Customed Recalls PERl GYN PACK Surgical Kits Due to Packaging Integrity Concerns
Customed, Inc. is recalling PERl GYN PACK surgical kits 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, fitting the High severity criteria.
Plain-English summary
Customed, Inc. is recalling one lot of PERl GYN PACK surgical kits, product code 900-1871, lot number 111072025. The recall involves 12 units of these EO sterilized surgical convenient packs, which contain various medical supplies including towels, drapes, gauze sponges, a catheter, and gowns.
The recall was initiated because Customed determined there is a possibility that the packaging integrity may be compromised. 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 in the United States (nationwide, specifically Florida, Puerto Rico, and USVI) and in the countries of Tortola, Trinidad, Dominican Republic, Costa Rica, and Mexico.
Healthcare facilities and consumers who have these specific surgical kits should stop using them immediately and contact Customed, Inc. for further instructions on how to return or dispose of the product.
The recalled product
- Product
- PERl GYN PACK - (1) TOWEL NON ABS. W/TAPE L/Free (1) DRAPE UNDERBUTTOCK W/POUCH (2) TOWELS ABSORBENT L/Free (2) LEGGINGS W/7" CUFF (1) DRAPE TOP WI ADHESIVE (1) TABLE COVER REINF. L/Free (10) GAUZE SPONGE 4" X 4" 16PLY XRD LIF (1) CATHETER 14FR ROBIN NELAT PVC (2) GOWN L
- Manufacturer
- Customed, Inc
- Category
- Medical Device — Surgical Kits
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)
- Product code 900-1871
- 1 lots: 111072025
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 · contamination
See all →- HighMedline Recalls Surgical Convenience Kits Due to Contaminated Components
FDA (Devices) · 2026-09-02
- HighMedline Recalls 263 Surgical Convenience Kits Due to Contamination
FDA (Devices) · 2026-09-02
- HighMedline Recalls 71 Convenience Kits Due to Contaminated Component
FDA (Devices) · 2026-09-02
- HighMedline C-Section Convenience Kits Recalled for Contaminated Components
FDA (Devices) · 2026-09-02
- HighMedline Recalls 419 Surgical Kits Due to Contaminated Component
FDA (Devices) · 2026-09-02