Custom Medical Specialties Recalls Arthrogram Trays Due to Lack of Microbial Testing
Custom Medical Specialties is recalling CMS-2981-R3 Arthrogram Trays because the manufacturer did not perform microbial testing, causing the product to fail finished goods specifications.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 3/5 (High).
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 medical device with a risk of harm (lack of microbial testing) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Custom Medical Specialties, Inc. is recalling 15 cases of CMS-2981-R3 Arthrogram Trays. These trays contain a 2 oz. bottle of PVP Prep Solution. The recall was initiated after the firm observed an FDA website notice regarding a manufacturer recall caused by the absence of microbial testing.
The product did not meet proper finished goods specifications due to the lack of microbial testing at the manufacturer. The affected lots are identified by codes 14327-0902 and 19929-1006.
The product was distributed nationwide, including in Georgia, Michigan, New York, and Pennsylvania. Consumers and healthcare facilities should check for these specific lot codes and stop using the product if found.
The recalled product
- Product
- CMS-2981-R3 Arthrogram Tray containing 2 oz. bottle PVP Prep Solution CMS-2981-R3 Arthrogram Tray containing 2 oz. bottle PVP Prep Solution
- Manufacturer
- Custom Medical Specialties, Inc.
- Category
- Medical Device — Surgical Trays
- Hazard
- Affected units
- 15
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)
- 14327-0902
- 19929-1006
Distribution
Part of a larger recall action
This product is one of 4 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 4 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 Hysteroscopy Kits Due to Microbial Testing Failures
FDA (Devices) · 2012-09-26
- SevereCustom Vein Tray Recalled for Povidone Iodine Prep Solution Quality Issues
FDA (Devices) · 2012-09-26
- SevereCustom Medical Specialties Recalls CT Biopsy Trays with PVP Prep Solution
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
- SevereCustom Medical Specialties Recalls CT Biopsy Trays with PVP Prep Solution
FDA (Devices) · 2012-09-26
- SevereCustom Medical Specialties Recalls Amnio Trays with PVP Prep Solution
FDA (Devices) · 2012-09-26
- SevereCustom Medical Specialties Recalls Myelogram Trays with PVP Prep Solution
FDA (Devices) · 2012-09-26
- SevereCustom Medical Specialties Recalls HSG Trays with PVP Prep Solution
FDA (Devices) · 2012-09-26
- SevereCustom Vein Tray Recalled for Missing Microbial Testing
FDA (Devices) · 2012-09-26
- SevereCustom Medical Specialties Recalls HSG Trays with Povidone Iodine Prep Solution
FDA (Devices) · 2012-09-26