Medline Recalls Gynecologic Robotic Surgery Kits Due to Contamination
Medline Industries is recalling 1,349 gynecologic robotic surgery kits nationwide because they contain a potentially contaminated component.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a potentially contaminated component in medical devices used for surgery, which poses a risk of harm, but the source text does not report any specific illnesses, injuries, or hospitalizations, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Medline Industries, LP is recalling 1,349 convenience kits used for gynecologic robotic and laparoscopic surgeries. The recall is being conducted because the kits contain a potentially contaminated component that was recalled by the manufacturer.
The affected products include various Medline kits such as GYN ROBOTIC CDS, GYN ROBOTIC ADD ON PACK, OH GYN/LAP ROBOT PACK, and GYN LAPAROSCOPY PACK. These kits were distributed nationwide in the states of AL, CA, FL, IL, KS, LA, MA, MD, MO, MS, MT, NV, NY, OH, OK, SC, TX, and WI.
Healthcare facilities and consumers should check their inventory for the specific Medline Kit SKUs and lot numbers listed in the official recall notice. If you have these products, do not use them and contact Medline Industries for instructions on how to return or dispose of the affected kits.
The recalled product
- Product
- Medline convenience kits labeled as: 1) GYN ROBOTIC CDS, Medline Kit SKU CDS982888Q; 2) GYN ROBOTIC ADD ON PACK, Medline Kit SKU DYNJ43837D; 3) OH GYN/LAP ROBOT PACK, Medline Kit SKU DYNJ89759; 4) GYN LAPAROSCOPY PACK, Medline Kit SKU DYNJ89781; 5) ROBOT ME RF, Medline
- Manufacturer
- Medline Industries, LP
- Category
- Medical Device — Surgical Kits
- Hazard
- Affected units
- 1,349
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Medline Kit SKU CDS982888Q
- UDI/DI 10198459521959 (each) 40198459521950 (case)
- Lot Number 26FBU894
- Lot Number 26BBF959
- Medline Kit SKU DYNJ43837D
- UDI/DI 10195327657222 (each) 40195327657223 (case)
- Lot Number 25KMH001
- Medline Kit SKU DYNJ89759
- UDI/DI 10198459289286 (each) 40198459289287 (case)
- Lot Number 26ABN671
- Lot Number 25JBT511
- Medline Kit SKU DYNJ89781
- UDI/DI 10198459289521 (each) 40198459289522 (case)
- Lot Number 26DBT722
- Lot Number 25JBL333
- Medline Kit SKU DYNJ900203N
- UDI/DI 10198459510144 (each) 40198459510145 (case)
- Lot Number 25KBF320
- Lot Number 25JBS159
- Medline Kit SKU DYNJ900541Q
Distribution
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