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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 97555

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
August 21, 2025
Product types
Device
Classifications
Class I
Statuses
Ongoing
Recalling firm wording
Medline Industries, LP

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

Medline Kits: 1) VALVE PACK-LF, Model Number: DYNJ0415366P; 2) VALVE PACK-LF, Model Number: DYNJ0415366Q

Z-2670-2025
Recall number
Z-2670-2025
Initiated
August 21, 2025
Classification
Class I
Status
Ongoing
Recalling firm
Medline Industries, LP
Quantity
828 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The kits contain certain lots of cannula products where the catheter may not retain its shape.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The kits contain certain lots of cannula products where the catheter may not retain its shape.

Code information

1) DYNJ0415366P, UDI-DI: 10195327177966(each), 40195327177967(case), Lot Number: 24DMG366; 2) DYNJ0415366Q, UDI-DI: 10195327678227(each), 40195327678228(case), Lot Number: 25EMD672; 3) DYNJ0415366Q, UDI-DI: 10195327678227(each), 40195327678228(case), Lot Number: 25GMD016; 4) DYNJ0415366Q, UDI-DI: 10195327678227(each), 40195327678228(case), Lot Number: 25AMB610; 5) DYNJ0415366Q, UDI-DI: 10195327678227(each), 40195327678228(case), Lot Number: 25BMJ241; 6) DYNJ0415366Q, UDI-DI: 10195327678227(each), 40195327678228(case), Lot Number: 25CMI425; 7) DYNJ0415366Q, UDI-DI: 10195327678227(each), 40195327678228(case), Lot Number: 24DMC189; 8) DYNJ0415366Q, UDI-DI: 10195327678227(each), 40195327678228(case), Lot Number: 24EMC463; 9) DYNJ0415366Q, UDI-DI: 10195327678227(each), 40195327678228(case), Lot Number: 24GMJ353; 10) DYNJ0415366Q, UDI-DI: 10195327678227(each), 40195327678228(case), Lot Number: 24IMB824; 11) DYNJ0415366Q, UDI-DI: 10195327678227(each), 40195327678228(case), Lot Number: 24KME116

Distribution pattern

US Nationwide distribution in the state of CA.