Carestream Health, Inc.: Medical Device Recall in 2013 - (Recall #: Z-0744-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

KODAK INSIGHT DENTAL FILM in SureSoft Packets, Size 2 Single Packet Film, Model Number IP21S, REF/Catalog Number 8118226 --- COMMON/USUAL NAME: Dental Intraoral Radiographic Film -- 20 cartons of 80 packets. Product Usage: Dental intraoral radiography

Product Classification:

Class III

Date Initiated: January 17, 2013

Date Posted: February 13, 2013

Recall Number: Z-0744-2013

Event ID: 64135

Reason for Recall:

Missing symbols and manufacturing information on the clear carton label. The expiration dating symbol is missing but the expiration date is not missing. The Lot symbol is missing but the lot number is not missing. The Manufacturer symbol, name and address including country of origin are missing. All of the remaining symbols and information are on the case label. Missing information is only a

Status: Terminated

Product Quantity: 101 cartons: Domestic - 95 cartons; Foreign - 6 cartons

Code Information:

Lot 2114596 (Exp. September 2014)

Distribution Pattern:

US Nationwide Distribution including the states of California, Florida, Texas, Illinois, Indiana, Maryland, Pennsylvania and Canada.

Voluntary or Mandated:

Voluntary: Firm initiated