Customed Laparoscopic Gynecology Surgical Packs Recalled for Sterilization Issues
Customed, Inc. is recalling 30 units of Laparoscopic Gynecology Surgical Packs due to inadequate sterilization validation and package integrity concerns.
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 risk-of-harm product (sterile surgical pack) where the hazard is theoretical due to inadequate sterilization validation, and no injuries or illnesses have been reported in the source text.
Plain-English summary
Customed, Inc. is recalling 30 units of Catalog Number 900484 Laparoscopic Gynecology 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 are SL15203 (150719885) with a date of 31-JUL-16 and SL15271 (150920829) with a date of 30-SEP-16.
The products were distributed only in Puerto Rico. Medical facilities and consumers who have these specific lots should stop using them and contact the recalling firm for instructions on return or disposal.
The recalled product
- Product
- Catalog Number: 900484 LAPAROSCOPIC GYNECOLOGY 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
- 30
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)
- LOTS: SL15203 (150719885) 31-JUL-16 SL15271 (150920829) 30-SEP-16
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
- SevereCustomed Recalls Laparoscopy-Gyn Surgical Packs Due to Sterilization Issues
FDA (Devices) · 2015-09-09
- HighCustomed Laparoscopy Packs Recalled for Sterilization Validation Issues
FDA (Devices) · 2015-09-09
- HighCustomed Laparotomy Surgical Packs Recalled for Sterilization Validation Issues
FDA (Devices) · 2015-09-09
- HighCustomed Laparoscopy-Colorectal Surgical Packs Recalled for Sterilization Issues
FDA (Devices) · 2015-09-09
- HighCustomed Laparotomy Packs Recalled for Sterilization Validation Deficiencies
FDA (Devices) · 2015-09-09
- HighCustomed Laparotomy Packs Recalled for Sterilization Validation Issues
FDA (Devices) · 2015-09-09