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Recalls affecting North Carolina

Data last updated: September 7, 2026 at 2:36 PM UTC

17,099 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/virusAnnounced 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/virusAnnounced 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)
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)
UnclassifiedAllergenUndeclaredAnnounced 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)
UnclassifiedBacteria/virusAnnounced 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/virusAnnounced 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 June 15, 2026

One-Piece Guedel Airway, size 000, ISO 3.5, Light Green. Oropharyngeal Airway Device.

Devices could potentially be occluded or partially occluded.

ALL 50 STATES
Full report

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

Recall #:
99284
Lot/product code:
REF: 1000035; Single Unit UDI: 5030267049844; Case UDI: 05030267044528; Lot No. 32190425, 32213076, 32221283, 32307261, 32317627, 32321305, 32513841, 32517565.
Recalling firm:
Intersurgical Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 15, 2026

L-Cath PICC S/L Peripherally Inserted Central Catheter: 26ga (1.9F) 0.60mm x 30cm, REF: 384539; 18ga (3.5F) 1.15mm x 60cm, REF: 384464; Basic Kit 28GA (1.2F) x 25cm 1 Lumen), REF: 384516; 20ga (3F) 1.00mm x 60cm, REF: 384463

Catheters, indicated for short/long-term peripheral access to central venous system for the administration of fluids, medications, nutrients; and sampling, may experience leaking and/or cracking at the hub, which may lead to replacement, inability to flush/aspirate catheter, catheter occlusion, therapy interruption, blood loss, tissue irritation, bloodstream infection.

Full report

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

Recall #:
99333
Lot/product code:
REF/UDI-DI/Lot(Expiration): 384539/00886333209934/11488167(7/14/2026), 11488168(7/17/2026), 11494535E(8/1/2026), 11507766(11/13/2026), 11550780(12/12/2026), 11551487(12/15/2026), 11551488(12/15/2026); 384464/00886333209835/11490593(7/28/2026), 11494886(8/28/2026)11501150(10/6/2026); 384516/00886333209910/11500410(8/14/2026), 11501856(8/14/2026), 11504222(9/9/2026), 11506952(9/9/2026), 11523868(9/18/2026), 11551789(9/18/2026), 11553909(11/13/2026), 11559226(11/20/2026); 384463/00886333209828/11490797(8/1/2026), 11490959(8/11/2026)
Recalling firm:
Argon Medical Devices, Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 15, 2026

L-Cath Midline S/L Catheter 20ga (3F) 1mm x 20cm, REF: 384620

Catheters, indicated for short/long-term peripheral access to central venous system for the administration of fluids, medications, nutrients; and sampling, may experience leaking and/or cracking at the hub, which may lead to replacement, inability to flush/aspirate catheter, catheter occlusion, therapy interruption, blood loss, tissue irritation, bloodstream infection.

Full report

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

Recall #:
99333
Lot/product code:
REF/UDI-DI/Lot(Expiration): 384620/00886333210008/11490543(7/28/2026)
Recalling firm:
Argon Medical Devices, Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 15, 2026

Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number: NCOCO6010 Software Version: N/A Product Description: In situ polymerizing peripheral nerve repair device Component: No

Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be relabeled to reflect revised shelf life of 26 months. The use of a medical device beyond its validated shelf life may result in perioperative breakage of the device rendering device unusable; worst-case outcome would be revision surgery.

ALL 50 STATES
Full report

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

Recall #:
99345
Lot/product code:
Lot Code: Model No NCOCO6010; UDI-DI ¿03760279380209; Lot Numbers 250700051, 251000044, and 251000045
Recalling firm:
TISSIUM SA
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 15, 2026

GLIDESHEATH SLENDER A-KIT 6F 10CM .021GW. 5 units per box. Product Code: 60-1060. The Glidesheath Slender is used to facilitate placing a catheter through the skin into the radial artery.

Product was packaged with the 0.025 guidewire instead of the 0.021 guidewire.

ALL 50 STATES
Full report

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

Recall #:
99285
Lot/product code:
Product Code: 60-1060. Shelfbox UDI-DI: 30389701011975; Pouch UDI-DI: 00389701011974; UDI-PI: (17)280501(10)0001441871. Lot Number: 0001441871.
Recalling firm:
Terumo Medical Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 15, 2026

Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number: NCOCO5010 Software Version: N/A Product Description: In situ polymerizing peripheral nerve repair device Component: No

Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be relabeled to reflect revised shelf life of 26 months. The use of a medical device beyond its validated shelf life may result in perioperative breakage of the device rendering device unusable; worst-case outcome would be revision surgery.

ALL 50 STATES
Full report

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

Recall #:
99345
Lot/product code:
Lot Code: Model No NCOCO5010; UDI-DI 03760279380179; Lot Numbers 250700050, 251000043, 260300048, 260300049, and 260300050
Recalling firm:
TISSIUM SA
View official FDA record (opens in a new tab)
Class IHigh risk
FoodBacteria/virusRecalled June 13, 2026

a.) nara organics brand; Whole Milk Organic Infant Formula; Milk-based Powder with Iron; 0-12 months; NET WT 24.7 OZ (700 G); UPC: 860013251901 b.) nara organics brand; Whole Milk Organic Infant Formula; Milk-based Powder with Iron; 0-12 months; NET WT 14.1 OZ (400 G); UPC: 860013251918

Product may be contaminated with Clostridium botulinum.

ALL 50 STATES
Full report

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

Recall #:
H-1137-2026
Lot/product code:
Recalled Lot Codes - 408125075E14F2 - 708125076E14F2 - 708125083E14F2 - 408125139E14F2 - 708125141E14F2 - 708125145E14F2 - 708125174E14F2 - 709125273E14F2 - 709125280E14F2 - 709125288E14F2 - 409125307E14F2 - 70926019ENNB - 70926029ENNB - 70926035ENNB - 70926039ENNB - 70926042ENNB Use-By dates span March 16, 2027 - February 11, 2028
Recalling firm:
NARA ORGANICS INC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 12, 2026

Medline Convenience Kits: 1) DRAWER 9 CRICOTHYROTOMY KIT, Model Number: ACC010741; 2) KIT ANESTHESIA L&D A- LINE SET, Model Number: DYKMBNDL199A

The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach of sterility in the packaging, due to wrinkles in the paper lidding which may extend to the seal area. If the sterile barrier is compromised, patients and users may be exposed to microbial contamination. Potential health consequences may include no injury, localized infection, or, less commonly, more serious infection requiring medical treatment, antimicrobial therapy, procedural intervention, or hospitalization. In rare cases, particularly in critically ill or immunocompromised patients, severe infection could become life-threatening.

ALL 50 STATES
Full report

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

Recall #:
99334
Lot/product code:
1) ACC010741, UDI-DI: 10195327515515(each), 40195327515516(case), Lot Number: 23KDB215; 2) DYKMBNDL199A, UDI-DI: 10193489848540(each), 40193489848541(case), Lot Number: 24LBT847; 3) DYKMBNDL199A, UDI-DI: 10193489848540(each), 40193489848541(case), Lot Number: 24LBB138
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 12, 2026

Medline Convenience Kits: 1) CDS840396X, Catalog Number: CDS840396X; 2) CDS840396Y, Catalog Number: CDS840396Y; 3) CDS983348AA, Catalog Number: CDS983348AA; 4) CDS983348AB, Catalog Number: CDS983348AB; 5) CDS983672O, Catalog Number: CDS983672O; 6) CDS983672P, Catalog Number: CDS983672P; 7) DYKM1982, Catalog Number: DYKM1982; 8) DYNDA1080, Catalog Number: DYNDA1080; 9) DYNJ67490C, Catalog Number: DYNJ67490C; 10) DYNJ907400D, Catalog Number: DYNJ907400D; 11) DYNJ908990A, Catalog Number: DYNJ908990A

The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach of sterility in the packaging, due to wrinkles in the paper lidding which may extend to the seal area. If the sterile barrier is compromised, patients and users may be exposed to microbial contamination. Potential health consequences may include no injury, localized infection, or, less commonly, more serious infection requiring medical treatment, antimicrobial therapy, procedural intervention, or hospitalization. In rare cases, particularly in critically ill or immunocompromised patients, severe infection could become life-threatening.

ALL 50 STATES
Full report

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

Recall #:
99334
Lot/product code:
1) CDS840396X, UDI-DI: 10193489461916(each), 40193489461917(case), Lot Number: 24ABC933; 2) CDS840396X, UDI-DI: 10193489461916(each), 40193489461917(case), Lot Number: 24ABK089; 3) CDS840396X, UDI-DI: 10193489461916(each), 40193489461917(case), Lot Number: 24ABL893; 4) CDS840396Y, UDI-DI: 10195327574932(each), 40195327574933(case), Lot Number: 25BBG163; 5) CDS840396Y, UDI-DI: 10195327574932(each), 40195327574933(case), Lot Number: 24KBK977; 6) CDS840396Y, UDI-DI: 10195327574932(each), 40195327574933(case), Lot Number: 24BBO585; 7) CDS840396Y, UDI-DI: 10195327574932(each), 40195327574933(case), Lot Number: 24CBR417; 8) CDS840396Y, UDI-DI: 10195327574932(each), 40195327574933(case), Lot Number: 24FBS930; 9) CDS840396Y, UDI-DI: 10195327574932(each), 40195327574933(case), Lot Number: 24IBK539; 10) CDS983348AA, UDI-DI: 10195327385088(each), 40195327385089(case), Lot Number: 24ABM288; 11) CDS983348AA, UDI-DI: 10195327385088(each), 40195327385089(case), Lot Number: 24ABR888; 12) CDS983348AA, UDI-DI: 10195327385088(each), 40195327385089(case), Lot Number: 24EBB218; 13) CDS983348AA, UDI-DI: 10195327385088(each), 40195327385089(case), Lot Number: 24EBM057; 14) CDS983348AA, UDI-DI: 10195327385088(each), 40195327385089(case), Lot Number: 24FBH873; 15) CDS983348AA, UDI-DI: 10195327385088(each), 40195327385089(case), Lot Number: 24HBG929; 16) CDS983348AB, UDI-DI: 10198459136986(each), 40198459136987(case), Lot Number: 25ABK077; 17) CDS983672O, UDI-DI: 10195327207625(each), 40195327207626(case), Lot Number: 24BBC413; 18) CDS983672O, UDI-DI: 10195327207625(each), 40195327207626(case), Lot Number: 24CBQ574; 19) CDS983672O, UDI-DI: 10195327207625(each), 40195327207626(case), Lot Number: 24IBC602; 20) CDS983672O, UDI-DI: 10195327207625(each), 40195327207626(case), Lot Number: 24JBC919; 21) CDS983672O, UDI-DI: 10195327207625(each), 40195327207626(case), Lot Number: 24JBK787; 22) CDS983672O, UDI-DI: 10195327207625(each), 40195327207626(case), Lot Number: 24JBL738; 23) CDS983672O, UDI-DI: 10195327207625(each), 40195327207626(case), Lot Number: 24KBB600; 24) CDS983672O, UDI-DI: 10195327207625(each), 40195327207626(case), Lot Number: 24KBE775; 25) CDS983672O, UDI-DI: 10195327207625(each), 40195327207626(case), Lot Number: 23JBR840; 26) CDS983672O, UDI-DI: 10195327207625(each), 40195327207626(case), Lot Number: 23KBM370; 27) CDS983672O, UDI-DI: 10195327207625(each), 40195327207626(case), Lot Number: 23LBD735; 28) CDS983672P, UDI-DI: 10198459149139(each), 40198459149130(case), Lot Number: 25ABI289; 29) CDS983672P, UDI-DI: 10198459149139(each), 40198459149130(case), Lot Number: 24LBO787; 30) DYKM1982, UDI-DI: 10193489417357(each), 40193489417358(case), Lot Number: 25BBB356; 31) DYKM1982, UDI-DI: 10193489417357(each), 40193489417358(case), Lot Number: 23LBU657; 32) DYKM1982, UDI-DI: 10193489417357(each), 40193489417358(case), Lot Number: 24CBF023; 33) DYKM1982, UDI-DI: 10193489417357(each), 40193489417358(case), Lot Number: 24CBL355; 34) DYKM1982, UDI-DI: 10193489417357(each), 40193489417358(case), Lot Number: 24KBA176; 35) DYNDA1080, UDI-DI: 10884389388679(each), 40884389388670(case), Lot Number: 25BBB185; 36) DYNDA1080, UDI-DI: 10884389388679(each), 40884389388670(case), Lot Number: 24EBE506; 37) DYNDA1080, UDI-DI: 10884389388679(each), 40884389388670(case), Lot Number: 24GBK362; 38) DYNJ67490C, UDI-DI: 10195327631710(each), 40195327631711(case), Lot Number: 24BBN881; 39) DYNJ907400D, UDI-DI: 10195327538552(each), 40195327538553(case), Lot Number: 24BBL947; 40) DYNJ908990A, UDI-DI: 10195327505219(each), 40195327505210(case), Lot Number: 25ALA775; 41) DYNJ908990A, UDI-DI: 10195327505219(each), 40195327505210(case), Lot Number: 25CLA341; 42) DYNJ908990A, UDI-DI: 10195327505219(each), 40195327505210(case), Lot Number: 24ILA196; 43) DYNJ908990A, UDI-DI: 10195327505219(each), 40195327505210(case), Lot Number: 24JLA337; 44) DYNJ908990A, UDI-DI: 10195327505219(each), 40195327505210(case), Lot Number: 24LLA178
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 12, 2026

Medline Convenience Kits: 1) IVS BLOOD CULTURE KIT, Model Number: DYNDH1920; 2) IVS BLOOD CULTURE KIT, Model Number: DYNDH1920A

The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach of sterility in the packaging, due to wrinkles in the paper lidding which may extend to the seal area. If the sterile barrier is compromised, patients and users may be exposed to microbial contamination. Potential health consequences may include no injury, localized infection, or, less commonly, more serious infection requiring medical treatment, antimicrobial therapy, procedural intervention, or hospitalization. In rare cases, particularly in critically ill or immunocompromised patients, severe infection could become life-threatening.

ALL 50 STATES
Full report

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

Recall #:
99334
Lot/product code:
1) DYNDH1920, UDI-DI: 10653160366317(each), 00653160366310(case), Lot Number: 2023111390; 2) DYNDH1920, UDI-DI: 10653160366317(each), 00653160366310(case), Lot Number: 2023121890; 3) DYNDH1920A, UDI-DI: 10653160385943(each), 00653160385946(case), Lot Number: 2025022790
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 12, 2026

Medline Convenience Kits: 1) IV START KIT LAB DRAW-SH, Model Number: CDS860014P; 2) IV START KIT, Model Number: DYKM1000B; 3) KIT, I V START NSK, Model Number: DYKM2187; 4) KIT, I V START NSK, Model Number: DYKM2187A; 5) IV BLOOD CULTURE KIT, Model Number: DYNDH1909A; 6) IV START W/EXT SET KIT, Model Number: DYNDV1615I

The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach of sterility in the packaging, due to wrinkles in the paper lidding which may extend to the seal area. If the sterile barrier is compromised, patients and users may be exposed to microbial contamination. Potential health consequences may include no injury, localized infection, or, less commonly, more serious infection requiring medical treatment, antimicrobial therapy, procedural intervention, or hospitalization. In rare cases, particularly in critically ill or immunocompromised patients, severe infection could become life-threatening.

ALL 50 STATES
Full report

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

Recall #:
99334
Lot/product code:
1) CDS860014P, UDI-DI: 10888277797819(each), 40888277797810(case), Lot Number: 25DBN710; 2) CDS860014P, UDI-DI: 10888277797819(each), 40888277797810(case), Lot Number: 24BBH722; 3) CDS860014P, UDI-DI: 10888277797819(each), 40888277797810(case), Lot Number: 24CBV460; 4) CDS860014P, UDI-DI: 10888277797819(each), 40888277797810(case), Lot Number: 24EBR549; 5) CDS860014P, UDI-DI: 10888277797819(each), 40888277797810(case), Lot Number: 24GBH769; 6) CDS860014P, UDI-DI: 10888277797819(each), 40888277797810(case), Lot Number: 23KBN939; 7) CDS860014P, UDI-DI: 10888277797819(each), 40888277797810(case), Lot Number: 23LBT913; 8) DYKM1000B, UDI-DI: 10889942508143(each), 40889942508144(case), Lot Number: 24AMB256; 9) DYKM1000B, UDI-DI: 10889942508143(each), 40889942508144(case), Lot Number: 24BMF851; 10) DYKM1000B, UDI-DI: 10889942508143(each), 40889942508144(case), Lot Number: 24DMC055; 11) DYKM1000B, UDI-DI: 10889942508143(each), 40889942508144(case), Lot Number: 24FMB552; 12) DYKM1000B, UDI-DI: 10889942508143(each), 40889942508144(case), Lot Number: 24IMF355; 13) DYKM1000B, UDI-DI: 10889942508143(each), 40889942508144(case), Lot Number: 24KMD782; 14) DYKM1000B, UDI-DI: 10889942508143(each), 40889942508144(case), Lot Number: 23IMI364; 15) DYKM1000B, UDI-DI: 10889942508143(each), 40889942508144(case), Lot Number: 23JMG372; 16) DYKM2187, UDI-DI: 10195327232924(each), 40195327232925(case), Lot Number: 23JBQ286; 17) DYKM2187A, UDI-DI: 10195327628826(each), 40195327628827(case), Lot Number: 25ABI946; 18) DYKM2187A, UDI-DI: 10195327628826(each), 40195327628827(case), Lot Number: 25ABV328; 19) DYKM2187A, UDI-DI: 10195327628826(each), 40195327628827(case), Lot Number: 24LBM058; 20) DYKM2187A, UDI-DI: 10195327628826(each), 40195327628827(case), Lot Number: 24LBO554; 21) DYKM2187A, UDI-DI: 10195327628826(each), 40195327628827(case), Lot Number: 24CBB880; 22) DYKM2187A, UDI-DI: 10195327628826(each), 40195327628827(case), Lot Number: 24CBT739; 23) DYKM2187A, UDI-DI: 10195327628826(each), 40195327628827(case), Lot Number: 24CBV226; 24) DYKM2187A, UDI-DI: 10195327628826(each), 40195327628827(case), Lot Number: 24IBL537; 25) DYKM2187A, UDI-DI: 10195327628826(each), 40195327628827(case), Lot Number: 24JBL006; 26) DYNDH1909A, UDI-DI: 10198459146794(each), 40198459146795(case), Lot Number: 25KME690; 27) DYNDH1909A, UDI-DI: 10198459146794(each), 40198459146795(case), Lot Number: 25AMI449; 28) DYNDH1909A, UDI-DI: 10198459146794(each), 40198459146795(case), Lot Number: 25BMB196; 29) DYNDH1909A, UDI-DI: 10198459146794(each), 40198459146795(case), Lot Number: 25BMI538; 30) DYNDH1909A, UDI-DI: 10198459146794(each), 40198459146795(case), Lot Number: 24JMG337; 31) DYNDH1909A, UDI-DI: 10198459146794(each), 40198459146795(case), Lot Number: 24KMH747; 32) DYNDV1615I, UDI-DI: 10195327407100(each), 40195327407101(case), Lot Number: 24DBM033
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 12, 2026

Medline Convenience Kits: 1) ORTHO ASPIRATION KIT, Model Number: DYKM1636A; 2) SHOULD BLOCK KIT, Model Number: DYKM1881A; 3) TRIMA KIT, Model Number: DYNDB3077C

The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach of sterility in the packaging, due to wrinkles in the paper lidding which may extend to the seal area. If the sterile barrier is compromised, patients and users may be exposed to microbial contamination. Potential health consequences may include no injury, localized infection, or, less commonly, more serious infection requiring medical treatment, antimicrobial therapy, procedural intervention, or hospitalization. In rare cases, particularly in critically ill or immunocompromised patients, severe infection could become life-threatening.

ALL 50 STATES
Full report

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

Recall #:
99334
Lot/product code:
1) DYKM1636A, UDI-DI: 10889942925858(each), 40889942925859(case), Lot Number: 25ABW688; 2) DYKM1636A, UDI-DI: 10889942925858(each), 40889942925859(case), Lot Number: 23LBT438; 3) DYKM1881A, UDI-DI: 10198459025174(each), 40198459025175(case), Lot Number: 24KBS611; 4) DYNDB3077C, UDI-DI: 10193489273809(each), 40193489273800(case), Lot Number: 25BBB106; 5) DYNDB3077C, UDI-DI: 10193489273809(each), 40193489273800(case), Lot Number: 24KBJ751; 6) DYNDB3077C, UDI-DI: 10193489273809(each), 40193489273800(case), Lot Number: 24LBO630; 7) DYNDB3077C, UDI-DI: 10193489273809(each), 40193489273800(case), Lot Number: 24ABB622; 8) DYNDB3077C, UDI-DI: 10193489273809(each), 40193489273800(case), Lot Number: 24CBG290; 9) DYNDB3077C, UDI-DI: 10193489273809(each), 40193489273800(case), Lot Number: 24CBG291; 10) DYNDB3077C, UDI-DI: 10193489273809(each), 40193489273800(case), Lot Number: 24CBT163; 11) DYNDB3077C, UDI-DI: 10193489273809(each), 40193489273800(case), Lot Number: 24EBM679; 12) DYNDB3077C, UDI-DI: 10193489273809(each), 40193489273800(case), Lot Number: 24FBL963; 13) DYNDB3077C, UDI-DI: 10193489273809(each), 40193489273800(case), Lot Number: 24HBV589; 14) DYNDB3077C, UDI-DI: 10193489273809(each), 40193489273800(case), Lot Number: 24HBV590; 15) DYNDB3077C, UDI-DI: 10193489273809(each), 40193489273800(case), Lot Number: 24HBV591; 16) DYNDB3077C, UDI-DI: 10193489273809(each), 40193489273800(case), Lot Number: 24HBV592; 17) DYNDB3077C, UDI-DI: 10193489273809(each), 40193489273800(case), Lot Number: 24HBV593; 18) DYNDB3077C, UDI-DI: 10193489273809(each), 40193489273800(case), Lot Number: 24JBV697; 19) DYNDB3077C, UDI-DI: 10193489273809(each), 40193489273800(case), Lot Number: 24JBV698; 20) DYNDB3077C, UDI-DI: 10193489273809(each), 40193489273800(case), Lot Number: 24JBV699; 21) DYNDB3077C, UDI-DI: 10193489273809(each), 40193489273800(case), Lot Number: 23IBT699; 22) DYNDB3077C, UDI-DI: 10193489273809(each), 40193489273800(case), Lot Number: 23JBS210
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 12, 2026

Medline Convenience Kits: 1) IV START KIT, Catalog Number: DYNDV2520; 2) PERIPHERAL LAB BLOOD CULTURE KIT, Catalog Number: DYNDH1983A; 3) PEDI EMERGENCY TRAY-PURPLE, Catalog Number: ACC010157C; 4) PEDS EMERGENCY TRAY- GREEN, Catalog Number: ACC010158C; 5) PEDI EMERGENCY TRAY-BLUE, Catalog Number: ACC010159C; 6) PEDS EMERGENCY TRAY-YELLOW, Catalog Number: ACC010160C; 7) PEDS EMERGENCY TRAY-WHITE, Catalog Number: ACC010161C; 8) PEDS EMERGENCY TRAY-ORANGE, Catalog Number: ACC010162C; 9) PEDS EMERGENCY TRAY-RED, Catalog Number: ACC010163C; 10) CVHP DRAWER -IV, Catalog Number: ACC010308A; 11) PEDI EMERGENCY TRAY-BLUE, Catalog Number: ACC010316A; 12) PEDS EMERGENCY TRAY- GREEN, Catalog Number: ACC010318A; 13) PEDS EMERGENCY TRAY-ORANGE, Catalog Number: ACC010319A; 14) DRAWER THREE - IV SET UP, Catalog Number: ACC010361; 15) DRAWER 1, Catalog Number: ACC010374A; 16) DRAWER 3 LAB DRAW & IV START, Catalog Number: ACC010417A; 17) DRAWER #6, Catalog Number: ACC010477B; 18) DRAWER #4, Catalog Number: ACC010479A; 19) ADULT DRAWER 4, Catalog Number: ACC010679; 20) DRAWER 2, Catalog Number: ACC010690; 21) DRAWER 2, Catalog Number: ACC010726; 22) DRAWER 2, Catalog Number: ACC010726A; 23) RRMC CODE CART DRAWER 3, Catalog Number: ACC010770; 24) DRAWER 2, Catalog Number: ACC010875; 25) BOTTOM DRAWER, Catalog Number: ACC010972; 26) CODE CART DRAWER TWO IV SUPPLI, Catalog Number: ACC010977; 27) DRAWER 4 CIRCULATION, Catalog Number: ACC011088; 28) NON-SUTURED SHEATH #113197 KIT, Catalog Number: DYKM1495; 29) SUTURED SHEATH W/SCI #113198, Catalog Number: DYKM1496; 30) LABOR TRIAGE KIT - LF #13232, Catalog Number: DYKM1564; 31) FINGER THORACOSTOMY PCC KIT, Catalog Number: DYKM2676A; 32) UVC KIT, Catalog Number: DYKM2677A; 33) CRIC KIT, Catalog Number: DYKM2678A; 34) SCOPE KIT 3, Catalog Number: DYKM2750; 35) SURGICAL KIT, Catalog Number: DYKM2752; 36) PRE OP KIT, Catalog Number: DYKS1022B; 37) MAC KIT, Catalog Number: DYKS1089B; 38) PRE OP KIT, Catalog Number: DYKS1091A; 39) PRE OP KIT, Catalog Number: DYKS1128B; 40) PRE OP KIT, Catalog Number: DYKS1325; 41) UCLA RAPID RESPONSE KIT, Catalog Number: DYLAB1097; 42) BSSM-WHOLE BLOOD PHLEBOTOMY, Catalog Number: DYNDB3061; 43) WHOLE BLOOD PHLEBOTOMY, Catalog Number: DYNDB3064; 44) WHOLE BLOOD/DOUBLE RED, Catalog Number: DYNDB3078C; 45) ACCESS KIT, Catalog Number: DYNDH1159A; 46) ADLT BLOOD CULTURE COLLECT KIT, Catalog Number: DYNDH1245; 47) ADULT BLOOD CULTURE KIT, Catalog Number: DYNDH1362; 48) PEDIATRIC BLOOD CULTURE KIT, Catalog Number: DYNDH1363; 49) STANFORD TIME TO POSITIVITY, Catalog Number: DYNDH1591; 50) BLOOD CULTURE PINK PERIPHERAL, Catalog Number: DYNDV1875; 51) BLOOD CULTURE BLUE PERIPHERAL, Catalog Number: DYNDV1876; 52) NICU LINE PACK, Catalog Number: DYNJ63410; 53) STUDENT PRACTICE BAG W LOGO, Catalog Number: EDUC1043; 53)

The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach of sterility in the packaging, due to wrinkles in the paper lidding which may extend to the seal area. If the sterile barrier is compromised, patients and users may be exposed to microbial contamination. Potential health consequences may include no injury, localized infection, or, less commonly, more serious infection requiring medical treatment, antimicrobial therapy, procedural intervention, or hospitalization. In rare cases, particularly in critically ill or immunocompromised patients, severe infection could become life-threatening.

ALL 50 STATES
Full report

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

Recall #:
99334
Lot/product code:
1) DYNDV2520, UDI-DI: 10653160384045(each), 00653160384048(case), Lot Number: 2023122690; 2) DYNDV2520, UDI-DI: 10653160384045(each), 00653160384048(case), Lot Number: 2024020790; 3) DYNDV2520, UDI-DI: 10653160384045(each), 00653160384048(case), Lot Number: 2024032790; 4) DYNDV2520, UDI-DI: 10653160384045(each), 00653160384048(case), Lot Number: 2024052390; 5) DYNDV2520, UDI-DI: 10653160384045(each), 00653160384048(case), Lot Number: 2024071190; 6) DYNDV2520, UDI-DI: 10653160384045(each), 00653160384048(case), Lot Number: 2024081490; 7) DYNDV2520, UDI-DI: 10653160384045(each), 00653160384048(case), Lot Number: 2024101090; 8) DYNDV2520, UDI-DI: 10653160384045(each), 00653160384048(case), Lot Number: 2024111990; 9) DYNDH1983A, UDI-DI: 10653160388920(each), 00653160388923(case), Lot Number: 2025073190; 10) ACC010157C, UDI-DI: 10195327492649(each), 40195327492640(case), Lot Number: 23JDB105; 11) ACC010158C, UDI-DI: 10195327492786(each), 40195327492787(case), Lot Number: 23JDB122; 12) ACC010159C, UDI-DI: 10195327492779(each), 40195327492770(case), Lot Number: 23JDB078; 13) ACC010160C, UDI-DI: 10195327492823(each), 40195327492824(case), Lot Number: 23JDA433; 14) ACC010160C, UDI-DI: 10195327492823(each), 40195327492824(case), Lot Number: 23JDB266; 15) ACC010161C, UDI-DI: 10195327492816(each), 40195327492817(case), Lot Number: 23JDA587; 16) ACC010161C, UDI-DI: 10195327492816(each), 40195327492817(case), Lot Number: 23JDB267; 17) ACC010161C, UDI-DI: 10195327492816(each), 40195327492817(case), Lot Number: 23JDC145; 18) ACC010162C, UDI-DI: 10195327492793(each), 40195327492794(case), Lot Number: 23JDB106; 19) ACC010163C, UDI-DI: 10195327492809(each), 40195327492800(case), Lot Number: 23JDB268; 20) ACC010308A, UDI-DI: 10889942424597(each), 40889942424598(case), Lot Number: 25DDA404; 21) ACC010308A, UDI-DI: 10889942424597(each), 40889942424598(case), Lot Number: 25EDB078; 22) ACC010308A, UDI-DI: 10889942424597(each), 40889942424598(case), Lot Number: 25FDA297; 23) ACC010308A, UDI-DI: 10889942424597(each), 40889942424598(case), Lot Number: 25FDB295; 24) ACC010308A, UDI-DI: 10889942424597(each), 40889942424598(case), Lot Number: 25GDA555; 25) ACC010308A, UDI-DI: 10889942424597(each), 40889942424598(case), Lot Number: 24FDB461; 26) ACC010308A, UDI-DI: 10889942424597(each), 40889942424598(case), Lot Number: 24FDB645; 27) ACC010308A, UDI-DI: 10889942424597(each), 40889942424598(case), Lot Number: 23KDC062; 28) ACC010308A, UDI-DI: 10889942424597(each), 40889942424598(case), Lot Number: 23LDB762; 29) ACC010316A, UDI-DI: 10889942831746(each), 40889942831747(case), Lot Number: 25CDB196; 30) ACC010316A, UDI-DI: 10889942831746(each), 40889942831747(case), Lot Number: 24DDA506; 31) ACC010316A, UDI-DI: 10889942831746(each), 40889942831747(case), Lot Number: 24EDA984; 32) ACC010316A, UDI-DI: 10889942831746(each), 40889942831747(case), Lot Number: 24LDA823; 33) ACC010318A, UDI-DI: 10889942831760(each), 40889942831761(case), Lot Number: 24EDC133; 34) ACC010318A, UDI-DI: 10889942831760(each), 40889942831761(case), Lot Number: 23KDA881; 35) ACC010319A, UDI-DI: 10889942831777(each), 40889942831778(case), Lot Number: 24DDA262; 36) ACC010319A, UDI-DI: 10889942831777(each), 40889942831778(case), Lot Number: 24DDA507; 37) ACC010319A, UDI-DI: 10889942831777(each), 40889942831778(case), Lot Number: 24EDB665; 38) ACC010319A, UDI-DI: 10889942831777(each), 40889942831778(case), Lot Number: 23JDB228; 39) ACC010361, UDI-DI: 10889942944989(each), 40889942944980(case), Lot Number: 24ADA597; 40) ACC010374A, UDI-DI: 10193489893977(each), 40193489893978(case), Lot Number: 25CDB687; 41) ACC010374A, UDI-DI: 10193489893977(each), 40193489893978(case), Lot Number: 25EDB273; 42) ACC010374A, UDI-DI: 10193489893977(each), 40193489893978(case), Lot Number: 25FDA380; 43) ACC010374A, UDI-DI: 10193489893977(each), 40193489893978(case), Lot Number: 24ADA326; 44) ACC010374A, UDI-DI: 10193489893977(each), 40193489893978(case), Lot Number: 24DDC115; 45) ACC010374A, UDI-DI: 10193489893977(each), 40193489893978(case), Lot Number: 24EDB585; 46) ACC010374A, UDI-DI: 10193489893977(each), 40193489893978(case), Lot Number: 24FDA451; 47) ACC010374A, UDI-DI: 10193489893977(each), 40193489893978(case), Lot Number: 24JDA313; 48) ACC010374A, UDI-DI: 10193489893977(each), 40193489893978(case), Lot Number: 24LDA107; 49) ACC010374A, UDI-DI: 10193489893977(each), 40193489893978(case), Lot Number: 23KDB464; 50) ACC010374A, UDI-DI: 10193489893977(each), 40193489893978(case), Lot Number: 23KDC441; 51) ACC010374A, UDI-DI: 10193489893977(each), 40193489893978(case), Lot Number: 23LDB221; 52) ACC010417A, UDI-DI: 10195327230043(each), 40195327230044(case), Lot Number: 25BDA421; 53) ACC010417A, UDI-DI: 10195327230043(each), 40195327230044(case), Lot Number: 25FDB683; 54) ACC010417A, UDI-DI: 10195327230043(each), 40195327230044(case), Lot Number: 24JDA799; 55) ACC010417A, UDI-DI: 10195327230043(each), 40195327230044(case), Lot Number: 24KDB853; 56) ACC010417A, UDI-DI: 10195327230043(each), 4019… (truncated, 27323 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 June 12, 2026

Medline Convenience Kits: 1) COLORECTAL ME, Model Number: DYNJ906437D

The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach of sterility in the packaging, due to wrinkles in the paper lidding which may extend to the seal area. If the sterile barrier is compromised, patients and users may be exposed to microbial contamination. Potential health consequences may include no injury, localized infection, or, less commonly, more serious infection requiring medical treatment, antimicrobial therapy, procedural intervention, or hospitalization. In rare cases, particularly in critically ill or immunocompromised patients, severe infection could become life-threatening.

ALL 50 STATES
Full report

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

Recall #:
99334
Lot/product code:
1) DYNJ906437D, UDI-DI: 10195327542085(each), 40195327542086(case), Lot Number: 23LBL348; 2) DYNJ906437D, UDI-DI: 10195327542085(each), 40195327542086(case), Lot Number: 24BBA259; 3) DYNJ906437D, UDI-DI: 10195327542085(each), 40195327542086(case), Lot Number: 24BBN513; 4) DYNJ906437D, UDI-DI: 10195327542085(each), 40195327542086(case), Lot Number: 24BBS350; 5) DYNJ906437D, UDI-DI: 10195327542085(each), 40195327542086(case), Lot Number: 24BBU576
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 12, 2026

Medline Convenience Kits: 1) BLOOD CULTURE TRAY PEDIATRIC, Model Number: DYNDH1193; 2) BLOOD CULTURE KIT 2 W/CONNECT, Model Number: DYNDH1487A

The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach of sterility in the packaging, due to wrinkles in the paper lidding which may extend to the seal area. If the sterile barrier is compromised, patients and users may be exposed to microbial contamination. Potential health consequences may include no injury, localized infection, or, less commonly, more serious infection requiring medical treatment, antimicrobial therapy, procedural intervention, or hospitalization. In rare cases, particularly in critically ill or immunocompromised patients, severe infection could become life-threatening.

ALL 50 STATES
Full report

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

Recall #:
99334
Lot/product code:
1) DYNDH1193, UDI-DI: 10889942499953(each), 40889942499954(case), Lot Number: 24ABA808; 2) DYNDH1193, UDI-DI: 10889942499953(each), 40889942499954(case), Lot Number: 24BBV222; 3) DYNDH1193, UDI-DI: 10889942499953(each), 40889942499954(case), Lot Number: 24GBT333; 4) DYNDH1193, UDI-DI: 10889942499953(each), 40889942499954(case), Lot Number: 24IBU725; 5) DYNDH1193, UDI-DI: 10889942499953(each), 40889942499954(case), Lot Number: 23KBX578; 6) DYNDH1193, UDI-DI: 10889942499953(each), 40889942499954(case), Lot Number: 23LBP536; 7) DYNDH1487A, UDI-DI: 10193489484311(each), 40193489484312(case), Lot Number: 25BMG311; 8) DYNDH1487A, UDI-DI: 10193489484311(each), 40193489484312(case), Lot Number: 24AME318; 9) DYNDH1487A, UDI-DI: 10193489484311(each), 40193489484312(case), Lot Number: 24BMI775; 10) DYNDH1487A, UDI-DI: 10193489484311(each), 40193489484312(case), Lot Number: 24CMJ550; 11) DYNDH1487A, UDI-DI: 10193489484311(each), 40193489484312(case), Lot Number: 24IMG215; 12) DYNDH1487A, UDI-DI: 10193489484311(each), 40193489484312(case), Lot Number: 23JME381
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 12, 2026

Medline Convenience Kits: 1) ULTRASOUND BREAST PACK, Model Number: DYNJ63375C

The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach of sterility in the packaging, due to wrinkles in the paper lidding which may extend to the seal area. If the sterile barrier is compromised, patients and users may be exposed to microbial contamination. Potential health consequences may include no injury, localized infection, or, less commonly, more serious infection requiring medical treatment, antimicrobial therapy, procedural intervention, or hospitalization. In rare cases, particularly in critically ill or immunocompromised patients, severe infection could become life-threatening.

ALL 50 STATES
Full report

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

Recall #:
99334
Lot/product code:
1) DYNJ63375C, UDI-DI: 10193489851823(each), 40193489851824(case), Lot Number: 23LMC035
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 12, 2026

Medline Convenience Kits: 1) DYKM1414, Catalog Number: DYKM1414; 2) DYKM1414, Catalog Number: DYKM1414; 3) DYNDH1462A, Catalog Number: DYNDH1462A; 4) DYNJ38145F, Catalog Number: DYNJ38145F; 5) DYNJ63199A, Catalog Number: DYNJ63199A

The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach of sterility in the packaging, due to wrinkles in the paper lidding which may extend to the seal area. If the sterile barrier is compromised, patients and users may be exposed to microbial contamination. Potential health consequences may include no injury, localized infection, or, less commonly, more serious infection requiring medical treatment, antimicrobial therapy, procedural intervention, or hospitalization. In rare cases, particularly in critically ill or immunocompromised patients, severe infection could become life-threatening.

ALL 50 STATES
Full report

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

Recall #:
99334
Lot/product code:
1) DYKM1414, UDI-DI: 10889942481293(each), 40889942481294(case), Lot Number: 25BBB327; 2) DYKM1414, UDI-DI: 10889942481293(each), 40889942481294(case), Lot Number: 24KBE261; 3) DYNDH1462A, UDI-DI: 10193489993424(each), 40193489993425(case), Lot Number: 24ABC301; 4) DYNDH1462A, UDI-DI: 10193489993424(each), 40193489993425(case), Lot Number: 24ABT704; 5) DYNDH1462A, UDI-DI: 10193489993424(each), 40193489993425(case), Lot Number: 24BBO246; 6) DYNDH1462A, UDI-DI: 10193489993424(each), 40193489993425(case), Lot Number: 24BBU663; 7) DYNDH1462A, UDI-DI: 10193489993424(each), 40193489993425(case), Lot Number: 24CBJ141; 8) DYNDH1462A, UDI-DI: 10193489993424(each), 40193489993425(case), Lot Number: 23JBH263; 9) DYNDH1462A, UDI-DI: 10193489993424(each), 40193489993425(case), Lot Number: 23JBO539; 10) DYNDH1462A, UDI-DI: 10193489993424(each), 40193489993425(case), Lot Number: 23KBG333; 11) DYNDH1462A, UDI-DI: 10193489993424(each), 40193489993425(case), Lot Number: 23KBV434; 12) DYNDH1462A, UDI-DI: 10193489993424(each), 40193489993425(case), Lot Number: 23LBM123; 13) DYNJ38145F, UDI-DI: 10193489277173(each), 40193489277174(case), Lot Number: 25ABS139; 14) DYNJ38145F, UDI-DI: 10193489277173(each), 40193489277174(case), Lot Number: 24EBP237; 15) DYNJ38145F, UDI-DI: 10193489277173(each), 40193489277174(case), Lot Number: 24KBE336; 16) DYNJ38145F, UDI-DI: 10193489277173(each), 40193489277174(case), Lot Number: 23JBM582; 17) DYNJ38145F, UDI-DI: 10193489277173(each), 40193489277174(case), Lot Number: 23LBM892; 18) DYNJ63199A, UDI-DI: 10193489311730(each), 40193489311731(case), Lot Number: 24EBG970
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 12, 2026

Medline Convenience Kits: 1) ARTERIAL LINE INSERTION KIT, Model Number: ART1295

The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach of sterility in the packaging, due to wrinkles in the paper lidding which may extend to the seal area. If the sterile barrier is compromised, patients and users may be exposed to microbial contamination. Potential health consequences may include no injury, localized infection, or, less commonly, more serious infection requiring medical treatment, antimicrobial therapy, procedural intervention, or hospitalization. In rare cases, particularly in critically ill or immunocompromised patients, severe infection could become life-threatening.

ALL 50 STATES
Full report

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

Recall #:
99334
Lot/product code:
1) ART1295, UDI-DI: 10653160380733(each), 00653160380736(case), Lot Number: 2024092790; 2) ART1295, UDI-DI: 10653160380733(each), 00653160380736(case), Lot Number: 2025042590; 3) ART1295, UDI-DI: 10653160380733(each), 00653160380736(case), Lot Number: 2025070290
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled June 12, 2026

Buprenorphine HCl, CIII, Injection, 0.3 mg/mL, 5 x 1 mL Single Dose Vials per Carton, Rx Only, For Intramuscular or Intravenous use, Manufactured for: Endo USA, Malvern, PA 19355, NDC 42023-179-05

Crystallization; identified as Buprenorphine free base

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-0596-2026
Lot/product code:
Lot #: 82886, exp 09/30/2026; 89646, exp 05/31/2027
Recalling firm:
Par Health USA, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 12, 2026

Medline Convenience Kits: 1) BLOOD DRAW KIT, Catalog Number: DYLAB1081; 2) WHOLE BLOOD PHLEBOTOMY KIT, Catalog Number: DYNDB3005D; 3) QP KIT, Catalog Number: DYNDB3005F; 4) DOUBLE RED CELL PHLEBOTOMY KIT, Catalog Number: DYNDB3006C; 5) PLATELET PHLEBOTOMY KIT, Catalog Number: DYNDB3007C; 6) WHOLE BLOOD KIT, Catalog Number: DYNDB3041D; 7) PHLEBOTOMY, Catalog Number: DYNDB3044D; 8) PHLEBOTOMY, Catalog Number: DYNDB3044F; 9) DONATION - WB, Catalog Number: DYNDB3086D; 10) DONATION - ALYX/TRIMA W/O TOUR, Catalog Number: DYNDB3088B; 11) THERAPEUTIC NFT, Catalog Number: DYNDB3100; 12) BLOOD CULTURE TRAY ADULT, Catalog Number: DYNDH1194A; 13) ADULT BLOOD CULTURE KIT, Catalog Number: DYNDH1444D; 14) PEDS BLOOD CULTURE KIT, Catalog Number: DYNDH1445C; 15) BLOOD CULTURE KIT, Catalog Number: DYNDH1462B; 16) BLOOD CULTURE ADULT, Catalog Number: DYNDH1619A; 17) BLOOD CULTURE PEDI, Catalog Number: DYNDH1620A; 18) BLOOD CULTURE KIT, Catalog Number: DYNDH1622C; 19) BLOOD CULTURE KIT, Catalog Number: DYNDH1622D; 20) BLOOD CULTURE COLLECTION KIT, Catalog Number: DYNDH1626B; 21) ADULT BLOOD CULTURE KIT, Catalog Number: DYNDH1694A; 22) ADULT BLOOD CULTURE KIT, Catalog Number: DYNDH1695; 23) BLOOD CULTURE KIT, Catalog Number: DYNDH1708A; 24) BLOOD CULTURE COLLECTION KIT, Catalog Number: DYNDH1714A; 25) BLOOD CULTURE KIT, Catalog Number: DYNDH1715B; 26) BLOOD CULTURE KIT, Catalog Number: DYNDH1723; 27) NS BLOOD CULTURE 23G KIT, Catalog Number: DYNDH1740A; 28) NS BLOOD CULTURE 23G KIT, Catalog Number: DYNDH1740B; 29) NS BLOOD CULTURE 21G KIT, Catalog Number: DYNDH1741A; 30) NS BLOOD CULTURE 21G KIT, Catalog Number: DYNDH1741B; 31) PEDS BLOOD CULTURE KIT, Catalog Number: DYNDH1771A; 32) BLOOD CULTURE KIT, Catalog Number: DYNDH1805B; 33) BLOOD CULTURE KIT, Catalog Number: DYNDH1817A; 34) BLOOD CULTR KT DIVRSN DEVICE, Catalog Number: DYNDH1866; 35) BLOOD CULTURE KIT, Catalog Number: DYNDH1867; 36) BLOOD CULTURE KIT, Catalog Number: DYNDH1884; 37) PHLEBOTOMY BLOOD CULTURE KIT, Catalog Number: DYNDH1908; 38) BLOOD CULTURE KIT, Catalog Number: DYNDH1912; 39) BLOOD CULTURE KIT, Catalog Number: DYNDH1940; 40) BLOOD CULTURE KIT W/O BOTTLES, Catalog Number: DYNDH1985; 41) BLOOD CULTURE KIT, Catalog Number: DYNDH1988; 42) BLOOD CULTURE, Catalog Number: DYNDH2002; 43) BLOOD CULTURE W/NO IV, Catalog Number: DYNDH2016; 44) BLOOD CULTURE W/IV, Catalog Number: DYNDH2017; 45) BLOOD CULTURE KIT, Catalog Number: DYNDH2023; 46) BLOOD CULTURE KIT, Catalog Number: DYNDH2028; 47) BLOOD CULTURE KIT, Catalog Number: DYNDH2030; 48) BLOOD CULTURE KIT, Catalog Number: DYNDH2048; 49) BLOOD CULTURE KIT, Catalog Number: DYNDH2059; 50) BLOOD CULTURE KIT 450, Catalog Number: DYNDH2074; 51) BLOOD CULTURE-NB, Catalog Number: DYNDH2089

The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach of sterility in the packaging, due to wrinkles in the paper lidding which may extend to the seal area. If the sterile barrier is compromised, patients and users may be exposed to microbial contamination. Potential health consequences may include no injury, localized infection, or, less commonly, more serious infection requiring medical treatment, antimicrobial therapy, procedural intervention, or hospitalization. In rare cases, particularly in critically ill or immunocompromised patients, severe infection could become life-threatening.

ALL 50 STATES
Full report

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

Recall #:
99334
Lot/product code:
1) DYLAB1081, UDI-DI: 10198459199608(each), 40198459199609(case), Lot Number: 25CMC514; 2) DYNDB3005D, UDI-DI: 10195327038700(each), 40195327038701(case), Lot Number: 24CBG614; 3) DYNDB3005D, UDI-DI: 10195327038700(each), 40195327038701(case), Lot Number: 24CBT912; 4) DYNDB3005D, UDI-DI: 10195327038700(each), 40195327038701(case), Lot Number: 23HBH298; 5) DYNDB3005D, UDI-DI: 10195327038700(each), 40195327038701(case), Lot Number: 23JBN521; 6) DYNDB3005D, UDI-DI: 10195327038700(each), 40195327038701(case), Lot Number: 23KBT270; 7) DYNDB3005F, UDI-DI: 10198459025068(each), 40198459025069(case), Lot Number: 25BBD241; 8) DYNDB3005F, UDI-DI: 10198459025068(each), 40198459025069(case), Lot Number: 25BBP477; 9) DYNDB3005F, UDI-DI: 10198459025068(each), 40198459025069(case), Lot Number: 25CBI161; 10) DYNDB3005F, UDI-DI: 10198459025068(each), 40198459025069(case), Lot Number: 24LBM458; 11) DYNDB3005F, UDI-DI: 10198459025068(each), 40198459025069(case), Lot Number: 24FBL961; 12) DYNDB3005F, UDI-DI: 10198459025068(each), 40198459025069(case), Lot Number: 24FBS200; 13) DYNDB3005F, UDI-DI: 10198459025068(each), 40198459025069(case), Lot Number: 24IBO183; 14) DYNDB3006C, UDI-DI: 10195327038717(each), 40195327038718(case), Lot Number: 24ABB637; 15) DYNDB3006C, UDI-DI: 10195327038717(each), 40195327038718(case), Lot Number: 24ABY532; 16) DYNDB3006C, UDI-DI: 10195327038717(each), 40195327038718(case), Lot Number: 24CBH932; 17) DYNDB3006C, UDI-DI: 10195327038717(each), 40195327038718(case), Lot Number: 23JBN434; 18) DYNDB3006C, UDI-DI: 10195327038717(each), 40195327038718(case), Lot Number: 23LBH909; 19) DYNDB3007C, UDI-DI: 10195327038724(each), 40195327038725(case), Lot Number: 24CBL044; 20) DYNDB3007C, UDI-DI: 10195327038724(each), 40195327038725(case), Lot Number: 23JBC957; 21) DYNDB3007C, UDI-DI: 10195327038724(each), 40195327038725(case), Lot Number: 23KBT835; 22) DYNDB3007C, UDI-DI: 10195327038724(each), 40195327038725(case), Lot Number: 23LBI822; 23) DYNDB3041D, UDI-DI: 10195327170738(each), 40195327170739(case), Lot Number: 24KBS893; 24) DYNDB3044D, UDI-DI: 10195327028565(each), 40195327028566(case), Lot Number: 24ABH596; 25) DYNDB3044D, UDI-DI: 10195327028565(each), 40195327028566(case), Lot Number: 23KBB360; 26) DYNDB3044D, UDI-DI: 10195327028565(each), 40195327028566(case), Lot Number: 23LBI693; 27) DYNDB3044F, UDI-DI: 10195327661236(each), 40195327661237(case), Lot Number: 25BBA987; 28) DYNDB3044F, UDI-DI: 10195327661236(each), 40195327661237(case), Lot Number: 24LBE163; 29) DYNDB3044F, UDI-DI: 10195327661236(each), 40195327661237(case), Lot Number: 24DBO764; 30) DYNDB3044F, UDI-DI: 10195327661236(each), 40195327661237(case), Lot Number: 24DBO786; 31) DYNDB3044F, UDI-DI: 10195327661236(each), 40195327661237(case), Lot Number: 24EBD140; 32) DYNDB3044F, UDI-DI: 10195327661236(each), 40195327661237(case), Lot Number: 24GBR601; 33) DYNDB3044F, UDI-DI: 10195327661236(each), 40195327661237(case), Lot Number: 24IBR933; 34) DYNDB3086D, UDI-DI: 10195327313234(each), 40195327313235(case), Lot Number: 24LBR503; 35) DYNDB3086D, UDI-DI: 10195327313234(each), 40195327313235(case), Lot Number: 23LBM024; 36) DYNDB3086D, UDI-DI: 10195327313234(each), 40195327313235(case), Lot Number: 24BBM148; 37) DYNDB3086D, UDI-DI: 10195327313234(each), 40195327313235(case), Lot Number: 24CBN122; 38) DYNDB3086D, UDI-DI: 10195327313234(each), 40195327313235(case), Lot Number: 24FBC084; 39) DYNDB3086D, UDI-DI: 10195327313234(each), 40195327313235(case), Lot Number: 24JBV595; 40) DYNDB3086D, UDI-DI: 10195327313234(each), 40195327313235(case), Lot Number: 23JBL111; 41) DYNDB3088B, UDI-DI: 10195327086275(each), 40195327086276(case), Lot Number: 25ABB075; 42) DYNDB3088B, UDI-DI: 10195327086275(each), 40195327086276(case), Lot Number: 24BBO180; 43) DYNDB3088B, UDI-DI: 10195327086275(each), 40195327086276(case), Lot Number: 24CBN068; 44) DYNDB3088B, UDI-DI: 10195327086275(each), 40195327086276(case), Lot Number: 24DBW006; 45) DYNDB3088B, UDI-DI: 10195327086275(each), 40195327086276(case), Lot Number: 24IBC763; 46) DYNDB3088B, UDI-DI: 10195327086275(each), 40195327086276(case), Lot Number: 24JBA762; 47) DYNDB3088B, UDI-DI: 10195327086275(each), 40195327086276(case), Lot Number: 24JBX189; 48) DYNDB3088B, UDI-DI: 10195327086275(each), 40195327086276(case), Lot Number: 23JBY503; 49) DYNDB3088B, UDI-DI: 10195327086275(each), 40195327086276(case), Lot Number: 23LBM098; 50) DYNDB3100, UDI-DI: 10198459028915(each), 40198459028916(case), Lot Number: 24GBF854; 51) DYNDH1194A, UDI-DI: 10195327432300(each), 40195327432301(case), Lot Number: 23KBQ229; 52) DYNDH1444D, UDI-DI: 10195327502492(each), 40195327502493(case), Lot Number: 25ABW691; 53) DYNDH1444D, UDI-DI: 10195327502492(each), 40195327502493(case), Lot Number: 25DBO475; 54) DYNDH1444D, UDI-DI: 10195327502492(each), 40195327502493(case), Lot Number: 25EBD598; 55) DYNDH1444D, UDI-DI: 10195327502492(each), 40195327502493(case), Lot Number: 25FBQ279; 56) DYNDH1444D, UDI-DI: 10195327502492(each), 40195327502493(… (truncated, 37599 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 June 12, 2026

Medline Convenience Kits: 1) C-SECTION PREP, Model Number: DYNJ32702B

The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach of sterility in the packaging, due to wrinkles in the paper lidding which may extend to the seal area. If the sterile barrier is compromised, patients and users may be exposed to microbial contamination. Potential health consequences may include no injury, localized infection, or, less commonly, more serious infection requiring medical treatment, antimicrobial therapy, procedural intervention, or hospitalization. In rare cases, particularly in critically ill or immunocompromised patients, severe infection could become life-threatening.

ALL 50 STATES
Full report

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

Recall #:
99334
Lot/product code:
1) DYNJ32702B, UDI-DI: 10193489431070(each), 40193489431071(case), Lot Number: 25BBG443; 2) DYNJ32702B, UDI-DI: 10193489431070(each), 40193489431071(case), Lot Number: 25EBL829; 3) DYNJ32702B, UDI-DI: 10193489431070(each), 40193489431071(case), Lot Number: 24EBR761; 4) DYNJ32702B, UDI-DI: 10193489431070(each), 40193489431071(case), Lot Number: 24GBC622; 5) DYNJ32702B, UDI-DI: 10193489431070(each), 40193489431071(case), Lot Number: 24GBX458; 6) DYNJ32702B, UDI-DI: 10193489431070(each), 40193489431071(case), Lot Number: 23LBT973
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 12, 2026

Medline Convenience Kits: 1) PRE-OP KIT, Catalog Number: DYKS1043F; 2) PRE OP KIT, Catalog Number: DYKS1128C; 3) PRE OP KIT, Catalog Number: DYKS1216I; 4) PRE OP KIT, Catalog Number: DYKS1325A; 5) CATARACT PREOP KIT, Catalog Number: DYKS1583; 6) GENERAL PREOP KIT, Catalog Number: DYKS1584; 7) GENERAL PREOP KIT, Catalog Number: DYKS1584A; 8) GENERAL PREOP KIT, Catalog Number: DYKS1584B

The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach of sterility in the packaging, due to wrinkles in the paper lidding which may extend to the seal area. If the sterile barrier is compromised, patients and users may be exposed to microbial contamination. Potential health consequences may include no injury, localized infection, or, less commonly, more serious infection requiring medical treatment, antimicrobial therapy, procedural intervention, or hospitalization. In rare cases, particularly in critically ill or immunocompromised patients, severe infection could become life-threatening.

ALL 50 STATES
Full report

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

Recall #:
99334
Lot/product code:
1) DYKS1043F, UDI-DI: 10195327392086(each), 40195327392087(case), Lot Number: 23KBL520; 2) DYKS1043F, UDI-DI: 10195327392086(each), 40195327392087(case), Lot Number: 23LBP488; 3) DYKS1128C, UDI-DI: 10195327549374(each), 40195327549375(case), Lot Number: 25ABQ496; 4) DYKS1128C, UDI-DI: 10195327549374(each), 40195327549375(case), Lot Number: 24CBI654; 5) DYKS1128C, UDI-DI: 10195327549374(each), 40195327549375(case), Lot Number: 24DBU596; 6) DYKS1128C, UDI-DI: 10195327549374(each), 40195327549375(case), Lot Number: 24FBA388; 7) DYKS1128C, UDI-DI: 10195327549374(each), 40195327549375(case), Lot Number: 24GBD436; 8) DYKS1128C, UDI-DI: 10195327549374(each), 40195327549375(case), Lot Number: 24JBC974; 9) DYKS1128C, UDI-DI: 10195327549374(each), 40195327549375(case), Lot Number: 24KBA645; 10) DYKS1128C, UDI-DI: 10195327549374(each), 40195327549375(case), Lot Number: 23LBB037; 11) DYKS1216I, UDI-DI: 10198459362668(each), 40198459362669(case), Lot Number: 25GBP888; 12) DYKS1325A, UDI-DI: 10195327549343(each), 40195327549344(case), Lot Number: 25ABT088; 13) DYKS1325A, UDI-DI: 10195327549343(each), 40195327549344(case), Lot Number: 24KBO407; 14) DYKS1325A, UDI-DI: 10195327549343(each), 40195327549344(case), Lot Number: 24ABO808; 15) DYKS1325A, UDI-DI: 10195327549343(each), 40195327549344(case), Lot Number: 24CBI736; 16) DYKS1325A, UDI-DI: 10195327549343(each), 40195327549344(case), Lot Number: 24EBN336; 17) DYKS1325A, UDI-DI: 10195327549343(each), 40195327549344(case), Lot Number: 24IBP255; 18) DYKS1583, UDI-DI: 10198459027666(each), 40198459027667(case), Lot Number: 24GBW364; 19) DYKS1584, UDI-DI: 10198459027659(each), 40198459027650(case), Lot Number: 24GBW365; 20) DYKS1584A, UDI-DI: 10198459146633(each), 40198459146634(case), Lot Number: 24JBA740; 21) DYKS1584B, UDI-DI: 10198459292750(each), 40198459292751(case), Lot Number: 25EBD220
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 12, 2026

Medline Convenience Kits: 1) LABOR CDS, Model Number: CDS981762B; 2) VAG DELIVERY ADMISSION BAG, Model Number: DYKA1054F

The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach of sterility in the packaging, due to wrinkles in the paper lidding which may extend to the seal area. If the sterile barrier is compromised, patients and users may be exposed to microbial contamination. Potential health consequences may include no injury, localized infection, or, less commonly, more serious infection requiring medical treatment, antimicrobial therapy, procedural intervention, or hospitalization. In rare cases, particularly in critically ill or immunocompromised patients, severe infection could become life-threatening.

ALL 50 STATES
Full report

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

Recall #:
99334
Lot/product code:
1) CDS981762B, UDI-DI: 10193489306767(each), 40193489306768(case), Lot Number: 25ABK513; 2) CDS981762B, UDI-DI: 10193489306767(each), 40193489306768(case), Lot Number: 25DBM841; 3) CDS981762B, UDI-DI: 10193489306767(each), 40193489306768(case), Lot Number: 25EBU475; 4) CDS981762B, UDI-DI: 10193489306767(each), 40193489306768(case), Lot Number: 25FBQ817; 5) CDS981762B, UDI-DI: 10193489306767(each), 40193489306768(case), Lot Number: 25HBK086; 6) CDS981762B, UDI-DI: 10193489306767(each), 40193489306768(case), Lot Number: 23LBV280; 7) CDS981762B, UDI-DI: 10193489306767(each), 40193489306768(case), Lot Number: 24BBN930; 8) CDS981762B, UDI-DI: 10193489306767(each), 40193489306768(case), Lot Number: 24DBK663; 9) CDS981762B, UDI-DI: 10193489306767(each), 40193489306768(case), Lot Number: 24DBS890; 10) CDS981762B, UDI-DI: 10193489306767(each), 40193489306768(case), Lot Number: 24FBH870; 11) CDS981762B, UDI-DI: 10193489306767(each), 40193489306768(case), Lot Number: 24GBR415; 12) CDS981762B, UDI-DI: 10193489306767(each), 40193489306768(case), Lot Number: 24HBK593; 13) CDS981762B, UDI-DI: 10193489306767(each), 40193489306768(case), Lot Number: 24JBE456; 14) CDS981762B, UDI-DI: 10193489306767(each), 40193489306768(case), Lot Number: 24JBN932; 15) CDS981762B, UDI-DI: 10193489306767(each), 40193489306768(case), Lot Number: 23KBQ478; 16) DYKA1054F, UDI-DI: 10193489312607(each), 40193489312608(case), Lot Number: 25DLA351; 17) DYKA1054F, UDI-DI: 10193489312607(each), 40193489312608(case), Lot Number: 25ELA624; 18) DYKA1054F, UDI-DI: 10193489312607(each), 40193489312608(case), Lot Number: 24BLA086; 19) DYKA1054F, UDI-DI: 10193489312607(each), 40193489312608(case), Lot Number: 24CLA271; 20) DYKA1054F, UDI-DI: 10193489312607(each), 40193489312608(case), Lot Number: 24DLA466; 21) DYKA1054F, UDI-DI: 10193489312607(each), 40193489312608(case), Lot Number: 24FLA328; 22) DYKA1054F, UDI-DI: 10193489312607(each), 40193489312608(case), Lot Number: 24GLA526; 23) DYKA1054F, UDI-DI: 10193489312607(each), 40193489312608(case), Lot Number: 23JLB277; 24) DYKA1054F, UDI-DI: 10193489312607(each), 40193489312608(case), Lot Number: 23KLB020
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 12, 2026

ST AIA-Pack Testosterone, IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of testosterone in human serum on specific Tosoh AIA System analyzers, Model Number 0025204

The Test cup lot F level 1 low-quality control results values for the device were lower than expected on the Automated Immunoassay Analyzer (AIA) which could cause falsely elevated or falsely low total testosterone results. Such erroneous test results may lead to additional testing/diagnostic interventions and in limited cases, may lead to a delay in diagnosis and/or initiation of unnecessary or incorrect clinical treatment measures.

ALL 50 STATES
Full report

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

Recall #:
99210
Lot/product code:
UDI-DI: 14560189210032; Lot Numbers: FX12404, FY12407, FY12406, FZ12408
Recalling firm:
Tosoh Bioscience Inc
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UnclassifiedRisk not yet known
Medical deviceRecalled June 12, 2026

Medline Convenience Kits: 1) EYE KIT, Model Number: DYKM2751; 2) EYE KIT, Model Number: DYKM2751A; 3) CATARACT PREOP KIT, Model Number: DYKS1583A; 4) CATARACT PREOP KIT, Model Number: DYKS1583B

The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach of sterility in the packaging, due to wrinkles in the paper lidding which may extend to the seal area. If the sterile barrier is compromised, patients and users may be exposed to microbial contamination. Potential health consequences may include no injury, localized infection, or, less commonly, more serious infection requiring medical treatment, antimicrobial therapy, procedural intervention, or hospitalization. In rare cases, particularly in critically ill or immunocompromised patients, severe infection could become life-threatening.

ALL 50 STATES
Full report

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

Recall #:
99334
Lot/product code:
1) DYKM2751, UDI-DI: 10198459118395(each), 40198459118396(case), Lot Number: 24LBQ727; 2) DYKM2751, UDI-DI: 10198459118395(each), 40198459118396(case), Lot Number: 24JBB775; 3) DYKM2751A, UDI-DI: 10198459313301(each), 40198459313302(case), Lot Number: 25KMD727; 4) DYKS1583A, UDI-DI: 10198459146640(each), 40198459146641(case), Lot Number: 24KBP388; 5) DYKS1583A, UDI-DI: 10198459146640(each), 40198459146641(case), Lot Number: 24JBA739; 6) DYKS1583B, UDI-DI: 10198459292699(each), 40198459292690(case), Lot Number: 25DBM037
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)