Exact FDA event identifier

Event 91312

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

Open FDA event record

Event summary

Timeline bucket: September 28, 2022
Product types: Device
Classifications: Class II
Statuses: Ongoing
Recalling firm wording: TELEFLEX LLC

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

Pilling Wecksorb Cylindrical Sponges

Z-0772-2023

Recall number: Z-0772-2023
Initiated: September 28, 2022
Classification: Class II
Status: Ongoing
Recalling firm: TELEFLEX LLC
Quantity: 1,000 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Specific lots have not been irradiated to eliminate pyronema and therefore the sterility of the affected products may be compromised.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Specific lots have not been irradiated to eliminate pyronema and therefore the sterility of the affected products may be compromised.

Code information

Catalog Number: 200400, Lot Number: 22B0395

Distribution pattern

Domestic distribution to IL, MS, PA, TN.