FDA Recalls Sterile Custom Surgical Packs Due to Unregistered Facility
American Contract Systems is recalling 2,868 sterile custom surgical packs because they were manufactured in a facility not registered with the FDA.
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 2/5 (Moderate).
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 confirmed biological contamination or injury, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
American Contract Systems is voluntarily recalling 2,868 sterile custom packs intended for use in surgical procedures. The recall was initiated because the surgical gowns included in these packs were manufactured in a facility that is not registered by the FDA.
The affected products 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, including lots expiring in October and December 2020.
Healthcare facilities and consumers should stop using these specific sterile custom packs immediately. Users should contact American Contract Systems for further instructions on how to return or dispose of the affected products.
The recalled product
- Product
- Sterile Custom Packs to be used in surgical procedures.
- Manufacturer
- American Contract Systems
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 (9)
- ACS Tray Numbers: AGPP38I
- Lot # 644191
- Exp. Date 12/22/2020 (2 kits) and Lot # 713191
- Exp. Date 10/14/2020 (12 kits) AGHA64J
- Lot # 663191
- Exp. Date 12/03/2020 (72 kits) and Lot # 716191
- Exp. Date 10/11/2020 (10 kits) WPBU64H
- Lot # 670191
- Exp. Date 11/26/2020 (16 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
FDA (Devices) · 2020-06-10
- 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
Same hazard · regulatory non compliance
See all →- ModerateLimitless Cryo Spa LLC Recalls Glypto Devices for Lack of 510(k) Clearance
FDA (Devices) · 2026-10-14
- SevereSempio Recalls Ready-to-Eat Chicken Stew Imported Without Reinspection
USDA FSIS · 2026-09-25
- ModerateMedline Polycarbonate Syringes Recalled for Unapproved Design Changes
FDA (Devices) · 2026-07-01
- SevereMedline polycarbonate syringes recalled for unapproved design changes
FDA (Devices) · 2026-07-01
- ModerateMedline 10mL Polycarbonate Syringes Recalled for Unapproved Design Changes
FDA (Devices) · 2026-07-01
Similar recalls
- HighObstetric and gynecology surgical packs recalled for unvalidated sterilization exposure
FDA (Devices) · 2022-09-14
- SevereCustomed Recalls Surgical Packs Due to Compromised Sterility and Contamination Risk
FDA (Devices) · 2014-12-10
- SevereCustomed Plastic Surgery Packs Recalled for Compromised Sterility
FDA (Devices) · 2014-12-10
- SevereCustomed Plastic Surgery Pack Recalled for Sterility Compromise
FDA (Devices) · 2014-12-10
- SevereCustomed Laparotomy Packs Recalled Due to Compromised Sterility
FDA (Devices) · 2014-12-10
- SevereCustomed C-Section Surgical Packs Recalled for Sterility Compromise
FDA (Devices) · 2014-12-10