Medline Dental Pack Recall Due to Breather Pouch Seal Defect
Medline is recalling Dental Pack surgical kits (Lot 22DBE139) because breather pouches have openings in their seals that could compromise sterility. Affected units were distributed to healthcare facilities in eight US states.
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: FDA Class II recall with potential for sterility compromise due to seal defects in surgical kit packaging. No illnesses or injuries reported in the source text; the hazard remains theoretical.
Plain-English summary
Medline Industries is recalling Medline Dental Pack surgical kits (Reference DYNJ66983, Lot Number 22DBE139) after receiving complaints that breather pouches within the sterile kits show openings in their seals.
The openings in the breather pouch seals could allow the sterile surgical kits to become contaminated. This defect poses a potential risk to patients and healthcare workers who rely on the sterility of these surgical kits for medical procedures.
The recall affects 60 units that were distributed nationwide to healthcare facilities in California, Minnesota, North Carolina, New York, Oklahoma, Pennsylvania, Tennessee, and Texas.
Healthcare facilities that have received these kits should cease use immediately. Contact Medline Industries for further information about the recall.
The recalled product
- Product
- MEDLINE DENTAL PACK, REF DYNJ66983. Convenience kit used in medical procedures.
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Category
- Medical Device — Surgical kits
- Affected units
- 60
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)
- GTIN (01) 40193489385404
- Lot Number 22DBE139
Distribution
Part of a larger recall action
This product is one of 13 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 13 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 · packaging defect
See all →- High
- SevereSI-BONE iFuse TORQ Implant System Recalled for Sterility Assurance Issues
FDA (Devices) · 2026-10-21
- HighEmbosphere Microspheres Recalled Due to Packaging Sterility Concerns
FDA (Devices) · 2026-10-07
- ModerateAmneal Recalls Estradiol Gel Packets Due to Empty or Partially Full Containers
FDA (Drugs) · 2026-10-07
- ModerateAVID Medical Recalls Halyard IV Start Kits Due to Packaging Seal Issues
FDA (Devices) · 2026-09-30
Similar recalls
- HighMedline dental pack may contain non-sterile product due to packaging defect
FDA (Devices) · 2024-10-30
- HighMedline Rhinoplasty Pack kits recalled for potential breather pouch seal failures
FDA (Devices) · 2025-04-23
- HighMedline dental convenience kits recalled for potential weak seal packaging
FDA (Devices) · 2025-04-23
- HighMedline Convenience Kits Recalled for Potential Breather Pouch Seal Defects
FDA (Devices) · 2025-04-23
- HighMedline Convenience Kits Recalled Due to Weak Breather Pouch Seals
FDA (Devices) · 2025-04-23
- ModerateMedline Convenience Kits Recalled for Potentially Open Breather Pouches
FDA (Devices) · 2025-04-23