Customed Recalls Surgical Gown Packs Due to Packaging Integrity Concerns
Customed, Inc. is recalling EO sterilized surgical gown packs because packaging integrity may be compromised, potentially leading to product contamination or loss of 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 risk-of-harm product (loss of sterility/contamination) where injury has not yet been reported, aligning with the 'High' severity criteria for theoretical hazards without confirmed illness.
Plain-English summary
Customed, Inc. is recalling 1,500 units of Gown Surgical Soft SMS Non Reinforced, code 900-2725. The product consists of EO sterilized surgical convenient packs containing a gown, towel, and wrapper, packaged in a polyester/polyethylene breather bag with Tyvek double vents. The recall involves two specific lots with codes 112093989 and 113057519.
The recall was initiated because Customed determined that packaging integrity may be compromised on different catalog numbers. This defect could result in product contamination or a loss of sterility condition, which poses a risk of injury to patients.
The affected products were distributed worldwide, including nationwide in the United States (specifically Florida, Puerto Rico, and the US Virgin Islands) and in the countries of Tortola, Trinidad, Dominican Republic, Costa Rica, and Mexico. Users should stop using the affected lots and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- Gown Surgical Soft SMS Non Reinforced, code 900-2725, contains: (1) GOWN SOFT SMS STD X-LARGE SET IN SLEEVE (1) TOWEL ABSORBENT 15" X 20" (1) WRAPPER 24" X 24" Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek
- Manufacturer
- Customed, Inc
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)
- Code 900-2725: 2 lots 112093989 113057519
Distribution
Part of a larger recall action
This product is one of 233 recalled by Customed, 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 233 products in this recall →Related recalls
Same manufacturer · Customed, Inc
See all →- HighCustomed Arthroscopy Surgical Packs Recalled for Sterilization Validation Issues
FDA (Devices) · 2016-04-20
- HighCustomed Laparotomy Surgical Packs Recalled for Sterilization Validation Issues
FDA (Devices) · 2016-04-20
- HighCustomed Femoral Surgical Pack Recalled for Sterilization Validation Issues
FDA (Devices) · 2016-04-20
- HighCustomed Cystoscopy Surgical Packs Recalled for Sterilization Validation Issues
FDA (Devices) · 2016-04-20
- HighCustomed Basic Surgical Pack IV Recalled for Sterilization Validation Issues
FDA (Devices) · 2016-04-20
Same hazard · loss of sterility
See all →- ModerateIntramedullary Bone Saw Blade Assembly Recalled Due to Potential Packaging Damage
FDA (Devices) · 2026-08-12
- HighDaig Livewire Steerable Reprocessed Electrophysiology Catheter Recall
FDA (Devices) · 2026-05-20
- HighMedihoney Calcium Alginate Dressings Recalled Due to Potential Sterile Barrier Breach
FDA (Devices) · 2026-02-25
- SevereChloraPrep One-Step Applicators Recalled Due to Compromised Sterile Packaging
FDA (Drugs) · 2025-05-28
- HighProxima Drape sterile drapes recalled for potential packaging breach risk
FDA (Devices) · 2025-03-26