FDA Recalls Sterile Surgical Packs from Unregistered Facility
American Contract Systems is recalling sterile custom surgical packs because they were manufactured in a facility not registered by 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, but the source text does not report any illnesses, injuries, or hospitalizations. The hazard is regulatory non-compliance (unregistered facility) rather than a confirmed biological or physical defect causing harm, fitting the 'Moderate' criteria for low-risk or precautionary issues.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a recall for sterile custom packs intended for use in surgical procedures. The recalling firm is American Contract Systems. The recall involves 2,868 kits distributed nationwide, including in Pennsylvania.
The reason for the recall is that the surgical gowns included in these packs were manufactured in a facility that is not registered by the FDA. This regulatory non-compliance raises concerns about the quality and safety controls of the manufacturing process.
Healthcare facilities and consumers who have these specific sterile custom packs should stop using them immediately. The affected products are identified by specific ACS Tray Numbers and lot numbers, including AGD1401, WPP147H, and SVOH38N, with expiration dates ranging from March 2020 to December 2020. Users should contact the manufacturer or their supplier for instructions on return or replacement.
The recalled product
- Product
- Sterile Custom Packs to be used in surgical procedures.
- Manufacturer
- American Contract Systems
- 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 (5)
- ACS Tray Numbers: AGD1401
- Lot # 647191
- Lot # 684191
- Lot # 654191
- Exp. Date 12/12/2020 (32 kits)
Distribution
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
See all →- ModerateFDA Recalls Sterile Surgical Packs from Unregistered Facility
FDA (Devices) · 2020-06-10
- HighFDA Recalls Sterile Surgical Packs from Unregistered Facility
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- HighFDA Recalls Sterile Custom Surgical Packs Due to Unregistered Facility
FDA (Devices) · 2020-06-10
- HighFDA Recalls Sterile Custom Surgical Packs from Unregistered Facility
FDA (Devices) · 2020-06-10
- ModerateFDA Recalls Surgical Gowns from Unregistered Facility
FDA (Devices) · 2020-06-10
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