Medical Procedure Kits Recalled Due to Unconfirmed Sterilization
American Contract Systems is recalling 6,617 medical procedure kits because the company cannot confirm sterilization requirements were met. The affected kits were distributed to healthcare facilities in Illinois and Louisiana.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of medical procedure kits where sterilization assurance cannot be confirmed. While no illnesses or injuries have been reported, the inability to ensure proper sterilization of surgical equipment poses a significant risk of infection, meeting the criteria for a risk-of-harm product without reported injury.
Plain-English summary
American Contract Systems Inc. is recalling 6,617 medical procedure kits and surgical trays distributed to healthcare facilities in Illinois and Louisiana. The kits are used in various surgical procedures.
During an internal investigation, American Contract Systems determined that the scientific rationale for sterilizing certain components in these kits was not justified. Consequently, the company cannot confirm that sterilization assurance requirements were met. Non-sterile medical devices used in surgical and invasive procedures pose a significant risk of infection.
The recall involves 16 different kit models with specific lot numbers and unique device identifiers. Healthcare providers with these kits should verify their inventory against the provided lot numbers and contact the manufacturer for further instructions.
The recalled product
- Product
- AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) A-C SUPPLEMENT PACK - 205946, Model/Item Number ANCV67X; 2) KIDNEY PERFUSION PACK - 208439, Model/Item Number ANKP15AD; 3) LAPCHOLAPPY PACK, Model/Item Number FYLA38G; 4) CYSTO PACK, Model/Item N
- Manufacturer
- American Contract Systems Inc
- Hazard
- sterilization-failure
- infection-risk
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 1) Model/Item Number ANCV67X: UDI/DI 00191072203021
- Kit Lot Numbers: 42-7789611
- 42-8074911
- 42-7925811
- 42-8005111
- 2) Model/Item Number ANKP15AD: UDI/DI 00191072235176
- Kit Lot Numbers: 42-7916611
- 42-8047711
- 3) Model/Item Number FYLA38G: UDI/DI 00191072003706
- Kit Lot Numbers: 42-7905711
- 42-8134111
- 4) Model/Item Number HSCY13M: UDI/DI 00191072005571
- Kit Lot Numbers: 42-8125311
- 42-7959411
- 5) Model/Item Number HSDR10K: UDI/DI 00191072005588
- Kit Lot Numbers: 42-7984111
- 42-7883711
- 6) Model/Item Number HSMD20H: UDI/DI 00191072237262
- Kit Lot Numbers: 42-7937911
- 7) Model/Item Number PDSA12D: UDI/DI 00191072137111
Distribution
Distributed in 2 states:
- IL
- LA
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