MOLLI 2 System System includes: MM1000 — Class II medical device recall Z-1427-2026
Ongoing recall by Stryker Corporation, reported 2026-02-25, distributed nationwide. Due to a need to update the product labeling (Instructions for Use IFU) as a result of the magnetized surgical
| Recall number | Z-1427-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Stryker Corporation, San Jose, CA, United States |
| Recall initiated | 2026-01-21 |
| Classified | 2026-02-17 |
| Reported by FDA | 2026-02-25 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, JM, KY, PA, SG |
| Quantity | 5,864 |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 00850024195028, 00850024195134, 00850024195141, 00850024195158, 00850024195219 |
| Serial numbers | 0010, 0023, 0030, 0031, 0032, 0033, 0034, 0035, 0036, 0038, 0039, 0041, 0042, 0043, 0044, 0045, 0046, 0049, 0050, 0052, 0054, 0055, 0056, 0057, 0059 and 475 more |
| Model numbers | MM1000, MP2001, MP2015A, MS-00009, MT2001 |
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): 00850024195141 MP2015A - MOLLI OncoPen UDI (GTIN): 00850024195219 MT2001 - MOLLI 2 Tablet UDI (GTIN): 00850024195158 The MOLLI Marker is intended to be placed percutaneously in soft tissue to temporarily mark a surgical site intended for surgical removal. the MOLLI Marker is located and surgically removed with the target tissue.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1427-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.