Recalls affecting Puerto Rico

FDA has not published a risk classification for this recall yet.

Recall #:

98087

Lot/product code:

(1) Model/Catalog Number: M14000; UDI-DI: 05707995032270; Serial Numbers: 616606, 616604, 591003, 591002, 590906, 590901, 590904, 590903, 590902, 591001, 604101, 604005, 591703, 591007, 591006, 591005, 591004, 615105, 615104, 615103, 615102, 615101, 604004, 604003, 604002, 604001, 614202, 614201, 591702, 591701, 616603, 615106, 590905; (2) Model/Catalog Number: M1401; UDI-DI: 05707995032270; Serial Numbers: 593302, 593301, 593303, 612507, 612506, 612508, 612505, 612503, 620702, 612504, 612502, 612501, 593304, 593305, 620703, 620701; (3) Model/Catalog Number: M1402; UDI-DI: 05707995032270; Serial Numbers: 612601; (4) Model/Catalog Number: M14050; UDI-DI: 05707995032270; Serial Numbers: 590801, 596701, 585701, 584501, 591801, 604405, 604406, 604402, 604404, 604403, 604401, 604303, 604302, 604301; (5) Model/Catalog Number: M14150; UDI-DI: 05707995032270; Serial Numbers: 585811, 585810, 585809, 585808, 585806, 585805, 585804, 585803, 585801, 596604, 596603, 596602, 596601, 596611, 596610, 596609, 596608, 596607, 596606, 596605, 585807, 585802; (6) Model/Catalog Number: M1402-01; UDI-DI: 05707995032270; Serial Numbers: 612701, 612703, 612702; (7) Model/Catalog Number: M14050-00; UDI-DI: 05707995032270; Serial Numbers: 584307; (8) Model/Catalog Number: M14001; UDI-DI: 05707995032270; Serial Numbers: 603501, 599801, 599802, 604202, 604201;

Recalling firm:

ETAC A/S

FDA has not published a risk classification for this recall yet.

Recall #:

98073

Lot/product code:

UDI/DI 03760124132076, All monitors

Recalling firm:

Sophysa

FDA has not published a risk classification for this recall yet.

Recall #:

98087

Lot/product code:

(1) Model/Catalog Number: 1430116; UDI-DI: TBD; (2) Model/Catalog Number: 1430117; UDI-DI: TBD; (3) Model/Catalog Number: 1430115; UDI-DI: TBD;

Recalling firm:

ETAC A/S

FDA has not published a risk classification for this recall yet.

Recall #:

98087

Lot/product code:

(1) Model/Catalog Number: M1501; UDI-DI: TBD; Serial Numbers: 601005, 601002, 611506, 621101, 621106, 621104, 621105, 621102, 611505, 611504, 611503, 611502, 611501, 601008, 611507, 601007, 601006, 601001, 621103, 601003, 601004; (2) Model/Catalog Number: M1502; UDI-DI: TBD; Serial Numbers: 611409, 611408, 611407, 611406, 611405, 611404, 611403, 611402, 611401, 611412, 611411, 611410; (3) Model/Catalog Number: M1504; UDI-DI: TBD; Serial Numbers: 600902, 600901, 611303, 611302, 611301; (4) Model/Catalog Number: M15050; UDI-DI: TBD; Serial Numbers: 586003, 586001, 585905, 585903, 585902, 585901, 598605, 586101, 585904, 603602, 591401, 586002, 586006, 586005, 586004, 598608, 598607, 585906, 591601, 598606, 598604, 598602, 598601, 596501, 603601, 598609, 598603; (5) Model/Catalog Number: M15151; UDI-DI: TBD; Serial Numbers: 599703, 599702, 599701; (6) Model/Catalog Number: M15001; UDI-DI: TBD; Serial Numbers: 584401; (7) Model/Catalog Number: M15002; UDI-DI: TBD; Serial Numbers: 591501, 591502;

Recalling firm:

ETAC A/S

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:

D-0239-2026

Lot/product code:

Lot: J1325J, I1725P, EXP Date: 4/30/2027.

Recalling firm:

Preferred Pharmaceuticals, Inc.

FDA has not published a risk classification for this recall yet.

Recall #:

98087

Lot/product code:

(1) Model/Catalog Number: 1530101; UDI-DI: TBD; (2) Model/Catalog Number: 1530102; UDI-DI: TBD;

Recalling firm:

ETAC A/S

FDA has not published a risk classification for this recall yet.

Recall #:

98068

Lot/product code:

UDI-DI: 10842418100975. Lot Number: 25-45. Expiration Date: 2028-11-01

Recalling firm:

Sheathing Technologies Inc

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:

D-0226-2026

Lot/product code:

Lot 5PB0183, exp 1/31/2027

Recalling firm:

Cipla USA, Inc.

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:

D-0224-2026

Lot/product code:

Lot, expiry: Lot 4PB0109, exp 1/31/2026; Lot 5PB0172, exp 1/31/2027

Recalling firm:

Cipla USA, Inc.

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:

D-0225-2026

Lot/product code:

Lot 5PB0164, exp 1/31/2027

Recalling firm:

Cipla USA, Inc.

FDA has not published a risk classification for this recall yet.

Recall #:

98359

Lot/product code:

Model/Catalog Number: SPL-S; UDI: 00821925044197; Serial Numbers: All;

Recalling firm:

Olympus Corporation of the Americas

FDA has not published a risk classification for this recall yet.

Recall #:

98359

Lot/product code:

Model/Catalog Number: SPL-SR; UDI: 00821925043824; Serial Numbers: All;

Recalling firm:

Olympus Corporation of the Americas

FDA has not published a risk classification for this recall yet.

Recall #:

98064

Lot/product code:

REF 1012-9620-222: GTIN 00195278626301; REF 1012-9620-000: GTIN 00840682103985; REF 1012-9620-200: GTIN 00195278439536; REF 1012-9620-202: GTIN 00195278626158; REF 1012-9620-212: GTIN 00195278626561; REF 1012-9650-222: GTIN 00195278626592; REF 1012-9650-000: GTIN 00840682103947; REF 1012-9650-200: GTIN 00195278439529; REF 1012-9650-202: GTIN 00195278626585; REF 1012-9650-212: GTIN 00195278625687; REF 1012-9655-202: GTIN 00195278625953; REF 1012-9620-002: GTIN 00840682124546; REF 1012-9620-012: GTIN 00195278569677; REF 1012-9650-002: GTIN 00840682124560; REF 1012-9650-012: GTIN 00195278569684; REF 1012-9655-000: GTIN 00840682103954; REF 1012-9655-002: GTIN 00840682124539; REF 1012-9655-200: GTIN 00195278439543.

Recalling firm:

GE Medical Systems China Co., Ltd.

FDA has not published a risk classification for this recall yet.

Recall #:

98064

Lot/product code:

REF 1012-9750-000: GTIN 00840682145596; REF 1012-9750-002: GTIN 00840682146470; REF 1012-9755-000: GTIN 00840682146425; REF 1012-9755-002: GTIN 00840682146463.

Recalling firm:

GE Medical Systems China Co., Ltd.

FDA has not published a risk classification for this recall yet.

Recall #:

98064

Lot/product code:

FRU 2076139-001-S, distributed between June 2, 2025 and October 21, 2025

Recalling firm:

GE Medical Systems China Co., Ltd.

FDA has not published a risk classification for this recall yet.

Recall #:

98359

Lot/product code:

Model/Catalog Number: SPL-G; UDI: 00821925044203; Serial Numbers: All;

Recalling firm:

Olympus Corporation of the Americas

FDA has not published a risk classification for this recall yet.

Recall #:

98031

Lot/product code:

UDI-DI: 00380740137410. GTIN: 06952999490048. Software versions 3.6.1 and lower. Serial Numbers: SCM01010 SCM01012 SCM01016 SCM01035 SCM01043 SCM01051 SCM01063 SCM01069 SCM01075 SCM01076 SCM01078 SCM01082 SCM01085 SCM01086 SCM01087 SCM01088 SCM01092 SCM01093 SCM01094 SCM01095 SCM01098 SCM01099 SCM01101 SCM01102 SCM01106 SCM01107 SCM01110 SCM01115 SCM01116 SCM01120 SCM01121 SCM01122 SCM01123 SCM01124 SCM01126 SCM01127 SCM01128 SCM01129 SCM01132 SCM01134 SCM01135 SCM01136 SCM01137 SCM01138 SCM01142 SCM01143 SCM01149 SCM01150 SCM01151 SCM01154 SCM01163 SCM01166 SCM01170 SCM01171 SCM01172 SCM01174 SCM01175 SCM01176 SCM01179 SCM01180 SCM01181 SCM01184 SCM01192 SCM01193 SCM01194 SCM01196 SCM01197 SCM01198 SCM01199 SCM01200 SCM01201 SCM01203 SCM01204 SCM01205 SCM01207 SCM01211 SCM01213 SCM01216 SCM01217 SCM01219 SCM01220 SCM01221 SCM01222 SCM01223 SCM01224 SCM01225 SCM01226 SCM01229 SCM01230 SCM01232 SCM01236 SCM01237 SCM01238 SCM01239 SCM01240 SCM01244 SCM01247 SCM01249 SCM01251 SCM01252 SCM01253 SCM01254 SCM01255 SCM01256 SCM01257 SCM01258 SCM01267 SCM01268 SCM01269 SCM01270 SCM01271 SCM01273 SCM01274 SCM01277 SCM01279 SCM01281 SCM01282 SCM01283 SCM01284 SCM01286 SCM01289 SCM01290 SCM01291 SCM01293 SCM01294 SCM01297 SCM01298 SCM01300 SCM01301 SCM01302 SCM01305 SCM01306 SCM01307 SCM01308 SCM01310 SCM01312 SCM01313 SCM01314 SCM01315 SCM01316 SCM01317 SCM01320 SCM01321 SCM01323 SCM01326 SCM01328 SCM01333 SCM01334 SCM01335 SCM01336 SCM01337 SCM01338 SCM01339 SCM01340 SCM01341 SCM01342 SCM01343 SCM01344 SCM01345 SCM01346 SCM01348 SCM01349 SCM01350 SCM01354 SCM01355 SCM01356 SCM01357 SCM01361 SCM01362 SCM01365 SCM01368 SCM01370 SCM01371 SCM01372 SCM01373 SCM01374 SCM01375 SCM01376 SCM01377 SCM01378 SCM01379 SCM01380 SCM01381 SCM01382 SCM01383 SCM01385 SCM01386 SCM01387 SCM01388 SCM01389 SCM01393 SCM01394 SCM01395 SCM01396 SCM01397 SCM01399 SCM01401 SCM01402 SCM01403 SCM01404 SCM01405 SCM01406 SCM01407 SCM01408 SCM01409 SCM01411 SCM01412 SCM01414 SCM01415 SCM01416 SCM01417 SCM01418 SCM01421 SCM01422 SCM01423 SCM01424 SCM01425 SCM01429 SCM01430 SCM01431 SCM01432 SCM01433 SCM01434 SCM01437 SCM01438 SCM01439 SCM01440 SCM01442 SCM01443 SCM01444 SCM01445 SCM01446 SCM01447 SCM01448 SCM01449 SCM01450 SCM01451 SCM01452 SCM01453 SCM01454 SCM01455 SCM01456 SCM01457 SCM01458 SCM01460 SCM01461 SCM01462 SCM01465 SCM01466 SCM01467 SCM01468 SCM01469 SCM01470 SCM01471 SCM01473 SCM01474 SCM01475 SCM01476 SCM01478 SCM01479 SCM01480 SCM01481 SCM01483 SCM01485 SCM01486 SCM01487 SCM01489 SCM01491 SCM01492 SCM01493 SCM01494 SCM01495 SCM01496 SCM01497 SCM01499 SCM01501 SCM01503 SCM01504 SCM01505 SCM01506 SCM01508 SCM01511 SCM01512 SCM01513 SCM01515 SCM01517 SCM01518 SCM01519 SCM01524 SCM01525 SCM01526 SCM01527 SCM01528 SCM01529 SCM01530 SCM01531 SCM01532 SCM01534 SCM01535 SCM01536 SCM01539 SCM01540 SCM01542 SCM01544 SCM01545 SCM01547 SCM01548 SCM01553 SCM01556 SCM01557 SCM01558 SCM01560 SCM01561 SCM01562 SCM01563 SCM01564 SCM01566 SCM01567 SCM01568 SCM01569 SCM01570 SCM01571 SCM01572 SCM01575 SCM01576 SCM01577 SCM01579 SCM01580 SCM01581 SCM01582 SCM01584 SCM01586 SCM01587 SCM01588 SCM01589 SCM01593 SCM01594 SCM01595 SCM01597 SCM01598 SCM01599 SCM01600 SCM01601 SCM01602 SCM01603 SCM01604 SCM01605 SCM01607 SCM01608 SCM01609 SCM01610 SCM01611 SCM01613 SCM01615 SCM01616 SCM01617 SCM01618 SCM01619 SCM01620 SCM01622 SCM01623 SCM01624 SCM01625 SCM01627 SCM01630 SCM01631 SCM01632 SCM01633 SCM01634 SCM01635 SCM01636 SCM01638 SCM01641 SCM01642 SCM01645 SCM01647 SCM01648 SCM01649 SCM01650 SCM01651 SCM01652 SCM01654 SCM01655 SCM01657 SCM01659 SCM01660 SCM01661 SCM01662 SCM01665 SCM01666 SCM01668 SCM01669 SCM01670 SCM01678 SCM01680 SCM01681 SCM01682 SCM01683 SCM01684 SCM01686 SCM01687 SCM01688 SCM01689 SCM01690 SCM01693 SCM01697 SCM01698 SCM01699 SCM01700 SCM01701 SCM01704 SCM01705 SCM01707 SCM01708 SCM01709 SCM01711 SCM01712 SCM01714 SCM01715 SCM01716 SCM01717 SCM01718 SCM01719 SCM01720 SCM01721 SCM01722 SCM01725 SCM01728 SCM01729 SCM01730 SCM01731 SCM01732 SCM01733 SCM01734 SCM01735 SCM01738 SCM01739 SCM01740 SCM01741 SCM01744 SCM01749 SCM01750 SCM01751 SCM01752 SCM01753 SCM01754 SCM01755 SCM01756 SCM01757 SCM01758 SCM01759 SCM01760 SCM01761 SCM01762 SCM01763 SCM01764 SCM01765 SCM01767 SCM01768 SCM01770 SCM01772 SCM01773 SCM01776 SCM01778 SCM01779 SCM01780 SCM01781 SCM01782 SCM01783 SCM01784 SCM01785 SCM01786 SCM01787 SCM01788 SCM01789 SCM01790 SCM01791 SCM01792 SCM01794 SCM01795 SCM01797 SCM01798 SCM01799 SCM01800 SCM01802 SCM01803 SCM01806 SCM01807 SCM01808 SCM01809 SCM01810 SCM01811 SCM01812 SCM01813 SCM01814 SCM01815 SCM01816 SCM01817 SCM01818 SCM01819 SCM01820 SCM01821 SCM01822 SCM01823 SCM01824 SCM01825 SCM01826 SCM01827 SCM01828 SCM01829 SCM01830 SCM01831 SCM01832 SCM01833 SCM01835 SCM01838 SCM01840 SCM01842 SCM01843 SCM01844 SCM01845 SCM01846 SCM01848 SCM01849 SCM01851 SCM01852 SCM01856 SCM01857 SCM01858 SCM01859 SCM01860 SCM01862 SCM01866 SCM01867 SCM01868 SCM01869 SCM01870 SCM01871 SCM01872 SCM01873 SCM01874 SCM01877 SCM01878 SCM01879 SCM018… (truncated, 104974 characters total — see the official FDA record for the full value)

Recalling firm:

Abbott Laboratories

FDA has not published a risk classification for this recall yet.

Recall #:

98066

Lot/product code:

DYND04000, UDI-DI: 10193489191349(each), 20193489191346(case), Lot Number: 2023102590

Recalling firm:

Medline Industries, LP

FDA has not published a risk classification for this recall yet.

Recall #:

97987

Lot/product code:

UDI-DI: 30845357020018; Lot Number: 818-111-7

Recalling firm:

Microbiologics Inc

FDA has not published a risk classification for this recall yet.

Recall #:

98066

Lot/product code:

DYNJ04048, UDI-DI: 10193489195248(each), 20193489195245(case), Lot Number: 2023112290

Recalling firm:

Medline Industries, LP

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:

D-0179-2026

Lot/product code:

Lot#: 71409, Expires: 02/28/2027; 71861, Expires: 08/31/2027.

Recalling firm:

Medical Products Laboratories, Inc.

FDA has not published a risk classification for this recall yet.

Recall #:

97967

Lot/product code:

1. UDI-DI 848838018831, lots 305529, 311228, 316019, 320993 2. UDI-DI 848838091353, lot 317287

Recalling firm:

Remel, Inc

FDA has not published a risk classification for this recall yet.

Recall #:

97976

Lot/product code:

Product Code Lot # UDI-DI (GTIN): CT5500T ALL LOT NUMBERS LESS THAN OR EQUAL TO 22GASN045 CS- 50885380172371 EA- 20885380172370; CT5502T ALL LOT NUMBERS LESS THAN OR EQUAL TO 22GASN044 CS 50885380172395 EA - 20885380172394; CT5503T ALL LOT NUMBERS LESS THAN OR EQUAL TO 22GASN036 CS 50885380172418 EA - 20885380172417; CT5504T ALL LOT NUMBERS LESS THAN OR EQUAL TO 22EASN004 CS- 50885380172432 EA- 20885380172431; CT5505T ALL LOT NUMBERS LESS THAN OR EQUAL TO 22GASN043 CS- 50885380172456 EA- 20885380172455; DP5001GT ALL LOT NUMBERS LESS THAN OR EQUAL TO 22GASN033 CS- 50885380173989 EA-20885380173988; DP5002GT ALL LOT NUMBERS LESS THAN OR EQUAL TO 22EASN020 CS- 50885380173996 EA-20885380173995; DP5003GT ALL LOT NUMBERS LESS THAN OR EQUAL TO 22GASN020 CS- 50885380173972 EA-20885380173971; DP5004GT ALL LOT NUMBERS LESS THAN OR EQUAL TO 22BASN087 CS- 50885380174009 EA-20885380174008; CT5500TS 21KAS095 CS- 50885380172388 EA-20885380172387; CT5502TS 21KAS059 CS- 50885380172401 EA-10885380172403; CT5503TS 21KAS106, 21LAS004, 21LAS017 CS- 50885380172425 EA-10885380172427; CT5504TS 21KAS064, 21KAS072, 21KAS109 CS- 50885380172449 EA-10885380172441; CT5505TS 21KAS019, 21KAS031 CS- 50885380172463 EA-10885380172465;

Recalling firm:

Cardinal Health 200, LLC

FDA has not published a risk classification for this recall yet.

Recall #:

97988

Lot/product code:

Part Number: 6000-390-000; UDI-DI: 37613327097628; Lots: 6000106885, 6000106894, 6000106895, 6000106896;

Recalling firm:

Howmedica Osteonics Corp.

FDA has not published a risk classification for this recall yet.

Recall #:

98288

Lot/product code:

Model No. WA22017A; UDI: 04042761051514; All Lots.

Recalling firm:

Olympus Corporation of the Americas