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Recalls affecting Hawaii

Data last updated: September 9, 2026 at 1:18 PM UTC

16,268 recalls found
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Just announced

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

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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

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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

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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

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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

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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)
Wording
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

Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. CENTRAL LINE TRAY DYNJ41089 FISTULAGRAM PACK DYNJ62827A FISTULOGRAM PACK DYNJ47899A INVASIVE LINE INSERTION DYNJ44123B NON VASCULAR PACK DYNJ68037A VASCULAR ACCESS PACK-LF DYNJ0101291F

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:
DYNJ41089 UDI-DI 10884389891360 Lot 21BBB592 DYNJ62827A UDI-DI 10193489306606 Lot 24BBN289 DYNJ47899A UDI-DI 10889942574681 Lots 21GBI377 21IBL299 21LBE099 21LBU529 22JBV803 DYNJ44123B UDI-DI 10195327381653 Lots 23FBR833 23GBN041 23HBW014 23JBO264 23JBW218 23KBI873 DYNJ68037A UDI-DI 10195327003630 Lots 21JBQ304 21LBQ205 22ABN185 22DBT349 22EBL611 22HBH550 22IBN880 22JBH689 22KBS987 22OBA368 23ABD642 23BBH830 23DBL865 23EBT367 23FBM946 23GBT261 DYNJ0101291F UDI-DI 10195327286644 Lots 22KDB751 23EDA119 23EDB388 23FDA396 23GDA313 23HDA759 23LDB909 24ADB667 24GDA294 24HDB515
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 Pro SuperPulsed Laser System Product Name: SOLTIVE Pro Laser System TFL-SLS Model/Catalog Number: TFL-SLS containing TFL-CSLU 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-SLS; UDI: 00821925044135; Component Part: TFL-CSLU; UDI: 00821925044593; Serial #: MDUF190114, MDUF220073, MDUF220331, MDUF220353, MDUF220354, MDUF220356, MDUF220411, MDUF220412, MDUF220413, MDUF220414, MDUF220427, MDUF220451, MDUF220453, MDUF220454, MDUF220455, MDUF220456, MDUF230004, MDUF230005, MDUF230006, MDUF230007, MDUF230076, MDUF230140, MDUF230141, MDUF230163, MDUF230164, MDUF230166, MDUF230167, MDUF230234, MDUF230283, MDUF230284, MDUF230331, MDUF230332, MDUF230361, MDUF230362, MDUF230363, MDUF230364, MDUF230365, MDUF230366, MDUF230411, MDUF230412, MDUF230413;
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 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

Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as follows: 1. ROBOTIC PACK, Medline SKU # DYNJ58475F; 2. URO/GEN ROBOTIC PACK, Medline SKU # DYNJ60803J.

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 # DYNJ58475F, UDI/DI each 10198459572388, UDI/DI case 40198459572389, Lot Number: 25LMK173; Medline SKU # DYNJ60803J, UDI/DI each 10195327138820, UDI/DI case 40195327138821, Lot Number: 26BMA268; Medline SKU # DYNJ60803J, UDI/DI each 10195327138820, UDI/DI case 40195327138821, Lot Number: 26AMH928; Medline SKU # DYNJ60803J, UDI/DI each 10195327138820, UDI/DI case 40195327138821, Lot Number: 25EMD876; Medline SKU # DYNJ60803J, UDI/DI each 10195327138820, UDI/DI case 40195327138821, Lot Number: 25EMA519; Medline SKU # DYNJ60803J, UDI/DI each 10195327138820, UDI/DI case 40195327138821, Lot Number: 25DMA846; Medline SKU # DYNJ60803J, UDI/DI each 10195327138820, UDI/DI case 40195327138821, Lot Number: 25BMH004; Medline SKU # DYNJ60803J, UDI/DI each 10195327138820, UDI/DI case 40195327138821, Lot Number: 25BMA218; Medline SKU # DYNJ60803J, UDI/DI each 10195327138820, UDI/DI case 40195327138821, Lot Number: 24KMI208; Medline SKU # DYNJ60803J, UDI/DI each 10195327138820, UDI/DI case 40195327138821, Lot Number: 24KMC007; Medline SKU # DYNJ60803J, UDI/DI each 10195327138820, UDI/DI case 40195327138821, Lot Number: 24JMD850; Medline SKU # DYNJ60803J, UDI/DI each 10195327138820, UDI/DI case 40195327138821, Lot Number: 24IMI939; Medline SKU # DYNJ60803J, UDI/DI each 10195327138820, UDI/DI case 40195327138821, Lot Number: 24EDB694; Medline SKU # DYNJ60803J, UDI/DI each 10195327138820, UDI/DI case 40195327138821, Lot Number: 24DDB793; Medline SKU # DYNJ60803J, UDI/DI each 10195327138820, UDI/DI case 40195327138821, Lot Number: 24CDB207; Medline SKU # DYNJ60803J, UDI/DI each 10195327138820, UDI/DI case 40195327138821, Lot Number: 24BDB439; Medline SKU # DYNJ60803J, UDI/DI each 10195327138820, UDI/DI case 40195327138821, Lot Number: 23GDB756; Medline SKU # DYNJ60803J, UDI/DI each 10195327138820, UDI/DI case 40195327138821, Lot Number: 23GDA532.
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 TAVR PACK DYNJ69246B ABDOMINAL VASCULAR-LF DYNJ905291D ANGIOGRAPHIC PACK DYNJ86769 AORTAGRAM PACK DYNJ26783D AV FISTULA PACK CHS-LF DYNJ35615G AV SHUNT PACK-LF DYNJ0842516G CATHETER PACK DYNJ61926 EP DRAPE PACK-LF DYNJ47645C EP PACK DYNJ47782G EPS ACCESSORY PACK DYNJT2201S H CLINIC VASCULAR PK DYNJ33415A HEART FAILURE PACK DYNJ64877B HYBRID PACK DYNJ65925D INTERVENTIONAL RAD PACK DYNJ44100M INTERVENTIONAL RADIOLOGY PK-LF DYNJ0516014AG MV-PACEMAKER PACK-LF DYNJ41556F NEURO RADIOLOGY RICHMOND DYNJ68365D OR HYBRID-M DYNJ907758D, DYNJ907758F PACEMAKER DYNJ907960C PACEMAKER PACK DYNJ42557B DYNJ61411 DYNJ61411A DYNJ61411B DYNJ80160 PACER PACK DYNJ40952B PERIPHERAL ARTERIOGRAM RAD DYNJ61383B RADIOLOGY PACK DYNJ54762D TAVR PACK DYNJ55338B DYNJ69246A VASCULAR ACCESS TRAY DYNJ52606F VASCULAR TRAY DYNJ49802C VEIN PACK DYNJ57512 DYNJ58063 DYNJ84953

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:
DYNJ69246B UDI-DI 10198459335266 (EA) 40198459335267 (CS) LOT 25EBM356 DYNJ905291D UDI-DI 10195327393090 (EA) 40195327393091 (CS) LOTS 24JBO127 24LBJ199 DYNJ86769 UDI-DI 10195327674168 (EA) 40195327674169 (CS) LOT 24EMF716 DYNJ26783D UDI-DI 10193489616750 (EA) 40193489616751 (CS) LOTS 23DBJ248 23EBK921 23FBS130 23HBB516 23IBS065 23JBP123 23LBP196 24ABR004 24ABR121 24BBG855 24GBV377 24JBI914 24KBD153 24LBB665 DYNJ35615G UDI-DI 10195327099404 (EA) 40195327099405 (CS) LOT 23EBR748 DYNJ0842516G UDI-DI 10195327286392 (EA) 40195327286393 (CS) LOTS 24CDB991 24GDB891 24IDA796 24KDB683 DYNJ61926 UDI-DI 10193489610406 (EA) 40193489610407 (CS) LOTS 23CBK311 23DBM226 23FBP893 23GBN159 23HBC859 23JBH552 23LBV456 24DBM081 24EBS504 24FBR479 DYNJ47645C UDI-DI 10195327355173 (EA) 40195327355174 (CS) LOTS 23IMH312 23LMD467 24BMB620 24DMD512 24FMF757 24GMD538 24JMC369 24KMB831 24LMD945 DYNJ47782G UDI-DI 10195327495640 (EA) 40195327495641 (CS) LOT 24GMA622 DYNJT2201S UDI-DI 10195327263003 (EA) 40195327263004 (CS) LOT 23HMG629 DYNJ33415A UDI-DI 10888277792555 (EA) 40888277792556 (CS) LOT 24CBG963 DYNJ64877B UDI-DI 10193489415896 (EA) 40193489415897 (CS) LOTS 23CBF259 23HBM117 23HBO973 23KBD360 23LBG859 24ABB266 24CMJ034 24FMD963 24HMH185 24JMD105 DYNJ65925D UDI-DI 10195327531188 (EA) 40195327531189 (CS) LOT 24DLA029 DYNJ44100M UDI-DI 10195327324988 (EA) 40195327324989 (CS) LOTS 23IMG347 23JMI669 23LME170 24AMI085 24CMA877 24CMJ446 24DME309 24FMC387 24FMC900 24FMF012 24FMH007 24GMC363 24HMF632 24JMF664 24LMD487 DYNJ0516014AG UDI-DI 10195327271640 (EA) 40195327271641 (CS) LOTS 23BME190 23DMH005 23KMH805 23KMI253 23LMH275 24AMH347 24CMI868 24DMI402 24DMK427 24EMG633 24IMB650 24IMJ127 24KMC298 DYNJ41556F UDI-DI 10193489968170 (EA) 40193489968171 (CS) LOTS 23IME423 23IMH983 DYNJ68365D UDI-DI 10195327525040 (EA) 40195327525041 (CS) LOT 23JBH517 DYNJ907758D UDI-DI 10195327351335 (EA) 40195327351336 (CS) LOTS 23FBP055 23HBC362 23HBL227 23HBX060 23KBB106 24CBT278 24CBV291 24HBE808 24HBR182 DYNJ907758F UDI-DI 10198459128622 (EA) 40198459128623 (CS) LOTS 24JBM379 24KBC281 DYNJ907960C UDI-DI 10195327347451 (EA) 40195327347452 (CS) LOT 24CBT833 DYNJ42557B UDI-DI 10889942135806 (EA) 40889942135807 (CS) LOT 24BBA461 DYNJ61411 UDI-DI 10193489562705 (EA) 40193489562706 (CS) LOT 23GBH973 DYNJ61411A UDI-DI 10195327483234 (EA) 40195327483235 (CS) LOTS 23IBH456 23JBN809 DYNJ61411B UDI-DI 10195327628697 (EA) 40195327628698 (CS) LOTS 24DBE155 24LBE209 DYNJ80160 UDI-DI 10195327013226 (EA) 40195327013227 (CS) LOT 24CBJ103 DYNJ40952B UDI-DI 10195327203726 (EA) 40195327203727 (CS) LOTS 24EBT279 24GBQ711 24HBR555 24JBO326 24LBM313 DYNJ61383B UDI-DI 10193489751277 (EA) 40193489751278 (CS) LOTS 23FLA104 23HLA490 23ILB095 23KBP994 23LBD911 24ALA301 DYNJ54762D UDI-DI 10195327031725 (EA) 40195327031726 (CS) LOT 24ABX637 DYNJ55338B UDI-DI 10193489859027 (EA) 40193489859028 (CS) LOT 22GMG972 DYNJ69246A UDI-DI 10198459178931 (EA) 40198459178932 (CS) LOTS 24LBA791 25ABA813 25CBF356 25DBA846 DYNJ52606F UDI-DI 10193489343298 (EA) 40193489343299 (CS) LOTS 23ELB102 23GLA496 23HLB190 23JLA642 23JLB201 24BLA295 24DLA690 24FLA227 24GLA493 24HLA557 24ILA766 24KLA315 DYNJ49802C UDI-DI 10193489461602 (EA) 40193489461603 (CS) LOT 24BBD110 DYNJ57512 UDI-DI 10889942748273 (EA) 40889942748274 (CS) LOT 24ABS819 DYNJ58063 10889942816675 40889942816676 24ABM343 DYNJ84953 10195327440299 40195327440290 24FBM720 ***Updated 5/20/26 - The following lots were included in the customer notification but not the FDA submission.*** DYNJ0516014AG Lots 22LMD393 23DMG745 23HMB539 23LMH275A; DYNJ0842516G Lots 22KDA699 22LDC077 23DDB550 23GDA061 23HDC455 23JDA626 23LDB990 25BMH951 25BMI475; DYNJ26783D Lots 21CBL983 21FBE677 21GBR689 21JBA358 21KBF796 21LBG769 22ABX397 22CBA514 22FBK918 22GBO115 22JBU884 22KBJ430 23ABN303 23BBN053 25ABH287 25ABV765 25BBE142 25CBE875; DYNJ40952B Lots 22HBH043 22JBJ979 23DBR448 23FBE598 23JBL097 23KBH476 24ABR924 25BBS344 DYNJ44100M Lots 23AMJ315 23CMH807 23EMG216 23EMG763 23GMH722 23HMF163 23LMC066 25BMB884 25CMC633 25EMG169; DYNJ47645C Lots 23CMB852 23DMB824 23FMB662 25AMC532; DYNJ52606F Lots 21AKA467 21DKA121 21GLA734 21HLA612 21ILA348 21JLA304 21LLA164 22ALA074 22ALA885 22BLA931 22DLA955 22FLA562 22HLA294 22ILB142 22JLA807 23BLA662 23CLA943 25ALA106 25CLA447; DYNJ61383B Lots 21CLA367 21FLA054 21GLA195 21JLA060 21LLA062 22CLA063 22CLA337 22DLA685 22DLB071 22ELB118 22JLA236 22KLA964 23ALA936 23CLA512 23ELA390 23FLA461 23GLA377 23JLB155 23KLA301 23KLA89… (truncated, 5621 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 27, 2026

Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes ADD A ENDOVASCULAR PACK-LF DYNJ0429339L, DYNJ0429339M ANGIO ARTERIOGRAM PACK-LF DYNJ0774026K ANGIO KIT PACK DYNJ83746B ANGIO TRAY NO LIDO DYNJ85557A ANGIOGRAPHY PACK II DYNJ17218S, DYNJ17218T ARTERIOGRAM NEURO PACK-LF DYNJ0842499L ARTERIOGRAM PACK-LF DYNJ0842478M CARDIAC CATH II PK DYNJ21259O CARDIAC CATH PACK DYNJ68653D CATH LAB ANGIOGRAPHY PACK DYNJ50779G CATH LAB-LF DYNJ51423G CRANIOTOMY PACK-LF DYNJ0101292I DEEP BRAIN STIMULATION PACK DYNJ0842793I ENDO VASCULAR MINOR DYNJ87263 GENERAL ENDO PACK-LF DYNJ0842873L LEFT HEART DYNJ45984J LIPO PACK DYNJ87218 MAA Y90 TRAY DYNJ82191D MAIN OR CATH LAB DYNJ61373B MINIMALLY INVASIVE PACK-LF DYNJ0843063M NEURO CERVICAL PACK DYNJ0101287M NEURO RADIOLOGY RICHMOND DYNJ68365F NEURO VP SHUNT PACK-LF DYNJ0843121L NON-VASCULAR PACK DYNJ56386C, DYNJ56386D OR ANGIOGRAM PACK-LF DYNJ83656A, DYNJ83656B OR RADIOLOGY PACK DYNJ62747A PERCUTANEOUS ARTERIAL CATH PK DYNJ30551J PERIPHERAL ARTERIOGRAM RAD DYNJ61383C PICC ABSCESS PACK-LF DYNJ0774005I PICC TRAY DYNJ30554I PODIATRY PACK DYNJ46333G POSTERIOR SPINE PACK-LF DYNJ0843339P RRMC ANGIO PACK DYNJ36338D SPECIAL PROCEDURE PACK DYNJ88258 VASCULAR ACCESS PACK-LF DYNJ0101291G VASCULAR HYBRID DYNJ57543K VASCULAR PACK DYNJ82220D VISCERAL ANGIOGRAM PACK-LF DYNJ0429121M WPH EP PACK DYNJ62745A

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

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

Recall #:
98601
Lot/product code:
DYNJ0429339L UDI-DI 10195327586508 (EA) 40195327586509 (CS) LOTS 24BMG223 24DMG627 DYNJ0429339M UDI-DI 10198459021541 (EA) 40198459021542 (CS) LOTS 24GMH043 24HMK218 DYNJ0774026K UDI-DI 10198459053115 (EA) 40198459053116 (CS) LOTS 24FBR752 24GBE275 24HBJ727 24IBD206 24KBB390 24KBT291 DYNJ83746B UDI-DI 10198459077760 (EA) 40198459077761 (CS) LOTS 24HBB576 24JBF419 24LBG659 DYNJ85557A UDI-DI 10195327657901 (EA) 40195327657902 (CS) LOT 24HBT042 DYNJ17218S UDI-DI 10195327617547 (EA) 40195327617548 (CS) LOTS 24ADC205 24DDA061 DYNJ17218T UDI-DI 10198459014956 (EA) 40198459014957 (CS) LOTS 24FDA217 24GDB466 24IDB458 DYNJ0842499L UDI-DI 10198459119248 (EA) 40198459119249 (CS) LOT 24LDB079 DYNJ0842478M UDI-DI 10198459119255 (EA) 40198459119256 (CS) LOT 24LDB078 DYNJ21259O UDI-DI 10195327666323 (EA) 40195327666324 (CS) LOTS 24EBQ265 24EBQ331 24KBG416 24LBP987 DYNJ68653D UDI-DI 10198459123122 (EA) 40198459123123 (CS) LOTS 24IBI799 24JBJ553 24KBT807 24LBQ652 DYNJ50779G UDI-DI 10195327686499 (EA) 40195327686490 (CS) LOTS 24GMA788 24HMA312 24IMI472 24KMC197 DYNJ51423G UDI-DI 10198459022395 (EA) 40198459022396 (CS) LOTS 24FLA167 24HLA548 24HLA720 24JLA538 DYNJ0101292I UDI-DI 10198459119064 (EA) 40198459119065 (CS) LOTS 24JDA749 24KDB872 24LDA883 DYNJ0842793I UDI-DI 10198459119095 (EA) 40198459119096 (CS) LOTS 24IDA565 24JDB658 DYNJ87263 UDI-DI 10198459026263 (EA) 40198459026264 (CS) LOTS 24GMF532 24KME090 DYNJ0842873L UDI-DI 10198459119163 (EA) 40198459119164 (CS) LOTS 24JDB216 24KMI624 DYNJ45984J UDI-DI 10198459072499 (EA) 40198459072490 (CS) LOTS 24HMD351 24IMJ054 DYNJ87218 UDI-DI 10198459018800 (EA) 40198459018801 (CS) LOTS 24GBA517 24IBO012 24LBT366 DYNJ82191D UDI-DI 10198459099755 (EA) 40198459099756 (CS) LOTS 24HMI555 24IMF587 24KMD232 DYNJ61373B UDI-DI 10195327591298 (EA) 40195327591299 (CS) LOTS 23LBS736 24ABA334 24KBF375 24LBM612 DYNJ0843063M UDI-DI 10198459119460 (EA) 40198459119461 (CS) LOTS 24LDB299 DYNJ0101287M UDI-DI 10198459119491 (EA) 40198459119492 (CS) LOTS 24JDA631 24KDB258 DYNJ68365F UDI-DI 10198459130038 (EA) 40198459130039 (CS) LOTS 24LBA409 24LBJ115 24LBJ634 DYNJ0843121L UDI-DI 10198459119507 (EA) 40198459119508 (CS) LOTS 24JMB397 24JMF145 DYNJ56386C UDI-DI 10195327571252 (EA) 40195327571253 (CS) LOTS 23LBI856 24CBJ902 24FBG624 24FBI743 24FBO911 24HBM314 DYNJ56386D UDI-DI 10198459123382 (EA) 40198459123383 (CS) LOTS 24JBX744 24KBH891 24LBS655 DYNJ83656A UDI-DI 10195327600006 (EA) 40195327600007 (CS) LOTS 24DMF381 24GMG344 DYNJ83656B UDI-DI 10198459119538 (EA) 40198459119539 (CS) LOT 24KMF093 DYNJ62747A UDI-DI 10195327576530 (EA) 40195327576531 (CS) LOTS 24EBI547 24FBR560 24IBG783 24LBK728 DYNJ30551J UDI-DI 10198459131004 (EA) 40198459131005 (CS) LOTS 24LLA323 25HLA222 DYNJ61383C UDI-DI 10195327593346 (EA) 40195327593347 (CS) LOTS 24CLA801 24DLA314 24ELA254 24FLA499 24GLA460 24HLA582 24HLB160 24JLB130 24KLB068 24LLA374 25ALA225 25ALB027 25CLA749 25DLA276 25GLA032 25ILA468 25JLA750 DYNJ0774005I UDI-DI 10198459053184 (EA) 40198459053185 (CS) LOTS 24GBE276 24HBS310 DYNJ30554I UDI-DI 10198459131011 (EA) 40198459131012 (CS) LOTS 24LLB049 25HLA223 25HLA971 DYNJ46333G UDI-DI 10195327542320 (EA) 40195327542321 (CS) LOT 24ABS351 DYNJ0843339P UDI-DI 10198459119330 (EA) 40198459119331 (CS) LOTS 24JDC273 24LDA042 DYNJ36338D UDI-DI 10195327624002 (EA) 40195327624003 (CS) LOTS 24BMJ645 24CMG670 24DMC608 24EMH999 24FME392 24JMD753 24JMI596 24KME048 24LMA450 DYNJ88258 UDI-DI 10198459133114 (EA) 40198459133115 (CS) LOT 24JBB074 DYNJ0101291G UDI-DI 10198459119439 (EA) 40198459119430 (CS) LOTS 24IDB422 24KDB372 DYNJ57543K UDI-DI 10198459004124 (EA) 40198459004125 (CS) LOTS 24FMI037 24GMF547 24IMA891 24JME621 DYNJ82220D UDI-DI 10198459103377 (EA) 40198459103378 (CS) LOT 24LMC859 DYNJ0429121M UDI-DI 10195327675813 (EA) 40195327675814 (CS) LOTS 24DMA039 24DMG180 24EMH743 24IMF503 DYNJ62745A UDI-DI 10195327686222 (EA) 40195327686223 (CS) LOTS 24KBR735 24LBK675 ***Updated 5/20/26 - The following lots were included in the customer letter but not the FDA submission.*** DYNJ0101287M lots 25BMC014; DYNJ0429121M lots 24GME309 25AMA768 25AMI616 25CMC127 25DME972 25EMH823; DYNJ0429339M lots 25AMI338 25BMI962 25DMG132; DYNJ0774005I lots 25ABU445 25EBJ726; DYNJ0774026K lots 25ABL910 25CBC859; DYNJ0842478M lots 25BMD033; DYNJ0842499L lots 25ADA394 25ADB067 25BDB213; DYNJ0842873L lots 25AMF044 25BMI157 25CMJ723; DYNJ0843063M lots 24KDA944 25BMC710 25CMB746; DYNJ0843121L lots 25BMA139 25BMG893; DYNJ0843339P lots 25AMC… (truncated, 5722 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 27, 2026

Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes EYE PACK DYNJ35056A HEART CATH PACK DYNJ69318A

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

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

Recall #:
98601
Lot/product code:
DYNJ35056A UDI-DI 10889942227563 (EA) 40889942227564 (CS) LOT 24ABN639 DYNJ69318A UDI-DI 10195327370756 (EA) 40195327370757 (CS) LOTS 23DMD456 23EMB847 23HMB969 23IMC364 23JME011 23JMI841 23LMC384 24BMD333 24CMB768 24CMJ586 24EMJ527 24GMD970 24JMB408 24JMI594 24KMC774 ***Updated 5/20/26 - The following lots were included in the customer letter but not the FDA submission.*** DYNJ69318A lots 23FMA845 23FMA924 25BMF603
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: TAVR PACK, Medline SKU # DYNJ84472

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.

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

Recall #:
98598
Lot/product code:
Medline SKU # DYNJ84472, UDI/DI each 10195327369286, UDI/DI case 40195327369287, Lot Numbers: 23LBN016, 23KBL255, 23HBL885, 23FBV799.
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 E P DRAPE PACK-LF DYNJ0373061J

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

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▸Full report

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

Recall #:
98601
Lot/product code:
DYNJ0373061J UDI-DI 10889942396856 (EA) 40889942396857 (CS) LOT 24ABR895
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 ENSEMBLE GYNECO SCOPIE-LF DYNJ53744B LAVH GRH-LF DYNJ41792G

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

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

Recall #:
98601
Lot/product code:
DYNJ53744B UDI-DI 10193489761689 (EA) 40193489761680 (CS) LOT 24ABS765 DYNJ41792G UDI-DI 10195327547127 (EA) 40195327547128 (CS) LOT 24ABT556
Recalling firm:
Medline Industries, LP
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

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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)
UnclassifiedRisk not yet known
Medical deviceRecalled February 25, 2026

Medline Kits: 1) GYN LAPAROSCOPY PACK, Model Number: DYNJ41257F

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) DYNJ41257F, UDI-DI: 10193489708523(each), 40193489708524(case), Lot Number: 25GBL423
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 25, 2026

Medline Kits: 1) SYR CONTROL 8ML ROTATING, Model Number: DNSC89369; 2) SYRINGE 10ML CONTROL MLL, Model Number: DYNJSYR10C

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) DNSC89369, UDI-DI: 10889942596225(each), 40889942596226(case), Lot Number: 25BDB731; 2) DYNJSYR10C, UDI-DI: 10884389676462(each), 40884389676463(case), Lot Number: 21BBM369; 3) DYNJSYR10C, UDI-DI: 10884389676462(each), 40884389676463(case), Lot Number: 21DBO183; 4) DYNJSYR10C, UDI-DI: 10884389676462(each), 40884389676463(case), Lot Number: 21DBY321; 5) DYNJSYR10C, UDI-DI: 10884389676462(each), 40884389676463(case), Lot Number: 21FBC554; 6) DYNJSYR10C, UDI-DI: 10884389676462(each), 40884389676463(case), Lot Number: 21FBJ020; 7) DYNJSYR10C, UDI-DI: 10884389676462(each), 40884389676463(case), Lot Number: 21FBU555; 8) DYNJSYR10C, UDI-DI: 10884389676462(each), 40884389676463(case), Lot Number: 21KBN994; 9) DYNJSYR10C, UDI-DI: 10884389676462(each), 40884389676463(case), Lot Number: 21KBV737; 10) DYNJSYR10C, UDI-DI: 10884389676462(each), 40884389676463(case), Lot Number: 22ABI338; 11) DYNJSYR10C, UDI-DI: 10884389676462(each), 40884389676463(case), Lot Number: 22DBT508; 12) DYNJSYR10C, UDI-DI: 10884389676462(each), 40884389676463(case), Lot Number: 22EBK614; 13) DYNJSYR10C, UDI-DI: 10884389676462(each), 40884389676463(case), Lot Number: 22IBH075; 14) DYNJSYR10C, UDI-DI: 10884389676462(each), 40884389676463(case), Lot Number: 22IBH622; 15) DYNJSYR10C, UDI-DI: 10884389676462(each), 40884389676463(case), Lot Number: 22IBU135; 16) DYNJSYR10C, UDI-DI: 10884389676462(each), 40884389676463(case), Lot Number: 22JBN943; 17) DYNJSYR10C, UDI-DI: 10884389676462(each), 40884389676463(case), Lot Number: 22LBO542; 18) DYNJSYR10C, UDI-DI: 10884389676462(each), 40884389676463(case), Lot Number: 22OBA220; 19) DYNJSYR10C, UDI-DI: 10884389676462(each), 40884389676463(case), Lot Number: 22OBG844; 20) DYNJSYR10C, UDI-DI: 10884389676462(each), 40884389676463(case), Lot Number: 23DBO855; 21) DYNJSYR10C, UDI-DI: 10884389676462(each), 40884389676463(case), Lot Number: 23FBM361; 22) DYNJSYR10C, UDI-DI: 10884389676462(each), 40884389676463(case), Lot Number: 23HBF967; 23) DYNJSYR10C, UDI-DI: 10884389676462(each), 40884389676463(case), Lot Number: 23HBM037; 24) DYNJSYR10C, UDI-DI: 10884389676462(each), 40884389676463(case), Lot Number: 23HBM038; 25) DYNJSYR10C, UDI-DI: 10884389676462(each), 40884389676463(case), Lot Number: 23HBZ420; 26) DYNJSYR10C, UDI-DI: 10884389676462(each), 40884389676463(case), Lot Number: 23IBD522; 27) DYNJSYR10C, UDI-DI: 10884389676462(each), 40884389676463(case), Lot Number: 23KBQ419; 28) DYNJSYR10C, UDI-DI: 10884389676462(each), 40884389676463(case), Lot Number: 24BBB469; 29) DYNJSYR10C, UDI-DI: 10884389676462(each), 40884389676463(case), Lot Number: 24EBT832; 30) DYNJSYR10C, UDI-DI: 10884389676462(each), 40884389676463(case), Lot Number: 24EBU578; 31) DYNJSYR10C, UDI-DI: 10884389676462(each), 40884389676463(case), Lot Number: 24EBV379; 32) DYNJSYR10C, UDI-DI: 10884389676462(each), 40884389676463(case), Lot Number: 24GBC953; 33) DYNJSYR10C, UDI-DI: 10884389676462(each), 40884389676463(case), Lot Number: 24GBK311; 34) DYNJSYR10C, UDI-DI: 10884389676462(each), 40884389676463(case), Lot Number: 24GBP361; 35) DYNJSYR10C, UDI-DI: 10884389676462(each), 40884389676463(case), Lot Number: 24GBQ243; 36) DYNJSYR10C, UDI-DI: 10884389676462(each), 40884389676463(case), Lot Number: 24GBV309; 37) DYNJSYR10C, UDI-DI: 10884389676462(each), 40884389676463(case), Lot Number: 24HBQ322; 38) DYNJSYR10C, UDI-DI: 10884389676462(each), 40884389676463(case), Lot Number: 24IBV756; 39) DYNJSYR10C, UDI-DI: 10884389676462(each), 40884389676463(case), Lot Number: 24KBF922; 40) DYNJSYR10C, UDI-DI: 10884389676462(each), 40884389676463(case), Lot Number: 24LBL381; 41) DYNJSYR10C, UDI-DI: 10884389676462(each), 40884389676463(case), Lot Number: 25ABI838; 42) DYNJSYR10C, UDI-DI: 10884389676462(each), 40884389676463(case), Lot Number: 25ABN037; 43) DYNJSYR10C, UDI-DI: 10884389676462(each), 40884389676463(case), Lot Number: 25ABO304; 44) DYNJSYR10C, UDI-DI: 10884389676462(each), 40884389676463(case), Lot Number: 25ABP830; 45) DYNJSYR10C, UDI-DI: 10884389676462(each), 40884389676463(case), Lot Number: 25BBA706; 46) DYNJSYR10C, UDI-DI: 10884389676462(each), 40884389676463(case), Lot Number: 25BBO573; 47) DYNJSYR10C, UDI-DI: 10884389676462(each), 40884389676463(case), Lot Number: 25CBQ928; 48) DYNJSYR10C, UDI-DI: 10884389676462(each), 40884389676463(case), Lot Number: 25EBC625; 49) DYNJSYR10C, UDI-DI: 10884389676462(each), 40884389676463(case), Lot Number: 25EBG123; 50) DYNJSYR10C, UDI-DI: 10884389676462(each), 40884389676463(case), Lot Number: 25EBJ932; 51) DYNJSYR10C, UDI-DI: 10884389676462(each), 40884389676463(case), Lot Number: 25EBN364; 52) DYNJSYR10C, UDI-DI: 10884389676462(each), 40884389676463(case), Lot Number: 25EBO179; 53) DYNJSYR10C, UDI-DI: 10884389676462(each), 40884389676463(case), Lot Number: 25EBQ230; 54) DYNJSYR10C, UDI-DI: 10884389676462(each), 40884389676463(case), Lot Number: 25EBT991; 55) DYNJSYR10C, UDI-DI: 10884389676462(each), 40884389676463(case), Lot Number: 25GBK401; 56) DYNJSYR10C, UDI-DI: 10884389676462(each), 40884389676463… (truncated, 5568 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

Medline Kits: 1) LABOR PACK-22025208-LF, Model Number: DYNJ44813D

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) DYNJ44813D, UDI-DI: 10193489467642(each), 40193489467643(case), Lot Number: 21CBJ477; 2) DYNJ44813D, UDI-DI: 10193489467642(each), 40193489467643(case), Lot Number: 21GBE184; 3) DYNJ44813D, UDI-DI: 10193489467642(each), 40193489467643(case), Lot Number: 21GBJ527; 4) DYNJ44813D, UDI-DI: 10193489467642(each), 40193489467643(case), Lot Number: 21HBL388; 5) DYNJ44813D, UDI-DI: 10193489467642(each), 40193489467643(case), Lot Number: 21IBT013; 6) DYNJ44813D, UDI-DI: 10193489467642(each), 40193489467643(case), Lot Number: 21LBS718; 7) DYNJ44813D, UDI-DI: 10193489467642(each), 40193489467643(case), Lot Number: 22BBD935; 8) DYNJ44813D, UDI-DI: 10193489467642(each), 40193489467643(case), Lot Number: 22CBA262; 9) DYNJ44813D, UDI-DI: 10193489467642(each), 40193489467643(case), Lot Number: 22FBM910; 10) DYNJ44813D, UDI-DI: 10193489467642(each), 40193489467643(case), Lot Number: 22LBQ838; 11) DYNJ44813D, UDI-DI: 10193489467642(each), 40193489467643(case), Lot Number: 23FBS838; 12) DYNJ44813D, UDI-DI: 10193489467642(each), 40193489467643(case), Lot Number: 23IBD099; 13) DYNJ44813D, UDI-DI: 10193489467642(each), 40193489467643(case), Lot Number: 23KBA057; 14) DYNJ44813D, UDI-DI: 10193489467642(each), 40193489467643(case), Lot Number: 24ABJ743; 15) DYNJ44813D, UDI-DI: 10193489467642(each), 40193489467643(case), Lot Number: 24EBG776; 16) DYNJ44813D, UDI-DI: 10193489467642(each), 40193489467643(case), Lot Number: 24FBC225; 17) DYNJ44813D, UDI-DI: 10193489467642(each), 40193489467643(case), Lot Number: 24IBW215; 18) DYNJ44813D, UDI-DI: 10193489467642(each), 40193489467643(case), Lot Number: 24LBU055; 19) DYNJ44813D, UDI-DI: 10193489467642(each), 40193489467643(case), Lot Number: 22HBG782; 20) DYNJ44813D, UDI-DI: 10193489467642(each), 40193489467643(case), Lot Number: 25DBP554
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 25, 2026

Medline Kits: 1) ENT PACK, Model Number: DYNJ59030B; 2) ENT, Model Number: DYNJ908586C; 3) LH 3 PORT W/O WASTEBAG, Model Number: VASC1081C

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) DYNJ59030B, UDI-DI: 10198459176920(each), 40198459176921(case), Lot Number: 24KBL574; 2) DYNJ908586C, UDI-DI: 10198459058677(each), 40198459058678(case), Lot Number: 24IBJ666; 3) DYNJ908586C, UDI-DI: 10198459058677(each), 40198459058678(case), Lot Number: 24JBM014; 4) DYNJ908586C, UDI-DI: 10198459058677(each), 40198459058678(case), Lot Number: 24KBE220; 5) DYNJ908586C, UDI-DI: 10198459058677(each), 40198459058678(case), Lot Number: 24LBJ174; 6) DYNJ908586C, UDI-DI: 10198459058677(each), 40198459058678(case), Lot Number: 25ABW145; 7) DYNJ908586C, UDI-DI: 10198459058677(each), 40198459058678(case), Lot Number: 25CBK525; 8) DYNJ908586C, UDI-DI: 10198459058677(each), 40198459058678(case), Lot Number: 25EBA897; 9) DYNJ908586C, UDI-DI: 10198459058677(each), 40198459058678(case), Lot Number: 25GBK561; 10) VASC1081C, UDI-DI: 10195327054519(each), 40195327054510(case), Lot Number: 25FBA927
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 25, 2026

Medline Kits: 1) HEART TRANSPLANT BIOPSY, Model Number: DYNJ37543A

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) DYNJ37543A, UDI-DI: 10193489919561(each), 40193489919562(case), Lot Number: 24DDA193
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 PK Cutting Forceps, 5mm 33cm Product Name: PK Cutting Forceps Model/Catalog Number: PK-CF0533 Product Description: An assembly of devices intended to generate and apply radio-frequency (RF) alternating current to soft tissues for cutting and coagulation during an endoscopic or open surgical procedure.

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: PK-CF0533; UDI: 00821925035867; 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

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)
UnclassifiedRisk not yet known
Medical deviceRecalled February 25, 2026

Medline Kits: 1) NEWBORN ADMISSION, Model Number: DYKB1038; 2) DRAINAGE TRAY, Model Number: DYNDA3188; 3) VA ORLANDO SHOULDER PACK, Model Number: DYNJG001027B; 4) TUMESCENT SYRINGE KIT, Model Number: DYNJTUMSYR; 5) OMC PTCA PACK, Model Number: DYNJT3719; 6) PORT PACK, Model Number: DYNJT5667; 7) WASTE MANAGEMENT KIT - 2, Model Number: DYNJWASTEKIT2; 8) CARDIAC CATH, Model Number: DYNJ20175J; 9) D&C PACK-POB, Model Number: DYNJ33521D; 10) BASIC PACK, Model Number: DYNJ38533F; 11) CATH PACK IMPLANT, Model Number: DYNJ39230D; 12) CERVICAL SPINE PACK, Model Number: DYNJ40886B; 13) MV-IR ANGIO DRAPE PACK-LF, Model Number: DYNJ41553F; 14) TV ENDOVASCULAR-LF, Model Number: DYNJ41558D; 15) MAJOR PACK-LF, Model Number: DYNJ44816J; 16) ANGIOGRAPHY PACK, Model Number: DYNJ48683A; 17) EXTREMITY PACK, Model Number: DYNJ55922C; 18) NEURO PACK, Model Number: DYNJ57785C; 19) PACEMAKER PACK, Model Number: DYNJ61377B; 20) VASCULAR PACK, Model Number: DYNJ62683D; 21) LINQ INSERTION PK W/OUT LIDO, Model Number: DYNJ63668B; 22) BASIC PACK, Model Number: DYNJ83324; 23) OMF MINOR PACK, Model Number: DYNJ83991B; 24) ARTERIOGRAM SUMMIT PACK, Model Number: DYNJ84040B; 25) HMWB NEURO NAMIC PACK, Model Number: DYNJ86600; 26) VCH CARDIAC CATH PACK, Model Number: DYNJ89064; 27) RADIOLOGY PACK, Model Number: DYNJ89080; 28) LITHOTOMY PACK, Model Number: DYNJ89959; 29) AHT SPINE PACK, Model Number: DYNJ903566D; 30) LAP, Model Number: DYNJ904576B; 31) EP MERCY JANESVILLE, Model Number: DYNJ907013; 32) LHK, US, RUBY MEMORIAL HOSP, Model Number: NAM0032; 33) CHERIAN CATH KIT, Model Number: VASC1086; 34) RIGHT HEART KIT - LAKE NONA, Model Number: VASC1120; 35) KIT ANGIO CSTM-SHAWNEE, Model Number: VASC1151; 36) LEFT HEART KIT - OAKBEND, Model Number: VASC1155; 37) IR 2 PORT-ARROWHEAD REGIONAL, Model Number: VASC1404; 38) LHK - ARROWHEAD REGIONAL MED, Model Number: VASC1405; 39) LHK - UMC DOUBLE TRANSDUCER, Model Number: VASC1415A; 40) SDMC, EP TWO PORT CUSTOM KIT, Model Number: VASC1533; 41) ARTERIOGRAM TRAY, Model Number: 00-402001V

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) DYKB1038, UDI-DI: 10193489502428(each), 40193489502429(case), Lot Number: 22GBJ869; 2) DYNDA3188, UDI-DI: 10198459303579(each), 40198459303570(case), Lot Number: 25DBF256; 3) DYNJG001027B, UDI-DI: 10198459065453(each), 40198459065454(case), Lot Number: 25ELA998; 4) DYNJG001027B, UDI-DI: 10198459065453(each), 40198459065454(case), Lot Number: 25ELA723; 5) DYNJTUMSYR, UDI-DI: 10884389882054(each), 40884389882055(case), Lot Number: 21BBH579; 6) DYNJTUMSYR, UDI-DI: 10884389882054(each), 40884389882055(case), Lot Number: 21BBS213; 7) DYNJTUMSYR, UDI-DI: 10884389882054(each), 40884389882055(case), Lot Number: 21DBS220; 8) DYNJTUMSYR, UDI-DI: 10884389882054(each), 40884389882055(case), Lot Number: 21HBK178; 9) DYNJTUMSYR, UDI-DI: 10884389882054(each), 40884389882055(case), Lot Number: 21IBV194; 10) DYNJTUMSYR, UDI-DI: 10884389882054(each), 40884389882055(case), Lot Number: 21JBJ063; 11) DYNJTUMSYR, UDI-DI: 10884389882054(each), 40884389882055(case), Lot Number: 21JBM583; 12) DYNJTUMSYR, UDI-DI: 10884389882054(each), 40884389882055(case), Lot Number: 22ABG678; 13) DYNJTUMSYR, UDI-DI: 10884389882054(each), 40884389882055(case), Lot Number: 22ABZ724; 14) DYNJTUMSYR, UDI-DI: 10884389882054(each), 40884389882055(case), Lot Number: 22DBL342; 15) DYNJTUMSYR, UDI-DI: 10884389882054(each), 40884389882055(case), Lot Number: 22IBS978; 16) DYNJTUMSYR, UDI-DI: 10884389882054(each), 40884389882055(case), Lot Number: 22JBV884; 17) DYNJTUMSYR, UDI-DI: 10884389882054(each), 40884389882055(case), Lot Number: 22LBH141; 18) DYNJTUMSYR, UDI-DI: 10884389882054(each), 40884389882055(case), Lot Number: 22OBE023; 19) DYNJTUMSYR, UDI-DI: 10884389882054(each), 40884389882055(case), Lot Number: 22OBE024; 20) DYNJTUMSYR, UDI-DI: 10884389882054(each), 40884389882055(case), Lot Number: 22OBE025; 21) DYNJTUMSYR, UDI-DI: 10884389882054(each), 40884389882055(case), Lot Number: 23CBP389; 22) DYNJTUMSYR, UDI-DI: 10884389882054(each), 40884389882055(case), Lot Number: 23EBB429; 23) DYNJTUMSYR, UDI-DI: 10884389882054(each), 40884389882055(case), Lot Number: 23EBQ437; 24) DYNJTUMSYR, UDI-DI: 10884389882054(each), 40884389882055(case), Lot Number: 23GBB278; 25) DYNJTUMSYR, UDI-DI: 10884389882054(each), 40884389882055(case), Lot Number: 23HBD985; 26) DYNJTUMSYR, UDI-DI: 10884389882054(each), 40884389882055(case), Lot Number: 23JBN242; 27) DYNJTUMSYR, UDI-DI: 10884389882054(each), 40884389882055(case), Lot Number: 23LBP034; 28) DYNJTUMSYR, UDI-DI: 10884389882054(each), 40884389882055(case), Lot Number: 23LBP432; 29) DYNJTUMSYR, UDI-DI: 10884389882054(each), 40884389882055(case), Lot Number: 24ABA416; 30) DYNJTUMSYR, UDI-DI: 10884389882054(each), 40884389882055(case), Lot Number: 24EBF244; 31) DYNJTUMSYR, UDI-DI: 10884389882054(each), 40884389882055(case), Lot Number: 24FBB647; 32) DYNJTUMSYR, UDI-DI: 10884389882054(each), 40884389882055(case), Lot Number: 24FBO960; 33) DYNJTUMSYR, UDI-DI: 10884389882054(each), 40884389882055(case), Lot Number: 24GBE249; 34) DYNJTUMSYR, UDI-DI: 10884389882054(each), 40884389882055(case), Lot Number: 24GBW947; 35) DYNJTUMSYR, UDI-DI: 10884389882054(each), 40884389882055(case), Lot Number: 24HBN439; 36) DYNJTUMSYR, UDI-DI: 10884389882054(each), 40884389882055(case), Lot Number: 24JBC123; 37) DYNJTUMSYR, UDI-DI: 10884389882054(each), 40884389882055(case), Lot Number: 24KBI920; 38) DYNJTUMSYR, UDI-DI: 10884389882054(each), 40884389882055(case), Lot Number: 24LBO860; 39) DYNJTUMSYR, UDI-DI: 10884389882054(each), 40884389882055(case), Lot Number: 21JBV362; 40) DYNJTUMSYR, UDI-DI: 10884389882054(each), 40884389882055(case), Lot Number: 23BBU890; 41) DYNJTUMSYR, UDI-DI: 10884389882054(each), 40884389882055(case), Lot Number: 24ABN982; 42) DYNJTUMSYR, UDI-DI: 10884389882054(each), 40884389882055(case), Lot Number: 25HBM032; 43) DYNJT3719, UDI-DI: 10198459347054(each), 40198459347055(case), Lot Number: 25EBU996; 44) DYNJT5667, UDI-DI: 10198459492129(each), 40198459492120(case), Lot Number: 25HDB174; 45) DYNJWASTEKIT2, UDI-DI: 10193489548204(each), 40193489548205(case), Lot Number: 22HBK640; 46) DYNJ20175J, UDI-DI: 10198459023750(each), 40198459023751(case), Lot Number: 25DMI117; 47) DYNJ20175J, UDI-DI: 10198459023750(each), 40198459023751(case), Lot Number: 25BMC155; 48) DYNJ33521D, UDI-DI: 10198459015656(each), 40198459015657(case), Lot Number: 24FDB534; 49) DYNJ33521D, UDI-DI: 10198459015656(each), 40198459015657(case), Lot Number: 24HDC006; 50) DYNJ33521D, UDI-DI: 10198459015656(each), 40198459015657(case), Lot Number: 24IDB770; 51) DYNJ33521D, UDI-DI: 10198459015656(each), 40198459015657(case), Lot Number: 24KDA884; 52) DYNJ33521D, UDI-DI: 10198459015656(each), 40198459015657(case), Lot Number: 24LDA938; 53) DYNJ33521D, UDI-DI: 10198459015656(each), 40198459015657(case), Lot Number: 25ADB529; 54) DYNJ33521D, UDI-DI: 10198459015656(each), 40198459015657(case), Lot Number: 25BDB719; 55) DYNJ33521D, UDI-DI: 10198459015656(each), 40198459015657(case), Lot Number: 25DDB454; 56) DYNJ33521D, UDI-DI: 10198459015656(each), 40198459015… (truncated, 17185 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 w/Cord, 5mm 24cm Product Name: PKS Cutting Forceps Model/Catalog Number: 920000PK 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: 920000PK; UDI: 00821925038080; 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

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.

ALL 50 STATES
▸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) ARTHROGRAM TRAY, Model Number: DYNJ07425; 2) TOL NEURO ANGIO PACK, Model Number: DYNJ38610I 3) ANGIOGRAPHY PACK, Model Number: DYNJ45234A 4) C.I.C.N. ANGIO PACK, Model Number: DYNJ53064B 5) DR. ALLEYNE NEURO PACK, Model Number: DYNJ63779A 6) NEURO CTM IR PACK, Model Number: DYNJ87817

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) DYNJ07425, UDI-DI: 10080196866465(each), 40080196866466(case), Lot Number: 23DBP927; 2) DYNJ07425, UDI-DI: 10080196866465(each), 40080196866466(case), Lot Number: 23EBS362; 3) DYNJ38610I, UDI-DI: 10198459323102(each), 40198459323103(case), Lot Number: 25DBM593; 4) DYNJ38610I, UDI-DI: 10198459323102(each), 40198459323103(case), Lot Number: 25GBO740; 5) DYNJ45234A, UDI-DI: 10193489782554(each), 40193489782555(case), Lot Number: 23LBU617; 6) DYNJ45234A, UDI-DI: 10193489782554(each), 40193489782555(case), Lot Number: 23HBK865; 7) DYNJ53064B, UDI-DI: 10193489789164(each), 40193489789165(case), Lot Number: 24BMC721; 8) DYNJ53064B, UDI-DI: 10193489789164(each), 40193489789165(case), Lot Number: 24EMF715; 9) DYNJ53064B, UDI-DI: 10193489789164(each), 40193489789165(case), Lot Number: 24AMI140; 10) DYNJ63779A, UDI-DI: 10193489355840(each), 40193489355841(case), Lot Number: 25HBM008; 11) DYNJ87817, UDI-DI: 10198459069185(each), 40198459069186(case), Lot Number: 24HBF527; 12) DYNJ87817, UDI-DI: 10198459069185(each), 40198459069186(case), Lot Number: 25BBL663; 13) DYNJ87817, UDI-DI: 10198459069185(each), 40198459069186(case), Lot Number: 25CBN143; 14) DYNJ87817, UDI-DI: 10198459069185(each), 40198459069186(case), Lot Number: 25EBJ520; 15) DYNJ87817, UDI-DI: 10198459069185(each), 40198459069186(case), Lot Number: 25FBC657
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 Everest Bipolar Cutting Forceps w/Cord, 5mm 33 cm Product Name: Everest Bipolar Cutting Forceps Model/Catalog Number: 3006 Product Description: The OLYMPUS Everest Bipolar Cutting Forceps are intended to be passed through a 5 mm cannula. Coagulation is achieved using electrosurgical energy under visualization. The device is intended to be used with the bipolar outputs of compatible generators.

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

Recall #:
98454
Lot/product code:
Model: 3006; UDI: 00821925035898; Lot Numbers: All unexpired;
Recalling firm:
Olympus Corporation of the Americas
View official FDA record (opens in a new tab)