FDA Medical Device Recalls (openFDA)
Ellman International, Inc.: 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.
- Recall number
- Z-1624-2012
- 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.
- Status
- Terminated
- Initiated
- 2012-05-04
- Posted
- 2012-05-17
- Terminated
- 2016-02-12
- Reason
- Ellman International is recalling its Pelleve reusable handpiece because of possible cable failure and sparking.
- 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
- 1,088 units
- Distribution
- Worldwide Distribution
- Lot, serial or model codes
- All lots of the Pelleve handpieces (product codes D110FSHP, D115FSHP only) manufactured to date are subject to this recall.
- 510(k) numbers
- ["K082834"]
- PMA numbers
- not on file
- Product code
- GEI
- Firm FEI
- 2428235
- Firm city
- Oceanside
- Firm state
- NY
- 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