Medline Convenience kits used for various procedures: 1) DENTAL PACK-LF, Model Number: DYNJ84880; 2) DENTAL PACK, Model Number: DYNJ56229A; 3) DENTAL PACK-LF, Model Number: PHS807626F; 4) DENTAL PACK SMGH, Model Number: DYNJ41929D; 5) DENTAL PACK, Model Number: DYNJ51841C; 6) NYGH-MINOR DENTAL-PLASTIC-LF, Model Number: DYNJ905551C
Reported: April 23, 2025 Initiated: March 3, 2025 #Z-1595-2025
Product Description
Medline Convenience kits used for various procedures: 1) DENTAL PACK-LF, Model Number: DYNJ84880; 2) DENTAL PACK, Model Number: DYNJ56229A; 3) DENTAL PACK-LF, Model Number: PHS807626F; 4) DENTAL PACK SMGH, Model Number: DYNJ41929D; 5) DENTAL PACK, Model Number: DYNJ51841C; 6) NYGH-MINOR DENTAL-PLASTIC-LF, Model Number: DYNJ905551C
Reason for Recall
There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
Details
- Recalling Firm
- MEDLINE INDUSTRIES, LP - Northfield
- Units Affected
- 573 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, Mexico, Panama, Virgin Islands.
- Location
- Northfield, IL
Frequently Asked Questions
What product was recalled? ▼
Medline Convenience kits used for various procedures: 1) DENTAL PACK-LF, Model Number: DYNJ84880; 2) DENTAL PACK, Model Number: DYNJ56229A; 3) DENTAL PACK-LF, Model Number: PHS807626F; 4) DENTAL PACK SMGH, Model Number: DYNJ41929D; 5) DENTAL PACK, Model Number: DYNJ51841C; 6) NYGH-MINOR DENTAL-PLASTIC-LF, Model Number: DYNJ905551C. Recalled by MEDLINE INDUSTRIES, LP - Northfield. Units affected: 573 units.
Why was this product recalled? ▼
There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 23, 2025. Severity: Moderate. Recall number: Z-1595-2025.
Related Recalls
FDA Devices Moderate
Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience Kit - FXX VS0644.25-FXX 3.2…
Vortex Surgical Inc. · 2026-02-11
FDA Devices Moderate
COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffered diluent in conju…
Beckman Coulter, Inc. · 2026-02-11
FDA Devices Moderate
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1520 Product Description: These inst…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0330 Product Description: These in…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558 Software Version: Not Applicable Produc…
Fujirebio Diagnostics, Inc. · 2026-02-11