Stryker MOLLI 2 System Recall: Marker Dislodgement Risk
Stryker is recalling the MOLLI 2 System due to magnetized surgical tools that may dislodge markers during target tissue removal procedures. The recall affects 5,864 units distributed worldwide.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: This is an FDA Class II recall involving a risk-of-harm product where injury has not yet been reported. The magnetized surgical tools may dislodge markers during procedures, posing a potential risk to patients, but no injuries have been reported at this time.
Plain-English summary
Stryker Corporation is recalling the MOLLI 2 System, a surgical device used to temporarily mark tissue during surgical procedures. The system includes the MOLLI Marker, which is placed percutaneously in soft tissue to mark a surgical site intended for removal.
The recall is due to a labeling issue. The Instructions for Use (IFU) need to be updated because magnetized surgical tools can dislodge the markers during target tissue removal procedures. This could affect the accuracy of the surgical procedure.
The recall affects 5,864 units distributed worldwide, including U.S. nationwide distribution across all 50 states and the District of Columbia, as well as in Canada, Singapore, Panama, Jamaica, and the Cayman Islands. Specific catalog numbers and serial numbers are listed in the recall notice.
Healthcare facilities and users should contact Stryker Corporation regarding the MOLLI 2 System recall. They should review the affected serial numbers and follow any instructions provided by the manufacturer. Consumers with questions should consult their healthcare provider or contact Stryker directly.
The recalled product
- Product
- MOLLI 2 System System includes: MM1000 (Pack of 10) - MOLLI Introducer (8cm, 14G) and MOLLI Marker UDI (GTIN): 00850024195028 MS-00009 (Pack of 10) - MOLLI Introducer (12cm, 14G) and MOLLI Marker UDI (GTIN): 00850024195134 MP2001 - MOLLI 2 Wand UDI (GTIN)…
- Manufacturer
- Stryker Corporation
- Affected units
- 5,864
Distribution
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