Moderate FDA (Devices)·Z-2168-2020·Announced 2020-06-10

FDA Recalls Surgical Gowns from Unregistered Facility

American Contract Systems is recalling 2,868 surgical gown kits because they were manufactured in a facility not registered with the FDA.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II. The hazard is a regulatory compliance issue (unregistered facility) rather than a direct physical defect or reported illness, fitting the criteria for moderate severity.

Plain-English summary

American Contract Systems is recalling 2,868 custom surgical gown kits used in surgical procedures. The recall was initiated because the surgical gowns were manufactured in a facility that is not registered by the FDA.

The affected products include specific lots of custom packs distributed nationwide in the United States, including in Pennsylvania. The recall covers kits with expiration dates ranging from August 2020 to January 2021.

Consumers and healthcare facilities should stop using these products and contact the recalling firm for further instructions.

The recalled product

Product: Custom Packs to be used in surgical procedures.
Manufacturer: American Contract Systems
Category: Medical Device — Surgical Gowns
Hazard: unregistered-facility

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 (7)

WPGA21L
Lot # 998201
Exp. Date 01/02/2021 (24 kits) and Lot # 6781914
Exp date 11/18/2020 (4 kits) AGGL48H
Lot# 643191
Exp. Date 12/23/2020 (80 kits) AGGM59N: Lot # 761191
Exp. Date 08/27/2020 (5 kits)

Distribution

Distributed nationwide across the United States.

The notice also names 2 states specifically:

Part of a larger recall action

This product is one of 14 recalled by American Contract Systems 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 14 products in this recall →

Same manufacturer · American Contract Systems

See all →

Moderate
FDA Recalls Sterile Surgical Packs from Unregistered Facility
FDA (Devices) · 2020-06-10
High
FDA Recalls Sterile Surgical Packs from Unregistered Facility
FDA (Devices) · 2020-06-10
High
FDA Recalls Sterile Custom Surgical Packs Due to Unregistered Facility
FDA (Devices) · 2020-06-10
High
FDA Recalls Sterile Custom Surgical Packs from Unregistered Facility
FDA (Devices) · 2020-06-10
High
FDA Recalls Sterile Custom Surgical Packs from Unregistered Facility
FDA (Devices) · 2020-06-10

Same hazard · unregistered facility