Centurion PT225 Pain Management Tray Recalled for Incomplete Seals
Centurion Medical Products Corporation is recalling 420 PT225 Pain Management Trays due to incomplete seals that may compromise sterility.
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 where a defect (incomplete seals) may compromise sterility, posing a risk of infection. This fits the 'High' severity criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Centurion Medical Products Corporation is recalling 420 units of the PT225 Pain Management Tray. The recall was initiated because incomplete seals on the sterile package may compromise the sterility of the product.
The affected units are identified by Lot Number 2019021490. The product was distributed nationwide and in Ghana.
Consumers and healthcare facilities should stop using the recalled trays and contact Centurion Medical Products Corporation for further instructions.
The recalled product
- Product
- Centurion- PT225 PAIN MANAGEMENT TRAY
- Manufacturer
- Centurion Medical Products Corporation
- Category
- Medical Device — Surgical Trays
- Hazard
- Affected units
- 420
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)
- Lot Number: 2019021490
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 54 recalled by Centurion Medical Products Corporation 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 54 products in this recall →Related recalls
Same manufacturer · Centurion Medical Products Corporation
See all →- HighCenturion Difficult IV Kit Recalled for False Carboxyhemoglobin Results
FDA (Devices) · 2020-07-15
- HighCenturion ENT Snuffer Kit Recalled for Incomplete Sterile Package Seals
FDA (Devices) · 2020-02-12
- HighCenturion Chest Tube Trays Recalled for Incomplete Package Seals
FDA (Devices) · 2020-02-12
- HighCenturion Medical Products Recalls Sterile Pitcher Kits Due to Seal Defects
FDA (Devices) · 2020-02-12
- HighCenturion Medical Products Recalls Sterile Hyperalimentation and Dressing Change Trays
FDA (Devices) · 2020-02-12
Same hazard · sterility compromise
See all →- ModerateAVID Medical Recalls Halyard IV Start Kits Due to Packaging Seal Issues
FDA (Devices) · 2026-09-30
- HighMedline Recalls Cataract Convenience Kits Due to Open Sterile Seals
FDA (Devices) · 2026-09-23
- HighMedline Myringotomy Kits Recalled for Potential Sterility Compromise
FDA (Devices) · 2026-09-23
- HighMedline Anesthesia Pain Kits Recalled for Potential Sterility Compromise
FDA (Devices) · 2026-09-23
- HighMaquet Percutaneous Insertion Kit Recalled for Sterile Barrier Integrity Issues
FDA (Devices) · 2026-09-23
Similar recalls
- HighCenturion Medical Recalls Circumcision Trays Due to Sterile Packaging Concerns
FDA (Devices) · 2019-08-14
- HighCenturion Medical Recalls Suture Trays Due to Sterile Packaging Concerns
FDA (Devices) · 2019-08-14
- HighCenturion Laceration Tray Kits Recalled for Potential Sterile Packaging Compromise
FDA (Devices) · 2019-08-14
- HighCenturion Medical Recalls Driveline Management Tray Kits Due to Packaging Risk
FDA (Devices) · 2019-08-14
- HighMedline Centurion Medical Procedure Kits Recalled for Sterility Risk
FDA (Devices) · 2024-10-30
- HighCenturion Medical Recalls Circumcision Kits Due to Sterile Packaging Concerns
FDA (Devices) · 2019-08-14