Agency classClass IIOur severity:High FDA (Devices)·Z-1693-2022·Announced 2022-09-14

ENT Surgical Packs Recalled Due to Sterilization Validation Failure

American Contract Systems recalls various ENT surgical packs that may not have been properly sterilized due to multiple sterilization cycles without adequate validation. The packs were distributed to healthcare facilities in 13 states.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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: The recall is classified as High severity because it involves a risk-of-harm product—surgical packs that may not be properly sterilized—without any reported injuries or illnesses to date. The sterilization validation failure poses a potential contamination risk to patients undergoing surgical procedures.

Plain-English summary

American Contract Systems, Inc. is recalling various ENT (ear, nose, and throat) surgical packs that were distributed to healthcare facilities and medical distributors throughout the United States. The recall affects three specific packs identified by their tray numbers, sterilization lot numbers, and bag serial numbers.

The products are being recalled because they were exposed to multiple sterilization cycles without proper validation for repeated exposures. The sterilization process failure may affect the sterility assurance of the affected packs, potentially compromising their safety for use in surgical procedures.

The recalled packs were distributed to healthcare systems and distributors in 13 states: Arizona, Florida, Iowa, Illinois, Massachusetts, Minnesota, Missouri, Ohio, Nebraska, Pennsylvania, Rhode Island, South Dakota, and Texas.

Healthcare facilities and practitioners who have received these packs should verify their inventory against the provided lot and serial numbers. Those with affected packs should contact American Contract Systems, Inc. for guidance regarding the recall and any required actions.

The recalled product

Product: Various ENT Packs
Manufacturer: American Contract Systems, Inc.
Category: Medical Device — ENT Surgical Packs
Hazard: sterilization-failure
contamination
Affected units: 3

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 (13)

Tray Number
Sterilization Lot
Lot Number
Bag Serial Number 1) LSRHPENTLHA
2106181
838211
14882942 2) MREN03G
2104262
887211
14934943 3) COEN27K
2108102
779211
15093749-004

Distribution

Distributed in 13 states:

Part of a larger recall action

This product is one of 17 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 17 products in this recall →

Same manufacturer · American Contract Systems, Inc.

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