CLASS II Device recall · Reported 15 Jan 2014 · FDA Enforcement Report

POGS 33C Portable Oxygen Generation System recalled

On Site Gas Systems is recalling On Site Gas Systems POGS 33C Portable Oxygen Generation System, distributed in Pennsylvania. The recall was initiated on 19 Dec 2013 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSerial Numbers: 4220FA 4221FA 4222FA 4223FA 4224FA 4225FA 4226FA 4227FA 4228FA 4229FA 4230FA 4231FA 4232FA 4233FA 4234FA 4235FA 4236FA 4237FA 4238FA 4239FA 4240FA 4241FA 4242FA 4243FA 4244FA 4245FA 4246FA 4247FA 4248FA 4249FA 4250FA 4251FA 4252FA 4253FA 4254FA 4255FA 4256FA 4257FA 4258FA 4259FA 4260FA 4261FA 4262FA 4263FA 4264FA 4265FA 4266FA 4267FA 4268FA 4269FA 4270FA 4271FA 4272FA 4273FA 4274FA 4275FA 4276FA 4277FA 4278FA 4279FA 4280FA 4281FA 4282FA 4283FA 4284FA 4285FA 4286FA 4287FA 4288FA 4289FA 4290FA 4291FA 4292FA 4293FA 4294FA 4295FA 4296FA 4297FA 4298FA 4299FA 4300FA 4301FA 4302FA 4303FA 4304FA 4305FA 4306FA 4307FA 4308FA 4309FA 4310FA 4311FA 4312FA 4313FA 4314FA 4315FA 4316FA 4317FA 4318FA 4319FA 4320FA 4322FA 4323FA 4324FA 4325FA 4326FA 4327FA 4328FA 4329FA 4330FA 4331FA 4332FA 4333FA 4334FA 4335FA 4336FA 4337FA 4338FA 4339FA 4340FA 4341FA 4342FA 4343FA 4344FA 4345FA 4346FA 4347FA 4348FA 4349FA 4350FA 4351FA 4352FA 4353FA 4354FA 4355FA 4356FA 4357FA 4358FA 4359FA 4360FA 4361FA 4362FA 4363FA 4364FA 4365FA 4366FA 4367FA 4368FA 4369FA 4370FA 4371FA 4372FA 4373FA 4374FA 4375FA 4376FA 4377FA 4378FA 4379FA 4380FA 4381FA 4382FA 4383FA 4384FA 4385FA 4386FA 4387FA 4388FA. 4389FA 4390FA 4391FA 4392FA 4393FA 4394FA 4395FA 4396FA 4397FA 4398FA 4399FA 4400FA 4401FA 4402FA 4403FA 4404FA 4405FA 4406FA 4407FA 4408FA 4409FA 4410FA 4411FA 4412FA 4413FA 4414FA 4415FA 4416FA 4417FA 4418FA

Quantity recalled198 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0647-2014
FDA event ID: 67132
Recalling firm: On Site Gas Systems, Newington, CT
Classification: Class II
Status: Terminated
Recall initiated: 19 Dec 2013
FDA classified: 8 Jan 2014
Reported: 15 Jan 2014
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

19 Dec 2013	Recall initiated by company
8 Jan 2014	Classified by FDA	+20 days
15 Jan 2014	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Heat exchanger hose becomes weak and may fail.

Product as listed by the FDA

On Site Gas Systems POGS 33C Portable Oxygen Generation System

Where it was distributed

US Distribution: PA only.

Pennsylvania

Questions about this recall

Is POGS 33C Portable Oxygen Generation System recalled?

Yes. On Site Gas Systems recalled POGS 33C Portable Oxygen Generation System on 19 Dec 2013. The recall is Class II and its status is Terminated. Recall number Z-0647-2014.

Why was it recalled?

Heat exchanger hose becomes weak and may fail.

Which lots are affected?

Serial Numbers: 4220FA 4221FA 4222FA 4223FA 4224FA 4225FA 4226FA 4227FA 4228FA 4229FA 4230FA 4231FA 4232FA 4233FA 4234FA 4235FA 4236FA 4237FA 4238FA 4239FA 4240FA 4241FA 4242FA 4243FA 4244FA 4245FA 4246FA 4247FA 4248FA 4249FA 4250FA 4251FA 4252FA 4253FA 4254FA 4255FA 4256FA 4257FA 4258FA 4259FA 4260FA 4261FA 4262FA 4263FA 4264FA 4265FA 4266FA 4267FA 4268FA 4269FA 4270FA 4271FA 4272FA 4273FA 4274FA 4275FA 4276FA 4277FA 4278FA 4279FA 4280FA 4281FA 4282FA 4283FA 4284FA 4285FA 4286FA 4287FA 4288FA 4289FA 4290FA 4291FA 4292FA 4293FA 4294FA 4295FA 4296FA 4297FA 4298FA 4299FA 4300FA 4301FA 4302FA 4303FA 4304FA 4305FA 4306FA 4307FA 4308FA 4309FA 4310FA 4311FA 4312FA 4313FA 4314FA 4315FA 4316FA 4317FA 4318FA 4319FA 4320FA 4322FA 4323FA 4324FA 4325FA 4326FA 4327FA 4328FA 4329FA 4330FA 4331FA 4332FA 4333FA 4334FA 4335FA 4336FA 4337FA 4338FA 4339FA 4340FA 4341FA 4342FA 4343FA 4344FA 4345FA 4346FA 4347FA 4348FA 4349FA 4350FA 4351FA 4352FA 4353FA 4354FA 4355FA 4356FA 4357FA 4358FA 4359FA 4360FA 4361FA 4362FA 4363FA 4364FA 4365FA 4366FA 4367FA 4368FA 4369FA 4370FA 4371FA 4372FA 4373FA 4374FA 4375FA 4376FA 4377FA 4378FA 4379FA 4380FA 4381FA 4382FA 4383FA 4384FA 4385FA 4386FA 4387FA 4388FA. 4389FA 4390FA 4391FA 4392FA 4393FA 4394FA 4395FA 4396FA 4397FA 4398FA 4399FA 4400FA 4401FA 4402FA 4403FA 4404FA 4405FA 4406FA 4407FA 4408FA 4409FA 4410FA 4411FA 4412FA 4413FA 4414FA 4415FA 4416FA 4417FA 4418FA

Where was it sold?

US Distribution: PA only.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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