Customed Recalls Breast Pack MRT Surgical Kits Due to Packaging Integrity Concerns
Customed, Inc. is recalling 306 units of Breast Pack MRT surgical kits because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk of harm (injury due to contamination or loss of sterility) in a medical device, but the source text does not report any actual illnesses or injuries, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Customed, Inc. is recalling 306 units of Breast Pack MRT surgical kits, code 900-2658. The recall involves three specific lots: 112062217, 112093595, and 112093720. These kits contain various surgical items, including bulb syringes, gowns, cautery pencils, syringes, needle counters, utility bowls, and drapes.
The recall was initiated because the company determined there is a possibility that the packaging integrity of these kits may be compromised. This defect could result in product contamination or a loss of sterility, which poses a risk of injury to patients. The affected products were distributed worldwide, including in the United States (nationwide, specifically Florida, Puerto Rico, and the US Virgin Islands) and in the countries of Tortola, Trinidad, Dominican Republic, Costa Rica, and Mexico.
Healthcare facilities and consumers who have these specific lots should stop using the products and contact Customed, Inc. for further instructions on how to return or dispose of the recalled items.
The recalled product
- Product
- Breast Pack MRT, code 900-2658, contains: ( 1) BULB SYRINGE 60cc (2) GOWN SOFT SMS STD XLGE SET IN SLEEVE ( 1) CAUTERY PENCIL PUSH BOTTOM (2) SYRINGE 10cc W/0 NEEDLE LUER LOCK ( 1) NEEDLE and BLADE COUNTER 20c FOAM/MAG ( 1) UTILITY BOWL QUART 32oz ( 1) MAYO STAND COVER REI
- Manufacturer
- Customed, Inc
- Category
- Medical Device — Surgical Kits
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 900-2658
- 3 lots 112062217 112093595 112093720
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 →- HighMedline Recalls Surgical Convenience Kits Due to Contaminated Components
FDA (Devices) · 2026-09-02
- HighMedline Recalls 263 Surgical Convenience Kits Due to Contamination
FDA (Devices) · 2026-09-02
- HighMedline Recalls 71 Convenience Kits Due to Contaminated Component
FDA (Devices) · 2026-09-02
- HighMedline C-Section Convenience Kits Recalled for Contaminated Components
FDA (Devices) · 2026-09-02
- HighMedline Recalls 419 Surgical Kits Due to Contaminated Component
FDA (Devices) · 2026-09-02