Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.
LAPAROSCOPY CHOLECYSTECTOMY SURGICAL PACK - - (1) DRAPE LAPAROS/ABDOMINAL UF Recalled by Customed, Inc Due to Customed has determined that there is the possibility...
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
LAPAROSCOPY CHOLECYSTECTOMY SURGICAL PACK - - (1) DRAPE LAPAROS/ABDOMINAL UF (1) GOWN IMPER. EXTRA REINFORCED LGE TIVVRAP (1) BLADE SURGICAL #11 STAINLESS STEEL (1) TIME OUT BEACON NON WOVEN UF (10) GAUZE SPONGE 4" X 4" 16PLY XRD UF (1) GOWN XLARGE SMS IMPERV. REINFORCED (3) TOWEL ABSORBENT 15" X 20" UF (1) TUBBING INSUFFLATION SET WITHOUT RING (1) MAYO STAND COVER REINFORCED UF (1) NEEDLE & BLADE COUNTER 20c FOAM/MAG UF (1) TABLE COVER REINFORCED 50" X 90" UF (1) SKIN MARKER INKW/8LABEUTIME OUT/RULER (1) DRAPE SHEET 41 " X 58" SMS UF (1) BAG SUTURE FLORAL (4) DRAPE UTILITY UF (1) TUR CYSTO IRRIGATION SET 79" SINGLE UF (1) TUBE SUCTION CONNECT. 3/16 " x 12' UF EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
Quantity: 2 lots; 40 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.
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