FDA Medical Device Recalls (openFDA)
Inovo, Inc: INOVO Purefill Oxygen Compressor Model PF1100 Is an oxygen refill machine that you can attach to an oxygen concentrator to refill portable oxygen cylinders.
- Recall number
- Z-0760-2017
- Recalling firm
- Inovo, Inc
- Product
- INOVO Purefill Oxygen Compressor Model PF1100 Is an oxygen refill machine that you can attach to an oxygen concentrator to refill portable oxygen cylinders.
- Status
- Terminated
- Initiated
- 2016-07-21
- Posted
- not on file
- Terminated
- 2019-07-16
- Reason
- Device can fail during operation.
- Root cause
- Under Investigation by firm
- Action
- The firm, Inovo, Inc, sent an "URGENT: MEDICAL DEVICE RECALL" letter dated Sept 2, 2016 to all their consignees/customers. The letter described the product, problem and actions to be taken. The customers were instructed to quarantine and isolate the devices in their inventory and return them to Inovo Inc. Also, if the consignee sold or distributed the device, the consignee needs to retrieve and return the units to Inovo Inc. as soon as possible and complete and return the Medical Device Return Response form in the self-addressed stamped envelope provided or email to: regulatory@inovoin.com or fax to Inovo, Inc. Any questions please contact at 814-443-7602 or via e-mail at regulatory@inovoinc.com.
- Quantity
- 117 units
- Distribution
- US Nationwide Distribution to states of: AL, AR, CT, FL, IA, KS, KY, MD, MI, MN, MO, NE, NJ, NV, NY, OH, RI, SC, TN, TX, UT, and WA.
- Lot, serial or model codes
- Serial #'s: PFDM1500003 thru PFDM1500390 and PFDM1600391 thru PFMD1600843.
- 510(k) numbers
- ["K141967"]
- PMA numbers
- not on file
- Product code
- CAW
- Firm FEI
- 3000719543
- Firm city
- Lehigh Acres
- Firm state
- FL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28