Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 98455

3 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
February 16, 2026
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
ConvaTec, Inc

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

3 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 3

Convatec, EsteemBody Drainable Pouch REF:423643, 10-45mm

Z-1582-2026
Recall number
Z-1582-2026
Initiated
February 16, 2026
Classification
Class II
Status
Ongoing
Recalling firm
ConvaTec, Inc
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Drainable large pouch may leak due to manufacturing issue.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Drainable large pouch may leak due to manufacturing issue.

Code information

UDI: 00768455221264 Lot: 5K00011,5K00714

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Australia, Canada, China, Czech Republic, Denmark, Finland, Germany, Ireland, Italy, Japan, Netherlands, Norway, Poland, Slovakia, Sweden, Switzerland, UK.

device · product 2 of 3

Convatec, EsteemBody Drainable Pouch REF:423653 10-35mm

Z-1583-2026
Recall number
Z-1583-2026
Initiated
February 16, 2026
Classification
Class II
Status
Ongoing
Recalling firm
ConvaTec, Inc
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Drainable large pouch may leak due to manufacturing issue.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Drainable large pouch may leak due to manufacturing issue.

Code information

UDI: 00768455221363 Lot: 5K01728

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Australia, Canada, China, Czech Republic, Denmark, Finland, Germany, Ireland, Italy, Japan, Netherlands, Norway, Poland, Slovakia, Sweden, Switzerland, UK.

device · product 3 of 3

Convatec, EsteemBody Drainable Pouch REF:423657 10-35mm

Z-1584-2026
Recall number
Z-1584-2026
Initiated
February 16, 2026
Classification
Class II
Status
Ongoing
Recalling firm
ConvaTec, Inc
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Drainable large pouch may leak due to manufacturing issue.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Drainable large pouch may leak due to manufacturing issue.

Code information

UDI: 00768455221400/ Lot: 5J03908

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Australia, Canada, China, Czech Republic, Denmark, Finland, Germany, Ireland, Italy, Japan, Netherlands, Norway, Poland, Slovakia, Sweden, Switzerland, UK.