Basic Biopsy Tray; Item Number/Description: AKRB26D ROBOTIC, AMGL09AA GENERAL LAPAROSCOPY, ANLC35AD LAP CHOLE PAC
Summary
The FDA issued a Class II for Basic Biopsy Tray; Item Number/Description: AKRB26D ROBOTIC, AMGL09AA GENER by American Contract Systems Inc.. Reason: Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection pr.
Details
Source
Device Recall
External ID
Z-0171-2026
Action Date
2025-10-22
Status
Ongoing
Category
device
Product Description
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 Info: AKRB26D UDI-DI 191072229366 Lot 7350411 Bag Serial Number 68236939; AMGL09AA UDI-DI 191072207357 Lot 8459111 Bag Serial Numbers 68678361 68678364; ANLC35AD UDI-DI 191072211477 LOT 8021911 Bag Serial Number n/a Lot 8173811 Bag Serial Numbers 17556328 17556374 17556376 17556393; ANLP25AJ UDI-DI 191072236333 Lot 8306311 Bag Serial Numbers 47862596 47862598; FYLA38E UDI-DI 191072203519 Lot 8134111 Bag Serial Number 17488260; IHDA88AH UDI-DI 191072226303 Lot 8096211 Bag serial number N/A Lot 8150511 Bag Serial number 68277361; IHLC11AE UDI-DI 191072226372 Lot 8107911 Bag Serial Number N/A Lot 8192711 Bag Serial Numbers 68195543 68196275; MHLP45AJ UDI-DI 191072236500 Lot 8527411 Bag serial number 68873222; MHRB88AO UDI-DI 191072236531 Lot 8322811 Bag serial number 68596086; RCLC51C UDI-DI 191072235930 Lot 8230311 Bag serial number N/A; SMLC53C UDI-DI 191072223029 Lot 8195611 Bag serial numbers 68198164 68198213 68198222 68198228 68198229; UDLC17AE UDI-DI 191072214072 Lot 8501711 Bag serial number 17744347; UIRU84AE UDI-DI 191072235565 Lot 8319311 Bag serial number 68244060 * If "N/A" for bag serial number, then whole lot is affected
Quantity Affected: 32,433 total
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.
Distribution
US Nationwide distribution in the states of SD, IA, MN, WA, IL.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-09-04
Company
Grimes, IA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 237 device recalls issued in the same week, part of 403 device-related FDA actions this month.
American Contract Systems Inc. has 188 FDA actions in our database, including 188 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (American Contract Systems Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does American Contract Systems Inc. have FDA actions?
American Contract Systems Inc. has 188 FDA actions in our database, including 188 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0171-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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