Agency classClass IIOur severity:High FDA (Devices)·Z-0181-2026·Announced 2025-10-22

Caesarean section packs recalled after being sterilized more than once

American Contract Systems is recalling C-section convenience packs that were re-gassed after a sterilization nonconformance, without validation for multiple cycles.

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: Scored 3 under the risk-of-harm criterion: quality and safety cannot be confirmed for kits used in invasive procedures, and no injuries are reported.

Plain-English summary

Medical convenience kits used in caesarean sections are being recalled, covering item numbers FHCP08Y (C Section Pack), HICS50I (C-Section Pack) and HSCB90B (C-Section Basin Pack).

The identified products were re-gassed, meaning sterilized more than once, after a nonconformance occurred during the initial ethylene oxide gas injection process. These products have not been validated for exposure to multiple sterilization cycles, so product quality, safety and effectiveness cannot be confirmed.

The action covers 32,433 units in total across the firm's affected kits, distributed in South Dakota, Iowa, Minnesota, Washington and Illinois. The FDA has classified the action as Class II.

Facilities should identify affected item, lot and bag serial numbers, quarantine them and follow the firm's instructions.

The recalled product

Product: Medical convenience kits Item Number/Description FHCP08Y C SECTION PK HICS50I C-SECTION PACK HSCB90B C-SECTION BASIN PACK
Manufacturer: American Contract Systems Inc.
Category: Medical Device — Surgical kit
Hazard: resterilization
unvalidated-process
sterility-assurance
Affected units: 32,433

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)

FHCP08Y UDI-DI 191072232724 Lot 8216211 Bag serial number 68258296
HICS50I UDI-DI 191072212351 Lot 8161711 Bag serial number 68273637
then whole lot is affected

Distribution

Distributed nationwide across the United States.

The notice also names 5 states specifically:

Part of a larger recall action

This product is one of 18 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 18 products in this recall →

Same manufacturer · American Contract Systems Inc.

See all →

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Same hazard · resterilization