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RecallWatchMedical Device Safety
Class IIOngoingZ-1427-2026

Stryker Corporation recalls MOLLI 2 System System includes: MM1000 (Pack of 10) - MOLLI Introducer (8cm

Stryker CorporationSan Jose, CA, United StatesReported Feb 25, 2026 · 4 months ago
Legal News Analyst ·

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.

Affected product

Check your device

Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.

Affected products & lots

  • 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
    Catalog # Number
    400 affected lots
    23-035024-011824-028924-029024-029124-047224-047324-0474
    +392 more24-053424-053524-053624-065824-066024-069725-002025-002125-002225-016025-016125-016225-035325-035425-105725-105825-106025-108723-000323-004623-005723-006223-012523-012623-012923-017623-017723-017923-041323-041424-0413MS-0000922-013023-002223-013023-017824-003524-011724-022524-023524-023624-065924-069624-071925-025125-0252MP200100850024195141100101114115138155158160163164174180181182184186190199202203216217218220221222225226227228229230231232234235236237238239240241242243244245246249250251252253254255256257258259260261262263264265266267268269270271273274275276277278279280281282283284285286287288290291292293294295296297298299300301302303304305307310311313315316317318319320321322323324326327328329330331332333334335336337338339340341342343344345346347348349351352353354355356357358359360361362363364365366367368369370371372373374375376377378379380381382383384385386387388389390391392393394395396397398399400401402403405406408409410411412413414415416417418419420421422423424425426427428429430431432433434435436437438439440441442443444446447448449450451453454455456457458460461464465466467468469470471472473474475476477478479480481482483484485486487488489490491492493494495496497498499500501502503504505506507508509510511512513514515516517518519520521522523524525526527528529530531532533534535536537538539540541542543544545546547548549550551552553554555556558559560561562

What the firm is doing

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.

DistributionShow details

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.

Class IIWhat this means

Use of the product may cause temporary or medically reversible adverse health consequences.

Sources & references

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.

Taylor Coteus
Legal News Analyst

Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.

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