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FDA food · drug · device recalls, merged

Before you eat it, take it, or plug it in — check.

Big Nope pulls three separate FDA recall feeds into one list per state, so you’re not searching three government databases to get one answer.

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Straight from FDA press releases — not yet formally classified or risk-graded
UnclassifiedUndeclaredAnnounced September 4, 2026

Business Pill, Branch Manager for Men — dietary supplements marketed for male sexual enhancement

Products contain undeclared yohimbine

▸Full report
Dietary SupplementsFood & Beverages

Recalling firm: SUPPLX.com

Grant-Valkaria, Florida - SUPPLX.com is voluntarily recalling Business Pill and Branch Manager for Men, products marketed as dietary supplements for male sexual enhancement, because FDA laboratory analysis confirmed that both products contain yohimbine that is not declared on the product labels.

Company contact: (321) 341-9501 · SupplxRecall@gmail.com

View FDA’s announcement (opens in a new tab)
UnclassifiedBacteria/virusSalmonellaAnnounced September 4, 2026

Foods Alive — Moringa Leaf Powder

Potential to be contaminated with Salmonella

▸Full report
Food & BeveragesFoodborne Illness

Recalling firm: Foods Alive Inc.

Foods Alive Inc of Angola, IN, is recalling its 8-ounce packages of organic moringa leaf powder because they have the potential to be contaminated with Salmonella , an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.

View FDA’s announcement (opens in a new tab)
UnclassifiedAnnounced September 3, 2026

B. Braun — 0.9% Sodium Chloride Injection USP, 100 mL, in a 150 mL PAB® Container

Presence of particulate matter identified as iron oxide

▸Full report
Drugs

Recalling firm: B. Braun Medical Inc.

“On September 3, 2026 firm updated their press release to include additional contaminants.” FOR IMMEDIATE RELEASE – September 3, 2026– Bethlehem, PA, B. Braun Medical Inc (B. Braun) is voluntarily recalling three (3) lots of 0.9% Sodium Chloride Injection USP, 100 mL, in a 150 mL PAB® Container, to the hospital/healthcare facility/user level due to presence of particulate matter identified as iron…

Company contact: recalls@bbraunusa.com

View FDA’s announcement (opens in a new tab)
UnclassifiedBacteria/virusE. coliAnnounced September 3, 2026

Great Value — Organic Triple Berry Blend

Possible E. Coli Contamination

▸Full report
Food & BeveragesFoodborne Illness

Recalling firm: Frutas y Hortalizas del Sur S.A.

September 02, 2026. Frutas y Hortalizas del Sur S.A., San Carlos, Chile expands its July 3, 2026, recall of frozen organic IQF blueberries to include one lot of Great Value frozen Organic Triple Berry Blend 10 OZ because of potential contamination with Escherichia coli O145:H28 (E. coli O145) .

Company contact: Info.foodsafety@comfrut.com

View FDA’s announcement (opens in a new tab)
UnclassifiedAnnounced September 3, 2026

American Regent, Inc. — Epinephrine Injection, USP 30 mg/ 30 mL (1 mg/mL) multi dose vial

Presence of particulate matter and lack of sterility assurance

▸Full report
Food & Beverages

Recalling firm: American Regent, Inc.

FOR IMMEDIATE RELEASE – September 3, 2026 – New Albany, OH, American Regent, Inc. is conducting a nationwide voluntary recall of three lots of Epinephrine Injection, USP 30 mg/ 30 mL (1 mg/mL) multi dose vials to the consumer level. Customer complaints were received for leaking and cracked vials, resulting in lack of assurance of sterility.

View FDA’s announcement (opens in a new tab)
UnclassifiedAllergenMilkUndeclaredAnnounced August 31, 2026

Little Temptations — Chocolatey Eyeballs, 7 oz., 10 oz., 10.5 oz., 11 oz., and 16 oz.

Undeclared milk

▸Full report
Food & BeveragesAllergens

Recalling firm: Crystal Temptations

Crystal Temptations of North Arlington, NJ is recalling Halloween Chocolatey Eyeballs because they contain undeclared MILK allergens. People who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reaction if they consume these products.

View FDA’s announcement (opens in a new tab)
UnclassifiedUndeclaredAnnounced August 31, 2026

Lipofit — Lipofit Extreme 2.0 Fat Burner Dietary Supplement

Undeclared Fluoxetine and 2,4-Dinitrophenol (DNP)

▸Full report
Dietary SupplementsDrugs

Recalling firm: Ana Salazar Modela Tu Cuerpo Inc.

FOR IMMEDIATE RELEASE - August 27, 2026 - Davie, Florida – Ana Salazar Modela Tu Cuerpo Inc. is recalling Lipofit Extreme Fat Burner 2.0, Lot 25M12F, expiration date 09/2027, to the consumer level.

Company contact: (954) 305-1004 · yandrydy@gmail.com

View FDA’s announcement (opens in a new tab)
UnclassifiedAnnounced August 31, 2026

Kofinas — Garlic Mediterranean Infused Extra Virgin Olive Oil 500 ml, 250 ml, and 100 ml

Contains garlic essential oil not approved for culinary use

▸Full report
Food & BeveragesIngredients

Recalling firm: LMSI LLC

Cincinnati, OH (Aug. 29, 2026) - LMSI LLC/ Kofinas Olive Oil is issuing a voluntary recall of its Garlic Mediterranean infused extra virgin olive oil for using a garlic essential oil not approved for culinary use. The flavored oil was bottled in glass bottles in 500 ml, 250 ml, and 100 ml sizes.

View FDA’s announcement (opens in a new tab)
UnclassifiedBacteria/virusSalmonellaE. coliAnnounced August 29, 2026

Everything Sprouts — Robust Radish Mix, 5oz Cups

Potential to be contaminated with Shiga toxin-producing Escherichia coli (STEC) or Salmonella.

▸Full report
Food & BeveragesFoodborne Illness

Recalling firm: Everything Sprouts, LLC

Everything Sprouts, LLC, based in Minneapolis, MN is expanding its voluntary recall of sprouts to include certain lots of Robust Radish Sprout Mix because it has the potential to be contaminated with Shiga toxin producing Escherichia coli (STEC) or Salmonella bacteria.

Company contact: everythingsproutsmn@gmail.com

View FDA’s announcement (opens in a new tab)
UnclassifiedBacteria/virusSalmonellaAnnounced August 29, 2026

Martina — Mangoes

Potential contamination with Salmonella

▸Full report
Food & BeveragesFoodborne Illness

Recalling firm: Panorama Produce

MAMARONECK, NY, AUG. 28, 2026 - Panorama Produce is recalling 302 boxes of size 9 (nine) mangoes because they may be contaminated with Salmonella , an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.

Company contact: information@panoramaproduce.com

View FDA’s announcement (opens in a new tab)

Recalls nationwide

Data last updated: September 10, 2026 at 1:16 PM UTC

19,408 recalls found
Wording
UnclassifiedRisk not yet known
Medical deviceRecalled February 27, 2026

Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes ANGIO KIT PACK DYNJ50783B ANGIO PHC DYNJ37485C C.I.C.N. ANGIO PACK DYNJ53064B FHT P NEURO PACK DYNJ39931D NEURO ARTERIOGRAM PACK-LF DYNJ0948060F NEURO KIT NAM0003 NEURO PACK DYNJ61542D NEURO RADIOLOGY PACK DYNJ59903B NEURO TRAY DYNJ84872A PK, CATH LAB-ANGIO DYNJ44027F QVH IR NEURO PACK DYNJ62176

Unapproved design changes to the products outside of the 510(k) clearance.

ALL 50 STATES
▸Full report

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

Recall #:
98601
Lot/product code:
DYNJ50783B UDI-DI 10193489227376 (EA) 40193489227377 (CS) LOT 23FBF183 DYNJ37485C UDI-DI 10193489760002 (EA) 40193489760003 (CS) LOTS 20BBX692 20DBC089 20EBG816 20FBR153 20HBN288 20IBK578 20KBW291 21BBB266 21CBW198 21FBH674 21GBS840 21GBS842 21JBU703 21LBX721 22BBV337 22EBN708 22IBJ467 22JBH996 22KBU901 22OBJ150 23ABG615 23BBF603 23CBC306 DYNJ53064B UDI-DI 10193489789164 (EA) 40193489789165 (CS) LOT 23HMI416 DYNJ39931D UDI-DI 10193489459364 (EA) 40193489459365 (CS) LOTS 23BBB182 23DBK363 24HBJ427 24JBI915 24JBV985 24KBH817 25GBI670 25IBS445 DYNJ0948060F UDI-DI 10889942825103 (EA) 40889942825104 (CS) LOTS 23FMA240 24EBR693 24GLB224 24HLA705 24JLA904 NAM0003 UDI-DI 10193489222555 (EA) 40193489222556 (CS) LOTS 20DBO375 20GBC317 20GBJ719 20HBC159 20HBD815 20HBF519 20IBA514 23CMC981 23DMC490 23DMF161 23GMA353 23HME057 23HMG264 23IMF173 23JMF878 23JMH829 23KME885 23LMA780 23LMD088 23LMG059 24AMF167 24AMH128 24EMG747 24HMJ041 24JMC680 DYNJ61542D UDI-DI 10195327507923 (EA) 40195327507924 (CS) LOT 24FMC929 DYNJ59903B UDI-DI 10195327131203 (EA) 40195327131204 (CS) LOTS 23EBQ216 23HBC089 23IBE176 23KBL439 23LBO494 24ABL938 24CBQ708 24EBB108 24FBA584 24FBN897 24JBC983 24JBO349 24KBB061 24KBT242 24LBP491 DYNJ84872A UDI-DI 10195327481506 (EA) 40195327481507 (CS) LOTS 23LBN462 24ABC179 DYNJ44027F UDI-DI 10193489783490 (EA) 40193489783491 (CS) LOTS 21FLA184 21FLA910 21ILA783 21JLA542 21LLA177 22ALA731 22BLA802 22DLA497 22ELA818 22FLA432 22GLB161 22HLB062 22JBC795 22JBM045 22KBO209 22KBO210 23DBR512 23FBQ563 23GBK955 23HBY707 23JBT738 23KBF311 23KBU563 24ABW467 24GBK560 24HBB843 24IBI798 24IBR643 24JBF292 DYNJ62176 UDI-DI 10193489631784 (EA) 40193489631785 (CS) LOTS 23ELA677 23GLA263 23KLB156 ***Updated 5/20/26 - The following lots were included in the customer letter but not the FDA submission.*** DYNJ0948060F lots 21AMA919 21AMB491 21BMC178 21HMF800 21JMG472 22AMB406 22CMI927 22EMC824 22GMF261 22IMA651 22JMG952 22KME549 22LMD531 23AMD745 23AMJ626 23CMB808 23DMC060 23EMB613 23EMG672 23GMG693 23GMI438 23IMG055 23KBR802 24ABP567 25ALA622 25ALA678 25CLA317 25DLA949 25ELA692; DYNJ39931D lots 21ABW861 21CBY118 21DBN140 21HBN105 21KBO171 21LBP808 21LBP811 22CBY154 22FBA263 22JBU799 23BBR777 23BBT177 23EBS918 23FBO983 23GBR315 23GBW410 23HBJ976 23IBJ863 23KBC962 23LBU944 24ABK323 24ABP442 24BBH773 24GBO821; DYNJ44027F lots 21BLA158 21CLA034 21DLA700 25EBE984 25EBU842; DYNJ50783B lots 21DBL972 21FBK452 21GBA227 21IBA354 21JBO239 21KBP327 21LBB845 21LBU425 22DBC322 22DBN517 22EBK090 22FBK172 22HBU114 22KBQ551 22KBQ552 23BBJ725 23CBO941 23EBC283; DYNJ59903B lots 22EBI499 22FBF028 22FBR425 22IBJ538 22LBQ311 23ABN466 23CBJ596 23CBP099 25DBF626; DYNJ62176 lots 21ALA437 21BLA178 21BLA238 21BLA352 21CLA516 21GLB100 22ALA163 22BLB207 22ELB041 22KLA092 22LLA728 23ALA743 23BLA184 23KLB124 24BLA180 24ELA039 24JLA075; DYNJ84872A lots 23IBS046; NAM0003 lots 21BBF218 21CBE230 21DBV018 21EBS508 21GBI653 21KBO486 21LBB470 22CME110 22EMH496 25AMG212 25BMA481 25BMF357 25BMH684 25DMH014 25DMH503 25EMD617 25EMI879
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 27, 2026

Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. CRANIOTOMY PACK-LF DYNJ0101292F DYNJ0101292G HYBRID PACK DYNJ65925A LAMINECTOMY DYNJ905156L DYNJ905156M DYNJ905156N DYNJ905156O DYNJ905156P MAJOR EXTREMITY DYNJ905159F DYNJ905159I DYNJ905159J DYNJ905159K NEURO CERVICAL PACK DYNJ0101287J DYNJ0101287K NEURO SPINE PACK DYNJ81612C POSTERIOR SPINE PACK-LF DYNJ0843339L DYNJ0843339M DYNJ0843339N SPINE PACK DYNJ30150F

Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.

ALL 50 STATES
▸Full report

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

Recall #:
99062
Lot/product code:
DYNJ0101292F UDI-DI 10193489434040 Lots 21CDC411 21EDA768 21EDC107 21HDA937 21HDC815 21IDC204 21KDA780 22ADA317 22ADC159 22BDA066 22CDA470 22EDB043 22EDB214 22IDA695 DYNJ0101292G UDI-DI 10195327286255 Lots 22KDB031 23BDA768 23DDA637 23EDA187 23HDB829 23JDA057 23LDA727 24ADA469 24ADC048 24HDA453 DYNJ65925A UDI-DI 10193489427264 Lots 21BLA577 21DLA194 21DLA397 DYNJ905156L UDI-DI 10193489397369 Lots 21EBI411 DYNJ905156M UDI-DI 10193489908961 Lots 21HBC497 21HBT672 DYNJ905156N UDI-DI 10193489996371 Lots 21LBQ932 22BBB708 22DBP992 22DBQ776 22FBQ287 DYNJ905156O UDI-DI 10195327219949 Lots 22HBR341 22HBW892 22KBC930 22KBC932 22KBK539 23DBD118 23DBD666 23EBC709 DYNJ905156P UDI-DI 10195327405847 Lots 23GBH099 23GBH829 23GBH830 23HBK732 23JBS610 23JBS704 23LBD615 23LBO186 24ABQ915 24CBD453 DYNJ905159F UDI-DI 10193489397475 Lots 21CBF265 21FBF870 21HBK984 21HBO573 21JBD205 21LBC602 22BBQ673 22CMH568 22EMD159 22GMG564 DYNJ905159I UDI-DI 10195327219987 Lots 22JMF458 22LMH325 23DMI033 23EMF058 DYNJ905159J UDI-DI 10195327406028 Lots 23FMC192 23FMG785 23GMI481 23HMF747 23IMG923 23IMI383 23JMA274 DYNJ905159K UDI-DI 10195327556884 Lots 23LMF481 24BMA401 24CMJ402 DYNJ0101287J UDI-DI 10195327286484 Lots 23ADA628 23EDA927 23GDA587 23HDC199 DYNJ0101287K UDI-DI 10195327500177 Lot 23JDC525 DYNJ81612C UDI-DI 10195327536145 Lot 24BBB406 DYNJ0843339L UDI-DI 10193489345544 Lots 21EDC223 21FDB611 DYNJ0843339M UDI-DI 10193489964615 Lots 21HDB435 21IDB916 21KDC093 22BDA178 22DDA738 22EDA069 22EDB876 22HDC322 22JDA142 22KDB701 DYNJ0843339N UDI-DI 10195327286552 Lots 23ADA251 23BDB752 23DDB611 23FDA191 23HDB830 23IDB329 23JDA990 23LDA449 DYNJ30150F UDI-DI 10889942186679 Lot 24BBE416
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 27, 2026

Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as follows: SPECIAL PROCEDURE TRAY, Medline SKU # DYNJ80513B

Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.

ALL 50 STATES
▸Full report

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

Recall #:
98598
Lot/product code:
Medline SKU # DYNJ80513B, UDI/DI each 10198459389375, UDI/DI case 40198459389376, Lot Numbers: 26ABH752, 25LBL571, 25KBO421, 25IBF501, 25HBL993, 25FBU283.
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 27, 2026

Brand Name: Olympus SOLTIVE Premium SuperPulsed Laser System Product Name: SOLTIVE Premium Laser System TFL-PLS Model/Catalog Number: TFL-PLS containing TFL-CPLU Product Description: An electricity powered device assembly which emits a high-power laser beam to vaporize/ablate soft tissue with moderate hemostasis, little charring, and a thin zone of necrosis. Component: No

Following a complaint investigation, Olympus identified a potential defect in the 24V power supply module in some SOLTIVE laser units which may cause the system to become inoperable. Additionally, smoke or a burning smell may occur. By design, the issue causing the smoke or burning smell would be contained within the internal laser console enclosure and would be self-extinguishing.

ALL 50 STATES
▸Full report

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

Recall #:
98422
Lot/product code:
Laser system: TFL-PLS; UDI: 00821925044111; Component Part: TFL-CPLU; UDI: 00821925044586; Serial #: MDUF220005, MDUF220005, MDUF220437, MDUF220437, MDUF220446, MDUF220446, MDUF190072, MDUF200324, MDUF210030, MDUF210204, MDUF210379, MDUF220001, MDUF220002, MDUF220003, MDUF220007, MDUF220008, MDUF220009, MDUF220010, MDUF220011, MDUF220012, MDUF220013, MDUF220014, MDUF220015, MDUF220016, MDUF220017, MDUF220018, MDUF220019, MDUF220020, MDUF220021, MDUF220022, MDUF220023, MDUF220024, MDUF220025, MDUF220026, MDUF220027, MDUF220028, MDUF220029, MDUF220030, MDUF220031, MDUF220032, MDUF220033, MDUF220034, MDUF220035, MDUF220036, MDUF220037, MDUF220038, MDUF220039, MDUF220040, MDUF220042, MDUF220043, MDUF220044, MDUF220045, MDUF220046, MDUF220047, MDUF220048, MDUF220049, MDUF220050, MDUF220051, MDUF220052, MDUF220053, MDUF220054, MDUF220055, MDUF220056, MDUF220057, MDUF220058, MDUF220060, MDUF220061, MDUF220062, MDUF220063, MDUF220064, MDUF220065, MDUF220066, MDUF220067, MDUF220069, MDUF220070, MDUF220071, MDUF220072, MDUF220074, MDUF220075, MDUF220076, MDUF220077, MDUF220078, MDUF220079, MDUF220080, MDUF220081, MDUF220082, MDUF220083, MDUF220084, MDUF220085, MDUF220086, MDUF220087, MDUF220088, MDUF220089, MDUF220090, MDUF220091, MDUF220092, MDUF220093, MDUF220094, MDUF220095, MDUF220096, MDUF220097, MDUF220098, MDUF220100, MDUF220101, MDUF220102, MDUF220103, MDUF220106, MDUF220109, MDUF220110, MDUF220111, MDUF220113, MDUF220114, MDUF220115, MDUF220116, MDUF220117, MDUF220119, MDUF220120, MDUF220123, MDUF220124, MDUF220126, MDUF220127, MDUF220128, MDUF220130, MDUF220131, MDUF220133, MDUF220135, MDUF220137, MDUF220138, MDUF220139, MDUF220140, MDUF220141, MDUF220142, MDUF220143, MDUF220144, MDUF220145, MDUF220146, MDUF220147, MDUF220149, MDUF220150, MDUF220151, MDUF220152, MDUF220153, MDUF220154, MDUF220155, MDUF220156, MDUF220157, MDUF220158, MDUF220159, MDUF220160, MDUF220161, MDUF220162, MDUF220163, MDUF220164, MDUF220165, MDUF220166, MDUF220167, MDUF220168, MDUF220170, MDUF220171, MDUF220172, MDUF220173, MDUF220174, MDUF220175, MDUF220176, MDUF220177, MDUF220178, MDUF220179, MDUF220180, MDUF220181, MDUF220182, MDUF220183, MDUF220184, MDUF220185, MDUF220186, MDUF220187, MDUF220188, MDUF220189, MDUF220190, MDUF220191, MDUF220192, MDUF220193, MDUF220194, MDUF220195, MDUF220196, MDUF220198, MDUF220199, MDUF220200, MDUF220201, MDUF220202, MDUF220203, MDUF220204, MDUF220205, MDUF220206, MDUF220207, MDUF220208, MDUF220209, MDUF220210, MDUF220211, MDUF220212, MDUF220213, MDUF220214, MDUF220216, MDUF220217, MDUF220218, MDUF220219, MDUF220220, MDUF220221, MDUF220222, MDUF220223, MDUF220224, MDUF220225, MDUF220226, MDUF220227, MDUF220228, MDUF220229, MDUF220230, MDUF220231, MDUF220232, MDUF220233, MDUF220234, MDUF220235, MDUF220237, MDUF220238, MDUF220240, MDUF220241, MDUF220242, MDUF220243, MDUF220244, MDUF220245, MDUF220246, MDUF220247, MDUF220248, MDUF220249, MDUF220250, MDUF220251, MDUF220252, MDUF220253, MDUF220254, MDUF220255, MDUF220256, MDUF220257, MDUF220258, MDUF220259, MDUF220260, MDUF220261, MDUF220262, MDUF220263, MDUF220264, MDUF220265, MDUF220266, MDUF220267, MDUF220268, MDUF220269, MDUF220270, MDUF220271, MDUF220272, MDUF220273, MDUF220274, MDUF220275, MDUF220276, MDUF220277, MDUF220278, MDUF220279, MDUF220280, MDUF220281, MDUF220283, MDUF220284, MDUF220285, MDUF220286, MDUF220287, MDUF220288, MDUF220289, MDUF220291, MDUF220292, MDUF220294, MDUF220295, MDUF220296, MDUF220297, MDUF220298, MDUF220299, MDUF220300, MDUF220301, MDUF220302, MDUF220303, MDUF220304, MDUF220305, MDUF220306, MDUF220307, MDUF220308, MDUF220309, MDUF220310, MDUF220311, MDUF220312, MDUF220313, MDUF220314, MDUF220315, MDUF220316, MDUF220317, MDUF220318, MDUF220320, MDUF220321, MDUF220322, MDUF220323, MDUF220324, MDUF220326, MDUF220327, MDUF220328, MDUF220329, MDUF220330, MDUF220332, MDUF220333, MDUF220334, MDUF220335, MDUF220336, MDUF220337, MDUF220338, MDUF220339, MDUF220340, MDUF220341, MDUF220342, MDUF220343, MDUF220344, MDUF220345, MDUF220346, MDUF220347, MDUF220348, MDUF220349, MDUF220350, MDUF220351, MDUF220358, MDUF220359, MDUF220360, MDUF220361, MDUF220362, MDUF220364, MDUF220365, MDUF220366, MDUF220367, MDUF220368, MDUF220370, MDUF220371, MDUF220373, MDUF220374, MDUF220375, MDUF220377, MDUF220378, MDUF220379, MDUF220380, MDUF220381, MDUF220382, MDUF220383, MDUF220384, MDUF220385, MDUF220388, MDUF220389, MDUF220391, MDUF220392, MDUF220394, MDUF220397, MDUF220399, MDUF220400, MDUF220402, MDUF220403, MDUF220404, MDUF220405, MDUF220406, MDUF220407, MDUF220408, MDUF220409, MDUF220410, MDUF220415, MDUF220416, MDUF220417, MDUF220418, MDUF220419, MDUF220420, MDUF220421, MDUF220423, MDUF220424, MDUF220425, MDUF220426, MDUF220428, MDUF220429, MDUF220431, MDUF220432, MDUF220433, MDUF220434, MDUF220435, MDUF220436, MDUF220438, MDUF220439, MDUF220440, MDUF220441, MDUF220442, MDUF220443, MDUF220444, MDUF220445, MDUF220448, MDUF220449, MDUF220450, MDUF220457, MDUF220458, MDUF220459, MDUF220460, MDUF220461, MDUF220462, MDUF220463, M… (truncated, 11118 characters total — see the official FDA record for the full value)
Recalling firm:
Olympus Corporation of the Americas
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 27, 2026

Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes GU DAVINCI PACK - LF DYNJ909398A ROBOTIC PACK DYNJ908706D

Unapproved design changes to the products outside of the 510(k) clearance.

ALL 50 STATES
▸Full report

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

Recall #:
98601
Lot/product code:
DYNJ909398A UDI-DI 10195327338190 (EA) 40195327338191 (CS) LOTS 24GMH510 24HMG886 DYNJ908706D UDI-DI 10198459017773 (EA) 40198459017774 (CS) LOTS 24HMA783 24HMG308 24KMC651 24KMJ274 24LME931 25AME217 25BMI653 ***Updated 5/20/26 - The following lots were included in the customer letter but not in the FDA submission.*** DYNJ909398A lots 23EMF078 23HME512 23HMI269 23JMB528 23KME175 24EMC327
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 27, 2026

Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. FTMC C-SECTION TRAY-LF DYNJ54603B

Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.

ALL 50 STATES
▸Full report

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

Recall #:
99062
Lot/product code:
DYNJ54603B UDI-DI 10195327458188 Lot 24ABO124
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 27, 2026

Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. ANGIOGRAPHY PACK-LF DYNJ0854485S DEEP BRAIN STIMULATION PACK DYNJ0842793G NEURO ACCESSORY PACK DYNJ55385A NEURO ANGIO PACK DYNJ51697B DYNJ56509G DYNJ56509I DYNJ68063 DYNJ68845 DYNJ68845A DYNJ68845B NEURO CERVICAL PACK DYNJ0101287I DYNJ0101287L NEURO PACK DYNJ82103 DYNJ82103A NEURO TRAY DYNJ67075 DYNJ67075A DYNJ67075B NEURO VASCULAR PACK DYNJ62960B NEURO VP SHUNT PACK-LF DYNJ0843121J DYNJ0843121K NEUROLOGICAL CATH PACK DYNJ63434A DYNJ63434C NEURORADIOLOGY PK DYNJ40420D RADIOLOGY ANGIO MAJOR PACK-LF DYNJ62858A RADIOLOGY NEURO DRAPE PAC DYNJ61449 RRMC ANGIO PACK DYNJ36338B

Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.

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▸Full report

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

Recall #:
99062
Lot/product code:
DYNJ0854485S UDI-DI 10193489250558 Lot 21BMA604 DYNJ0842793G UDI-DI 10195327293666 Lots 22LDA183 23EDB049 23HDC042 23JDA988 24DDA005 DYNJ55385A UDI-DI 10193489762129 Lot 21ALA184 DYNJ51697B UDI-DI 10889942893652 Lots 21ABE325 21CBH476 21DBV407 21HBH690 21JBN408 21LBL194 21VBB105 22DBL109 22EBH117 22FBS410 22JBM660 22LBJ592 22NBG350 23BBR238 23CBH111 23DBN366 23GBE252 23HBP266 DYNJ56509G UDI-DI 10193489832082 Lots 21BBQ398 21BBR321 21CBO123 21DBM014 DYNJ56509I UDI-DI 10193489947113 Lots 21HBI572 21HBK163 DYNJ68063 UDI-DI 10193489872040 Lot 21FBN698 DYNJ68845 UDI-DI 10193489481006 Lot 21JBZ479 DYNJ68845A UDI-DI 10195327058104 Lot 22CBF908 22EBS916 DYNJ68845B UDI-DI 10195327211806 Lot 22HBL865 DYNJ0101287I UDI-DI 10193489434033 Lots 21CDA247 21EDA767 21GDC130 21HDA996 21KDA985 21LDA070 22BDA782 22CDC182 22EDB032 22GDA474 22IDB680 22KDB540 DYNJ0101287L UDI-DI 10195327567064 Lots 23LDB486 24BDB244 24FDA276 24FDB664 24HDC055 DYNJ82103 UDI-DI 10195327170998 Lots 22EMI175 22GMA639 DYNJ82103A UDI-DI 10195327260910 Lot 22KMH267 DYNJ67075 UDI-DI 10193489388473 Lot 21LLA292 DYNJ67075A UDI-DI 10195327054533 Lots 22CLB355 22DLA398 22ELA122 22ELA567 22FLA224 22HLA108 22HLB180 22ILB148 22KLA076 22LLA785 23ALA638 DYNJ67075B UDI-DI 10195327470852 Lots 23JLA177 23JLB271 23LLA274 24ALA492 24HLA695 24ILA933 24KLA029 24LLA559 25ALA880 DYNJ62960B UDI-DI 10193489911558 Lot 21HBD207 DYNJ0843121J UDI-DI 10193489444605 Lots 21ADB535 21CDC104 21FDC074 21HDB833 21HDC829 21LDA977 22ADB259 22BDB407 22EDB544 22GDA480 22HDB045 22KDA482 DYNJ0843121K UDI-DI 10195327286491 Lots 22KDB422 23DDB255 23EDB879 23GDA826 23IDC125 23JDA989 24ADC199 24BDB803 24GDB414 DYNJ63434A UDI-DI 10193489234886 Lots 21CBL981 21DBI016 21GBC948 21GBP926 21IBN513 21KBE479 21LBB983 22ABX228 22BBA201 22FBD018 22FBO659 22FBT491 22GBA743 22HBC353 22JBH927 22OBK976 DYNJ63434C UDI-DI 10195327445072 Lots 23GBQ452 23KBU655 DYNJ40420D UDI-DI 10193489925258 Lots 22BLB191 22DLA630 23ALA110 DYNJ62858A UDI-DI 10193489777550 Lot 21BMD592 DYNJ61449 UDI-DI 10193489567342 Lots 22LMD608 23EMG292 DYNJ36338B UDI-DI 10193489294071 Lots 21BMA293 21CMB071 21DMD790
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 27, 2026

Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as follows: 1. NON VASCULAR PACK, Medline SKU # DYNJ68037C; 2. VEIN, Medline SKU # DYNJ89845; 3. VEIN, Medline SKU # DYNJ89845A.

Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.

ALL 50 STATES
▸Full report

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

Recall #:
98598
Lot/product code:
Medline SKU # DYNJ68037C, UDI/DI each 10198459239328, UDI/DI case 40198459239329, Lot Number: 25HBV397; Medline SKU # DYNJ89845, UDI/DI each 10198459292460, UDI/DI case 40198459292461, Lot Number: 25CBU222; Medline SKU # DYNJ89845A, UDI/DI each 10198459490965, UDI/DI case 40198459490966, Lot Number: 26BBC195; Medline SKU # DYNJ89845A, UDI/DI each 10198459490965, UDI/DI case 40198459490966, Lot Number: 26ABI611; Medline SKU # DYNJ89845A, UDI/DI each 10198459490965, UDI/DI case 40198459490966, Lot Number: 25LBK402; Medline SKU # DYNJ89845A, UDI/DI each 10198459490965, UDI/DI case 40198459490966, Lot Number: 25KBH371; Medline SKU # DYNJ89845A, UDI/DI each 10198459490965, UDI/DI case 40198459490966, Lot Number: 25IBK975; Medline SKU # DYNJ89845A, UDI/DI each 10198459490965, UDI/DI case 40198459490966, Lot Number: 25HBQ426.
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 27, 2026

Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as follows: MINOR PLASTIC-LF, Medline Kit SKU # DYNJ86596

Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.

ALL 50 STATES
▸Full report

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

Recall #:
98598
Lot/product code:
Medline Kit SKU # DYNJ86596, UDI/DI each 10195327656119, UDI/DI case 40195327656110, Lot Numbers: 24FMI029, 24DMK138.
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 27, 2026

Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes EXTREMITY PACK DYNJ34846C HAND PACK DYNJ83218A, DYNJ85396 LAMINECTOMY DYNJ905156R MAJOR EXTREMITY DYNJ905159L, DYNJ905159M MAJOR EXTREMITY PACK DYNJ69926A PODIATRY PACK DYNJ41250B

Unapproved design changes to the products outside of the 510(k) clearance.

ALL 50 STATES
▸Full report

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

Recall #:
98601
Lot/product code:
DYNJ34846C UDI-DI 10193489781441 (EA) 40193489781442 (CS) LOT 24BBA459 DYNJ83218A UDI-DI 10195327382308 (EA) 40195327382309 (CS) LOT 24BBD199 DYNJ85396 UDI-DI 10195327497613 (EA) 40195327497614 (CS) LOT 24BBA503 DYNJ905156R UDI-DI 10198459017704 (EA) 40198459017705 (CS) LOTS 24HBG726 24JBJ484 25ABS758 25BBR196 25CBN174 25EBE136 DYNJ905159L UDI-DI 10195327664251 (EA) 40195327664252 (CS) LOT 24EMB726 DYNJ905159M UDI-DI 10198459017735 (EA) 40198459017736 (CS) LOT 24GMA714 24HMD401 24HMJ945 24JMD201 24KMG592 25AMC024 25BMD945 25CMG373 DYNJ69926A UDI-DI 10195327153601 (EA) 40195327153602 (CS) LOT 24ABS445 DYNJ41250B UDI-DI 10888277801257 (EA) 40888277801258 (CS) LOT 24ABO122 ***Updated 5/20/26 - The following lots were included in the customer letter but not the FDA submission.*** DYNJ905156R lots 24GBD135 24IBK563 24IBS862 25BBH767
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 27, 2026

Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. ANGIOGRAM PACK-LF DYNJ21574J JUDKINS PACK DYNJ51126

Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.

ALL 50 STATES
▸Full report

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

Recall #:
99062
Lot/product code:
DYNJ21574J UDI-DI 10889942153497 Lots 21ALA586 21CLA398 21ELA408 21FLA144 21FLA788 21HLA420 21ILA431 DYNJ51126 UDI-DI 10889942122820 Lots 21ADA917
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 27, 2026

SIGNA Premier systems

Whole-Body MR scanners used to produce images of the inside of the human body to aid diagnosis of disease may have been manufactured/serviced with ferrous (steel) fittings instead of non-ferrous (brass) fittings on the magnet rear and if system is accessed to perform service while the magnet is ramped, the magnetic field could attract the ferrous fittings potentially resulting in personnel injury.

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▸Full report

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

Recall #:
98579
Lot/product code:
UDI-DI/GTIN: 00840682135269, 00195278010797. System ID: 415353UMR2, 415723SHMR19, 413253MR3T, 908725MR, 609652MR3T, M48823, 7168453T, 513584MR5, 513636EASTMR, 513636T1MR, 605333MRPRM, 832522CRMR1, 703858PRE2, 804675VA3T, 082427110162, 082427220143, 082427020147, 082427200242, 082427160461, 082427250139, 082427140382, M4216469, 353745MR01, GON5655515, KRMR56474971, KRMR56203791, KRMR55433661, KRMR56344161, KRMR55774051, KRMR55914661, NOMRI26833321, 15974045, GON1882380, ESMRI27056983, ESMRI26960129, A203MR06, 690120MR01, 11524261, VNMRI26792525, VNMRI26592248, VNMRI26809677
Recalling firm:
GE Healthcare LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 27, 2026

Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as follows: 1. MTS RH LFT HRT KIT, Medline SKU # 60010508; 2. MTS 3V W/GUIDE, Medline SKU # 60100701; 3. ANGIOGRAPHY KIT, Medline SKU # 60131209; 4. MTS LHK, Medline SKU # 60160075; 5. MTS LHK, Medline SKU # 60161954; 6. MTO LHK, Medline SKU # 60230148; 7. GENERAL SURGERY TRAY, Medline SKU # 00-500510I; 8. BIOBURDEN TEST KIT - 686, Medline SKU # BIOB686; 9. RADIO ANGIO UNIV HOSP PACK-LF, Medline SKU # DYNJ0376145M; 10. SPECIALS PACK-LF, Medline SKU # DYNJ0392706K; 11. CARDIAC CATH PACK-LF, Medline SKU # DYNJ0451426O; 12. CARDIAC CATH PACK-LF, Medline SKU # DYNJ0451426P; 13. CARDIAC CATH PACK, Medline SKU # DYNJ07953N; 14. CATH PACK-LF, Medline SKU # DYNJ0803367J; 15. E.P. TRAY, Medline SKU # DYNJ19343J; 16. CARDIAC CATH PACK, Medline SKU # DYNJ20898T; 17. CATH LAB TRAY, Medline SKU # DYNJ24250G; 18. CATH LAB PACK-LF, Medline SKU # DYNJ38333D; 19. CATH LAB PACK-LF, Medline SKU # DYNJ38333F; 20. EP IMPLANT PACK-LF, Medline SKU # DYNJ38910D; 21. ADULT CATH LAB PACK, Medline SKU # DYNJ40380J; 22. CRANIOTOMY PACK-LF, Medline SKU # DYNJ43403D; 23. LAP CHOLE PACK, Medline SKU # DYNJ48487F; 24. CATH LAB ANGIOGRAPHY PACK, Medline SKU # DYNJ50779G; 25. CATH LAB ANGIOGRAPHY PACK, Medline SKU # DYNJ50779I; 26. HYBRID, Medline SKU # DYNJ57049N; 27. SPECIALS PK, Medline SKU # DYNJ57713C; 28. SPECIALS PK, Medline SKU # DYNJ57713D; 29. SPECIALS PK, Medline SKU # DYNJ57713F; 30. CARDIAC CATH LAB, Medline SKU # DYNJ57748A; 31. TAVR PACK, Medline SKU # DYNJ58771G; 32. CATH PACK GWV, Medline SKU # DYNJ59229F; 33. HEART CATH PACK, Medline SKU # DYNJ61294F; 34. CATH LAB PACK, Medline SKU # DYNJ61353C; 35. DEVICE IMPLANT PACK, Medline SKU # DYNJ64636A; 36. CUSTOM PROCEDURE KIT, Medline SKU # DYNJ65277A; 37. GENERAL VASCULAR PACK RFID-V2, Medline SKU # DYNJ66442F; 38. CARDIAC CATH PACK, Medline SKU # DYNJ69845C; 39. OMF MINOR PACK, Medline SKU # DYNJ83991C; 40. HEART CATH PACK, Medline SKU # DYNJ84133B; 41. SPECIAL PROCEDURES, Medline SKU # DYNJ85425B; 42. PRIMARY PACK, Medline SKU # DYNJT3093; 43. CARDIAC CATH PACK, Medline SKU # DYNJT3522A; 44. CARDIAC CATH PACK, Medline SKU # DYNJT3522B; 45. TOTAL KNEE PACK, Medline SKU # DYNJT4069; 46. CARDIAC CATH PACK, Medline SKU # DYNJT5685; 47. CATH PACK, Medline SKU # DYNJT6544; 48. PACK CARDIAC CATH, Medline SKU # DYNJT7591; 49. OBL CATH VEIN PACK, Medline SKU # DYNJT7863; 50. TUMESCENT SYRINGE KIT, Medline SKU # DYNJTUMSYR; 51. CSTM LH KIT, Medline SKU # VASC1054; 52. LHK, Medline SKU # VASC1130A; 53. MANIFOLD KIT, Medline SKU # VASC1137A; 54. LHK, Medline SKU # VASC1299A; 55. LHK, Medline SKU # VASC1399B; 56. LHK, Medline SKU # VASC1403; 57. IR 2 PORT, Medline SKU # VASC1404; 58. LHK, Medline SKU # VASC1405; 59. LHK, Medline SKU # VASC1455A; 60. TWO PORT MANIFOLD KIT, Medline SKU # VASC1496; 61. RHK, US, NAMIC MANIFOLD, Medline SKU # VASC1502; 62. LHK, Medline SKU # VASC1555; 63. 4 VALVE,PERC,MANIFOLD,KIT, Medline SKU # VASC1609; 64. LHK, Medline SKU # VASC1668; 65. LHK, Medline SKU # VASC1694; 66. LHK, Medline SKU # VASC1805; 67. TVR, Medline SKU # VASC1816.

Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.

ALL 50 STATES
▸Full report

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

Recall #:
98598
Lot/product code:
Medline SKU # 60010508, UDI/DI each 10193489040340, UDI/DI case 40193489040341, Lot Number: 26BBI625; Medline SKU # 60010508, UDI/DI each 10193489040340, UDI/DI case 40193489040341, Lot Number: 26ABB718; Medline SKU # 60010508, UDI/DI each 10193489040340, UDI/DI case 40193489040341, Lot Number: 25JBJ140; Medline SKU # 60010508, UDI/DI each 10193489040340, UDI/DI case 40193489040341, Lot Number: 25HBF702; Medline SKU # 60010508, UDI/DI each 10193489040340, UDI/DI case 40193489040341, Lot Number: 25GBC747; Medline SKU # 60010508, UDI/DI each 10193489040340, UDI/DI case 40193489040341, Lot Number: 25DBR341; Medline SKU # 60010508, UDI/DI each 10193489040340, UDI/DI case 40193489040341, Lot Number: 25CBK686; Medline SKU # 60010508, UDI/DI each 10193489040340, UDI/DI case 40193489040341, Lot Number: 25ABR102; Medline SKU # 60010508, UDI/DI each 10193489040340, UDI/DI case 40193489040341, Lot Number: 24IBK765; Medline SKU # 60010508, UDI/DI each 10193489040340, UDI/DI case 40193489040341, Lot Number: 24GBS605; Medline SKU # 60010508, UDI/DI each 10193489040340, UDI/DI case 40193489040341, Lot Number: 24EBO156; Medline SKU # 60010508, UDI/DI each 10193489040340, UDI/DI case 40193489040341, Lot Number: 24BBG055; Medline SKU # 60010508, UDI/DI each 10193489040340, UDI/DI case 40193489040341, Lot Number: 24ABH036; Medline SKU # 60010508, UDI/DI each 10193489040340, UDI/DI case 40193489040341, Lot Number: 23LBI829; Medline SKU # 60010508, UDI/DI each 10193489040340, UDI/DI case 40193489040341, Lot Number: 23KBN009; Medline SKU # 60010508, UDI/DI each 10193489040340, UDI/DI case 40193489040341, Lot Number: 23FBO996; Medline SKU # 60010508, UDI/DI each 10193489040340, UDI/DI case 40193489040341, Lot Number: 23FBA259; Medline SKU # 60010508, UDI/DI each 10193489040340, UDI/DI case 40193489040341, Lot Number: 23EBD151; Medline SKU # 60100701, UDI/DI each 10193489045246, UDI/DI case 40193489045247, Lot Number: 24IBE239; Medline SKU # 60100701, UDI/DI each 10193489045246, UDI/DI case 40193489045247, Lot Number: 24HBR112; Medline SKU # 60100701, UDI/DI each 10193489045246, UDI/DI case 40193489045247, Lot Number: 24GBY032; Medline SKU # 60100701, UDI/DI each 10193489045246, UDI/DI case 40193489045247, Lot Number: 24BBO470; Medline SKU # 60100701, UDI/DI each 10193489045246, UDI/DI case 40193489045247, Lot Number: 24ABB436; Medline SKU # 60100701, UDI/DI each 10193489045246, UDI/DI case 40193489045247, Lot Number: 23LBA225; Medline SKU # 60100701, UDI/DI each 10193489045246, UDI/DI case 40193489045247, Lot Number: 23GBK257; Medline SKU # 60100701, UDI/DI each 10193489045246, UDI/DI case 40193489045247, Lot Number: 23FBG433; Medline SKU # 60100701, UDI/DI each 10193489045246, UDI/DI case 40193489045247, Lot Number: 23FBC618; Medline SKU # 60100701, UDI/DI each 10193489045246, UDI/DI case 40193489045247, Lot Number: 23EBX036; Medline SKU # 60100701, UDI/DI each 10193489045246, UDI/DI case 40193489045247, Lot Number: 23DBD220; Medline SKU # 60131209, UDI/DI each 10193489046779, UDI/DI case 40193489046770, Lot Number: 24HBJ211; Medline SKU # 60160075, UDI/DI each 10193489048872, UDI/DI case 40193489048873, Lot Number: 24EBQ349; Medline SKU # 60160075, UDI/DI each 10193489048872, UDI/DI case 40193489048873, Lot Number: 24CBD613; Medline SKU # 60160075, UDI/DI each 10193489048872, UDI/DI case 40193489048873, Lot Number: 24ABL640; Medline SKU # 60160075, UDI/DI each 10193489048872, UDI/DI case 40193489048873, Lot Number: 23KBB857; Medline SKU # 60160075, UDI/DI each 10193489048872, UDI/DI case 40193489048873, Lot Number: 23IBC156; Medline SKU # 60160075, UDI/DI each 10193489048872, UDI/DI case 40193489048873, Lot Number: 23FBJ161; Medline SKU # 60160075, UDI/DI each 10193489048872, UDI/DI case 40193489048873, Lot Number: 23FBC907; Medline SKU # 60161954, UDI/DI each 10193489049091, UDI/DI case 40193489049092, Lot Number: 26ABD974; Medline SKU # 60161954, UDI/DI each 10193489049091, UDI/DI case 40193489049092, Lot Number: 25JBM213; Medline SKU # 60161954, UDI/DI each 10193489049091, UDI/DI case 40193489049092, Lot Number: 25FBK284; Medline SKU # 60161954, UDI/DI each 10193489049091, UDI/DI case 40193489049092, Lot Number: 25FBK967; Medline SKU # 60161954, UDI/DI each 10193489049091, UDI/DI case 40193489049092, Lot Number: 24KBN942; Medline SKU # 60161954, UDI/DI each 10193489049091, UDI/DI case 40193489049092, Lot Number: 24JBC074; Medline SKU # 60161954, UDI/DI each 10193489049091, UDI/DI case 40193489049092, Lot Number: 24HBQ995; Medline SKU # 60161954, UDI/DI each 10193489049091, UDI/DI case 40193489049092, Lot Number: 24GBP001; Medline SKU # 60161954, UDI/DI each 10193489049091, UDI/DI case 40193489049092, Lot Number: 24CBF239; Medline SKU # 60161954, UDI/DI each 10193489049091, UDI/DI case 40193489049092, Lot Number: 24ABJ769; Medline SKU # 60161954, UDI/DI each 10193489049091, UDI/DI case 40193489049092, Lot Number: 23LBP098; Medline SKU # 60161954, UDI/DI each 10193489049091, UDI/… (truncated, 34496 characters total — see the official FDA record for the full value)
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled February 26, 2026

Tirzepatide Inj, 10mg, Sterile Multi-Dose Vial, Rx only, Nomida, 25055 W Valley Pkwy, Suite 106, Olathe, KS 66061, NDC 84223-002-03.

Not guaranteed to be germ-free

OH
▸Full report

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

Recall #:
D-0394-2026
Lot/product code:
Lot 240709, exp 7/31/2026
Recalling firm:
New Life Pharma LLC
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled February 26, 2026

Levothyroxine Sodium Tablets USP 150 mcg, 1000 Tablets bottle, Rx Only, Manufactured for: Macleods Pharma USA, Inc., Princeton, NJ, Manufactured by: Macleods Pharmaceuticals Ltd., Sarigam, Valsad, Guajarat, INDIA NDC 33342-401-44

Weaker than it should be Drug

ALL 50 STATES
▸Full report

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

Recall #:
D-0403-2026
Lot/product code:
Lot 16240062A, exp date 3/2026
Recalling firm:
MACLEODS PHARMA USA, INC
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled February 26, 2026

Semaglutide Inj., 2 mg x 5, Sterile Multi-Dose Vial, Rx only, Nomida, 25055 W Valley Pkwy, Suite 106, Olathe, KS 66061, NDC 84223-001-06

Not guaranteed to be germ-free

OH
▸Full report

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

Recall #:
D-0393-2026
Lot/product code:
Lot 240903, exp 9/30/2026
Recalling firm:
New Life Pharma LLC
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled February 26, 2026

Tirzepatide Inj, 15mg x 4, Sterile Multi-Dose Vial, Rx only, Nomida, 25055 W Valley Pkwy, Suite 106, Olathe, KS 66061, NDC 84223-002-04.

Not guaranteed to be germ-free

OH
▸Full report

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

Recall #:
D-0395-2026
Lot/product code:
Lot 240709, exp 7/31/2026
Recalling firm:
New Life Pharma LLC
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled February 26, 2026

Semaglutide Inj, 2mg x 10, Sterile Multi-Dose Vial, Rx only, Nomida, 25055 W Valley Pkwy, Suite 106, Olathe, KS 66061, NDC 84223-001-07.

Not guaranteed to be germ-free

OH
▸Full report

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

Recall #:
D-0392-2026
Lot/product code:
Lot 241113, Exp Date 11/30/2026 & Lot 250103, Exp Date 1/31/2027
Recalling firm:
New Life Pharma LLC
View official FDA record (opens in a new tab)
Class IHigh risk
FoodAllergenEggUndeclaredRecalled February 26, 2026

House of Flavors 4893 Chicago Vanilla Naturally Flavored Ice Cream, 3 GAL tub

Not listed on the label egg

IL
▸Full report

The most serious kind of recall. Using this product could cause serious health problems or death.

Recall #:
H-0621-2026
Lot/product code:
24059, 24130, 24207, 24342, 25105, 25120, 25134, 25206, 25254, 25301
Recalling firm:
House Of Flavors, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 25, 2026

Medline Kits: 1) D AND C PACK, Model Number: DYNJ41254B

The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.

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

Recall #:
98599
Lot/product code:
1) DYNJ41254B, UDI-DI: 10888277882003(each), 40888277882004(case), Lot Number: 25FBA224
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 25, 2026

2.4 VOLT TAP LOCKING SCREW TAP TO 90MM. Part Number: 03.424.124-US.

A full lot swap between VOLT Locking Screw Tap 03.424.124 lot 68900P9 and Cortical Screw Tap 03.424.126 lot 68982P8, resulting in the bones taps having an incorrect thread.

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

Recall #:
98461
Lot/product code:
Part Number: 03.424.124-US. GTIN: 10886982335944. Lot Number: 68900P9.
Recalling firm:
Synthes (USA) Products LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 25, 2026

Medline Syringes: 1) SYRINGE 12ML CONTROL W/ROTATOR, Model Number: DYNJSYR12CWR; 2) SYRINGE 10ML CONTROL W/ROTATOR, Model Number: DYNJSYR10CWR; 3) SYR CONTROL PAD 12ML L/L, Model Number: DYNJSYR12CP; 4) TBG PRESS 72IN M/F ROT BRAID, Model Number: DYNJBRT72R; 5) SYRINGE 10ML CONTROL MLL, Model Number: DYNJSYR10C; 6) SYRINGE 8ML CONTROL MLL, Model Number: DYNJSYR8C; 7) SYRINGE 12ML CONTROL MLL, Model Number: DYNJSYR12C; 8) SYR CONTROL PAD 10ML L/L ROT, Model Number: DYNJSYR10CRP; 9) SYR CONTROL PAD 12ML L/L ROT, Model Number: DYNJSYR12CRP; 10) CTRL SYRINGE 6ML RING ROT L/L, Model Number: DYNJSYRC6CWR

The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.

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▸Full report

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

Recall #:
98599
Lot/product code:
1) DYNJSYR12CWR, UDI-DI: 10884389676486(each), 40884389676487(case), Lot Number: 25ABF227; 2) DYNJSYR12CWR, UDI-DI: 10884389676486(each), 40884389676487(case), Lot Number: 25CBC537; 3) DYNJSYR12CWR, UDI-DI: 10884389676486(each), 40884389676487(case), Lot Number: 25EBK855; 4) DYNJSYR12CWR, UDI-DI: 10884389676486(each), 40884389676487(case), Lot Number: 25IDA120; 5) DYNJSYR12CWR, UDI-DI: 10884389676486(each), 40884389676487(case), Lot Number: 25IDA552; 6) DYNJSYR12CWR, UDI-DI: 10884389676486(each), 40884389676487(case), Lot Number: 25IDA648; 7) DYNJSYR12CWR, UDI-DI: 10884389676486(each), 40884389676487(case), Lot Number: 25IDB507; 8) DYNJSYR10CWR, UDI-DI: 10884389672723(each), 40884389672724(case), Lot Number: 25EBH091; 9) DYNJSYR10CWR, UDI-DI: 10884389672723(each), 40884389672724(case), Lot Number: 25EBO178; 10) DYNJSYR10CWR, UDI-DI: 10884389672723(each), 40884389672724(case), Lot Number: 25IDA686; 11) DYNJSYR10CWR, UDI-DI: 10884389672723(each), 40884389672724(case), Lot Number: 25JDA207; 12) DYNJSYR10CWR, UDI-DI: 10884389672723(each), 40884389672724(case), Lot Number: 25JDB599; 13) DYNJSYR12CP, UDI-DI: 10888277236615(each), 40888277236616(case), Lot Number: 25GBD528; 14) DYNJSYR12CP, UDI-DI: 10888277236615(each), 40888277236616(case), Lot Number: 25JDB601; 15) DYNJBRT72R, UDI-DI: 10884389854211(each), 40884389854212(case), Lot Number: 25GBN402; 16) DYNJSYR10C, UDI-DI: 10884389676462(each), 40884389676463(case), Lot Number: 25GBS345; 17) DYNJSYR10C, UDI-DI: 10884389676462(each), 40884389676463(case), Lot Number: 25GBS857; 18) DYNJSYR10C, UDI-DI: 10884389676462(each), 40884389676463(case), Lot Number: 25GBU045; 19) DYNJSYR10C, UDI-DI: 10884389676462(each), 40884389676463(case), Lot Number: 25GBV139; 20) DYNJSYR8C, UDI-DI: 10884389676493(each), 40884389676494(case), Lot Number: 25IDB505; 21) DYNJSYR12C, UDI-DI: 10884389676479(each), 40884389676470(case), Lot Number: 25IDB506; 22) DYNJSYR12C, UDI-DI: 10884389676479(each), 40884389676470(case), Lot Number: 25JDA208; 23) DYNJSYR12C, UDI-DI: 10884389676479(each), 40884389676470(case), Lot Number: 25JDB827; 24) DYNJSYR10CRP, UDI-DI: 10888277236585(each), 40888277236586(case), Lot Number: 25JDA594; 25) DYNJSYR12CRP, UDI-DI: 10888277236592(each), 40888277236593(case), Lot Number: 25JDB600; 26) DYNJSYRC6CWR, UDI-DI: 10889942885732(each), 40889942885733(case), Lot Number: 25JDB602
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 25, 2026

Brand Name: Olympus PKS Cutting Forceps, 5mm 33cm Product Name: PKS Cutting Forceps Model/Catalog Number: 920005PK Product Description: The PKS Cutting Forceps are intended to be passed through a 5mm cannula. Coagulation is achieved using electrosurgical energy under visualization. The device is intended to be used with the PKS electrical generator.

Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately validate the welding process. Defective welds can result in the Cutting Forceps' jaw breaking during clinical use.

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▸Full report

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

Recall #:
98454
Lot/product code:
Model: 920005PK; UDI: 00821925036178; Lot Numbers: All unexpired;
Recalling firm:
Olympus Corporation of the Americas
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 25, 2026

Medline Kits: 1) MTS LEFT HEART KIT-CAROLINAS HOS, Model Number: 60021775; 2) DBD-MTS LHK BHS BAPTIST. LOUISVI, Model Number: 60022026; 3) MTO LEFT HEART KIT SUMMA BARBERT, Model Number: 60022673; 4) MTS LH KIT-UNIV OF MIAMI PG, Model Number: 60030817; 5) MTS LEFT HEART KIT SPRINGFIELD R, Model Number: 60031245; 6) MTS PERIPHERAL KIT SPRINGFIELD R, Model Number: 60031247; 7) MTS LEFT HEART KIT-COLISEUM MED, Model Number: 60031928; 8) MTS LEFT HEART KIT -2-CALIFORNIA, Model Number: 60033011; 9) MTS LEFT HEART KIT JOHN MUIR CON, Model Number: 60040273; 10) MTS EP MANIFOLD KIT TEXAS HLTH P, Model Number: 60041268; 11) MTS 3V MANIFOLD KIT-SPARROW HOSP, Model Number: 60050097; 12) MTS LEFT HEART KIT FORT SANDERS, Model Number: 60060387; 13) MTS LEFT HEART KIT-GOOD SAMARITA, Model Number: 60070435; 14) DBD-MTS ANGIO KIT-MOUNT HOOD MED, Model Number: 60070521; 15) MTS LFT HRT KIT-GRAND VIEW PG, Model Number: 60071743; 16) MTS CUSTOM MANIFOLD KIT-INGALLS, Model Number: 60090078; 17) MTS CATH LAB KIT - HEARTLAND PG, Model Number: 60090542; 18) MTS LEFT HEART KIT-W.C.A PG, Model Number: 60100071; 19) MTS MANIFOLD KIT-GENESYS REG MED, Model Number: 60100254; 20) MTS 4V W/PRO STA-ST.JOHNS REG ME, Model Number: 60100439; 21) MTS LEFT HEART KIT JEANES HOSPIT, Model Number: 60101773; 22) MTS LEFT HEART KIT-ST. MARYS OF, Model Number: 60131099; 23) DBD-MTS LEFT HEART KIT-LEHIGH VA, Model Number: 60132653; 24) MTS LEFT HEART KIT (3V DT WASTE), Model Number: 60138326; 25) MTS LF HRT KIT-PRESBYTERIAN UNIV, Model Number: 60160148; 26) MTS LEFT HEART KIT-PENINSULA REG, Model Number: 60160428; 27) MTS LEFT HEART KIT BARNES ST.PET, Model Number: 60161135; 28) MTO OR ENDO KIT - PARK RIDGE HOS, Model Number: 60163618; 29) MTS 3V W/DT-CORPUS CHRISTI M.C., Model Number: 60181531; 30) MTS 3V PERC MANIFOLD KIT WEST. A, Model Number: 60182137; 31) MTO CATH KIT PAMPA REGIONAL MED, Model Number: 60182661; 32) MTO HOPKINS LEFT HEART HOWARD CO, Model Number: 60183662; 33) MTS-CARDIOLOGY KIT-HARLINGEN MED, Model Number: 60184001; 34) MTS PERCEPTOR KIT METHODIST. RIC, Model Number: 60185432; 35) MTS LEFT HEART KIT SADDLEBACK ME, Model Number: 60191312; 36) MTS-CARD MAN KIT MARIAN MED CENT, Model Number: 60194273; 37) LEFT HEART KIT SOUTHERN HILLS HO, Model Number: 60195202; 38) MTS DR KHAIRALLAH LEFT HEART KIT, Model Number: 60200189; 39) MTS,4V,DIAG,KIT UNIV OF CONNECTICUT, Model Number: 60210014; 40) MTO L/H KIT-UNIV OF CLEVELAND -, Model Number: 60210047; 41) MTS LEFT HEART KIT-BAPTIST HLTH, Model Number: 60230503; 42) MTS CAN KIT ACCESSOIRE DIAGNOSTI, Model Number: 60700527; 43) MTS LEFT HEART W/SYRINGE-EMORY U, Model Number: 600503712; 44) MTS ACCESSORY KIT SAINT JOSEPH L, Model Number: 601010412; 45) MTS 3 PORT WHITE KIT LEESBURG RE, Model Number: 601222712; 46) MTS PEDS LFT RT HRT-SUNRISE HO, Model Number: 601905414; 47) MTS LHK ST. LOUIS CARDIO INST, Model Number: 606119072; 48) LHK CENTURA HLTH CORP (ST. ANTHO, Model Number: 6010030361; 49) MTS LHK CHAMPLAIN VALLEY, Model Number: 6010128411; 50) MTS LHK VANDERBILT COFFEE HARTON, Model Number: 6019705921; 51) DBD-LHK EPIC SURGERY CENTER LLC, Model Number: 6020410581; 52) DBD-MTS LHK MS HEALTHCARE MGMT, Model Number: 6061073001; 53) LHK - WESLEY MEDICAL CENTER, Model Number: 6010088152A; 54) IR ANGIOGRAPHY PACK-LF, Model Number: DYNJVB1077D; 55) RADIOLOGY SPECIALS TRAY, Model Number: DYNJVB1302B; 56) ANGIO LEFT HEART PACK, Model Number: DYNJ40632D; 57) ANGIO RIGHT HEART PACK, Model Number: DYNJ40633C; 58) ANGIO TRAY, Model Number: DYNJ43278C; 59) CARDIAC LEG PACK, Model Number: DYNJ44065C; 60) EP PACK, Model Number: DYNJ55512A; 61) VASCULAR PACK, Model Number: DYNJ58522A; 62) PERIPHERAL CATH, Model Number: DYNJ59220C; 63) CARDIAC CATH - NO SYR, Model Number: DYNJ62409A; 64) C V MINOR PACK, Model Number: DYNJ64862B; 65) ENDOVASCULAR PACK, Model Number: DYNJ65926

The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.

ALL 50 STATES
▸Full report

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

Recall #:
98599
Lot/product code:
1) 60021775, UDI-DI: 10193489041385(each), 20193489041382(case), Lot Number: 183372; 2) 60021775, UDI-DI: 10193489041385(each), 20193489041382(case), Lot Number: 185190; 3) 60022026, UDI-DI: 10193489087253(each), 20193489087250(case), Lot Number: 106008; 4) 60022026, UDI-DI: 10193489087253(each), 20193489087250(case), Lot Number: 117378; 5) 60022673, UDI-DI: 10193489041538(each), 20193489041535(case), Lot Number: 176180; 6) 60030817, UDI-DI: 10193489041972(each), 20193489041979(case), Lot Number: 185193; 7) 60031245, UDI-DI: 10193489042214(each), 20193489042211(case), Lot Number: 183374; 8) 60031247, UDI-DI: 10193489042238(each), 20193489042235(case), Lot Number: 174370; 9) 60031247, UDI-DI: 10193489042238(each), 20193489042235(case), Lot Number: 184424; 10) 60031247, UDI-DI: 10193489042238(each), 20193489042235(case), Lot Number: 185080; 11) 60031928, UDI-DI: 10193489042276(each), 20193489042273(case), Lot Number: 185195; 12) 60033011, UDI-DI: 10193489042429(each), 20193489042426(case), Lot Number: 181365; 13) 60040273, UDI-DI: 10193489042832(each), 20193489042839(case), Lot Number: 179872; 14) 60040273, UDI-DI: 10193489042832(each), 20193489042839(case), Lot Number: 183375; 15) 60041268, UDI-DI: 10193489043051(each), 20193489043058(case), Lot Number: 140365; 16) 60041268, UDI-DI: 10193489043051(each), 20193489043058(case), Lot Number: 170084; 17) 60050097, UDI-DI: 10193489043242(each), 20193489043249(case), Lot Number: 176186; 18) 60060387, UDI-DI: 10193489043693(each), 20193489043690(case), Lot Number: 183376; 19) 60060387, UDI-DI: 10193489043693(each), 20193489043690(case), Lot Number: 185194; 20) 60060387, UDI-DI: 10193489043693(each), 20193489043690(case), Lot Number: 187370; 21) 60070435, UDI-DI: 10193489044133(each), 20193489044130(case), Lot Number: 183377; 22) 60070435, UDI-DI: 10193489044133(each), 20193489044130(case), Lot Number: 187371; 23) 60070521, UDI-DI: 10193489044164(each), 20193489044161(case), Lot Number: 185196; 24) 60071743, UDI-DI: 10193489044348(each), 20193489044345(case), Lot Number: 176190; 25) 60090078, UDI-DI: 10193489044829(each), 20193489044826(case), Lot Number: 185197; 26) 60090542, UDI-DI: 10193489044867(each), 20193489044864(case), Lot Number: 181373; 27) 60090542, UDI-DI: 10193489044867(each), 20193489044864(case), Lot Number: 185198; 28) 60100071, UDI-DI: 10193489044959(each), 20193489044956(case), Lot Number: 176193; 29) 60100071, UDI-DI: 10193489044959(each), 20193489044956(case), Lot Number: 185189; 30) 60100254, UDI-DI: 10193489045024(each), 20193489045021(case), Lot Number: 185188; 31) 60100439, UDI-DI: 10193489045130(each), 20193489045137(case), Lot Number: 181369; 32) 60100439, UDI-DI: 10193489045130(each), 20193489045137(case), Lot Number: 185203; 33) 60101773, UDI-DI: 10193489045451(each), 20193489045458(case), Lot Number: 181364; 34) 60131099, UDI-DI: 10193489046717(each), 20193489046714(case), Lot Number: 181370; 35) 60131099, UDI-DI: 10193489046717(each), 20193489046714(case), Lot Number: 185204; 36) 60132653, UDI-DI: 10193489047332(each), 20193489047339(case), Lot Number: 181381; 37) 60138326, UDI-DI: 10193489047653(each), 20193489047650(case), Lot Number: 185205; 38) 60160148, UDI-DI: 10193489048704(each), 20193489048701(case), Lot Number: 183382; 39) 60160148, UDI-DI: 10193489048704(each), 20193489048701(case), Lot Number: 185207; 40) 60160428, UDI-DI: 10193489048773(each), 20193489048770(case), Lot Number: 181100; 41) 60161135, UDI-DI: 10193489049046(each), 20193489049043(case), Lot Number: 177936; 42) 60161135, UDI-DI: 10193489049046(each), 20193489049043(case), Lot Number: 185208; 43) 60163618, UDI-DI: 10193489049251(each), 20193489049258(case), Lot Number: 140392; 44) 60181531, UDI-DI: 10193489049619(each), 20193489049616(case), Lot Number: 185209; 45) 60182137, UDI-DI: 10193489049695(each), 20193489049692(case), Lot Number: 185522; 46) 60182137, UDI-DI: 10193489049695(each), 20193489049692(case), Lot Number: 187343; 47) 60182661, UDI-DI: 10193489049794(each), 20193489049791(case), Lot Number: 176203; 48) 60183662, UDI-DI: 10193489050080(each), 20193489050087(case), Lot Number: 181371; 49) 60184001, UDI-DI: 10193489050110(each), 20193489050117(case), Lot Number: 177939; 50) 60184001, UDI-DI: 10193489050110(each), 20193489050117(case), Lot Number: 185210; 51) 60185432, UDI-DI: 10193489050325(each), 20193489050322(case), Lot Number: 184739; 52) 60191312, UDI-DI: 10193489050820(each), 20193489050827(case), Lot Number: 185212; 53) 60194273, UDI-DI: 10193489051094(each), 20193489051091(case), Lot Number: 133064; 54) 60195202, UDI-DI: 10193489051322(each), 20193489051329(case), Lot Number: 181368; 55) 60195202, UDI-DI: 10193489051322(each), 20193489051329(case), Lot Number: 187374; 56) 60200189, UDI-DI: 10193489051513(each), 20193489051510(case), Lot Number: 176208; 57) 60200189, UDI-DI: 10193489051513(each), 20193489051510(case), Lot Number: 181375; 58) 60200189, UDI-DI: 10193489051513(each), 20193489051510(case), Lot Number: 185213; 59) 60210014, UDI-DI:… (truncated, 13411 characters total — see the official FDA record for the full value)
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 25, 2026

Brand Name: Olympus PKS Cutting Forceps, 5mm 33cm Product Name: PKS Cutting Forceps Model/Catalog Number: 3005PK Product Description: The PKS Cutting Forceps are intended to be passed through a 5mm cannula. Coagulation is achieved using electrosurgical energy under visualization. The device is intended to be used with the PKS electrical generator.

Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately validate the welding process. Defective welds can result in the Cutting Forceps' jaw breaking during clinical use.

ALL 50 STATES
▸Full report

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

Recall #:
98454
Lot/product code:
Model: 3005PK; UDI: 00821925036000; Lot Numbers: All unexpired;
Recalling firm:
Olympus Corporation of the Americas
View official FDA record (opens in a new tab)