Biopsy Drape Pack sterilization failure recall from American Contract Systems
American Contract Systems is recalling 224 Biopsy Drape Pack convenience kits due to insufficient aeration time during sterilization, which may have compromised the sterility of affected units. Lot 981241 distributed in CA, KS, ME, MN, MO, NE, and SD is affected.
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 a Class II FDA recall of a medical device with potential for serious harm (infection from non-sterile equipment used in biopsies). No illnesses or injuries have been reported to date, placing it in the High category per the rubric criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
American Contract Systems, Inc. is recalling its Biopsy Drape Pack convenience kit. The recall affects 224 units distributed nationwide to healthcare facilities in California, Kansas, Maine, Minnesota, Missouri, Nebraska, and South Dakota. Lot number 981241 with expiration date January 19, 2025 is affected.
The kits were released with insufficient aeration time during sterilization. Proper aeration after sterilization is critical to ensure the sterility of medical devices. When aeration time is insufficient, the sterility of kits sterilized on the same cycle or in the same aeration chamber may be compromised.
Non-sterile surgical drape packs pose a risk of infection when used in medical procedures such as biopsies. Healthcare facilities that have received these kits should discontinue use and contact American Contract Systems, Inc. for instructions on product handling or replacement.
The recalled product
- Product
- American Contract Systems Biopsy Drape Pack convenience kit
- Manufacturer
- American Contract Systems, Inc.
- Affected units
- 224
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 (3)
- UDI-DI 00191072202246
- Lot 981241
- Exp. Date 1/19/2025
Distribution
Part of a larger recall action
This product is one of 8 recalled by American Contract Systems, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 8 products in this recall →Related recalls
Same manufacturer · American Contract Systems, Inc.
See all →- ModerateAmerican Contract Systems Recalls Convenience Kits with Non-Conforming Catheters
FDA (Devices) · 2026-09-02
- ModerateAmerican Contract System Convenience Kit Recalled for Performance Failures
FDA (Devices) · 2026-09-02
- ModerateAmerican Contract System Convenience Kit Recalled for Performance Failures
FDA (Devices) · 2026-09-02
- ModerateAmerican Contract System Convenience Kits Recalled for Performance Failures
FDA (Devices) · 2026-09-02
- HighMedicom Recalls Neurological Sponges Due to Endotoxin Variability
FDA (Devices) · 2026-08-26
Same hazard · sterilization failure
See all →- HighOlympus Toomey Evacuator 50cc with Adaptor sterilization recall
FDA (Devices) · 2026-07-22
- HighOlympus Glass Body for 194 Ellik Evacuator Model 190A Sterilization Recall
FDA (Devices) · 2026-07-22
- HighVasoview Hemopro 2 Endoscopic Vessel Harvesting System Recall
FDA (Devices) · 2026-07-22
- SevereOlympus Ellik Evacuator Recalled for Inadequate Sterilization Risk
FDA (Devices) · 2026-07-22
- HighOlympus Toomey Evacuator 30cc medical device sterilization parameters recalled
FDA (Devices) · 2026-07-22