Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 89702

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

Open FDA event record

Event summary

Timeline bucket
February 14, 2022
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Draeger Medical, 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

2 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 2

Evita V500 Ventilator with Software 2.51.01 and Lower - intended for the ventilation of adult, pediatric and neonatal patients Catalog Number: 8416400

Z-0870-2022
Recall number
Z-0870-2022
Initiated
February 14, 2022
Classification
Class II
Status
Terminated
Recalling firm
Draeger Medical, Inc.
Quantity
24,337 (10,728 units US)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Cybersecurity Improvement Action-not equipped against potential cyber security threats

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Cybersecurity Improvement Action-not equipped against potential cyber security threats

Code information

All Lots/Serial Numbers. UDI: 04048675042266

Distribution pattern

US Nationwide

device · product 2 of 2

Babylog VN500 Ventilator with Software 2.51.01 and Lower- intended for the ventilation neonatal patients from 0.4 kg (0.88 lbs) up to 10 kg (22 lbs) and pediatric patients from 5 kg (11 lbs) up to 20 kg (44 lbs) bodyweight Catalog Number: 8417400

Z-0871-2022
Recall number
Z-0871-2022
Initiated
February 14, 2022
Classification
Class II
Status
Terminated
Recalling firm
Draeger Medical, Inc.
Quantity
13,687 (2,987 units US)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Cybersecurity Improvement Action-not equipped against potential cyber security threats

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Cybersecurity Improvement Action-not equipped against potential cyber security threats

Code information

All Lots/Serial Numbers. UDI: 04048675250418

Distribution pattern

US Nationwide