Custom Healthcare Systems Recalls Surgical Gown Kits Due to Sterility Compromise
Custom Healthcare Systems is recalling 7,200 surgical gown kits because incorrect sealing specifications compromised product sterility.
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: The recall is classified as FDA Class II and involves a risk-of-harm product (sterility compromise) where no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Custom Healthcare Systems, Inc. is recalling 7,200 units of CHS Custom Convenience Kit-SURGICAL GOWN, LARGE SET IN SLEEVES (Product Number: 1231-050L). The recall involves lot numbers W72018 and W71218, which have an expiration date of July 1, 2021.
The recall was initiated because the convenience kits were sealed in immediate Tyvek pouches using incorrect specifications, which compromised the sterility of the product. This is classified as an FDA Class II recall.
The affected products were distributed in Connecticut, Georgia, Kentucky, North Carolina, Virginia, Maryland, Oklahoma, Illinois, and South Carolina. Users should stop using these products and contact the manufacturer for further instructions.
The recalled product
- Product
- CHS Custom Convenience Kit-SURGICAL GOWN, LARGE SET IN SLEEVES Product Number:1231-050L
- Manufacturer
- Custom Healthcare Systems, Inc.
- Category
- Medical Device — Surgical Gowns
- Affected units
- 7,200
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 (2)
- Lot numbers: W72018
- W71218 Exp Date:7/1/2021
Distribution
Part of a larger recall action
This product is one of 29 recalled by Custom Healthcare 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 29 products in this recall →Related recalls
Same manufacturer · Custom Healthcare Systems, Inc.
See all →- HighCustom Healthcare Systems Recalls Inpatient Dialysis Kits Due to Latex
FDA (Devices) · 2020-02-05
- HighCustom Healthcare Systems Recalls Penrose Drain Kits Due to Sterility Compromise
FDA (Devices) · 2018-10-31
- HighCustom Healthcare Systems Recalls Suture Removal Kits Due to Sterility Compromise
FDA (Devices) · 2018-10-31
- HighCustom Healthcare Systems Recalls Convenience Kits Due to Sterility Compromise
FDA (Devices) · 2018-10-31
- HighCHS Custom Convenience Kits Recalled for Sterility Compromise
FDA (Devices) · 2018-10-31
Same hazard · sterility compromise
See all →- ModerateAVID Medical Recalls Halyard IV Start Kits Due to Packaging Seal Issues
FDA (Devices) · 2026-09-30
- HighMedline Recalls Cataract Convenience Kits Due to Open Sterile Seals
FDA (Devices) · 2026-09-23
- HighMedline Myringotomy Kits Recalled for Potential Sterility Compromise
FDA (Devices) · 2026-09-23
- HighMedline Anesthesia Pain Kits Recalled for Potential Sterility Compromise
FDA (Devices) · 2026-09-23
- HighMaquet Percutaneous Insertion Kit Recalled for Sterile Barrier Integrity Issues
FDA (Devices) · 2026-09-23
Similar recalls
- SevereCustomed Recalls Surgical Gowns Due to Compromised Sterility
FDA (Devices) · 2014-12-10
- SevereCustomed Surgeon Gowns Recalled Due to Compromised Sterility and Contamination Risk
FDA (Devices) · 2014-12-10
- SevereCustomed Surgical Gowns Recalled Due to Compromised Sterility
FDA (Devices) · 2014-12-10
- SevereCustomed Surgical Gowns Recalled Due to Compromised Sterility and Contamination Risk
FDA (Devices) · 2014-12-10
- HighCardinal Health Surgical Gowns Recalled Due to Compromised Packaging Seals
FDA (Devices) · 2021-12-22
- SevereCustomed Dressing Change Kits Recalled for Compromised Sterility
FDA (Devices) · 2014-12-10