Custom Healthcare Systems Recalls Foerster Sponge Forceps Kits Due to Sterility Compromise
Custom Healthcare Systems is recalling 50 units of Foerster Sponge Forceps kits because incorrect sealing specifications compromised product sterility.
What this means for you
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 involves a medical device where sterility was compromised, creating a risk of infection. This fits the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Custom Healthcare Systems, Inc. is recalling 50 units of CHS Custom Convenience Kit-FOERSTER SPONGE FORCEPS, SERR, ST (9.5) (Product Number D36-14623). The recall was initiated because the convenience kits were sealed in immediate Tyvek pouches using incorrect specifications, which compromised the sterility of the product.
The affected units are identified by Lot number 52418 and have an expiration date of 5/1/2021. The products were distributed to facilities in Connecticut, Georgia, Kentucky, North Carolina, Virginia, Maryland, Oklahoma, Illinois, and South Carolina.
Healthcare facilities should stop using the affected products and contact Custom Healthcare Systems, Inc. for further instructions regarding the recall.
The recalled product
- Product
- CHS Custom Convenience Kit-FOERSTER SPONGE FORCEPS, SERR, ST (9.5 ) Product Number:-D36-14623
- Manufacturer
- Custom Healthcare Systems, Inc.
- Affected units
- 50
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 (1)
- Lot number: 52418 Exp. Date: 5/1/2021
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 →- SevereSpectra Medical Devices Recalls Sodium Chloride Injection Ampules Due to Sterility Concerns
FDA (Devices) · 2026-08-19
- HighStryker Recalls Ahto Dual Spike Tube Set Due to Leaking Handpiece
FDA (Devices) · 2026-08-12
- HighIntramedullary Bone Saw Blade Assembly Recalled Due to Potential Sterile Barrier Damage
FDA (Devices) · 2026-08-12
- ModerateIntramedullary Bone Saw Blade Assembly Recalled Due to Potential Sterile Barrier Damage
FDA (Devices) · 2026-08-12
- HighIntramedullary Bone Saw Blade Assemblies Recalled Due to Potential Packaging Damage
FDA (Devices) · 2026-08-12