Z-1624-2012

Pelleve Non-Ablative Wrinkle Treatment Handpiece, Product Codes D110FSHP, D115FSHP (reusable) --- Pelleve...

Name: Z-1624-2012 Pelleve Non-Ablative Wrinkle Treatment Handpiece, Product Codes D110FSHP, D115FSHP (reusable) --- Pelleve...
Creator: Ellman International, Inc.
Published: 2012-05-04
License: https://open.fda.gov/license/

Ellman International, Inc. / initiated 2012-05-04 / Terminated / root cause: manufacturing process

FDA source

Ellman International, Inc. began a recall of Pelleve Non-Ablative Wrinkle Treatment Handpiece, Product Codes D110FSHP, D115FSHP (reusable) --- Pelleve --- Elegance through science --- Contents: One (1)... on 2012-05-04. The reason FDA records is "Ellman International is recalling its Pelleve reusable handpiece because of possible cable failure and sparking". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1624-2012
Status: Terminated
Initiated: 2012-05-04
Posted: 2012-05-17
Terminated: 2016-02-12
Recalling firm: Ellman International, Inc.
Product: Pelleve Non-Ablative Wrinkle Treatment Handpiece, Product Codes D110FSHP, D115FSHP (reusable) --- Pelleve --- Elegance through science --- Contents: One (1) Pelleve Handpiece (Reusable) --- Non-ablative treatment of mild to moderate facial wrinkles and rhytids for skin phototypes I-IV.
Product code: GEI Electrosurgical, Cutting & Coagulation & Accessories
Reason for recall: Ellman International is recalling its Pelleve reusable handpiece because of possible cable failure and sparking.
Root cause tag: manufacturing process
FDA root cause: Equipment maintenance
Action: Ellman will notify all consignees initially via UPS shipment with an Urgent: Medical Device Recall letter containing notification of the recall and instructions. The letter identifies the affected product, problem, and instructs customers to identify and return the handpieces in the enclosed prepaid mailer. Customers are to complete and return the Product Recall Verification Form and fax it to the number provided. In addition, customers are provided with a toll-free number, 1-877-522-7141, to call in the event that they have questions or require additional instruction. Customers will initially be provided with a fixed-life disposable GlideSafe handpiece and may choose to receive a replacement reusable handpiece with modified (more robust) cable, or additional GlideSafe handpieces.
Quantity in commerce: 1,088 units
Distribution: Worldwide Distribution
Product codes and lots: All lots of the Pelleve handpieces (product codes D110FSHP, D115FSHP only) manufactured to date are subject to this recall.

Product code GEI

K082834Class IIEllman International Non-Ablative Technique for Surgitron IecEllman Int'L, Inc. / cleared 2009-05-07

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)