Customed Recalls Laparoscopy Chole 4/CS Due to Sterilization Validation Issues
Customed, Inc. is recalling specific lots of Laparoscopy Chole 4/CS in Puerto Rico because the sterilization processes and package integrity were not adequately validated.
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 medical device) where the hazard is theoretical due to inadequate sterilization validation, and no injuries or illnesses have been reported.
Plain-English summary
Customed, Inc. is recalling specific lots of the Laparoscopy Chole 4/CS medical device. This product is used by medical staff to perform surgical procedures and patient care procedures, such as wound healing, suture removals, and wound irrigation. The recall is limited to products distributed only in Puerto Rico.
The recall was initiated due to inadequate validation and qualification of sterilization processes, as well as package integrity issues for products released for distribution as sterile. The affected lots include 140915489, 141216336, 150318022, 150318023, 150418408, 150418407, 150418588, 150619282, and 150619370, with expiration dates ranging from October 31, 2015, to June 30, 2016.
Healthcare facilities and consumers in Puerto Rico should check their inventory for these specific lot numbers and stop using the affected products. The source text does not report any illnesses or injuries associated with this recall.
The recalled product
- Product
- LAPAROSCOPY CHOLE 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
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 →- SevereSteris VERIFY Biological Indicator Recall Due to Spore Population Concerns
FDA (Devices) · 2026-10-14
- HighSteris VERIFY Dual Species Biological Indicator Recall for Spore Population Issues
FDA (Devices) · 2026-10-14
- SevereSteris VERIFY Biological Steam Test Pack Recalled for Spore Population Defect
FDA (Devices) · 2026-10-14
- SevereSteris VERIFY Biological/Integrator Challenge Pack Recall for Spore Population Defect
FDA (Devices) · 2026-10-14
- SevereSteris Recalls VERIFY Biological Steam Test Packs Due to Spore Population Concerns
FDA (Devices) · 2026-10-14
Similar recalls
- HighCustomed Laparoscopy-Colorectal Surgical Packs Recalled for Sterilization Validation Issues
FDA (Devices) · 2016-04-20
- HighCustomed Laparoscopy 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 Cystoscopy Surgical Packs Recalled for Sterilization Validation Issues
FDA (Devices) · 2016-04-20
- SevereCustomed Laparoscopy Chole Pack Recalled for Sterility Compromise
FDA (Devices) · 2014-12-10
- HighCustomed Laparoscopy Surgical Pack Recalled for Sterilization Validation Issues
FDA (Devices) · 2016-04-20