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CARDINAL HEALTH

Cardinal Health 200, LLC · Model SENHDDPV11 · UDI-DI 10197106908051

OFX Prescription

510(k) clearances

Adverse events

Recalls

Facilities

Description

ORP DENTAL PACK

Recalls

Date	Firm	Reason
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
2026-03-19	Medline Industries, LP	During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-o
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
2025-03-03	MEDLINE INDUSTRIES, LP - Northfield	There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
2024-11-08	Cardinal Health 200, LLC	Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits.
2024-11-08	Cardinal Health 200, LLC	Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.
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

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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.