Customed Liver and Pancreas Surgery Kits Recalled for Sterilization Issues
Customed, Inc. is recalling 20 liver and pancreas surgery kits 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 involves a medical device with a risk of harm due to potential lack of sterility, but the source text does not report any illnesses or injuries, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Customed, Inc. is recalling 20 units of Catalog Number 9001966 Liver & Pancreas Surgery kits. These products are used by medical staff to perform surgical procedures and patient care procedures, including 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 that were released for distribution as sterile. The affected lots are SL15195-01, SL15210, SL15211, SL15223, SL15224, and SL15275, with distribution dates ranging from July 31, 2016, to September 30, 2016.
The products were distributed only in Puerto Rico. Medical facilities and consumers should stop using these specific kits and contact the recalling firm for further instructions.
The recalled product
- Product
- Catalog Number: 9001966 LIVER & PANCREAS SURGERY 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 Kits
- Affected units
- 20
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 · infection
See all →- SevereSafeguard US Operating LLC Recalls Compression Bandages Due to Degradation
FDA (Devices) · 2026-10-14
- SevereStryker Bard EP XT Decapolar Steerable Diagnostic EP Catheter Recalled for Sterile Barrier Breach
FDA (Devices) · 2026-10-14
- HighEmbosphere Microspheres Recalled Due to Packaging Sterility Concerns
FDA (Devices) · 2026-10-07
- SevereAurolab Trust Recalls FOCUS PI Eye Drops Due to Sterility Concerns
FDA (Drugs) · 2026-10-07
- HighFDA Recalls Defective Blue Nitrile Patient Examination Gloves
FDA (Devices) · 2026-10-07
Similar recalls
- HighCustomed Laparotomy Kits Recalled for Sterilization Process Validation Issues
FDA (Devices) · 2015-09-09
- HighCustomed Labor and Delivery Kits Recalled for Sterilization Validation Issues
FDA (Devices) · 2015-09-09
- HighCustomed Labor and Delivery Kits Recalled for Sterilization Defects
FDA (Devices) · 2015-09-09
- HighCustomed Laparoscopy Kits Recalled for Sterilization Validation Defects
FDA (Devices) · 2015-09-09
- HighCustomed Recalls Sterile Surgical Kits Due to Sterilization Validation Issues
FDA (Devices) · 2015-09-09
- SevereCustomed Curations Kits Recalled Due to Sterilization Validation Issues
FDA (Devices) · 2015-09-09