Recall Z-3297-2026 ยท OHD Gynecological Laparoscopic Kit
Cardinal Health 200, LLC
Presource Packs Containing Stryker StrykeFlow PS and AHTO tube sets: 1) KIT, GYN LAPAROSCOPY NEW HAN , Catalog Number: PB23GLNLAC; 2) KIT, GYN LAPAROSCOPY NEW HAN , Catalog Number: PB23GLNLA1; 3) KIT, GYN LAPAROSCOPY NEW HAN , Catalog Number: PB23GLNLA2; 4) KIT, GYN LAPAROSCOPY NEW HAN , Catalog Number: PB23GLNLA3; 5) KIT, GYN LAPAROSCOPY NEW HAN , Catalog Number: PB23GLNLA4; 6) KIT, GYN
| Date | Sep 25, 2026 (initiated Aug 18, 2026) |
| Status | Open, Classified |
| Reason | The kits contain tube sets with handpieces that may leak during use. The impacted devices can have the following failures: fluid leakage from the hand piece that can pool on the floor. The impact can range from user dissatisfaction to the potential for the user of slip and fall. |
| Root cause | Under Investigation by firm |
| Action | An URGENT: PRODUCT CORRECTION notification letter dated 8/18/26 was sent to customers. Presource has completed its investigation regarding this recall and determined that you may have received Presource kits containing the affected Stryker component(s) and lot number(s). Please reference the attached report identifying your facility s kits, along with the corresponding lot numbers that are affected by this action. If you locate affected product within your facility, please do the following: 1. QUARANTINE affected kits. 2. ALERT your clinicians of this action. 3. AFFIX a WARNING LABEL to the f |
| Quantity | 2957 kits |
| Distribution | US Nationwide distribution in the states of CA, IL, KY, MO, NC, NY, OH, TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.