Customed Fanfold Drape Recalled for Sterility and Contamination Risks
Customed, Inc. is recalling 6,300 Fanfold Drapes due to compromised sterility and manufacturing deficiencies that may cause patient infection.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The source text explicitly states that the deficiencies 'may result in patient infection,' which constitutes a significant injury risk under the rubric for Severe (4) recalls.
Plain-English summary
Customed, Inc. is recalling 6,300 units of the Fanfold Drape, Catalog number 900-633. This medical device is used by medical staff to perform patient care procedures such as wound healing, suture removals, and wound irrigation.
The recall is due to significant compromised sterility, which is not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.
The affected products were distributed in the United States to Florida, New York, and Puerto Rico. The specific lot numbers involved are 140513350, 140613841, 140714395, 140814959, and 140815096. Healthcare facilities and consumers should stop using these products and contact the recalling firm for instructions.
The recalled product
- Product
- Fanfold Drape, Catalog number 900-633. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
- Manufacturer
- Customed, Inc
- Category
- Medical Device — Surgical Drapes
- Hazard
- Affected units
- 6,300
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)
- Lot numbers 140513350 140613841 140714395 140814959 140815096
Distribution
Part of a larger recall action
This product is one of 179 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 179 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 · contamination
See all →- SevereFDA Recalls Tirzepatide/Cyanocobalamin Injectable Due to Sterility Concerns
FDA (Drugs) · 2026-10-14
- ModerateAVID Medical Recalls 15 Laparoscopic Prostatectomy Kits for Lubricant Contamination
FDA (Devices) · 2026-10-14
- ModerateAVID Medical Recalls 23 ABD Hysterectomy Kits Due to Lubricant Contamination
FDA (Devices) · 2026-10-14
- SevereFDA Recalls Semaglutide/Cyanocobalamin Injectable Due to Sterility Concerns
FDA (Drugs) · 2026-10-14
- ModerateAVID Medical Recalls GYN Laparoscopy Kits for Potential Lubricant Contamination
FDA (Devices) · 2026-10-14
Similar recalls
- HighCustomed Fanfold Drapes Recalled for Sterilization Process Validation Issues
FDA (Devices) · 2015-09-09
- CriticalCustomed Fanfold Drapes Recalled for Potential Packaging Integrity Compromise
FDA (Devices) · 2014-09-10
- HighCustomed Utility Drapes Recalled for Sterilization Validation Issues
FDA (Devices) · 2015-09-09
- HighCustomed Fan Fold Sheets Recalled for Sterilization Validation Issues
FDA (Devices) · 2016-04-20
- HighCustomed Utility Drapes Recalled for Sterilization Validation Deficiencies
FDA (Devices) · 2016-04-20
- CriticalCustomed Recalls Central Line Full Body Drapes Due to Packaging Integrity Concerns
FDA (Devices) · 2014-09-10