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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 91438

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

Open FDA event record

Event summary

Timeline bucket
December 15, 2022
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
CooperSurgical, 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

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

BIOPSY MEDIUM 10ML, Reference Number 10620010 A, used for blastomere biopsy of cleavage stage embryos for Pre-implantation Genetic Diagnosis (PGD)

Z-1044-2023
Recall number
Z-1044-2023
Initiated
December 15, 2022
Classification
Class II
Status
Ongoing
Recalling firm
CooperSurgical, Inc.
Quantity
489 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The affected product may contain a medium other than the Biopsy Medium. There is a risk that use of the Product from this lot could cause degradation of the embryo.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling Change Control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The affected product may contain a medium other than the Biopsy Medium. There is a risk that use of the Product from this lot could cause degradation of the embryo.

Code information

Lot Number: 220506-006557

Distribution pattern

Global Distribution including countries of: Bahrain, Belgium, Bulgaria, Egypt, France, Georgia, Greece, Hong Kong, Iran, Iraq, Israel, Japan, Jordan, Kazakhstan, Kuwait, Lebanon, Libya, Nigeria, Oman, Pakistan, Poland, Republic of North Macedonia, Saudi Arabia, Slovenia, Spain, Thailand, Turkey, Turkmenistan, and United Arab Emirates.