FDA Medical Device Recalls (openFDA)
Superior Products Inc: Oxy Serve II Oxygen Conserving Regulator, Model Number: MCRB-870-6, Superior Products, Inc/SP Medical, LLC, Cleveland, Ohio 44144
- Recall number
- Z-0529-2008
- Recalling firm
- Superior Products Inc
- Product
- Oxy Serve II Oxygen Conserving Regulator, Model Number: MCRB-870-6, Superior Products, Inc/SP Medical, LLC, Cleveland, Ohio 44144
- Status
- Terminated
- Initiated
- 2007-10-19
- Posted
- 2008-01-23
- Terminated
- 2012-04-25
- Reason
- Leakage: Device was leaking oxygen
- Root cause
- Component design/selection
- Action
- A Voluntary Medical Device Recall notification was delivered by certified mail on or about 10/19/2007, to all consignee's; "bill to" and "sent to." Consignee's are asked to contact their customers (if any), notify them of the recall, and return all implicated products to Superior Products.
- Quantity
- 125
- Distribution
- Worldwide-USA including states of CA, FL, IA, IN, KY, OH, SC, TX, and WA. and countries of Singapore, Mexico City, MX, and Turkey
- Lot, serial or model codes
- Lot 051101 - (Serial #'s: 001009, 001010, 001012, 001017, 001019, 001023, 001025, 001027, & 001029) -- Lot 05111 - (Serial #: 001049)-- Lot 051121 (Serial #'s: 001022, 001015, 001026, 530002, 530004, 001013, 001014, 001016, & 001034)-- Lot 051130 (Serial #'s: 530003, 001011, 001018, 001021, 001024, 001031, 001033, 001035, 001037, 001038, 001039, & 001050) -- Lot 051202 (Serial # 001044)-- Lot 063759 (Serial #'s: 001206, 001054, 001055, 001056, 001073, 001077, 001164, 001168, 001180, 001191, 001207, 001078, 001166, 001154, 001178, 001169, 001170, 001174, 001153, 001155, 001157, 001171, 001175, 001177, 001182, 001200, 001203, 001208, 001140, & 001165) Lot 063426 (Serial # 001093, 001101, 001111, 001128, 001106, 001114, 001076, 001112, 001074, 001084, 001092, 001124, 001126, 001134, 001137, 001141, 001142, 001167, 001069, 001057, 001099, 001130, 001135, 001150, 001118, 001139, 001075, 001052, 001117, 001119, 001176, 001061, 001053, 001103, 0011363, 001108, 001067, 001110, 001070, 001136, 001098, 001121, 001113, 001051, 001063, 001082, 001071, 001116, 001064, 001066, 001095, 001109, 001085, 001087, 001088, 001089, 001090, 001091, 001094, 001096, 001125, 001127, 001144, & 001145)
- 510(k) numbers
- ["K051988"]
- PMA numbers
- not on file
- Product code
- NFB
- Firm FEI
- 1000515374
- Firm city
- Cleveland
- Firm state
- OH
- 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