Customed Laminectomy Pack Recalled for Sterilization Validation Deficiencies
Customed, Inc. is recalling Laminectomy Pack 3/C units in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
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 pack) where the hazard is theoretical (inadequate sterilization validation) and no injuries or illnesses have been reported.
Plain-English summary
Customed, Inc. is recalling Laminectomy Pack 3/C units distributed in Puerto Rico. These sterile surgical packs are used by medical staff to perform 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 include 140914968, 141015767, 141115973, and 150116516, with expiration dates ranging from October 31, 2015, to December 31, 2015.
The source text does not specify the number of units affected or report any illnesses or injuries. Consumers and medical facilities should stop using these specific lots and contact the manufacturer or their supplier for instructions on return or replacement.
The recalled product
- Product
- LAMINECTOMY PACK 3/C 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
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 170 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 170 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 →- SevereMedline Convenience Kits recalled for potential sterility assurance defects
FDA (Devices) · 2026-05-13
- ModerateMedline Burn Care Kits Recalled Due to Sterilization Calibration Issues
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