The Recall Desk
ModerateFDA (Devices)·Z-2166-2020·Announced 2020-06-10

FDA Recalls Sterile Surgical Kits from Unregistered Facility

American Contract Systems is recalling 2,868 sterile surgical 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, which typically involves a temporary or medically reversible adverse health consequence. The source text does not report any illnesses or injuries, and the hazard is related to regulatory compliance (unregistered facility) rather than a confirmed high-risk pathogen or structural defect.

Plain-English summary

The U.S. Food and Drug Administration (FDA) has issued a recall for 2,868 sterile custom surgical kits manufactured by American Contract Systems. The recall is being conducted because the surgical gowns included in these kits were manufactured in a facility that is not registered by the FDA.

The affected products are sterile custom packs intended for use in surgical procedures. The kits were distributed nationwide in the United States, including in the state of Pennsylvania. Specific lot numbers and expiration dates are listed in the agency's recall record.

Healthcare facilities and consumers who have these specific surgical kits should stop using them and contact American Contract Systems for further instructions or a refund. The FDA advises checking the recall number Z-2166-2020 to verify if a specific kit is affected.

The recalled product

Product
Sterile Custom Packs to be used in surgical procedures.
Manufacturer
American Contract Systems
Category
Medical Device — Surgical Kits
Hazard
Affected units
2,868

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 (11)

  • ACS Tray Numbers: SVOH98F
  • Lot # 676191
  • Exp. date 11/20/20 (3 kits) AHMV261
  • Exp. date 11/20/20 (10 kits) AGMV26L: Lot # 688191
  • Exp. date 11/08/2020 (36 kits) FBTO60G: Lot # 635191
  • Exp. date 12/31/2020 (25 kits) FBTO60G: Lot # 711191
  • Exp. date 10/16/2020 (3 kits) AGEP48G: Lot # 991201
  • Exp. date 01/09/2021 (72 kits) AGBR90D: Lot # 843191
  • Exp. date 06/06/2020 (48 kits) AGTP52J: Lot # 643191
  • Exp. date 12/23/2020 (42 kits) AGTP52J: Lot # 716191
  • Exp. date 10/11/2020 (8 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 →

Related recalls

Same manufacturer · American Contract Systems

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Same hazard · unregistered facility

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