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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 80401

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

Open FDA event record

Event summary

Timeline bucket
June 08, 2018
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Ethicon, 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

PDS Plus Antibacterial (Polydioxanone) Suture-PDS PLUS Undyed Suture 45cm (18") 4-0 Single Armed PS-4 Prime Needle Product Code: PDP507G (GTIN 10705031203983)

Z-2532-2018
Recall number
Z-2532-2018
Initiated
June 08, 2018
Classification
Class II
Status
Terminated
Recalling firm
Ethicon, Inc.
Quantity
4992

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Products do not meet a tensile strength specification

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

Products do not meet a tensile strength specification

Code information

Lot Number: MBK743

Distribution pattern

Japan

device · product 2 of 3

PDS Plus Antibacterial Suture-PDS PLUS Undyed Suture 45cm (18") 5-0 Single Armed P-3 Prime Needle Product Code: PDP493G (GTIN 10705031203945)

Z-2533-2018
Recall number
Z-2533-2018
Initiated
June 08, 2018
Classification
Class II
Status
Terminated
Recalling firm
Ethicon, Inc.
Quantity
756

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Products do not meet a tensile strength specification

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

Products do not meet a tensile strength specification

Code information

Lot Number:MCZ162

Distribution pattern

Japan

device · product 3 of 3

PDS II (Polydioxanoe) Suture Dyed & Undyed-PDSII Undyed 45cm (18") 5-0 Single Armed PS-6 Prime Needle Product Code: Z511G (GTIN 10705031061347)

Z-2534-2018
Recall number
Z-2534-2018
Initiated
June 08, 2018
Classification
Class II
Status
Terminated
Recalling firm
Ethicon, Inc.
Quantity
72

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Products do not meet a tensile strength specification

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

Products do not meet a tensile strength specification

Code information

Lot Number: MCZ363

Distribution pattern

Japan