RecallRadar

FDA Device recall Z-2496-2014

Tummy Tuck Pack, code 900-2684, contains: (3) GOWN SOFT SMS STD XLGE SET IN SLEEVE ( 1) CAUTERY PENCIL PUSH BOTTOM ( 1) TUBE SUCTION CONNEC…

On 2014-09-10 the FDA classified a Class I recall of Tummy Tuck Pack, code 900-2684, contains: (3) GOWN SOFT SMS STD XLGE SET IN SLEEVE ( 1) CAUTERY PENCIL PUSH BOTTOM ( 1) TUBE SUCTION CONNEC… by Customed, citing 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 t….

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-2496-2014
ClassificationClass I
Statusterminated
Initiated2014-05-20
Published2014-09-10
Last updated2026-09-13 11:53 UTC
CompanyCustomed
DistributionUS

Product

Tummy Tuck Pack, code 900-2684, contains: (3) GOWN SOFT SMS STD XLGE SET IN SLEEVE ( 1) CAUTERY PENCIL PUSH BOTTOM ( 1) TUBE SUCTION CONNECT ( 1) MAYO STAND COVER REINFORCED ( 1) SKIN MARKER INK W LABEL (2) TABLE COVER REINFORCED 50 X 90 ( 1) RULER 6 (6) TOWEL CLOTH HUCK (BLUE) (10) LAP SPONGE PREWASH 18 X 18 XRD ( 1) CAUTERY TIP POLISHER ( 1) DRAPE BREAST/CHEST SMS Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.

Reason

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.

Identifiers

code_infoCode 900-2684, 2 lots: 112093646 113057473

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2496-2014%22

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