Class I — Serious Health Hazard

Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.

Face Lift Recalled by Customed, Inc Due to Customed has determined that there is the possibility...

Date: May 20, 2014
Company: Customed, Inc
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Customed, Inc directly.

Affected Products

Face Lift , Code 900-3083, contains: (I) SHEET ENT SPLIT 110" X 77" LIF (I) COVER TABLE REINFORCED 50" X 90" LIF (I) DRAPE HEAD WITH TAPE 44" X 26" LIF (I) COVER MAYO STAND REINFORCED LIF (I) BAG SUTURE FLORAL LIF (3) GOWN STANDARD LARGE SMS VEL/NE LABEL SAMPLE (I) COUNTER NEEDLE & BLADE 20C FOAM/MAG LIF ( I) STAPLE SKIN 35 WIDE LIF ( I) TUBE SUCTION CONNECT W' X 12' L/F ( I) PENCIL CAUTERY ROCKER SWITCH WITH HOLSTER LIF (10) GAUZE SPONGE 4" X 4" 16PLY XRD LIF (2) BLADE # I5 CARBON RIB ( I) NEEDLE SPINAL ANEST22G X 3\12 LIF ( I) PR. GLOVE SURG. CUSTOMGUARD CHLOROPRENE 8.0 POWDER FREE LIF (2) *PR. GLOVE SURG. 6.5 POWDER LATEX (I) GUT PL FAST ABSORB 5-0 (2) SUTURE 2.0 VICRYL 25MM (3) TOWELS ABSORBENT 15" X 20" LIF Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.

Quantity: 5 lots/ 32 units, multiple units per lot

Why Was This Recalled?

Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Customed, Inc

Customed, Inc has 682 total recalls tracked by RecallDetector.

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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report