FDA Medical Device Recalls (openFDA)
Oculus Innovative Sciences Inc: Microcyn Dermatology HydroGel, Spray , 4 oz and 1.76 oz. Provided Pain Relief, Relieve Itch, Reduces symptoms of inflammation due to irritation, Provide a protective shield against contamination. Antibiotic-free, steroid-free and biodegradable.. Oculus Innovative Sciences . Petaluma, CA 94954. Intended for use by health care professionals in management of wounds including itch and pain relief associated with dermal irritation, sore, injuries and ulcers or dermal tissue. Microcyn Skin and Wound hydrogel is intended for use on first and second degree burns, excluding wounds such as leg ulcers, pressure ulcers, diabetic ulcers, and for the management of mechanically or surgically debrided wounds.
- Recall number
- Z-0451-2012
- Recalling firm
- Oculus Innovative Sciences Inc
- Product
- Microcyn Dermatology HydroGel, Spray , 4 oz and 1.76 oz. Provided Pain Relief, Relieve Itch, Reduces symptoms of inflammation due to irritation, Provide a protective shield against contamination. Antibiotic-free, steroid-free and biodegradable.. Oculus Innovative Sciences . Petaluma, CA 94954. Intended for use by health care professionals in management of wounds including itch and pain relief associated with dermal irritation, sore, injuries and ulcers or dermal tissue. Microcyn Skin and Wound hydrogel is intended for use on first and second degree burns, excluding wounds such as leg ulcers, pressure ulcers, diabetic ulcers, and for the management of mechanically or surgically debrided wounds.
- 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
- 4343 x 1.76 oz; 1.76 oz, 541 x 4 oz.
- Distribution
- Nationwide Distribution.
- Lot, serial or model codes
- Part number: 84811 - 1.76 oz. Lot numbers: 10C0030-03, exp 3/12; 10C0034-03, exp 3/12; 10D0051-01, exp 4/12; 10D0059-02, exp 4/12; 10E0076-01, exp 5/12; 10H0112-03, exp 8/12; 10H0116-03, exp 8/12; 10J0143-02, exp 10/12; 11B0051-01, exp 2/13. Part number 84828, 4 oz. lot 10C0032, exp 3/12.
- 510(k) numbers
- ["K093585"]
- 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
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
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