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Toothette Oral Care

SAGE PRODUCTS, LLC · Model 6550 · UDI-DI 00618029800657

NSB JOL

510(k) clearances

Adverse events

Recalls

Facilities

Description

Suction Swab System with Perox-A-Mint Solution

Recalls

Date	Firm	Reason
2026-07-20	Medline Industries, LP	Downstream recall - manufacturer recalled specific lots of BD ChloraPrep Clear - 1mL Applicators. Affected product may exhibit an open or incomplete seal on the packaging of the ap
2026-05-04	Medline Industries, LP	During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surfac
2026-01-07	Medline Industries, LP	Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packag
2026-01-07	Medline Industries, LP	Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packag
2025-11-26	Medline Industries, LP	Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were recalled due to customer complaints identifying that the check valve components may bec
2025-03-19	MEDLINE INDUSTRIES, LP - Northfield	It was identified that the Medline Sterile Water and Medline Sterile 0.9% Normal Saline bottles were leaking at the interface of the peel-foil and bottle opening.
2024-10-09	MEDLINE INDUSTRIES, LP - Northfield	Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.
2024-09-04	MEDLINE INDUSTRIES, LP - Northfield	It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal
2024-06-27	MEDLINE INDUSTRIES, LP - Northfield	Due to reported adverse events, Medline Industries, LP. is issuing a recall on specific SKUs and lots of 1500 cc semi-rigid liners manufactured from 09/2023-11/2023 due to the pote
2024-04-08	MEDLINE INDUSTRIES, LP - Northfield	Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that ma

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.