On Site Gas Systems POGS 33C Portable Oxygen Generation System
Medical device recall Z-0647-2014. Published in FDA’s Enforcement Report on Jan 15, 2014.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Jan 15, 2014. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Pennsylvania the one state its words name
- 198 units how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
Heat exchanger hose becomes weak and may fail.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
On Site Gas Systems POGS 33C Portable Oxygen Generation System
198 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
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…
Every code shown here, 1,402 characters
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
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
US Distribution: PA only.
The states and territories these words name
- Pennsylvania
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Dec 19, 2013.
- FDA classified it on Jan 8, 2014.
- FDA’s Enforcement Report published it on Jan 15, 2014.
- FDA terminated it on Oct 2, 2014.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- On Site Gas Systems Inc., of Newington, CT.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
-
U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.