Customed Recalls Lithotomy Pack III Due to Potential Packaging Integrity Issues
Customed, Inc. is recalling Lithotomy Pack III surgical packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
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 agency classified this recall as Class I — 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. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility…"
Plain-English summary
Customed, Inc. is recalling Lithotomy Pack III (code 900-2487) surgical packs. The recall involves 300 packed units manufactured under the firm's control, with zero units distributed. The product is an EO sterilized surgical convenient pack packaged into a polyester/polyethylene breather bag with Tyvek double vents.
The recall was initiated because Customed determined there is a possibility that packaging integrity may be compromised on different catalog numbers and multiple lots. This defect could result in an injury to the patient due to product contamination or loss of sterility condition.
The affected products were distributed worldwide, including the United States (nationwide, specifically Florida, Puerto Rico, and USVI St. John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica, and Mexico. The specific lot number identified is 113078525. Consumers and healthcare facilities should stop using the affected products and contact the manufacturer for further instructions.
The recalled product
- Product
- Lithotomy Pack III (3), code 900-2487, contains: (3) TOWEL ABSORBENT 15" X 20" (1) GOWN LARGE STANDARD SMS VELCRO NECK (2) LEGGINS WITH 7" CUFF 30" X 42" (1) DRAPE UNDERBUTTOCK WITH POUCH 44" X 35" (1) DRAPE ABDOMINAL WITH TAPE 40" X 54" (1) DRAPE UTILITY WITH TAPE (1)…
- Manufacturer
- Customed, Inc
- Category
- Medical Device — Surgical Packs
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 (2)
- code 900-2487
- 1 lot: 113078525
Distribution
Part of a larger recall action
This product is one of 233 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 233 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 Davinci Trucustom Bundles 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
- ModerateAVID Medical Recalls GYN Laparoscopy Packs Due to Lubricant Contamination
FDA (Devices) · 2026-10-14
Similar recalls
- SevereCustomed Lithotomy Pack Recalled for Sterility and Contamination Risks
FDA (Devices) · 2014-12-10
- SevereCustomed Laparotomy Packs Recalled for Sterility and Contamination Risks
FDA (Devices) · 2014-12-10
- SevereCustomed Cystoscopy Pack III Recalled for Sterility Compromise
FDA (Devices) · 2014-12-10
- SevereCustomed Laparotomy Packs Recalled Due to Sterility Compromise
FDA (Devices) · 2014-12-10
- SevereCustomed Basic Pack 1 (III) Recalled for Sterility Compromise
FDA (Devices) · 2014-12-10
- SevereCustomed Liposuction Pack Recalled for Sterility Compromise and Contamination Risk
FDA (Devices) · 2014-12-10