Customed Pery-Gyn Surgical Packs Recalled for Sterilization Validation Issues
Customed, Inc. is recalling Pery-Gyn Surgical Packs 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 packs) 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 912 units of Pery-Gyn Surgical Packs (Code 900548A). 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 have expiration dates ranging from November 30, 2015, to June 30, 2016.
The products were distributed only in Puerto Rico. Medical facilities and consumers should stop using these products and contact the recalling firm for instructions on return or disposal.
The recalled product
- Product
- PERY-GYN SURGICAL PACK 6/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
- Affected units
- 912
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 →- HighOlympus Toomey Evacuator 50cc with Adaptor sterilization recall
FDA (Devices) · 2026-07-22
- 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 30cc medical device sterilization parameters recalled
FDA (Devices) · 2026-07-22