Manufacturer

Vapotherm, Inc.

8 recalls in our database name Vapotherm, Inc. as the manufacturing or recalling firm.

What the numbers show

Total: 8
Critical: 0
Severe: 1
Most recent: 2014-10-01

Of the 8 recalls from Vapotherm, Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1 (13%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–8 of 8

SevereFDA (Devices)·Z-2702-2014·2014-10-01
Vapotherm Precision Flow Disposable Patient Circuit Recalled for Water Leaks
Vapotherm is recalling 387 Precision Flow Disposable Patient Circuits because they may allow water to leak into the center gas lumen.
Product
Vapotherm Precision Flow,Disposable Patient Circuit PFNODPC-High. For use with the Precision Flow system and Ikaria INOmax DSIR ¿ System. This DPC allows clinicians to administer nitric oxide non-invasively via high flow nasal cannula. In the Precision Flow High Flow Therapy
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2705-2014·2014-10-01
Vapotherm Precision Flow Disposable Patient Circuit Recalled for Water Leakage
Vapotherm, Inc. is recalling 865 units of Precision Flow Disposable Patient Circuits because they may allow water to leak into the center gas lumen.
Product
Vapotherm Precision Flow,Disposable Patient Circuit PFHDPC-Low. For use with the Heliox Precision Flow system Precision Flow" is intended for use to add warm moisture to breathing gases from an external source for administration to a neonate/infant, pediatric and adult patie
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2706-2014·2014-10-01
Vapotherm Precision Flow Patient Circuit Recalled for Potential Water Leakage
Vapotherm, Inc. is recalling 207 units of Precision Flow Disposable Patient Circuits because water may leak into the center gas lumen.
Product
Vapotherm Precision Flow,Disposable Patient Circuit PF-NODPC-Low. For use with the Precision Flow system and Ikaria INOmax DSIR ¿ System. This DPC allows clinicians to administer nitric oxide non-invasively via high flow nasal cannula. In the Precision Flow High Flow Thera
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2703-2014·2014-10-01
Vapotherm Precision Flow Disposable Patient Circuit Recalled for Water Leakage
Vapotherm is recalling 22,042 Precision Flow Disposable Patient Circuits because they may allow water to leak into the center gas lumen.
Product
Vapotherm Precision Flow,Disposable Patient Circuit PF-DPC-Low. For use with the Precision Flow system Precision Flow" is intended for use to add warm moisture to breathing gases from an external source for administration to a neonate/infant, pediatric and adult patients in th
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2701-2014·2014-10-01
Vapotherm Precision Flow Disposable Patient Circuit Recalled for Water Leakage
Vapotherm, Inc. is recalling 635 units of Precision Flow Disposable Patient Circuits because they may allow water to leak into the center gas lumen.
Product
Vapotherm Precision Flow,Disposable Patient Circuit PFH-DPC-High. For use with the Heliox Precision Flow system Precision Flow" is intended for use to add warm moisture to breathing gases from an external source for administration to a neonate/infant, pediatric and adult pati
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2704-2014·2014-10-01
Vapotherm Precision Flow Disposable Patient Circuit Recall for Water Leakage
Vapotherm, Inc. is recalling 360 units of Precision Flow Disposable Patient Circuits because they allow water to leak into the center gas lumen.
Product
Vapotherm Precision Flow,Disposable Patient Circuit PF-E-DPC-Low. PF-DPC-Low packaged with compatible cannulas for evaluation of the Precision Flow system
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2699-2014·2014-10-01
Vapotherm Precision Flow Patient Circuits Recalled for Water Leakage
Vapotherm, Inc. is recalling 22,828 Precision Flow Disposable Patient Circuits because they may allow water to leak into the gas lumen.
Product
Vapotherm Precision Flow, Disposable Patient Circuit PF-DPC-High. For use with the Precision Flow system Precision Flow" is intended for use to add warm moisture to breathing gases from an external source for administration to a neonate/infant, pediatric and adult patients in
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2700-2014·2014-10-01
Vapotherm Precision Flow Disposable Patient Circuit Recalled for Water Leakage
Vapotherm, Inc. is recalling 1,005 units of Precision Flow Disposable Patient Circuits because they may allow water to leak into the center gas lumen.
Product
Vapotherm Precision Flow,Disposable Patient Circuit PF-E-DPC-High. For use with the Precision Flow system Precision Flow" is intended for use to add warm moisture to breathing gases from an external source for administration to a neonate/infant, pediatric and adult patients i
Category
Medical Device
Distribution
Distributed nationwide

About this company

Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.

Vapotherm

medical device manufacturer

Country: United States
Founded: 1999

Official website

Source: Wikidata (Q19865696), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.