FDA Medical Device Recalls (openFDA)
Oculus Innovative Sciences Inc: Puracyn OTC; Wound & Skin Care Solution with Preservatives; Sold in 8 fl oz (trigger spray and finder pump) and 16 fl oz pump with insert. Kills 99.99% of Staph, MRSA, Strep and other Infectious Germs in 30 seconds in solution. Does not contain Antibiotics, Steroids or Alcohol. -Cleans infected wounds in one step - Safe to use around eyes, nose, m mouth and open wounds - Accelerated healing of minor wounds by keeping the wound clean -Non-toxic and non-irritating. Manufactured by Oculus Innovative Sciences for Innovaycen, Inc. 3546 N. Riverside Ave. Rialto, CA 92377 Made in USA. Intended for OTC use for the management of skin abrasions, lacerations, minor irritations, cuts, and intact skin.
- Recall number
- Z-0449-2012
- Recalling firm
- Oculus Innovative Sciences Inc
- Product
- Puracyn OTC; Wound & Skin Care Solution with Preservatives; Sold in 8 fl oz (trigger spray and finder pump) and 16 fl oz pump with insert. Kills 99.99% of Staph, MRSA, Strep and other Infectious Germs in 30 seconds in solution. Does not contain Antibiotics, Steroids or Alcohol. -Cleans infected wounds in one step - Safe to use around eyes, nose, m mouth and open wounds - Accelerated healing of minor wounds by keeping the wound clean -Non-toxic and non-irritating. Manufactured by Oculus Innovative Sciences for Innovaycen, Inc. 3546 N. Riverside Ave. Rialto, CA 92377 Made in USA. Intended for OTC use for the management of skin abrasions, lacerations, minor irritations, cuts, and intact skin.
- Status
- Terminated
- Initiated
- 2011-11-09
- Posted
- 2012-01-11
- Terminated
- 2012-12-07
- Reason
- Unapproved drug claims and those not approved under 510K clearance.
- Root cause
- Process control
- Action
- Oculus Innovative Sciences sent an"URGENT MEDICAL DEVICE RECALL" letter dated November 15, 2011 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers. The letter instructs customers to identify and remove all affected product from inventory. A Business Reply Card was attached to the letter for customers to complete and return via fax to 1-415-462-5181. Call Oculus Innovative Sciences Customer Service at 1-800-759-9305 for questions regarding this recall.
- Quantity
- 7894 x 8 oz pumps; 174 x 16 oz pumps
- Distribution
- Nationwide Distribution.
- Lot, serial or model codes
- Part number: 6000;80003 (8 oz trigger spray): Lot numbers: 10E0084-01, exp 11/11; 10F0099, exp 12/11; 10F0105, exp 12/11; 041311-01, exp 5/12. Part number: 6002; 80001, (8 oz finger pump); lot number s: 041311-01, exp 5/12; 081710-01, exp.9/11; 120810-01, exp 2/2012; 073010-02, exp 11/11. Part number: 6004; 80005. 16 oz with insert: 061511-02. exp 12/12.
- 510(k) numbers
- ["K090206"]
- PMA numbers
- not on file
- Product code
- FRO
- Firm FEI
- 3004554409
- Firm city
- Petaluma
- Firm state
- CA
- 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