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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 77304

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

Open FDA event record

Event summary

Timeline bucket
May 09, 2017
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Cook 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

Cook Multi-Use Holmium Laser Fibers, Supplied sterilized by ethylene oxide gas in peel-open packages

Z-2539-2017
Recall number
Z-2539-2017
Initiated
May 09, 2017
Classification
Class II
Status
Terminated
Recalling firm
Cook Inc.
Quantity
4369

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Correction to the product Instructions for Use because the current reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfection, and sterilization of these products.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Correction to the product Instructions for Use because the current reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfection, and sterilization of these products.

Code information

HLF-M273-H30 HLF-M365-H30 HLF-M550-H30 HLF-M940-H30 HLF-M273-HSMA HLF-M365-HSMA HLF-M550-HSMA HLF-M940-HSMA

Distribution pattern

Domestic: AL AR AZ CA CO FL GA HI ID IL IN KY LA MD MI MO MS NC NM NY OH OK OR PA SC TN TX UT VA WA WI Foreign: Austria, Australia, Argentina, Azerbaijan, Belgium, Bulgaria, Bahrain, Canada, Chile, China, Cyprus, Czech Republic, Denmark, Djibouti, Egypt, France, Hong Kong, Honduras, Croatia, Greece, Germany, Hungary, India, Ireland, Italy, Latvia, Malaysia, Morocco, Netherlands, Poland, Portugal, Puerto Rico, Saudi Arabia, Serbia, Spain, Slovenia, South Africa, Sri Lanka, Sweden, Singapore, Taiwan, Thailand, Tunisia, United Kingdom, and Uruguay

Field note

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