MOLLI 2 System System includes: MM1000 (Pack of 10) - MOLLI Introducer (8cm, 14G) and MOLLI Marker UDI (GTIN): 008500241
FDA device recall Z-1427-2026 · posted 2026-02-17 · Open, Classified
Recall details
- Recalling firm
- Stryker Corporation
- Reason for recall
- Due to a need to update the product labeling (Instructions for Use IFU) as a result of the magnetized surgical tools dislodging markers using during target tissue removal procedures.
- Action taken
- On 01/21/2026, the firm sent via USPS certified mail an "URGENT: Medical Device Recall" Letter to customers informing them that Stryker has updated the MOLLI 2 System Instructions for Use (IFU) following two Medical Device Reports (MDRs) submitted to the FDA. These reports involved patient injuries associated with MOLLI marker dislodgement or dislocation due to magnetic attraction from magnetized surgical tools. The updated IFU now includes an additional warning that using magnetized surgical tools in close proximity to the marker during localization may lead to marker dislodgement. Customers are instructed to: 1. Inform individuals within their organization who need to be aware of this warning statement. 2. Review Attachment A regarding the warning statement that will be added to the IFU. Stryker estimates the updated IFUs to be released by 28FEB2026. No product return is required. 3. Complete Attachment B, Business Reply Form (page 4), as an acknowledgement of this notice and return the completed form via email to EndoRecall@Stryker.com. Response is required. 4. If customers have further distributed product, complete the table in Attachment B, Business Reply Form (page 4) and return the completed form via email to EndoRecall@Stryker.com. 5. Maintain awareness of this communication internally. For questions - contact Endorecall@stryker.com or Stryker Customer Service at 800-624-4422.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- NEU
- Quantity affected
- 5,864
- Distribution
- Worldwide - U.S. Nationwide distribution including in the states of AL, AK, AZ, AR, CA, CO, CT, DC, FL, GA, HI ID, IL, IN, IA, KS, KY, LA, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, OH, O
- Date initiated
- 2026-01-21
- Date posted
- 2026-02-17
- Location
- San Jose, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MOLLI 2 System (K253888) | Stryker Endoscopy | 2025-12-31 |
| MOLLI 2 (K231579) | Molli Surgical, Inc. | 2023-10-26 |