FDA-Device2026-02-25Class II

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 s

Stryker Corporation

Hazard

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.

Sold states

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.

Affected count

5,864

Manufactured in

5900 Optical Ct, San Jose, CA, United States

Products

Official notice

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

Original summary

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. 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. 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 93 100 101 114 115 138 155 158 160 163 164 174 180 181 182 184 186 190 199 202 203 216 217 218 220 221 222 225 226 227 228 229 230 231 232 234 235 236 237 238 239 240 241 242 243 244 245 246 249 250 251 252 253 254 255 256 257 258 259 260 261 262 263 264 265 266 267 268 269 270 271 273 274 275 276 277 278 279 280 281 282 283 284 285 286 287 288 290 291 292 293 294 295 296 297 298 299 300 301 302 303 304 305 307 310 311 313 315 316 317 318 319 320 321 322 323 324 326 327 328 329 330 331 332 333 334 335 336 337 338 339 340 341 342 343 344 345 346 347 348 349 351 352 353 354 355 356 357 358 359 360 361 362 363 364 365 366 367 368 369 370 371 372 373 374 375 376 377 378 379 380 381 382 383 384 385 386 387 388 389 390 391 392 393 394 395 396 397 398 399 400 401 402 403 405 406 408 409 410 411 412 413 414 415 416 417 418 419 420 421 422 423 424 425 426 427 428 429 430 431 432 433 434 435 436 437 438 439 440 441 442 443 444 446 447 448 449 450 451 453 454 455 456 457 458 460 461 464 465 466 467 468 469 470 471 472 473 474 475 476 477 478 479 480 481 482 483 484 485 486 487 488 489 490 491 492 493 494 495 496 497 498 499 500 501 502 503 504 505 506 507 508 509 510 511 512 513 514 515 516 517 518 519 520 521 522 523 524 525 526 527 528 529 530 531 532 533 534 535 536 537 538 539 540 541 542 543 544 545 546 547 548 549 550 551 552 553 554 555 556 558 559 560 561 562 563 564 565 566 567 568 569 570 571 573 574 575 576 577 578 580 581 583 584 585 586 587 588 589 590 592 601 605 606 607 608 609 610 611 612 613 614 615 616 617 618 619 620 621 622 623 624 625 626 627 628 629 630 631 632 633 634 635 636 637 638 639 640 641 644 645 646 647 651 652 653 654 655 656 657 658 659 660 661 662 663 666 670 674 675 730 742 743 745 747 750 751 752 753 754 755 756 757 758 763 764 765 766 767 768 769 772 773 775 776 777 780 782 783 784 785 786 787 788 929 930 940 959 973 976 981 982 984 986 988 990 995 997 998 1001 1003 1004 1005 1006 1008 1009 1014 1015 1016 1092 Catalog Number: MP2015A UDI (GTIN): 00850024195219 Serial Numbers: 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 0110 0111 0112 0113 0114 0115 0116 0117 0118 0121 0122 0123 0124 0125 0126 0127 0128 0129 0131 0132 0133 0135 0136 0137 0138 0139 0140 0142 0143 0148 0149 0150 0151 0152 0153 0154 0155 0156 0157 0158 0159 0160 0161 0162 0164 0165 0166 0167 0168 0169 0170 0171 0172 0173 0174 0175 0176 0177 0179 0180 0181 0182 0183 0184 0186 0190 0192 0194 0197 0198 0199 0200 0201 0202 0203 0204 0205 0206 0207 0208 0209 0210 0211 0213 0215 0216 0217 0218 0219 0220 0221 0222 0223 0225 0226 0227 0229 0230 0231 0232 0234 0235 0236 0237 0238 0241 0242 0243 0245 0246 0247 0248 0249 0250 0251 0252 0253 0254 0255 0256 0257 0258 0259 0260 0262 0264 0265 0266 0267 0268 0270 0272 0273 0279 0280 0282 0283 0286 0289 0290 0291 0292 0293 0294 0296 0297 0298 0299 0300 0301 0302 0303 0304 0305 0306 0307 0308 0309 0310 0311 0312 0313 0314 0315 0316 0317 0318 0319 0321 0323 0324 0325 0326 0327 0328 0329 0330 0332 0333 0334 0335 0336 0337 0338 0339 0340 0341 0343 0344 0345 0346 0347 0348 0349 0350 0353 0355 0357 0359 0361 0362 0363 0364 0366 0368 0369 0371 0372 0373 0375 0376 0377 0379 0381 0382 0383 0384 0385 0386 0388 0389 0390 0391 0392 0393 0394 0395 0396 0397 039

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