High FDA (Devices)·Z-1595-2025·Announced 2025-04-23

Medline dental convenience kits recalled for potential weak seal packaging

Medline is recalling five models of dental convenience kits due to the potential for open or weak seals on the breather pouches used for packaging. The affected sterile kits were distributed nationwide in the US and internationally.

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 an FDA Class II recall of sterile medical device kits with compromised packaging that could lead to contamination. Although no illnesses or injuries are reported in the source, the risk of compromised sterility in packaged medical devices used in dental procedures represents a significant potential for harm.

Plain-English summary

Medline Industries, LP is recalling five models of dental convenience kits: DENTAL PACK-LF (Model DYNJ84880), DENTAL PACK (Model DYNJ56229A), DENTAL PACK-LF (Model PHS807626F), DENTAL PACK SMGH (Model DYNJ41929D), and DENTAL PACK (Model DYNJ51841C). The recall was initiated because of a potential for open or weak seals on breather pouches used for packaging these sterile convenience kits.

The affected products were distributed worldwide, including US Nationwide distribution and distribution to Canada, Mexico, Panama, and the Virgin Islands. A total of 573 units are involved in the recall. Specific lot numbers are associated with each model and are available through the FDA database.

Facilities that have received these convenience kits should stop use immediately and contact Medline Industries for instructions on return or replacement. Healthcare providers should inspect any kits received to verify seal integrity before use in patient procedures.

The recalled product

Product: 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: DYNJ51841
Manufacturer: MEDLINE INDUSTRIES, LP - Northfield
Category: Medical Device — Dental / Sterile Convenience Kits
Hazard: compromised-seal
sterility-risk
Affected units: 573

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 (20)

1) DYNJ84880
UDI-DI: 10195327432140(each)
40195327432141(case)
Lot Number: 24JBL926
2) DYNJ56229A
UDI-DI: 10198459108105(each)
40198459108106(case)
Lot Number: 24JBV124
3) PHS807626F
UDI-DI: 10198459028045(each)
40198459028046(case)
Lot Number: 24JBV611
4) DYNJ41929D
UDI-DI: 10198459160585(each)
40198459160586(case)
Lot Number: 24JBW877
5) DYNJ51841C
UDI-DI: 10195327522186(each)
40195327522187(case)
Lot Number: 24KBA623

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 34 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 34 products in this recall →

Same manufacturer · MEDLINE INDUSTRIES, LP - Northfield

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Same hazard · compromised seal