Customed Recalls Breast Surgical Packs Due to Potential Sterility Loss
Customed is recalling breast 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 the Breast pack TPSC, code 900-3431. This product is an EO sterilized surgical convenient pack packaged into a polyester/polyethylene breather bag with Tyvek double vents. The recall involves one lot (140513333) containing 45 units.
The recall was initiated because Customed determined there is a possibility that packaging integrity may be compromised. 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 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. The source text does not specify specific instructions for consumers or healthcare providers regarding the handling of these units.
The recalled product
- Product
- Breast pack TPSC, code 900-3431, contains: (1) GOWN LARGE STANDARD SMS AAMIIII (1) GOWN SOFT SMS STD. X-LARGE AAMIIII (4) TOWELS ABSORBENT 15" X 20" LIF (1) PENCIL CAUTERY PUSH BOTTOM LIF (1) SYRINGE 60ML LUER LOCK WITHOUT NEEDLE L/F (1) TUBE SUCTION CONNECT X" X 12' LIF…
- 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)
- 900-3431
- 1 lot: 140513333
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 · loss of sterility
See all →- ModerateIntramedullary Bone Saw Blade Assembly Recalled Due to Potential Packaging Damage
FDA (Devices) · 2026-08-12
- HighDaig Livewire Steerable Reprocessed Electrophysiology Catheter Recall
FDA (Devices) · 2026-05-20
- HighMedihoney Calcium Alginate Dressings Recalled Due to Potential Sterile Barrier Breach
FDA (Devices) · 2026-02-25
- SevereChloraPrep One-Step Applicators Recalled Due to Compromised Sterile Packaging
FDA (Drugs) · 2025-05-28
- HighProxima Drape sterile drapes recalled for potential packaging breach risk
FDA (Devices) · 2025-03-26
Similar recalls
- SevereCustomed Breat Pack-TPSC Recalled for Sterility Compromise and Contamination Risk
FDA (Devices) · 2014-12-10
- SevereCustomed Breast Packs Recalled Due to Sterility Compromise and Contamination Risk
FDA (Devices) · 2014-12-10
- HighCustomed Breast Pack Recall Due to Sterilization Validation Issues
FDA (Devices) · 2015-09-09
- ModerateCustomed Breast Packs Recalled for Sterilization Validation Deficiencies
FDA (Devices) · 2015-09-09
- SevereCustomed Liposuction Pack Recalled for Sterility Compromise and Contamination Risk
FDA (Devices) · 2014-12-10
- SevereCustomed Laparoscopy Gyn Pack Recalled for Sterility Compromise
FDA (Devices) · 2014-12-10