Reported Feb 25, 2026 · Ongoing

MOLLI 2 System System includes: MM1000 (Pack of 10) - MOLLI Introducer (8cm, 14G) and MOLLI Marker UDI (GTIN):…

Stryker Corporation

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Stryker Corporation · 5900 Optical Ct · San Jose, CA · 95138-1400

Is this the product you have?

  • 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
Lot codes and dates
  • Catalog NumberMM1000 (Pack
  • of 10) UDI (GTIN)00850024195028
  • Serial Numbers
    • 23-0350
    • 24-0118
    • 24-0289
    • 24-0290
    • 24-0291
    • 24-0472
    • 24-0473
    • 24-0474
    • 24-0534
    • 24-0535
    • 24-0536
    • 24-0658
    • 24-0660
    • 24-0697
    • 25-0020
    • 25-0021
    • 25-0022
    • 25-0160
    • 25-0161
    • 25-0162
    • 25-0353
    • 25-0354
    • 25-1057
    • 25-1058
    • 25-1060
    • 25-1087
    • 23-0003
    • 23-0046
    • 23-0057
    • 23-0062
    • 23-0125
    • 23-0126
    • 23-0129
    • 23-0176
    • 23-0177
    • 23-0179
    • 23-0413
    • 23-0414
    • 24-0413
  • Catalog NumberMS-00009 (Pack
  • of 10) UDI (GTIN)00850024195134
  • Serial Numbers
    • 22-0130
    • 23-0022
    • 23-0130
    • 23-0178
    • 24-0035
    • 24-0117
    • 24-0225
    • 24-0235
    • 24-0236
    • 24-0659
    • 24-0696
    • 24-0719
    • 25-0251
    • 25-0252
  • Catalog NumberMP2001
  • UDI (GTIN)00850024195141
  • Serial Numbers16 18 29 30 32 43 49 54 60 62 66 77 80 81 84 85 92 93

    489 of 489 codes

    • 100
    • 101
    • 114
    • 115
    • 138
    • 155
    • 158
    • 160
    • 163
    • 164
    • 174
    • 180
    • 181
    • 182
    • 184
    • 186
    • 190
    • 199
    • 202
    • 203
    • 216
    • 217
    • 218
    • 220
    • 221
    • 222
    • 225
    • 226
    • 227
    • 228
    • 229
    • 230
    • 231
    • 232
    • 234
    • 235
    • 236
    • 237
    • 238
    • 239
    • 240
    • 241
    • 242
    • 243
    • 244
    • 245
    • 246
    • 249
    • 250
    • 251
    • 252
    • 253
    • 254
    • 255
    • 256
    • 257
    • 258
    • 259
    • 260
    • 261
  • Catalog NumberMP2015A
  • UDI (GTIN)00850024195219
  • Serial Numbers

    408 of 408 codes

    • 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
    • 0063
    • 0065
    • 0066
    • 0070
    • 0073
    • 0074
    • 0075
    • 0076
    • 0078
    • 0079
    • 0080
    • 0081
    • 0082
    • 0085
    • 0086
    • 0087
    • 0088
    • 0089
    • 0090
    • 0091
    • 0092
    • 0094
    • 0095
    • 0096
    • 0097
    • 0099
    • 0100
    • 0101
    • 0103
    • 0104
    • 0105
    • 0106
    • 0107
    • 0108
    • 0109
  • Catalog NumberMT2001
  • UDI (GTIN)00850024195158
  • Serial Numbers3 33 34 35 36

    606 of 606 codes

    • 198
    • 202
    • 208
    • 210
    • 214
    • 215
    • 227
    • 228
    • 239
    • 240
    • 245
    • 246
    • 247
    • 247
    • 253
    • 263
    • 264
    • 268
    • 269
    • 270
    • 274
    • 277
    • 299
    • 302
    • 303
    • 304
    • 305
    • 306
    • 307
    • 308
    • 308
    • 309
    • 310
    • 311
    • 312
    • 313
    • 313
    • 314
    • 315
    • 316
    • 317
    • 318
    • 319
    • 320
    • 321
    • 322
    • 323
    • 403
    • 404
    • 505
    • 600
    • 602
    • 604
    • 606
    • 610
    • 611
    • 612
    • 613
    • 614
    • 615
Amount recalled
5,864

Where it was sold

Why it was recalled

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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 4:17 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.