Agency classClass IIOur severity:High FDA (Devices)·Z-1700-2022·Announced 2022-09-14

Neurology Surgical Packs Recalled for Sterilization Validation Failure

American Contract Systems recalls 37 units of neurology surgical packs distributed across 13 US states due to exposure to multiple sterilization cycles without proper validation.

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: This is an FDA Class II recall of medical device kits used in surgical procedures. The hazard—exposure to multiple sterilization cycles without validation—represents a risk-of-harm situation because inadequate sterilization could allow contamination during use. No illnesses or injuries have been reported, meeting the criterion for Score 3: 'risk-of-harm products where injury has not yet been reported.'

Plain-English summary

American Contract Systems, Inc. is recalling 37 units of various neurology surgical packs distributed to health systems and distributors in Arizona, Florida, Iowa, Illinois, Massachusetts, Minnesota, Missouri, Ohio, Nebraska, Pennsylvania, Rhode Island, South Dakota, and Texas.

The packs were exposed to multiple sterilization cycles without validation that they could safely withstand repeated sterilization. This creates a potential contamination risk, as adequate sterilization is critical to prevent microorganisms from surviving on surgical instruments and materials used in procedures.

No illnesses or injuries have been reported to date. Healthcare facilities that received these products should identify affected units using the tray numbers, sterilization lot numbers, and bag serial numbers listed in the FDA recall notice and quarantine them immediately. Do not use affected packs in surgical procedures. Contact American Contract Systems, Inc. for instructions on returning or replacing recalled units.

The recalled product

Product: Various neurology packs
Manufacturer: American Contract Systems, Inc.
Category: Medical Device — Surgical Packs
Hazard: sterilization-failure
contamination-risk
Affected units: 37

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) LSRLMNEINTC
2105181
870211
63990989 2) LSRSWRSPNC
2105251
861211
63990357 3) LSRLMNEUROG
2106161
845211
44139500 4) LSRSMHNEURE
2108101
793211
44139500 5) LSRNEURCRANIH
2108171
776211
64123199 6) LSRLMNEUROG
2110011

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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