MEDLINE procedural trays recalled for potential sterile packaging breach
MEDLINE is recalling procedural trays because sterile blades within the kits could puncture the outer foil packaging, potentially breaching the sterile barrier.
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: This is a Class II medical device recall involving a risk-of-harm product where injury has not yet been reported. The potential for compromised sterile packaging in medical devices presents a theoretical but significant contamination risk during procedures, warranting a High severity classification per the rubric.
Plain-English summary
MEDLINE INDUSTRIES, LP is recalling non-sterile procedural trays labeled as CRANI (Item Number DYNJ900413P, Lot Number 22JDB689). The recall affects 12 cases containing 24 units distributed nationwide in Arkansas, Maryland, Washington, and Wisconsin.
The recalled kits contain sterile blades that could potentially puncture the outer foil packaging, causing a breach in the sterile barrier. The FDA classified this as a Class II recall.
The recalled product
- Product
- Non-sterile procedural trays labeled as CRANI, 2 per case
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
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 (4)
- Item Number: DYNJ900413P
- UDI/GTIN Case: 40195327031665
- UDI/GTIN Each: 40195327031665
- Lot Number: 22JDB689
Distribution
Part of a larger recall action
This product is one of 7 recalled by MEDLINE INDUSTRIES, LP - Northfield 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 7 products in this recall →Related recalls
Same manufacturer · MEDLINE INDUSTRIES, LP - Northfield
See all →- CriticalIntubation trays recalled after laryngoscope handle lights failed to illuminate
FDA (Devices) · 2025-10-01
- SevereMedline Medical Convenience Kits with Defective Laryngoscope Handles
FDA (Devices) · 2025-10-01
- HighGood Neighbor alcohol prep pads recalled for alcohol below labeled concentration
FDA (Drugs) · 2025-09-03
- HighSurgical kits recalled because Foley tray inserts carry incorrect product information
FDA (Devices) · 2025-09-03
- HighSurgery trays recalled because they contain recalled tourniquet cuffs
FDA (Devices) · 2025-09-03
Same hazard · sterile packaging breach
See all →- HighCenturion Sterile Weitlaner Retractor recalled for sterile packaging puncture risk
FDA (Devices) · 2025-05-21
- HighTriathlon TS Plus tibial inserts recalled for potential packaging breaches
FDA (Devices) · 2024-03-13
- HighBlade Puncture Risk in Femoral Artery Sterile Procedural Trays
FDA (Devices) · 2023-02-15
- HighProcedural trays recalled for potential sterile packaging breach
FDA (Devices) · 2023-02-08
- HighMedline CISION Sterile Surgical Blades Recalled for Sterile Packaging Breach Risk
FDA (Devices) · 2023-01-18