Z-0529-2008

Oxy Serve II Oxygen Conserving Regulator, Model Number: MCRB-870-6, Superior Products, Inc/SP Medical, LLC...

Name: Z-0529-2008 Oxy Serve II Oxygen Conserving Regulator, Model Number: MCRB-870-6, Superior Products, Inc/SP Medical, LLC...
Creator: Superior Products Inc
Published: 2007-10-19
License: https://open.fda.gov/license/

Superior Products, LLC / initiated 2007-10-19 / Terminated / root cause: design

FDA source

Superior Products Inc began a recall of Oxy Serve II Oxygen Conserving Regulator, Model Number: MCRB-870-6, Superior Products, Inc/SP Medical, LLC, Cleveland, Ohio 44144 on 2007-10-19. The reason FDA records is "Leakage: Device was leaking oxygen". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0529-2008
Status: Terminated
Initiated: 2007-10-19
Posted: 2008-01-23
Terminated: 2012-04-25
Recalling firm: Superior Products, LLC
Product: Oxy Serve II Oxygen Conserving Regulator, Model Number: MCRB-870-6, Superior Products, Inc/SP Medical, LLC, Cleveland, Ohio 44144
Product code: NFB Conserver, Oxygen
Reason for recall: Leakage: Device was leaking oxygen
Root cause tag: design
FDA 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 in commerce: 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
Product codes and lots: 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)

Product code NFB

K051988Class IIOxy-Serve II Oxygen Conserving RegulatorSuperior Products, Inc. / cleared 2005-09-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)