Customed Recalls Face Pack BOD Due to Potential Packaging Integrity Issues
Customed, Inc. is recalling Face Pack BOD units 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 Face Pack BOD, code 900-3027, due to a potential compromise in packaging integrity. The recall affects 12 units from lot 113099552. The product consists of EO sterilized surgical convenient packs packaged in polyester/polyethylene breather bags with Tyvek double vents.
The recall was initiated because the compromised packaging could result in product contamination or a loss of sterility condition. This poses a risk of injury to patients using the medical devices.
The affected units were distributed worldwide, including nationwide in the United States (specifically Florida, Puerto Rico, and the US Virgin Islands) and in the countries of Tortola, Trinidad, Dominican Republic, Costa Rica, and Mexico. Users should stop using the affected products and contact the manufacturer for further instructions.
The recalled product
- Product
- Face Pack- BOD, code 900-3027, contains: (2) GOWN XL SMS IMPERVIOUS REINFORCED AAMI Ill (2) TOWELS ABSORBENT 15" X 20" (1 ) DRAPE INSTRUMENT MAGNETIC 10" X 16" (1 ) TRAY HALF DEEP (1) COUNTER NEEDLE/BLADE 20C FOAM/MAG (1) COVER MAYO STAND REINFORCED (1 ) SHEET ENT SPLIT…
- 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)
- 900-3027
- 1 lot: 113099552
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 →- SevereSpectrum Medical Recalls Quantum PureFlow Heat Exchangers Due to Leak Risk
FDA (Devices) · 2026-10-07
- SevereSpectrum Medical Recalls Quantum PureFlow Heat Exchangers Due to Leak Risk
FDA (Devices) · 2026-10-07
- ModerateBaxter Recalls Two VOLARA Systems Due to Potential Flow Rate Inaccuracy
FDA (Devices) · 2026-09-30
- HighICU Medical Recalls IV Sets with Potential Drip Chamber Discoloration
FDA (Devices) · 2026-09-23
- HighMedline Recalls Minor Pack Convenience Kits Due to Open Sterile Seals
FDA (Devices) · 2026-09-23
Similar recalls
- SevereCustomed Liposuction Pack Recalled for Sterility Compromise and Contamination Risk
FDA (Devices) · 2014-12-10
- SevereCustomed Shoulder Pack Recalled Due to Sterility Compromise and Contamination Risk
FDA (Devices) · 2014-12-10
- SevereCustomed Liposuction Pack Recalled for Sterility and Contamination Risks
FDA (Devices) · 2014-12-10
- SevereCustomed OB Packs Recalled Due to Sterility and Contamination Risks
FDA (Devices) · 2014-12-10
- SevereCustomed Basic Pack 1 (III) Recalled for Sterility Compromise
FDA (Devices) · 2014-12-10
- SevereCustomed Ophthalmic Packs Recalled Due to Compromised Sterility
FDA (Devices) · 2014-12-10