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Recalls affecting Kentucky

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

16,694 recalls found

Just announced

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

Business Pill, Branch Manager for Mendietary 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 AliveMoringa 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. Braun0.9% 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 ValueOrganic 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 TemptationsChocolatey 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

LipofitLipofit 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

KofinasGarlic 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 SproutsRobust 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

MartinaMangoes

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 March 25, 2026

DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff Maculorhexis Forceps, Model/Catalog Number: DVF4019-25-S

Field Safety Corrective Action for IFU in DEX Forceps and Scissors.

ALL 50 STATES
Full report

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

Recall #:
98660
Lot/product code:
Lot Code: Model No: DVF4019-25-S UDI-DI: (01)10840096205135(11)251017(17)281017(10)M50541 Lot Number: M50541 Expiration Date: 10/17/2028 Model No: DVF4019-25-S UDI-DI: (01)10840096205135(11)251017(17)281017(10)M50542 Lot Number: M50542 Expiration Date: 10/17/2028 Model No: DVF4019-25-S UDI-DI: (01)10840096205135(11)251023(17)281023(10)M50632 Lot Number: M50632 Expiration Date: 10/23/2028 Model No: DVF4019-25-S UDI-DI: (01)10840096205135(11)251023(17)281023(10)M50633 Lot Number: M50633 Expiration Date: 10/23/2028 Model No: DVF4019-25-S UDI-DI: (01)10840096205135(11)251113(17)281113(10)M50936 Lot Number: M50936 Expiration Date: 11/13/2028 Model No: DVF4019-25-S UDI-DI: (01)10840096205135(11)251113(17)281113(10)M50996 Lot Number: M50996 Expiration Date: 11/13/2028 Model No: DVF4019-25-S UDI-DI: (01)10840096205135(11)251125(17)281125(10)M51039 Lot Number: M51039 Expiration Date: 11/25/2028 Model No: DVF4019-25-S UDI-DI: (01)10840096205135(11)251125(17)281125(10)M51040 Lot Number: M51040 Expiration Date: 11/25/2028 Model No: DVF4019-25-S UDI-DI: (01)10840096205135(11)251125(17)281125(10)M51081 Lot Number: M51081 Expiration Date: 11/25/2028 Model No: DVF4019-25-S UDI-DI: (01)10840096205135(11)251126(17)281126(10)M51138 Lot Number: M51138 Expiration Date: 11/26/2028 Model No: DVF4019-25-S UDI-DI: (01)10840096205135(11)250422(17)280422(10)M47122 Lot Number: M47122 Expiration Date: 04/22/2028 Model No: DVF4019-25-S UDI-DI: (01)10840096205135(11)250422(17)280422(10)M47123 Lot Number: M47123 Expiration Date: 04/22/2028 Model No: DVF4019-25-S UDI-DI: (01)10840096205135(11)250429(17)280429(10)M47336 Lot Number: M47336 Expiration Date: 04/29/2028 Model No: DVF4019-25-S UDI-DI: (01)10840096205135(11)250618(17)280618(10)M48308 Lot Number: M48308 Expiration Date: 06/18/2028 Model No: DVF4019-25-S UDI-DI: (01)10840096205135(11)250709(17)280709(10)M48660 Lot Number: M48660 Expiration Date: 07/09/2028 Model No: DVF4019-25-S UDI-DI: (01)10840096205135(11)250807(17)280807(10)M49294 Lot Number: M49294 Expiration Date: 08/07/2028 Model No: DVF4019-25-S UDI-DI: (01)10840096205135(11)250819(17)280819(10)M49784 Lot Number: M49784 Expiration Date: 08/19/2028 Model No: DVF4019-25-S UDI-DI: (01)10840096205135(11)250826(17)280826(10)M49839 Lot Number: M49839 Expiration Date: 08/26/2028 Model No: DVF4019-25-S UDI-DI: (01)10840096205135(11)250826(17)280826(10)M49910 Lot Number: M49910 Expiration Date: 08/26/2028 Model No: DVF4019-25-S UDI-DI: (01)10840096205135(11)250904(17)280904(0)M49929 Lot Number: M49929 Expiration Date: 09/04/2028 Model No: DVF4019-25-S UDI-DI: (01)10840096205135(11)250909)17)280909(10)M49930 Lot Number: M49930 Expiration Date: 09/09/2028 Model No: DVF4019-25-S UDI-DI: (01)10840096205135(11)250917(17)280917(10)M50215 Lot Number: M50215 Expiration Date: 09/17/2028 Model No: DVF4019-25-S UDI-DI: (01)10840096205135(11)250924(17)280924(10)M50427 Lot Number: M50427 Expiration Date: 09/24/2028 Model No: DVF4019-25-S UDI-DI: (01)10840096205135(11)250924(17)280924(10)M50429 Lot Number: M50429 Expiration Date: Model No: DVF4019-25-S UDI-DI: (01)10840096205135(11)250924(17)280924(10)M50428 Lot Number: M50428 Expiration Date: 09/24/2028
Recalling firm:
Katalyst Surgical, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 25, 2026

Heraeus, PALAMIX duo. Material Number: 66057897.

Based on long-term stability testing, it was determined that in units older than 1.5 years (17 months) the mixing rod may, in rare cases, come loose from its lock during the mixing process. Notification is to reduce the shelf life from 3 years to 1.5 years (17 months).

ALL 50 STATES
Full report

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

Recall #:
98608
Lot/product code:
Material Number: 66057897; UDI-DI: 04260102133617; Batch: all batches with numbers below 520215;
Recalling firm:
Heraeus Medical GmbH (Dental Division)
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceBacteria/virusSalmonellaRecalled March 25, 2026

Oxoid Agglutinating Sera, Salmonella 9-0 R30957301

Affected lots are not performing to IFU criteria showing cross reactions with 2-0 within 60 seconds. Cross-reactivity may result in the misidentification of a Salmonella 9-O serotype as a 2-O serotype.

ALL 50 STATES
Full report

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

Recall #:
98652
Lot/product code:
UDI-DI 05056080500270 lots 6172600, 6172741, 6171393, 6150168, 6107767, 3766399, 3766400, 3780497, 3719592, 3709358, 6266130, 6253410, 6260215, 6222350, 6233859, 6233858
Recalling firm:
Remel Europe Ltd.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 25, 2026

OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2117.

Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.

ALL 50 STATES
Full report

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

Recall #:
98544
Lot/product code:
Model Number: MAJ-2117. UDI Number: 04953170404122. Lot Numbers: 09A, 0XA, 0YA, 0ZA, 11A, 12A, 24A, 25A, 26A, 27A, 28A, 29A, 2XA, 2YA, 2ZA, 31A, 32A, 33A, 34A, 35A, 36A, 37A, 39A, 3XA, 3YA, 3ZA, 41A, 42A, 43A, 44A, 45A, 46A, 47A, 48A, 49A, 4YA, 4ZA, 51A.
Recalling firm:
Olympus Corporation of the Americas
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 25, 2026

OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2119.

Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.

ALL 50 STATES
Full report

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

Recall #:
98544
Lot/product code:
Model Number: MAJ-2119. UDI Number: 04953170404146. Lot Numbers: 09A, 0XA, 0YA, 0ZA, 11A, 14A,15A, 16A, 17A, 18A,1XA, 1YA, 1ZA, 22A, 23A, 24A, 25A, 26A, 27A, 28A, 29A, 2XA, 2YA, 2ZA, 31A, 32A, 33A, 34A, 35A, 36A, 37A, 38A, 3XA, 3YA, 3ZA, 41A, 42A, 43A, 44A, 45A, 46A, 47A, 48A, 4XA, 4YA, 51A.
Recalling firm:
Olympus Corporation of the Americas
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 25, 2026

DEX Ophthalmic Tissue Forceps, 23ga DEX Maculorhexis Forceps, Model/Catalog Number: DVF4019-23

Field Safety Corrective Action for IFU in DEX Forceps and Scissors.

ALL 50 STATES
Full report

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

Recall #:
98660
Lot/product code:
Lot Code: Model No: DVF4019-23 UDI-DI: (01)10817489022136(11)250807(17)280807(10)M49267 Lot Number: M49267 Expiration Date: 08/07/2028 Model No: DVF4019-23 UDI-DI: (01)10817489022136(11)251017(17)281017(10)M50930 Lot Number: M50930 Expiration Date: 10/17/2028 Model No: DVF4019-23 UDI-DI: (01)10817489022136(11)251113(17)281113(10)M51230 Lot Number: M51230 Expiration Date: 11/13/2028 Model No: DVF4019-23 UDI-DI: (01)10817489022136(11)251212(17)281212(10)M51587 Lot Number: M51587 Expiration Date: 12/12/2028 Model No: DVF4019-23 UDI-DI: (01)10817489022136(11)260115(17)290115(10)M51696 Lot Number: M51696 Expiration Date: 01/15/2029 Model No: DVF4019-23 UDI-DI: (01)10817489022136(11)250904(17)280904(10)M49921 Lot Number: M49921 Expiration Date: 09/04/2028 Model No; DVF4019-23 UDI-DI: (01)10817489022136(11)251107(17)281107(10)M51128 Lot Number: M51128 Expiration Date: 11/07/2028
Recalling firm:
Katalyst Surgical, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceForeign materialRecalled March 25, 2026

Avitene Ultrafoam Microfibrillar Collagen Hemostat - 8cm x 6.25cm x 1cm. Catalog Number: 1050030.

Potential for product to contain foreign matter, confirmed to be inspect fragments.

ALL 50 STATES
Full report

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

Recall #:
98602
Lot/product code:
Catalog Number: 1050030. UDI: (01)00801741010538(17)270728(10)WBJS0055. Lot Number: WBJS0055. Expiration Date: 07/28/2027
Recalling firm:
Davol, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 25, 2026

Heraeus, PALAMIX uno. Material Number: 66057893.

Based on long-term stability testing, it was determined that in units older than 1.5 years (17 months) the mixing rod may, in rare cases, come loose from its lock during the mixing process. Notification is to reduce the shelf life from 3 years to 1.5 years (17 months).

ALL 50 STATES
Full report

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

Recall #:
98608
Lot/product code:
Material Number: 66057893; UDI-DI: 04260102133587; Batch: all batches with numbers below 223060;
Recalling firm:
Heraeus Medical GmbH (Dental Division)
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled March 24, 2026

GE Healthcare Omnipaque (iohexol) Injection, 350 mg/mL (64.7%), Rx Only, Distributed by: GE Healthcare Inc., Marlborough, MA 01752 USA, NDC 0407-1414-91.

Presence of particulate matter

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-0448-2026
Lot/product code:
Lot# 17333197; Exp. December 10, 2028 Lot# 17333198; Exp. November 17, 2028 Lot# 17396945; Exp. December 18, 2028 Lot# 17396948; Exp. December 22, 2028 Lot# 17396953; Exp. January 11, 2029 Lot# 17396956; Exp. January 9, 2029 Lot# 17423503; Exp. January 1, 2029 Lot# 17423525; Exp. January 3, 2029 Lot# 17426429; Exp. January 1, 2029 Lot# 17426440; Exp. January 4, 2029 Lot# 17431310; Exp. January 11, 2029
Recalling firm:
GE Healthcare Ireland Limited
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 24, 2026

Namic Angiographic Manifold, custom, Medline Product Number/SKU 64038200; Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting.

Medline has identified the presence of particulate within the fluid path of the Manifolds.

ALL 50 STATES
Full report

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

Recall #:
98735
Lot/product code:
UDI/DI each 10193489059144, UDI/Di case 30193489059148, Lot Numbers: 90184, 94779, 97786, 106351, 108597, 109876, 114056, 114989, 115459, 115931, 116358, 116865, 118245, 122974, 126077, 127795, 129531, 130557, 136114, 150501, 151591, 152772, 154514, 156045, 160318, 163255, 168053.
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 24, 2026

Medline medical convenience kits, containing Namic Manifold, Labeled as: HEART CATH PACK-LF, Medline Kit Number/SKU DYNJ36478B

Medline has identified the presence of particulate within the fluid path of the Manifolds.

ALL 50 STATES
Full report

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

Recall #:
98735
Lot/product code:
UDI/DI each 10889942814619, UDI/DI case 40889942814610, Lot Number: 26CMC977
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 24, 2026

Namic Angiographic Manifold, custom, Medline Product Number/SKU 64038301; Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting.

Medline has identified the presence of particulate within the fluid path of the Manifolds.

ALL 50 STATES
Full report

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

Recall #:
98735
Lot/product code:
UDI/DI each 10193489059168, UDI/DI case 30193489059162, Lot Numbers: 89631, 92244, 92464, 93148, 94033, 94851, 101093, 101989, 103550, 109976, 112236, 112333, 114288, 115691, 121707, 126993, 137933, 142147, 162786, 191812.
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 24, 2026

Yeastone Broth, 11ML, 10/BOX YY3462

Products may report incorrect AST results during quality control. Health consequences may include delayed response or the need to change to another antifungal agent if laboratory ignores Quality Control test result.

ALL 50 STATES
Full report

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

Recall #:
98616
Lot/product code:
UDI-DI 848838018817 lots 321046, 329835, 330316, 327069, 330317, 336325, 338314, 341161, 303851, 311723
Recalling firm:
Remel, Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 24, 2026

Hintermann Series Talar Implant, Left, Size 2 REF 302112

Through customer complaints, the ankle replacement system was found to contain incorrect devices: Left implant packaging and labeling bears a right implant device.

ALL 50 STATES
Full report

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

Recall #:
98987
Lot/product code:
Lot: AACAA/ DI: B095302112
Recalling firm:
DT MedTech, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 24, 2026

Namic Angiographic Manifold, custom, Medline Product Number/SKU 64038402; Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting.

Medline has identified the presence of particulate within the fluid path of the Manifolds.

ALL 50 STATES
Full report

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

Recall #:
98735
Lot/product code:
UDI/DI each 10193489059182, UDI/DI case 30193489059186, Lot Numbers: 92261, 152082, 163966, 163256.
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 24, 2026

Namic Preceptor Manifold, custom, Medline Product Number/SKU 64039307; Extravascular blood pressure transducer

Medline has identified the presence of particulate within the fluid path of the Manifolds.

ALL 50 STATES
Full report

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

Recall #:
98735
Lot/product code:
UDI/DI each 10193489059205, UDI/DI case 30193489059209, Lot Numbers: 117277, 119982, 122210, 122199, 130129, 133014, 136396, 138613, 139138, 157974, 162399, 164317, 175538, 193515, 193531.
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 24, 2026

Hintermann Series Talar Implant, Left, Size 2 REF 302112

Through customer complaints, the ankle replacement system was found to contain incorrect devices: Left implant packaging and labeling bears a right implant device.

ALL 50 STATES
Full report

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

Recall #:
98987
Lot/product code:
Lot: AACAA/ DI: B095302112
Recalling firm:
DT MedTech, LLC
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled March 24, 2026

GE Healthcare Omnipaque (iohexol) Injection, 300 mg/mL (64.7%), Rx Only, Distributed by: GE Healthcare Inc., Marlborough, MA 01752 USA, NDC 0407-1413-63.

Presence of particulate matter

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-0447-2026
Lot/product code:
Lot# 17225029; Exp. September 3, 2028 Lot# 17265376; Exp. October 3, 2028 Lot# 17270885; Exp. September 10, 2028 Lot# 17292246; Exp. October 4, 2028 Lot# 17301805; Exp. October 18, 2028 Lot# 17301807; Exp. September 7, 2028 Lot# 17301810; Exp. October 20, 2028 Lot# 17304992; Exp. October 5, 2028 Lot# 17304993; Exp. October 19, 2028 Lot# 17304996; Exp. November 25, 2028 Lot# 17321225; Exp. September 8, 2028 Lot# 17333589; Exp. November 24, 2028 Lot# 17333611; Exp. November 26. 2028 Lot# 17333613; Exp. November 23. 2028 Lot# 17357000; Exp. December 5, 2028 Lot# 17366399; Exp. December 14, 2028 Lot# 17376486; Exp. December 14, 2028 Lot# 17404114; Exp. December 6, 2028
Recalling firm:
GE Healthcare Ireland Limited
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled March 24, 2026

Memantine Hydrochloride Extended-Release, Capsules, 7 mg, 100 Capsules (10 x 10 blister packs), Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268, NDC 0904-6734-61

Failed Dissolution Specifications

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-0485-2026
Lot/product code:
Lot # N02425, Exp Date: 05/31/2027.
Recalling firm:
The Harvard Drug Group LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 24, 2026

Oncology Kit w/60" (152 cm) Appx 2.2 ml, Smallbore Ext Set w/ChemoLock Port, Clamp, Anti-Siphon Valve, Spiros; ChemoLock; Syringe Transfer Set w/MicroClave, ChemoLock Port, REF: CL3960

Oncology sets/closed system transfer devices with extension sets may leak resulting in therapy delayed if noticed and corrected during setup, but if the leak occurs during therapy this may result in therapy interruption with the potential for the patient to receive less infusion solution than intended. Exposure of hazardous substances to the patient, caregiver, or pharmacy technician is possible.

ALL 50 STATES
Full report

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

Recall #:
98622
Lot/product code:
UDI-DI: 10887709083278. Lots: 13919794, 14134777, 14196319
Recalling firm:
ICU Medical, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 24, 2026

Medline medical convenience kits, containing Namic Manifold, Labeled as: 1. MTS,RT,HANDED/LFT,HRT,KIT, Medline Kit Number/SKU 60010508; 2. DBD-MTS,LEFT HEART,KIT, Medline Kit Number/SKU 60160075; 3. CARDIAC CATH PACK, Medline Kit Number/SKU DYNJ04636N; 4. CATH LAB TRAY, Medline Kit Number/SKU DYNJ24250G; 5. CATH LAB PACK-LF, Medline Kit Number/SKU DYNJ38333D; 6. CATH LAB PACK-LF, Medline Kit Number/SKU DYNJ38333F; 7. CATH LAB ANGIOGRAPHY PACK, Medline Kit Number/SKU DYNJ50779G; 8. CATH LAB ANGIOGRAPHY PACK, Medline Kit Number/SKU DYNJ50779I; 9. CLOT RETRIEVAL PACK, Medline Kit Number/SKU DYNJ56140C; 10. TAVR PACK NO SYR, Medline Kit Number/SKU DYNJ62310C; 11. TAVR PACK, Medline Kit Number/SKU DYNJ62310D; 12. TAVR PACK, Medline Kit Number/SKU DYNJ62310F; 13. DIAGNOSTIC 2 PACK, Medline Kit Number/SKU DYNJ81911; 14. DIAGNOSTIC 2 PACK, Medline Kit Number/SKU DYNJ81911A; 15. CATH PACK, Medline Kit Number/SKU DYNJT6544; 16. LHK, Medline Kit Number/SKU NAM0015; 17. SLU LHK, Medline Kit Number/SKU SAMPC0706.

Medline has identified the presence of particulate within the fluid path of the Manifolds.

ALL 50 STATES
Full report

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

Recall #:
98735
Lot/product code:
Medline Kit Number/SKU 60010508: UDI/DI each 10193489040340, UDI/DI case 40193489040341, Lot Number: 23KBN009; Medline Kit Number/SKU 60010508: UDI/DI each 10193489040340, UDI/DI case 40193489040341, Lot Number: 23LBI829; Medline Kit Number/SKU 60010508: UDI/DI each 10193489040340, UDI/DI case 40193489040341, Lot Number: 24ABH036; Medline Kit Number/SKU 60010508: UDI/DI each 10193489040340, UDI/DI case 40193489040341, Lot Number: 24BBG055; Medline Kit Number/SKU 60010508: UDI/DI each 10193489040340, UDI/DI case 40193489040341, Lot Number: 24EBO156; Medline Kit Number/SKU 60010508: UDI/DI each 10193489040340, UDI/DI case 40193489040341, Lot Number: 24GBS605; Medline Kit Number/SKU 60010508: UDI/DI each 10193489040340, UDI/DI case 40193489040341, Lot Number: 24IBK765; Medline Kit Number/SKU 60010508: UDI/DI each 10193489040340, UDI/DI case 40193489040341, Lot Number: 25ABR102; Medline Kit Number/SKU 60010508: UDI/DI each 10193489040340, UDI/DI case 40193489040341, Lot Number: 25CBK686; Medline Kit Number/SKU 60010508: UDI/DI each 10193489040340, UDI/DI case 40193489040341, Lot Number: 25DBR341; Medline Kit Number/SKU 60010508: UDI/DI each 10193489040340, UDI/DI case 40193489040341, Lot Number: 25EBB568; Medline Kit Number/SKU 60010508: UDI/DI each 10193489040340, UDI/DI case 40193489040341, Lot Number: 25FBB624; Medline Kit Number/SKU 60010508: UDI/DI each 10193489040340, UDI/DI case 40193489040341, Lot Number: 25GBC747; Medline Kit Number/SKU 60010508: UDI/DI each 10193489040340, UDI/DI case 40193489040341, Lot Number: 25HBF702; Medline Kit Number/SKU 60010508: UDI/DI each 10193489040340, UDI/DI case 40193489040341, Lot Number: 25JBJ140; Medline Kit Number/SKU 60010508: UDI/DI each 10193489040340, UDI/DI case 40193489040341, Lot Number: 26ABB718; Medline Kit Number/SKU 60010508: UDI/DI each 10193489040340, UDI/DI case 40193489040341, Lot Number: 26BBI625; Medline Kit Number/SKU 60160075: UDI/DI each 10193489048872, UDI/DI case 40193489048873, Lot Number: 23IBC156; Medline Kit Number/SKU 60160075: UDI/DI each 10193489048872, UDI/DI case 40193489048873, Lot Number: 23KBB857; Medline Kit Number/SKU 60160075: UDI/DI each 10193489048872, UDI/DI case 40193489048873, Lot Number: 24ABL640; Medline Kit Number/SKU 60160075: UDI/DI each 10193489048872, UDI/DI case 40193489048873, Lot Number: 24CBD613; Medline Kit Number/SKU 60160075: UDI/DI each 10193489048872, UDI/DI case 40193489048873, Lot Number: 24EBQ349; Medline Kit Number/SKU DYNJ04636N: UDI/DI each 10198459580918, UDI/DI case 40198459580919, Lot Number: 26AMC406; Medline Kit Number/SKU DYNJ04636N: UDI/DI each 10198459580918, UDI/DI case 40198459580919, Lot Number: 26CMA066; Medline Kit Number/SKU DYNJ24250G: UDI/DI each 10198459416590, UDI/DI case 40198459416591, Lot Number: 25GBI702; Medline Kit Number/SKU DYNJ24250G: UDI/DI each 10198459416590, UDI/DI case 40198459416591, Lot Number: 25GBQ931; Medline Kit Number/SKU DYNJ24250G: UDI/DI each 10198459416590, UDI/DI case 40198459416591, Lot Number: 25JBG417; Medline Kit Number/SKU DYNJ24250G: UDI/DI each 10198459416590, UDI/DI case 40198459416591, Lot Number: 25KBH544; Medline Kit Number/SKU DYNJ24250G: UDI/DI each 10198459416590, UDI/DI case 40198459416591, Lot Number: 26AMC371; Medline Kit Number/SKU DYNJ24250G: UDI/DI each 10198459416590, UDI/DI case 40198459416591, Lot Number: 26AMC433; Medline Kit Number/SKU DYNJ24250G: UDI/DI each 10198459416590, UDI/DI case 40198459416591, Lot Number: 26CMC609; Medline Kit Number/SKU DYNJ24250G: UDI/DI each 10198459416590, UDI/DI case 40198459416591, Lot Number: 26CMC660; Medline Kit Number/SKU DYNJ38333D: UDI/DI each 10198459032981, UDI/DI case 40198459032982, Lot Number: 24GMH056; Medline Kit Number/SKU DYNJ38333D: UDI/DI each 10198459032981, UDI/DI case 40198459032982, Lot Number: 24HMB740; Medline Kit Number/SKU DYNJ38333D: UDI/DI each 10198459032981, UDI/DI case 40198459032982, Lot Number: 24JME459; Medline Kit Number/SKU DYNJ38333D: UDI/DI each 10198459032981, UDI/DI case 40198459032982, Lot Number: 24KMJ018; Medline Kit Number/SKU DYNJ38333D: UDI/DI each 10198459032981, UDI/DI case 40198459032982, Lot Number: 25AMG765; Medline Kit Number/SKU DYNJ38333F: UDI/DI each 10198459258633, UDI/DI case 40198459258634, Lot Number: 25CME621; Medline Kit Number/SKU DYNJ38333F: UDI/DI each 10198459258633, UDI/DI case 40198459258634, Lot Number: 25EMB706; Medline Kit Number/SKU DYNJ38333F: UDI/DI each 10198459258633, UDI/DI case 40198459258634, Lot Number: 25EME362; Medline Kit Number/SKU DYNJ38333F: UDI/DI each 10198459258633, UDI/DI case 40198459258634, Lot Number: 25HME818; Medline Kit Number/SKU DYNJ38333F: UDI/DI each 10198459258633, UDI/DI case 40198459258634, Lot Number: 25KME742; Medline Kit Number/SKU DYNJ38333F: UDI/DI each 10198459258633, UDI/DI case 40198459258634, Lot Number: 26AME732; Medline Kit Number/SKU DYNJ38333F: UDI/DI each 10198459258633, UDI/DI case 40198459258634, Lot Num… (truncated, 11210 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 March 24, 2026

1. 3 VALVE MAN KIT, Medline Kit SKU Number: 65101544; 2. 3V MANIFOLD KIT, Medline Kit SKU Number: 65110351; 3. HEART CATH PACK-LF, Medline Kit SKU Number: DYNJ0373285M; 4. ANGIO DRAPE CARDIAC PACK, Medline Kit SKU Number: DYNJ51615P; 5. ANGIO DRAPE CARDIAC PACK, Medline Kit SKU Number: DYNJ51615R; 6. HEART RADIAL LAB PACK, Medline Kit SKU Number: DYNJ61982C; 7. HEART RADIAL LAB PACK, Medline Kit SKU Number: DYNJ61982D; 8. HEART ABLATION DRAPE PACK, Medline Kit SKU Number: DYNJ61984C; 9. TAVR PACK, Medline Kit SKU Number: DYNJ62310B; 10. HEART TAVR PACK, Medline Kit SKU Number: DYNJ65174G; 11. FEMORAL CARDIAC CATH, Medline Kit SKU Number: DYNJ66343A; 12. CARDIAC CATH PACK, Medline Kit SKU Number: DYNJ66693C; 13. TAVR PACK, Medline Kit SKU Number: DYNJ67225C; 14. AFIB TRAY, Medline Kit SKU Number: DYNJ85069; 15. AFIB TRAY, Medline Kit SKU Number: DYNJ85069A; 16. AFIB TRAY, Medline Kit SKU Number: DYNJ85069B; 17. MTO,LEFT HEART,KIT, Medline Kit SKU Number: VASC1811. Namic medical convenience kits, containing Namic Manifold, Labeled as: 1. DBD-MTS,3V,MAN,KIT, Medline Kit Number/SKU 60010195; 2. MTS,4 VALVE,LFT,HRT,KIT, Medline Kit Number/SKU 60010468; 3. MTO,ADD,ON,KIT, Medline Kit Number/SKU 60010469; 4. MTS,RT,HANDED/LFT,HRT,KIT, Medline Kit Number/SKU 60010508; 5. MTS,LFT,HRT,KIT, Medline Kit Number/SKU 60012911; 6. MTO,RIGHT HEART,KIT, Medline Kit Number/SKU 60012912; 7. DBD-MTS,LEFT HEART,KIT, Medline Kit Number/SKU 60013001; 8. MTS,LEFT HEART,KIT, Medline Kit Number/SKU 60013101; 9. MTS,LFT,HRT,W/WIRE, Medline Kit Number/SKU 60013112; 10. MTS,-,3V,KIT, Medline Kit Number/SKU 60020608; 11. MTO,ANGIO,KIT, Medline Kit Number/SKU 60032681; 12. MTS-LEFT HEART,KIT, Medline Kit Number/SKU 60033123; 13. MTS,RIGHT HEART,KIT, Medline Kit Number/SKU 60033124; 14. MTO,LEFT HEART,KIT, Medline Kit Number/SKU 60034644; 15. MTS,LEFT HEART,KIT, Medline Kit Number/SKU 60040273; 16. MTO,2V,LEFT HEART,KIT, Medline Kit Number/SKU 60040424; 17. MTS,3,VAVLE,KIT, Medline Kit Number/SKU 60041082; 18. MTS,2V,KIT, Medline Kit Number/SKU 60042453; 19. MTO,3V,KIT, Medline Kit Number/SKU 60042454; 20. MTS,LEFT HEART,KIT, Medline Kit Number/SKU 60042721; 21. MTS,3 VALVE,KIT, Medline Kit Number/SKU 60050183; 22. MTS,3 VALVE,MANIFOLD,KIT, Medline Kit Number/SKU 60060268; 23. MTO,RT,HRT,KIT, Medline Kit Number/SKU 60060564; 24. MTO,LEFT HEART,KIT, Medline Kit Number/SKU 60060569; 25. MTS, Medline Kit Number/SKU 60062021; 26. MTS,LEFT HEART,KIT, Medline Kit Number/SKU 60071232; 27. MTO,CATH,LAB,KIT, Medline Kit Number/SKU 60080221; 28. MTO,RIGHT, Medline Kit Number/SKU 60080347; 29. MTS,LEFT HEART,KIT, Medline Kit Number/SKU 60080349; 30. MTS,MANIFOLD,KIT, Medline Kit Number/SKU 60080716; 31. MTS,LEFT,HRT,KIT, Medline Kit Number/SKU 60081001; 32. MTS,RIGHT HEART,KIT, Medline Kit Number/SKU 60081002; 33. MTO,LEFT,HRT(RT,HANDED), Medline Kit Number/SKU 60081168; 34. MTO,RIGHT HEART,KIT, Medline Kit Number/SKU 60090123; 35. MTS,LEFT HEART,KIT, Medline Kit Number/SKU 60091111; 36. MTS,EP,KIT, Medline Kit Number/SKU 60100056; 37. MTS,3 VALVE,LEFT HEART,KIT, Medline Kit Number/SKU 60100338; 38. MTO,RIGHT HEART,KIT, Medline Kit Number/SKU 60100339; 39. DBD-MTO,LEFT HEART,KIT, Medline Kit Number/SKU 60110273; 40. MTO,RIGHT HEART,KIT, Medline Kit Number/SKU 60110701; 41. MTS,3 VALVE,KIT, Medline Kit Number/SKU 60120693; 42. MTS,LEFT HEART,KIT, Medline Kit Number/SKU 60121817; 43. MTO,CATH,KIT, Medline Kit Number/SKU 60130124; 44. MTO,LEFT HEART,KIT, Medline Kit Number/SKU 60130318; 45. DBD-MTS,3 VALVE,KIT, Medline Kit Number/SKU 60130506; 46. MTO,RT HEART,KIT, Medline Kit Number/SKU 60131323; 47. MTS,LEFT,HRT,KIT, Medline Kit Number/SKU 60131324; 48. DBD-MTS,LEFT HEART,KIT, Medline Kit Number/SKU 60131554; 49. MTS,LEFT HEART,KIT, Medline Kit Number/SKU 60131815; 50. MTO,RT,HRT,KIT, Medline Kit Number/SKU 60

Medline has identified the presence of particulate within the fluid path of the Manifolds.

ALL 50 STATES
Full report

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

Recall #:
98735
Lot/product code:
Medline Kit Number/SKU 60010195: UDI/DI each 10193489040234, UDI/DI case 30193489040238, Lot Number: 91637; Medline Kit Number/SKU 60010195: UDI/DI each 10193489040234, UDI/DI case 30193489040238, Lot Number: 91667; Medline Kit Number/SKU 60010195: UDI/DI each 10193489040234, UDI/DI case 30193489040238, Lot Number: 92995; Medline Kit Number/SKU 60010195: UDI/DI each 10193489040234, UDI/DI case 30193489040238, Lot Number: 95615; Medline Kit Number/SKU 60010195: UDI/DI each 10193489040234, UDI/DI case 30193489040238, Lot Number: 97091; Medline Kit Number/SKU 60010195: UDI/DI each 10193489040234, UDI/DI case 30193489040238, Lot Number: 102177; Medline Kit Number/SKU 60010195: UDI/DI each 10193489040234, UDI/DI case 30193489040238, Lot Number: 104282; Medline Kit Number/SKU 60010195: UDI/DI each 10193489040234, UDI/DI case 30193489040238, Lot Number: 108922; Medline Kit Number/SKU 60010195: UDI/DI each 10193489040234, UDI/DI case 30193489040238, Lot Number: 110250; Medline Kit Number/SKU 60010468: UDI/DI each 10193489040319, UDI/DI case 30193489040313, Lot Number: 89290; Medline Kit Number/SKU 60010468: UDI/DI each 10193489040319, UDI/DI case 30193489040313, Lot Number: 91926; Medline Kit Number/SKU 60010468: UDI/DI each 10193489040319, UDI/DI case 30193489040313, Lot Number: 98742; Medline Kit Number/SKU 60010468: UDI/DI each 10193489040319, UDI/DI case 30193489040313, Lot Number: 100867; Medline Kit Number/SKU 60010468: UDI/DI each 10193489040319, UDI/DI case 30193489040313, Lot Number: 103336; Medline Kit Number/SKU 60010468: UDI/DI each 10193489040319, UDI/DI case 30193489040313, Lot Number: 112524; Medline Kit Number/SKU 60010468: UDI/DI each 10193489040319, UDI/DI case 30193489040313, Lot Number: 120251; Medline Kit Number/SKU 60010468: UDI/DI each 10193489040319, UDI/DI case 30193489040313, Lot Number: 123676; Medline Kit Number/SKU 60010468: UDI/DI each 10193489040319, UDI/DI case 30193489040313, Lot Number: 126203; Medline Kit Number/SKU 60010468: UDI/DI each 10193489040319, UDI/DI case 30193489040313, Lot Number: 133960; Medline Kit Number/SKU 60010468: UDI/DI each 10193489040319, UDI/DI case 30193489040313, Lot Number: 135744; Medline Kit Number/SKU 60010468: UDI/DI each 10193489040319, UDI/DI case 30193489040313, Lot Number: 140099; Medline Kit Number/SKU 60010468: UDI/DI each 10193489040319, UDI/DI case 30193489040313, Lot Number: 142801; Medline Kit Number/SKU 60010468: UDI/DI each 10193489040319, UDI/DI case 30193489040313, Lot Number: 144713; Medline Kit Number/SKU 60010468: UDI/DI each 10193489040319, UDI/DI case 30193489040313, Lot Number: 146930; Medline Kit Number/SKU 60010468: UDI/DI each 10193489040319, UDI/DI case 30193489040313, Lot Number: 149252; Medline Kit Number/SKU 60010468: UDI/DI each 10193489040319, UDI/DI case 30193489040313, Lot Number: 152505; Medline Kit Number/SKU 60010468: UDI/DI each 10193489040319, UDI/DI case 30193489040313, Lot Number: 155032; Medline Kit Number/SKU 60010468: UDI/DI each 10193489040319, UDI/DI case 30193489040313, Lot Number: 159209; Medline Kit Number/SKU 60010468: UDI/DI each 10193489040319, UDI/DI case 30193489040313, Lot Number: 163547; Medline Kit Number/SKU 60010468: UDI/DI each 10193489040319, UDI/DI case 30193489040313, Lot Number: 168371; Medline Kit Number/SKU 60010468: UDI/DI each 10193489040319, UDI/DI case 30193489040313, Lot Number: 173236; Medline Kit Number/SKU 60010468: UDI/DI each 10193489040319, UDI/DI case 30193489040313, Lot Number: 173695; Medline Kit Number/SKU 60010468: UDI/DI each 10193489040319, UDI/DI case 30193489040313, Lot Number: 177889; Medline Kit Number/SKU 60010468: UDI/DI each 10193489040319, UDI/DI case 30193489040313, Lot Number: 180765; Medline Kit Number/SKU 60010468: UDI/DI each 10193489040319, UDI/DI case 30193489040313, Lot Number: 185246; Medline Kit Number/SKU 60010469: UDI/DI each 10193489040326, UDI/DI case 30193489040320, Lot Number: 103509; Medline Kit Number/SKU 60010469: UDI/DI each 10193489040326, UDI/DI case 30193489040320, Lot Number: 105131; Medline Kit Number/SKU 60010469: UDI/DI each 10193489040326, UDI/DI case 30193489040320, Lot Number: 141748; Medline Kit Number/SKU 60010469: UDI/DI each 10193489040326, UDI/DI case 30193489040320, Lot Number: 146031; Medline Kit Number/SKU 60010469: UDI/DI each 10193489040326, UDI/DI case 30193489040320, Lot Number: 172932; Medline Kit Number/SKU 60010469: UDI/DI each 10193489040326, UDI/DI case 30193489040320, Lot Number: 180179; Medline Kit Number/SKU 60010469: UDI/DI each 10193489040326, UDI/DI case 30193489040320, Lot Number: 180226; Medline Kit Number/SKU 60010469: UDI/DI each 10193489040326, UDI/DI case 30193489040320, Lot Number: 185514; Medline Kit Number/SKU 60010508: UDI/DI each 10193489040340, UDI/DI case 30193489040344, Lot Number: 101553; Medline Kit Number/SKU 60010508: UDI/DI each 10193489040340, UDI/DI case 30193489040344, Lot Number: 103798; Medline Kit N… (truncated, 412543 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 March 24, 2026

1. DBD-MTS,3V,MAN,KIT, Medline Kit Number/SKU 60010195; 2. MTS-LEFT HEART,KIT, Medline Kit Number/SKU 60033123; 3. MTS,3 VALVE,KIT, Medline Kit Number/SKU 60050183; 4. MTS,LEFT HEART,KIT, Medline Kit Number/SKU 60080349; 5. MTS,3 VALVE,LEFT HEART,KIT, Medline Kit Number/SKU 60100338; 6. MTS LHK, Medline Kit Number/SKU 60101017; 7. DBD-MTS,3 VALVE,KIT, Medline Kit Number/SKU 60130506; 8. MTS,LEFT,HRT,KIT, Medline Kit Number/SKU 60131324; 9. MTS,LEFT HEART,KIT, Medline Kit Number/SKU 60132238; 10. MTS,3,PORT,KIT, Medline Kit Number/SKU 60138301; 11. MTS,LEFT HEART,KIT, Medline Kit Number/SKU 60140589; 12. MTS,3 VALVE,W/, Medline Kit Number/SKU 60192012; 13. DBD-MTS,4V,MANIFOLD,KIT, Medline Kit Number/SKU 60220488; 14. MTS,LHK, Medline Kit Number/SKU 60232091; 15. MTO,3 VALVE,MANIFOLD,KIT, Medline Kit Number/SKU 65010037; 16. MTO,LEFT HEART,KIT, Medline Kit Number/SKU 65012819; 17. DBD-MTO,2V,LEFT HEART,KIT, Medline Kit Number/SKU 65040421; 18. DBD-MTO,LEFT HEART,KIT, Medline Kit Number/SKU 65183482; 19. MTS KIM, Medline Kit Number/SKU 65660872; 20. LHK,-, Medline Kit Number/SKU 601006269; 21. DBD-MTS,MANIFOLD,KIT, Medline Kit Number/SKU 601203616; 22. MTO,4V,KIT, Medline Kit Number/SKU 650104611; 23. MTO,MANIFOLD,KIT, Medline Kit Number/SKU 651304116; 24. KIMAL 3 PORT RH OFF WITH CC PG, Medline Kit Number/SKU 656206837; 25. KIM MANIFOLD SET VER ONE - PG, Medline Kit Number/SKU 656608724; 26. CARDIAC MAN PG, Medline Kit Number/SKU 656608737; 27. MTO MANIFOLD, Medline Kit Number/SKU 656608739; 28. CARDIAC MANIFOLD SET, Medline Kit Number/SKU 656608749; 29. CARDIAC MAN SET, Medline Kit Number/SKU 656608753; 30. KIMAL 3 PORT MAN KIT, Medline Kit Number/SKU 656608755; 31. DBD-MTS,LHK, Medline Kit Number/SKU 6010236231; 32. LHK, Medline Kit Number/SKU 6561068101; 33. LHK, Medline Kit Number/SKU 60022681B; 34. CARDIAC CATH PACK-LF, Medline Kit Number/SKU DYNJ0376288O; 35. CARDIAC CATH PACK-LF, Medline Kit Number/SKU DYNJ0376288P; 36. CARDIAC CATH PACK, Medline Kit Number/SKU DYNJ04636M; 37. CATH LAB PACK-LF, Medline Kit Number/SKU DYNJ0771922AA; 38. CATH LAB PACK-LF, Medline Kit Number/SKU DYNJ0771922Y; 39. CATH PACK, Medline Kit Number/SKU DYNJ21810L; 40. CATH PACK, Medline Kit Number/SKU DYNJ21810M; 41. CATH PACK, Medline Kit Number/SKU DYNJ21810N; 42. CARDIAC CATH PACK W/ADD ON, Medline Kit Number/SKU DYNJ22553F; 43. CATH LAB TRAY, Medline Kit Number/SKU DYNJ24250F; 44. HEART CATH, Medline Kit Number/SKU DYNJ27274J; 45. HEART CATH, Medline Kit Number/SKU DYNJ27274K; 46. HEART CATH, Medline Kit Number/SKU DYNJ27274L; 47. CARDIAC CATH PACK, Medline Kit Number/SKU DYNJ32376G; 48. CARDIAC CATH PACK, Medline Kit Number/SKU DYNJ32376I; 49. CATH/ANGIO PACK, Medline Kit Number/SKU DYNJ38087G; 50. CATH LAB PACK-LF, Medline Kit Number/SKU DYNJ38333C; 51. CATH PACK, Medline Kit Number/SKU DYNJ44473C; 52. CATH PACK, Medline Kit Number/SKU DYNJ44473D; 53. CATH LAB ANGIOGRAPHY PACK, Medline Kit Number/SKU DYNJ50779F; 54. ANGIO DRAPE CARDIAC PACK, Medline Kit Number/SKU DYNJ51615N; 55. ANGIO DRAPE CARDIAC PACK, Medline Kit Number/SKU DYNJ51615O; 56. ANGIO DRAPE CARDIAC PACK, Medline Kit Number/SKU DYNJ51615Q; 57. CARDIAC CATH IMF 86040- LF, Medline Kit Number/SKU DYNJ53947I; 58. CARDIAC CATH IMF 86040- LF, Medline Kit Number/SKU DYNJ53947J; 59. CARDIAC CATH LAB, Medline Kit Number/SKU DYNJ57748B; 60. PK CUST CATH LAB, Medline Kit Number/SKU DYNJ60584F; 61. PK CUST CATH LAB, Medline Kit Number/SKU DYNJ60584G; 62. PK CUST CATH LAB, Medline Kit Number/SKU DYNJ60584I; 63. HEART ABLATION DRAPE PACK, Medline Kit Number/SKU DYNJ61984B; 64. ANGIOGRAPHY PACK, Medline Kit Number/SKU DYNJ64525B; 65. HMSL ANGIOGRAPHY PACK, Medline Kit Number/SKU DYNJ64525C; 66. CATH LAB PACK, Medline Kit Number/SKU DYNJ64548D; 67. CATH LAB PACK, Medline Kit Number/SKU DYNJ64548F; 68. CATH LAB & E. P. PACK, Medline Kit Number/SKU DYNJ646

Medline has identified the presence of particulate within the fluid path of the Manifolds.

ALL 50 STATES
Full report

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

Recall #:
98735
Lot/product code:
Medline Kit Number/SKU 60010195: UDI/DI each 10193489040234, UDI/DI case 40193489040235, Lot Number: 24CBF820; Medline Kit Number/SKU 60010195: UDI/DI each 10193489040234, UDI/DI case 40193489040235, Lot Number: 24DBR149; Medline Kit Number/SKU 60010195: UDI/DI each 10193489040234, UDI/DI case 40193489040235, Lot Number: 24HBO437; Medline Kit Number/SKU 60010195: UDI/DI each 10193489040234, UDI/DI case 40193489040235, Lot Number: 24IBJ827; Medline Kit Number/SKU 60010195: UDI/DI each 10193489040234, UDI/DI case 40193489040235, Lot Number: 25ABI082; Medline Kit Number/SKU 60033123: UDI/DI each 10193489042436, UDI/DI case 40193489042437, Lot Number: 25BBI613; Medline Kit Number/SKU 60033123: UDI/DI each 10193489042436, UDI/DI case 40193489042437, Lot Number: 25BBR862; Medline Kit Number/SKU 60033123: UDI/DI each 10193489042436, UDI/DI case 40193489042437, Lot Number: 25DBC934; Medline Kit Number/SKU 60033123: UDI/DI each 10193489042436, UDI/DI case 40193489042437, Lot Number: 25DBT579; Medline Kit Number/SKU 60033123: UDI/DI each 10193489042436, UDI/DI case 40193489042437, Lot Number: 25FBF145; Medline Kit Number/SKU 60033123: UDI/DI each 10193489042436, UDI/DI case 40193489042437, Lot Number: 25GBJ123; Medline Kit Number/SKU 60033123: UDI/DI each 10193489042436, UDI/DI case 40193489042437, Lot Number: 25HBQ032; Medline Kit Number/SKU 60033123: UDI/DI each 10193489042436, UDI/DI case 40193489042437, Lot Number: 25IBF219; Medline Kit Number/SKU 60033123: UDI/DI each 10193489042436, UDI/DI case 40193489042437, Lot Number: 25JBS750; Medline Kit Number/SKU 60033123: UDI/DI each 10193489042436, UDI/DI case 40193489042437, Lot Number: 25LBD357; Medline Kit Number/SKU 60050183: UDI/DI each 10193489043273, UDI/DI case 40193489043274, Lot Number: 25ABW077; Medline Kit Number/SKU 60050183: UDI/DI each 10193489043273, UDI/DI case 40193489043274, Lot Number: 25CBO600; Medline Kit Number/SKU 60050183: UDI/DI each 10193489043273, UDI/DI case 40193489043274, Lot Number: 25DBR987; Medline Kit Number/SKU 60050183: UDI/DI each 10193489043273, UDI/DI case 40193489043274, Lot Number: 25FBH978; Medline Kit Number/SKU 60050183: UDI/DI each 10193489043273, UDI/DI case 40193489043274, Lot Number: 25IBF270; Medline Kit Number/SKU 60050183: UDI/DI each 10193489043273, UDI/DI case 40193489043274, Lot Number: 25KBJ395; Medline Kit Number/SKU 60080349: UDI/DI each 10193489044539, UDI/DI case 40193489044530, Lot Number: 24LBN469; Medline Kit Number/SKU 60080349: UDI/DI each 10193489044539, UDI/DI case 40193489044530, Lot Number: 25CBA408; Medline Kit Number/SKU 60080349: UDI/DI each 10193489044539, UDI/DI case 40193489044530, Lot Number: 25CBK717; Medline Kit Number/SKU 60080349: UDI/DI each 10193489044539, UDI/DI case 40193489044530, Lot Number: 25EBF843; Medline Kit Number/SKU 60080349: UDI/DI each 10193489044539, UDI/DI case 40193489044530, Lot Number: 25IBF307; Medline Kit Number/SKU 60080349: UDI/DI each 10193489044539, UDI/DI case 40193489044530, Lot Number: 25KBA752; Medline Kit Number/SKU 60080349: UDI/DI each 10193489044539, UDI/DI case 40193489044530, Lot Number: 26ABT007; Medline Kit Number/SKU 60100338: UDI/DI each 10193489045062, UDI/DI case 40193489045063, Lot Number: 24LBT840; Medline Kit Number/SKU 60100338: UDI/DI each 10193489045062, UDI/DI case 40193489045063, Lot Number: 25ABU494; Medline Kit Number/SKU 60100338: UDI/DI each 10193489045062, UDI/DI case 40193489045063, Lot Number: 25BBR313; Medline Kit Number/SKU 60100338: UDI/DI each 10193489045062, UDI/DI case 40193489045063, Lot Number: 25DBR517; Medline Kit Number/SKU 60100338: UDI/DI each 10193489045062, UDI/DI case 40193489045063, Lot Number: 25EBB825; Medline Kit Number/SKU 60100338: UDI/DI each 10193489045062, UDI/DI case 40193489045063, Lot Number: 25EBS427; Medline Kit Number/SKU 60100338: UDI/DI each 10193489045062, UDI/DI case 40193489045063, Lot Number: 25FBT465; Medline Kit Number/SKU 60100338: UDI/DI each 10193489045062, UDI/DI case 40193489045063, Lot Number: 25IBJ517; Medline Kit Number/SKU 60100338: UDI/DI each 10193489045062, UDI/DI case 40193489045063, Lot Number: 25LBC673; Medline Kit Number/SKU 60100338: UDI/DI each 10193489045062, UDI/DI case 40193489045063, Lot Number: 26BBF073; Medline Kit Number/SKU 60101017: UDI/DI each 10193489045383, UDI/DI case 40193489045384, Lot Number: 23HBX390; Medline Kit Number/SKU 60101017: UDI/DI each 10193489045383, UDI/DI case 40193489045384, Lot Number: 23IBD647; Medline Kit Number/SKU 60101017: UDI/DI each 10193489045383, UDI/DI case 40193489045384, Lot Number: 23LBC207; Medline Kit Number/SKU 60101017: UDI/DI each 10193489045383, UDI/DI case 40193489045384, Lot Number: 24ABK892; Medline Kit Number/SKU 60101017: UDI/DI each 10193489045383, UDI/DI case 40193489045384, Lot Number: 24DBA937; Medline Kit Number/SKU 60101017: UDI/DI each 10193489045383, UDI/DI case 40193489045384, Lot Number: 24DBJ585; Medline Kit Number/SKU 60101… (truncated, 139117 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 March 24, 2026

Medline medical convenience kits, containing Namic Manifold, Labeled as: TAVI, Medline Kit Number/SKU DYNJ904981C

Medline has identified the presence of particulate within the fluid path of the Manifolds.

ALL 50 STATES
Full report

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

Recall #:
98735
Lot/product code:
UDI/DI each 10193489475135, UDI/DI case 40193489475136, Lot Numbers: 23GBR742, 23IBC951, 23JBM554, 23LBK506, 24BBO670, 24GBM624.
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled March 24, 2026

Namic Preceptor Manifold, custom, Medline Product Number/SKU 64037107; Extravascular blood pressure transducer

Medline has identified the presence of particulate within the fluid path of the Manifolds.

ALL 50 STATES
Full report

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

Recall #:
98735
Lot/product code:
UDI/DI each 10193489059137, UDI/DI case 30193489059131, Lot Numbers: 89181, 95326, 95254, 102287, 102286, 102706, 105362, 105558, 108608, 112242, 112243, 115437, 118477, 121180, 121645, 122708, 126024, 131603, 136583, 140860, 142371, 146728, 147474, 148571, 152020, 153175, 163216, 175580, 176810, 184394, 191388, 193141.
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)