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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 94768

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

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Event summary

Timeline bucket
June 04, 2024
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Zyno Medical LLC

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

Zyno Medical Z800, Z800F, Z800W, and Z800WF Infusion Pumps

Z-2263-2024
Recall number
Z-2263-2024
Initiated
June 04, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Zyno Medical LLC
Quantity
88 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Zyno Medical has found that certain Z800, Z800F, Z800W, and Z800WF pumps have faulty power supply modules that will not provide a charge to the rechargeable battery within the pump. This may lead to the battery having insufficient or no charge available to the pump when it is unplugged from the AC mains power.

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

Zyno Medical has found that certain Z800, Z800F, Z800W, and Z800WF pumps have faulty power supply modules that will not provide a charge to the rechargeable battery within the pump. This may lead to the battery having insufficient or no charge available to the pump when it is unplugged from the AC mains power.

Code information

UDI-DI: Z800: 008143771020006 Z800F: 00814371020013 Z800W: 00814371020020 Z800WF: 00814371020037; Serial Numbers: Z-800: 905283 Z-800F: 610844 609115 616225 608843 608854 608878 609662 611192 611221 605032 607483 613133 619542 609315 607545 602521 611251 601782 601905 604576 602023 604135 601424 602518 608407 608335 608361 608399 608438 607773 608590 609773 608955 608960 608962 610650 607324 610217 607402 608152 608197 609143 609380 608996 607439 611588 611605 614257 609672 609730 601191 614278 608497 608641 610128 610132 610158 601438 615722 616791 603717 607171 608826 608150 608137 609199 609276 602280 610713 613781 607496 608918 609355 605090 608790 603096 615110 Z-800W: 700568 Z-800WF: 503770 500010 500054 501954 502832 504296 504496 503950 500066

Distribution pattern

US Nationwide distribution.