Custom Medical Specialties Recalls Amnio Trays with PVP Prep Solution
Custom Medical Specialties is recalling CMS-2586 Custom Amnio Trays containing PVP Prep Solution because the product lacked microbial testing and did not meet finished goods specifications.
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 classification is Class I, which mandates a minimum severity score of 4 according to the rubric.
Plain-English summary
Custom Medical Specialties, Inc. is recalling 7 cases of CMS-2586 Custom Amnio Trays containing a 2 oz. bottle of PVP Prep Solution. The product is used for skin preparation. The recall was initiated after the firm observed an FDA website notice regarding a recall of the Povidone Iodine Prep Solution component due to a lack of microbial testing and failure to meet proper finished goods specifications.
The affected products were distributed nationwide, including in Colorado, Florida, Kansas, Massachusetts, Michigan, New Jersey, and Pennsylvania. The specific lot codes involved are 20144-1006 and 19702-1005.
Healthcare facilities and consumers should stop using the affected trays and contact Custom Medical Specialties, Inc. for instructions on returning the product or obtaining a replacement.
The recalled product
- Product
- CMS-2586 Custom Amnio Tray containing 2 oz. bottle PVP Prep Solution Product Usage: Usage: The PVP contained in the kit is used in skin prep
- Manufacturer
- Custom Medical Specialties, Inc.
- Category
- Medical Device — Surgical Trays
- Affected units
- 7
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)
- 20144-1006
- 19702-1005
Distribution
Part of a larger recall action
This product is one of 12 recalled by Custom Medical Specialties, 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 12 products in this recall →Related recalls
Same manufacturer · Custom Medical Specialties, Inc.
See all →- HighCustom Medical Specialties Recalls Biopsy Trays with Syringes Due to Sterility Concerns
FDA (Devices) · 2017-03-01
- HighCustom Medical Specialties Recalls Ultrasound Probe Covers for Missing Endotoxin Testing
FDA (Devices) · 2014-02-19
- SevereCustom Medical Specialties Recalls HSG Trays with PVP Prep Solution
FDA (Devices) · 2012-09-26
- SevereCustom Medical Specialties Recalls CT Biopsy Trays with PVP Prep Solution
FDA (Devices) · 2012-09-26
- SevereCustom Vein Tray Recalled for Povidone Iodine Prep Solution Quality Issues
FDA (Devices) · 2012-09-26
Same hazard · microbial contamination
See all →- HighSV Labs Recalls Benzoyl Peroxide Wash Due to Microbial Contamination
FDA (Drugs) · 2026-10-07
- HighSV Labs Recalls Benzoyl Peroxide Wash Due to Microbial Contamination
FDA (Drugs) · 2026-10-07
- SevereMedline Ultrasound Breast Pack Recalled for Potential Sterility Breach
FDA (Devices) · 2026-09-09
- HighMedline Convenience Kits Recalled for Potential Sterility Breach
FDA (Devices) · 2026-09-09
- CriticalOptimal Balance Pharmacy Recalls Contaminated Glutathione Injection Vials
FDA (Drugs) · 2026-09-09
Similar recalls
- HighCustom Medical Specialties Recalls CMS-2890 Needle Local Trays
FDA (Devices) · 2012-09-19
- HighCustom Medical Specialties Recalls PVP Prep Solution Due to Lack of Microbial Testing
FDA (Devices) · 2012-09-19
- HighCustom Medical Specialties Recalls Arthrogram Trays Due to Lack of Microbial Testing
FDA (Devices) · 2012-09-19
- HighCustom Medical Specialties Recalls Cysto Pack Due to Missing Microbial Testing
FDA (Devices) · 2012-09-19
- HighCustom Breast Biopsy Tray Recalled for Potential Particulate Matter
FDA (Devices) · 2013-02-13
- ModerateCenturion Medical Products Recalls Circumcision Trays Due to Iodine Levels
FDA (Devices) · 2018-03-28