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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 90620

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

Open FDA event record

Event summary

Timeline bucket
July 19, 2022
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Myolyn 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

Power electronic box, Part #AS-0066, subassembly for the MyoCycle MC-2.

Z-1523-2022
Recall number
Z-1523-2022
Initiated
July 19, 2022
Classification
Class II
Status
Terminated
Recalling firm
Myolyn Inc.
Quantity
45 devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Screws mounting an internal power supply may come loose during shipping resulting in increased risk of high voltage electrical shock.

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

Screws mounting an internal power supply may come loose during shipping resulting in increased risk of high voltage electrical shock.

Code information

Serial numbers 000800 thru 000819, 000821 thru 000822, 000824 thru 000827, 000829 thru 000831, 000835, 000836, 000840 thru 000842, 000850 thru 000852, and 000857 thru 000859; UDI 000861553000417

Distribution pattern

Distribution was made to AZ, CA, CT, FL, GA, ID, IL, KY, MA, MI, MN, MO, MN, NC, NJ, NM, NY, OH, OR, TX, UT, VA, WA, and WI. There was no foreign/military/government distribution.