# FDA recall Z-1427-2026

> **Stryker Corporation** · Class II · device recall initiated 2026-01-21.

## 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.

## 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, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WV, WI, and WY. The countries of Canada, Singapore, Panama, Jamaica, and Cayman Islands.

## Key facts

- **Recall number:** Z-1427-2026
- **Recalling firm:** Stryker Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2026-01-21
- **Report date:** 2026-02-25

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** San Jose, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1427-2026

## Citation

> AI Analytics. FDA recall Z-1427-2026. Retrieved 2026-08-18 from https://api.ai-analytics.org/recall/Z-1427-2026. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*