Customed Major Lap Pack Recalled for Sterilization Validation Issues
Customed, Inc. is recalling Major Lap Packs due to inadequate validation of sterilization processes and package integrity.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 is classified as FDA Class II. The hazard involves a risk-of-harm product (sterile surgical packs) where the failure of sterilization validation poses a risk of infection, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Customed, Inc. is recalling 2,736 units of Major Lap Packs (Code 900404) that were distributed in Puerto Rico. These medical device packs 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 the sterilization processes and package integrity for the products released for distribution as sterile. The affected lots have expiration dates ranging from October 31, 2015, to June 30, 2016.
Healthcare facilities and consumers who possess these specific lots should stop using the products and contact the recalling firm for further instructions.
The recalled product
- Product
- MAJOR LAP PACK 4/CS 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
- 2,736
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 failure
See all →- HighBayer Medical Care Recalls Stellant FLEX Syringe Kits Due to Sterilization Issues
FDA (Devices) · 2026-09-23
- HighOlympus Glass Body for 194 Ellik Evacuator Model 190A Sterilization Recall
FDA (Devices) · 2026-07-22
- HighVasoview Hemopro 2 Endoscopic Vessel Harvesting System Recall
FDA (Devices) · 2026-07-22
- SevereOlympus Ellik Evacuator Recalled for Inadequate Sterilization Risk
FDA (Devices) · 2026-07-22
- HighOlympus Toomey Evacuator 50cc with Adaptor sterilization recall
FDA (Devices) · 2026-07-22
Similar recalls
- SevereCustomed Major Lap Pack Recalled for Sterility and Contamination Risks
FDA (Devices) · 2014-12-10
- HighCustomed Basic Surgical Pack IV Recalled for Sterilization Validation Issues
FDA (Devices) · 2016-04-20
- HighCustomed Basic Surgical Pack Recalled for Sterilization Validation Issues
FDA (Devices) · 2016-04-20
- HighCustomed Premium Laparotomy Pack Recalled for Sterilization Validation Issues
FDA (Devices) · 2016-04-20
- HighCustomed Lap-Cholecystectomy Surgical Packs Recalled for Sterilization Validation Issues
FDA (Devices) · 2016-04-20
- HighCustomed Basic Surgical Packs Recalled for Sterilization Validation Defects
FDA (Devices) · 2016-04-20