Surgical instrument convenience packs recalled for inadequate sterilization validation
American Contract Systems is recalling 118 convenience packs of surgical instruments because they were exposed to multiple sterilization cycles without validation of the product's ability to withstand repeated sterilizations.
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 FDA Class II recall involves surgical instruments exposed to multiple sterilization cycles without validation of adequate sterilization. Although no illnesses or injuries have been reported, improperly sterilized surgical instruments represent a significant risk of harm through potential infection; therefore this meets the rubric criterion for High severity as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
American Contract Systems, Inc. is recalling various convenience packs of surgical and orthopedic instruments totaling 118 units. The products were exposed to multiple sterilization cycles without validation that the instruments could withstand repeated sterilization. This represents a deviation from required sterilization standards.
The recalled products were distributed to health systems and distributors in Arizona, Florida, Iowa, Illinois, Massachusetts, Minnesota, Missouri, Ohio, Nebraska, Pennsylvania, Rhode Island, South Dakota, and Texas.
Healthcare facilities that received these convenience packs should stop using them and contact American Contract Systems, Inc. for instructions on replacement or return. Patients and healthcare providers should consult with their medical team regarding any procedures performed with these instruments.
The recalled product
- Product
- Various convenience packs
- 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)
- Tray Number
- Sterilization Lot
- Lot Number
- Bag Serial Number 1) LSRHUMTOTPKC
- 2104192
- 894211
- 14881385 2) LSRLMHANDA
- 2104221
- 901211
- 64119577 3) LSRHUMTOTPKC
- 14881385 4) LSRTOTJOINTM
- 2104301
- 888211
- 63993926 5) LSRTOTJOINTM
- 63993926 6) LSRLMHANDA
- 2105101
- 883211
- 63991195 7) LSRORTHOMINH
- 2107221
- 818211
Distribution
Distributed in 13 states:
- AZ
- FL
- IA
- IL
- MA
- MN
- MO
- NE
- OH
- PA
- RI
- SD
- TX
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