Z-0566-2008

HAENG LIM --Acupunture Needles- PRE-STERILIZED GAMMA-RAY; 100 PKGS (10 NEEDLES/PACKAGE-1,000 needles in each...

Name: Z-0566-2008 HAENG LIM --Acupunture Needles- PRE-STERILIZED GAMMA-RAY; 100 PKGS (10 NEEDLES/PACKAGE-1,000 needles in each...
Creator: Marknew Products
Published: 2007-11-28
License: https://open.fda.gov/license/

Marknew Products / initiated 2007-11-28 / Terminated

FDA source

Marknew Products began a recall of HAENG LIM --Acupunture Needles- PRE-STERILIZED GAMMA-RAY; 100 PKGS (10 NEEDLES/PACKAGE-1,000 needles in each box). Sale Agency HAENG LIM SEO WON #45-9... on 2007-11-28. The reason FDA records is "Marketed without 510(k)". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0566-2008
Status: Terminated
Initiated: 2007-11-28
Posted: 2008-01-04
Terminated: 2012-01-18
Recalling firm: Marknew Products
Product: HAENG LIM --Acupunture Needles- PRE-STERILIZED GAMMA-RAY; 100 PKGS (10 NEEDLES/PACKAGE-1,000 needles in each box). Sale Agency HAENG LIM SEO WON #45-9, Gunjang-ri, Ganam-myeon, Yeoju-gun, Kyungki-do, Korea
Product code: MQX Needle, Acupuncture, Single Use
Reason for recall: Marketed without 510(k)
FDA root cause: PMA
Action: Marknew Products, LLC, sent an Important Recall Notice to their customers on November 27, 2007, advising them that all Haeng Lim Seo Won Acupuncture Needles that they have received, have not been cleared for distribution in the USA. All customers have been requested to return product back to Marknew Products for credit. A response form was included. If customers have questions concerning this product, they are asked to call 562-908-5000.
Quantity in commerce: 320-380 boxes/100 packages (10 needles/package)
Distribution: Nationwide Distribution
Product codes and lots: All Lot Numbers and Serial Numbers

Product code MQX

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)