Quick Facts at a Glance
- Recall Date
- September 4, 2025
- Hazard Level
- HIGH
- Brand
- American Contract Systems
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- American Contract Systems
- Product type
- Biopsy Tray
- Model numbers
- 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 +5 more
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
September 4, 2025
Reported by FDA DEVICE
October 22, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
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.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact American Contract Systems Inc. or your healthcare provider for instructions. Notification method: Letter
About This Product
Biopsy trays are used to hold tissue samples during surgical procedures. These trays are sterilized and packaged for single-use or limited reuse in operating rooms.
Why This Is Dangerous
Re-gassed trays have not been validated for repeated sterilization cycles. Using them could compromise sterility, safety, and effectiveness in clinical settings.
Industry Context
This recall is not described as part of a broader industry pattern.
Real-World Impact
Hospitals and surgical centers may need to replace affected trays. The recall could affect operating room supply chains and procurement records.
Practical Guidance
How to identify if yours is affected
- Review inventory for the listed model numbers and UDIs
- Cross-check lot numbers and bag serial numbers against the recall list
- Isolate and quarantine any trays matching the affected identifiers
Where to find product info
Refer to the FDA enforcement page linked in the recall notice for model and lot details
What timeline to expect
No timeline is provided for remediation or replacement in the recall notice
If the manufacturer is unresponsive
- Escalate to the hospital procurement manager
- Document all communications with the supplier
- Consider legal guidance if the provider cannot obtain replacement trays within a reasonable timeframe
How to prevent similar issues
- Maintain centralized tracking for sterile supplies
- Verify sterilization validation for products that may undergo multiple EO cycles
- Consult manufacturer guidance before re-processing sterilized medical devices
Documentation advice
Keep recall letter, inventory listings, and supplier communications as part of the chain-of-custody records
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Product Details
Model numbers/descriptions include 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). The reason: re-gassed after EO sterilization nonconformance.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- 32,433 total units recalled
- US nationwide distribution in SD, IA, MN, WA, IL
- Multiple model numbers and lot numbers listed in recall
- Re-gassed after EO sterilization nonconformance
- Not validated for multiple sterilization cycles
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Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
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