Sterile Trach Pack procedure kits recalled due to blade puncture risk
Medline Industries is recalling TRACH PACK sterile procedure kits because sterile blades within the kits can puncture the outer foil packaging, potentially compromising product 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: FDA Class II recall with no reported illnesses or injuries. The hazard is theoretical—potential for blade puncture to compromise sterility. Per the rubric, risk-of-harm products where injury has not yet been reported score as High.
Plain-English summary
Medline Industries, LP is recalling TRACH PACK Sterile Procedural Trays. These are sterile kits containing supplies and instrumentation for tracheotomy procedures.
The recall was initiated because sterile blades within the kits have the potential to puncture the outer foil layer of the sterile packaging, which is designed to maintain product sterility.
The affected products include lot numbers 22JMB321, 22JMA904, and 22HMD287. These kits were distributed worldwide, including the United States, Canada, Japan, Mexico, Panama, Turks & Caicos, and United Arab Emirates, with a total of 28 cases (112 units) affected.
Individuals and facilities with these kits should contact Medline Industries regarding this recall.
The recalled product
- Product
- TRACH PACK. Sterile Procedural Tray.
- 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 (6)
- Item Number: DYNJ46518G
- Case UDI/GTIN: 40195327009169
- Unit UDI/GTIN: 10195327009168
- Lot Number: 22JMB321
- 22JMA904
- 22HMD287
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 38 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 38 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 · blade puncture
See all →- HighSterile surgical trays recalled due to packaging puncture risk
FDA (Devices) · 2023-02-15
- HighMedline Sterile Procedural Trays recalled due to packaging defect risk
FDA (Devices) · 2023-02-15
- HighSterile Surgical Trays Recalled for Blade Puncture of Packaging
FDA (Devices) · 2023-02-15
- HighSterile Procedural Trays Recalled Due to Blade Packaging Puncture Hazard
FDA (Devices) · 2023-02-15
- HighSterile Procedural Trays Recalled Due to Blade Puncture Risk
FDA (Devices) · 2023-02-15