322811 Bag serial number 68596086 10 191072235930RCLC51C UDI-DI 191072235930 Lot 8230311 Bag serial number N/A 11 191072223029SMLC53C UDI-DI 191072223029 Lot 8195611 Bag serial numbers 68198164 68198213 68198222 68198228 68198229 12 191072214072UDLC17AE UDI-DI 191072214072 Lot 8501711 Bag serial number 17744347 13 191072235565UIRU84AE UDI-DI 191072235565 Lot 8319311 Bag serial number 68244060 * If "N/A" for bag serial number, then whole lot is affected - Amount recalled
- 32,433 total
This recall covers 18 products
The agency filed one notice per product. You are reading one of them; the other 17 are below.
5 more are in the archive.
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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