FDA Medical devices recall · February 25, 2026

MOLLI 2 System System includes: MM1000 (Pack of 10) - MOLLI Introducer… recall

Read the official FDA notice ↗

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.

Why was it 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.

What should you do?

FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.

Product codes & lot numbers

Catalog Number: MM1000 (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 Number: MS-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 Number: MP2001 UDI (GTIN): 00850024195141 Serial Numbers: 16 18 29 30 32 43 49 54 60 62 66 77 80 81 84 85 92 93 100 101 114 115 138 155 158 160 163 164 174 180 181 182 184 186 190 199 202 203 216 217 218 220 221 222 225 226 227 228 229 230 231 232 234 235 236 237 238 239 240 241 242 243 244 245 246 249 250 251 252 253 254 255 256 257 258 259 260 261 262 263 264 265 266 267 268 269 270 271 273 274 275 276 277 278 279 280 281 282 283 284 285 286 287 288 290 291 292 293 294 295 296 297 298 299 300 301 302 303 304 305 307 310 311 313 315 316 317 318 319 320 321 322 323 324 326 327 328 329 330 331 332 333 334 335 336 337 338 339 340 341 342 343 344 345 346 347 348 349 351 352 353 354 355 356 357 358 359 360 361 362 363 364 365 366 367 368 369 370 371 372 373 374 375 376 377 378 379 380 381 382 383 384 385 386 387 388 389 390 391 392 393 394 395 396 397 398 399 400 401 402 403 405 406 408 409 410 411 4

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.

States: Alaska Alabama Arkansas Arizona California Colorado Connecticut District of Columbia Florida Georgia Hawaii Iowa Idaho Illinois Indiana Kansas Kentucky Louisiana Massachusetts Maryland Michigan Minnesota Missouri Mississippi Montana North Carolina Nebraska New Hampshire New Jersey New Mexico Nevada New York Ohio Oklahoma Oregon Pennsylvania South Carolina South Dakota Tennessee Texas Utah Virginia Vermont Washington Wisconsin West Virginia Wyoming

What does Class II mean?

Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.

Source: FDA (medical devices), recall Z-1427-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.