American Contract Systems Surgical Kits Recalled Due to Unconfirmed Sterilization
American Contract Systems is recalling 588 surgical procedure kits distributed in Illinois and Louisiana due to inability to confirm proper sterilization of certain components. The kits may not meet sterilization assurance requirements.
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: FDA Class II medical device with unconfirmed sterilization assurance. While no injuries have been reported, surgical kits used in invasive orthopedic procedures represent risk-of-harm products where sterilization cannot be confirmed, meeting the rubric criterion for High severity.
Plain-English summary
American Contract Systems Inc. is recalling 588 surgical procedure and orthopedic kits distributed to facilities in Illinois and Louisiana. The recall affects seven product models with specific lot numbers, including Anterior Hip Packs, Total Knee Kits, Hip Prosthesis Packs, and Knee Arthroscopy Kits used in surgical procedures.
The manufacturer determined during an internal investigation that the sterilization procedures for certain components were not adequately justified and may not be fit for further sterilization according to company procedures. As a result, American Contract Systems cannot confirm that sterilization assurance requirements were met for these components.
Healthcare facilities that received these kits should stop using them and contact American Contract Systems or the FDA for further guidance on product disposition and replacement.
The recalled product
- Product
- AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) ANTERIOR HIP PACK, MODEL/ITEM NUMBER AMAH40N; 2)TOTAL KNEE DAN MYER, MODEL/ITEM NUMBER CCKM67F; 3)HIP PROTHESIS PACK, MODEL/ITEM NUMBER HSTH03N; 4)DTC ANTERIOR HIP PACK (PS 209459), MODEL/ITEM NUM
- 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 AMAH40N: UDI/DI 00191072235473
- Kit Lot Numbers: 42-7886011
- 42-7990911
- 2)MODEL/ITEM NUMBER CCKM67F: UDI/DI 00191072233578
- Kit Lot Numbers: 70-053862
- 70-053457
- 70-053042
- 70-052715
- 70-052358
- 70-051850
- 70-051243
- 3)MODEL/ITEM NUMBER HSTH03N: UDI/DI 00191072189615
- Kit Lot Numbers: 42-7115711
- 4)MODEL/ITEM NUMBER MIAH65B: UDI/DI 00191072235411
- Kit Lot Numbers: 42-8134311
- 5)MODEL/ITEM NUMBER MPWH01B: UDI/DI 00191072233271
- Kit Lot Numbers: 5436801
- 6)MODEL/ITEM NUMBER SPKA57T: UDI/DI 00191072235848
- Kit Lot Numbers: 12-7400011
- 12-7381311
Distribution
Distributed in 2 states:
- IL
- LA
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