Customed Cesarean Section Surgical Packs Recalled for Sterilization Defects
Customed, Inc. is recalling 96 Cesarean Section Surgical Packs due to inadequate sterilization validation and package integrity issues.
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 (sterile surgical packs) where injury has not yet been reported, fitting the High severity criteria for theoretical hazards.
Plain-English summary
Customed, Inc. is recalling 96 units of Catalog Number 900410 Cesarean Section Surgical Packs. These products are used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, and wound irrigation.
The recall was initiated because of inadequate validation and qualification of sterilization processes, as well as package integrity issues for products released for distribution as sterile. The affected lots were distributed only in Puerto Rico.
Healthcare facilities and consumers should stop using these products and contact the recalling firm for further instructions.
The recalled product
- Product
- Catalog Number: 900410 CESAREAN SECTION SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
- Manufacturer
- Customed, Inc
- Category
- Medical Device — Surgical Packs
- Affected units
- 96
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 100 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 100 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 · sterilization defect
See all →- ModerateMedline Burn Care Kits Recalled Due to Sterilization Calibration Issues
FDA (Devices) · 2026-05-13
- SevereMedline Convenience Kits recalled for potential sterility assurance defects
FDA (Devices) · 2026-05-13
- HighMedline PPE Kit recalled for sterilization calibration issues
FDA (Devices) · 2026-05-13
- SevereMedline Convenience Kits recalled for potential sterilization issues
FDA (Devices) · 2026-05-13
- HighMedline Convenience Kits recalled due to sterilization equipment calibration issues
FDA (Devices) · 2026-05-13