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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 83318

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

Open FDA event record

Event summary

Timeline bucket
May 30, 2019
Product types
Device
Classifications
Class I
Statuses
Terminated
Recalling firm wording
Galemed Corporation

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

3 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 3

Babi.Plus 12.5 cm H2O Pressure Relief Manifold, REF 1030, RX Only, UDI: 04710810093562

Z-0020-2020
Recall number
Z-0020-2020
Initiated
May 30, 2019
Classification
Class I
Status
Terminated
Recalling firm
Galemed Corporation
Quantity
2880

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Reports of pressure relief manifold venting gas below the standard pressure.

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

Reports of pressure relief manifold venting gas below the standard pressure.

Code information

UDI: 04710810093562 Lot: 180718, 181204, 190215, and 190610 (Reworked Product)

Distribution pattern

US distribution to distributors in the states of: NC and NV.

device · product 2 of 3

Babi.Plus Bubble PAP Valve with 12.5 cm H2O Pressure Relief Manifold, REF 1002, Rx Only, UDI: 24710810093559

Z-0021-2020
Recall number
Z-0021-2020
Initiated
May 30, 2019
Classification
Class I
Status
Terminated
Recalling firm
Galemed Corporation
Quantity
12000

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Reports of pressure relief manifold venting gas below the standard pressure.

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

Reports of pressure relief manifold venting gas below the standard pressure.

Code information

UDI: 24710810093559 Lot: 180718, 181107, 181127, 190220, and 190220-190610 (Reworked Product)

Distribution pattern

US distribution to distributors in the states of: NC and NV.

device · product 3 of 3

Babi.Plus 12.5 cm H2O Pressure Relief Manifold with Gas Supply Tube and Oxygen Sensor Port, REF 2691, Rx Only, UDI: 04710810100802

Z-0022-2020
Recall number
Z-0022-2020
Initiated
May 30, 2019
Classification
Class I
Status
Terminated
Recalling firm
Galemed Corporation
Quantity
14964

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Reports of pressure relief manifold venting gas below the standard pressure.

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

Reports of pressure relief manifold venting gas below the standard pressure.

Code information

UDI: 04710810100802 Lot: 180806, 180910, 181029, 181105, 181204, 190225, 190327

Distribution pattern

US distribution to distributors in the states of: NC and NV.