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MOLLI 2 Surgical Marker System
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MEDICAL DEVICE RECALLMODERATE

MOLLI 2 Surgical Marker System

Stryker is updating the MOLLI 2 System labeling due to the risk of magnetized surgical tools dislodging markers during tissue removal.

What to do

Healthcare providers should review the updated Instructions for Use provided by the manufacturer and ensure all staff are aware of the potential for marker dislodgement when using magnetized surgical tools.

Recalled
Listed
Updated
Recall No.
Z-1427-2026
Agency
FDA
Firm
Stryker Corporation
Recall ID
98295
Status
ONGOING

Why it was recalled

Stryker is recalling the MOLLI 2 System due to a need to update the Instructions for Use regarding the potential for magnetized surgical tools to dislodge markers during tissue removal procedures. This recall was distributed nationwide.

Is mine affected?

Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.

ProductUDI-DI
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 Marker00850024195028, 00850024195134, 00850024195141
MM1000 (Pack of 10) - MOLLI Introducer (8cm, 14G) and MOLLI Marker00850024195028
MS-00009 (Pack of 10) - MOLLI Introducer (12cm, 14G) and MOLLI Marker00850024195134
MP2001 - MOLLI 2 Wand00850024195141
MP2015A - MOLLI OncoPen00850024195219
MT2001 - MOLLI 2 Tablet00850024195158

Where it was sold

Distributed nationwide.

Timeline

  1. Firm initiated recall
  2. Publicly announced
  3. Listed on Recall Canary
  4. Summary updated

Other recent recalls from Stryker Corporation

All recalls from Stryker Corporation

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Editorial summary by Recall Canary · summary updated 2026-06-11 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification