Customed Recalls Cesarean Packs Due to Potential Packaging Integrity Issues
Customed is recalling 1,095 units of EO sterilized Cesarean Packs because packaging integrity may be compromised, potentially leading to loss of sterility and patient injury.
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 20 lots of EO sterilized Cesarean Packs, totaling 1,095 units. The recall is due to a determination that packaging integrity may be compromised on different catalog numbers. The affected product is a surgical convenient pack packaged into a polyester/polyethylene breather bag with Tyvek double vents.
The compromised packaging integrity could result in product contamination or a loss of sterility condition, which poses a risk of injury to the patient. The recall covers 20 specific lots, including lot numbers 111113026, 111123373, and 140513464, among others.
The affected products 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 check their inventory for the specific lot numbers listed in the recall notice and stop using any affected units.
The recalled product
- Product
- CESAREAN PACK - (1) BABY BLANKET IMP. 30" X 30" POLY ABS. (1) NEEDLE & BLADE COUNTER 60c FOAM/STRIP MAG/STRIP LIF (1) DRESSING ISLAND 4" x 10" (1) CESAREAN DRAPE 71" x 125" LIF (2) GOWN SURG REINFORCED LARGE TOWEL/WRAP (10) LAP SPONGES PREWASH XRD LIF (1) BABY BEANNIES…
- 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 (1)
- Product code 900-1689
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 Cesarean Pack Recalled Due to Compromised Sterility and Contamination Risk
FDA (Devices) · 2014-12-10
- SevereCustomed Cesarean Packs Recalled Due to Compromised Sterility
FDA (Devices) · 2014-12-10
- SevereCustomed Cesarean Pack Recalled Due to Sterility and Contamination Risks
FDA (Devices) · 2014-12-10
- SevereCustomed Cesarean Pack Recalled for Sterility and Contamination Risks
FDA (Devices) · 2014-12-10
- SevereCustomed Cesarean Packs Recalled Due to Compromised Sterility and Contamination Risk
FDA (Devices) · 2014-12-10
- SevereCustomed Premium Cesarean Pack Recalled Due to Compromised Sterility
FDA (Devices) · 2014-12-10