Customed Major Lap Pack Recalled for Sterility and Contamination Risks
Customed, Inc. is recalling 1,680 Major Lap Packs due to compromised sterility and manufacturing deficiencies that may cause patient infection.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class I, which mandates a minimum severity score of 4 per the rubric. The hazard involves compromised sterility and potential patient infection, which constitutes a serious health risk.
Plain-English summary
Customed, Inc. is recalling 1,680 units of the Major Lap Pack, Catalog number 900-404. These medical packs are used by staff for patient care procedures such as wound healing, suture removals, and wound irrigation. The affected lot numbers are 140513247, 140613834, 140714393, and 140814875.
The recall is due to significant compromised sterility, which is not limited to potentially damaged packaging. The FDA identified serious deficiencies in manufacturing processes and uncontrolled, inadequate storage conditions. These issues increase the risk of contamination and may result in patient infection.
The product was distributed in the United States to Florida, New York, and Puerto Rico. Medical facilities and consumers who have these specific lot numbers should stop using the product and contact the recalling firm for instructions.
The recalled product
- Product
- Major Lap Pack, Catalog number 900-404. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
- Manufacturer
- Customed, Inc
- Category
- Medical Device — Surgical Packs
- Hazard
- Affected units
- 1,680
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 numbers 140513247 140613834 140714393 140814875
Distribution
Part of a larger recall action
This product is one of 179 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 179 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 663 Surgical Convenience Kits Due to Contamination
FDA (Devices) · 2026-09-02
- HighMedline Recalls Gynecologic Robotic Surgery Kits Due to Contamination
FDA (Devices) · 2026-09-02
- HighMedline Recalls Neurosurgical Convenience Kits Due to Contamination
FDA (Devices) · 2026-09-02
- HighMedline recalls surgical convenience kits due to potential contamination
FDA (Devices) · 2026-09-02
- HighMedline Recalls 71 Convenience Kits Due to Contaminated Component
FDA (Devices) · 2026-09-02