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Recalls affecting New York

Data last updated: September 11, 2026 at 1:08 PM UTC

17,416 recalls found
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Straight from FDA press releases — not yet formally classified or risk-graded
UnclassifiedUndeclaredAnnounced September 4, 2026

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

Products contain undeclared yohimbine

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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

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UnclassifiedBacteria/virusSalmonellaAnnounced September 4, 2026

Foods Alive — Moringa Leaf Powder

Potential to be contaminated with Salmonella

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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.

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UnclassifiedAnnounced September 3, 2026

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

Presence of particulate matter identified as iron oxide

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Drugs

Recalling firm: B. Braun Medical Inc.

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

Company contact: recalls@bbraunusa.com

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UnclassifiedBacteria/virusE. coliAnnounced September 3, 2026

Great Value — Organic Triple Berry Blend

Possible E. Coli Contamination

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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

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UnclassifiedAnnounced September 3, 2026

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

Presence of particulate matter and lack of sterility assurance

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Food & Beverages

Recalling firm: American Regent, Inc.

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

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UnclassifiedAllergenMilkUndeclaredAnnounced August 31, 2026

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

Undeclared milk

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Food & BeveragesAllergens

Recalling firm: Crystal Temptations

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

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UnclassifiedUndeclaredAnnounced August 31, 2026

Lipofit — Lipofit Extreme 2.0 Fat Burner Dietary Supplement

Undeclared Fluoxetine and 2,4-Dinitrophenol (DNP)

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Dietary SupplementsDrugs

Recalling firm: Ana Salazar Modela Tu Cuerpo Inc.

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

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

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UnclassifiedAnnounced August 31, 2026

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

Contains garlic essential oil not approved for culinary use

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Food & BeveragesIngredients

Recalling firm: LMSI LLC

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

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

Everything Sprouts — Robust Radish Mix, 5oz Cups

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

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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

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UnclassifiedBacteria/virusSalmonellaAnnounced August 29, 2026

Martina — Mangoes

Potential contamination with Salmonella

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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 December 15, 2025

Plum Duo Infusion System, List Number 40002-04-01

ICU Medical received one lot of defective primary speakers from our supplier that may fail to produce an audible sound. If the primary speaker in your Plum Duo Infusion Pump fails, the pump may not produce audible alarms, alerts, or provide audible feedback for touchscreen inputs.

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

Recall #:
98129
Lot/product code:
UDI-DI: M335400021; Serial Numbers: 50000221 50000294 50000295 50000296 50000298 50000299 50000300 50000303 50000304 50000309 50001663 50001664 50001665 50001666 50001667 50001668 50001669 50001670 50001671 50001672 50001673 50001674 50001675 50001676 50001677 50001678 50001679 50001680 50001681 50001682 50001683 50001684 50001685 50001686 50001687 50001688 50001689 50001690 50001691 50001692 50001693 50001694 50001695 50001696 50001697 50001698 50001699 50001700 50001701 50001702 50001703 50001704 50001705 50001706 50001707 50001708 50001709 50001710 50001711 50001712 50001713 50001714 50001715 50001716 50001717 50001718 50001719 50001720 50001721 50001722 50001723 50001724 50001725 50001726 50001727 50001728 50001729 50001730 50001731 50001732 50001733 50001734 50001735 50001736 50001737 50001738 50001739 50001740 50001741 50001742 50001743 50001744 50001745 50001746 50001747 50001748 50001749 50001750 50001751 50001752 50001753 50001754 50001755 50001756 50001757 50001758 50001759 50001760 50001761 50001762 50001763 50001765 50001766 50001768 50001770 50001771 50001772 50001773 50001774 50001775 50001776 50001777 50001778 50001779 50001780 50001781 50001782 50001783 50001784 50001785 50001786 50001787 50001788 50001789 50001790 50001791 50001792 50001793 50001794 50001795 50001796 50001797 50001798 50001799 50001800 50001801 50001802 50001803 50001804 50001805 50001806 50001807 50001809 50001810 50001811 50001812 50001813 50001814 50001815 50001816 50001817 50001818 50001819 50001820 50001821 50001822 50001823 50001824 50001825 50001826 50001827 50001828 50001829 50001831 50001833 50001834 50001835 50001836 50001837 50001838 50001839 50001840 50001841 50001842 50001843 50001844 50001845 50001846 50001847 50002285 50003548 50003626 50003702 50003703 50003704 50003705 50003706 50003707 50003708 50003709 50003710 50003712 50003713 50003715 50003716 50003717 50003718 50003719 50003720 50003722 50003723 50003725 50003726 50003727 50003728 50003730 50003732 50003733 50003734 50003735 50003736 50003737 50003738 50003740 50003741 50003742 50003743 50003745 50003746 50003747 50003748 50003749 50003751 50003752 50003754 50003755 50003756 50003757 50003758 50003759 50003760 50003761 50003762 50003763 50003764 50003765 50003766 50003767 50003768 50003770 50003771 50003774 50003775 50003776 50003777 50003779 50003784 50003785 50003786 50003787 50003789 50003792 50003793 50003794 50003797 50003798 50003799 50003800 50003801 50003802 50003803 50003804 50003805 50003807 50004219 50004913 50004939 50005129 50005199 50000004 50000005 50000006 50000008 50000009 50000010 50000011 50000012 50000013 50000014 50000015 50000016 50000017 50000018 50000019 50000020 50000021 50000022 50000023 50000024 50000025 50000026 50000027 50000028 50000030 50000031 50000032 50000034 50000035 50000036 50000037 50000038 50000039 50000041 50000042 50000043 50000044 50000045 50000047 50000048 50000049 50000050 50000051 50000052 50000053 50000055 50000056 50000057 50000058 50000059 50000060 50000061 50000063 50000064 50000065 50000066 50000067 50000068 50000069 50000070 50000071 50000072 50000073 50000074 50000075 50000076 50000077 50000078 50000079 50000080 50000081 50000083 50000084 50000085 50000087 50000088 50000089 50000090 50000092 50000093 50000094 50000095 50000096 50000097 50000098 50000099 50000100 50000101 50000104 50000105 50000106 50000107 50000108 50000109 50000110 50000112 50000113 50000114 50000115 50000116 50000117 50000007 50000033 50000046 50000054 50000062 50000082 50000091 50000102 50000103 50000111 50000249 50000273 50000277 50000283 50000306 50000311 50003711 50003714 50003721 50003724 50003729 50003731 50003739 50003744 50003750 50003769 50003772 50003778 50003782 50003783 50003788 50003790 50003791 50003795 50003806 50003808 50003809 50003810 50004066 50004274 50004364 50001764 50001830
Recalling firm:
ICU Medical, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 15, 2025

TS-10/TS-10H Tube Sorter, automatic sorting system for sorting barcoded sample tubes, Catalog Number BN168792, running software versions 00-17

Under specific conditions, the lift's electromagnetic holding force may disengage unexpectedly, allowing unintended downward movement of the lift.

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

Recall #:
98213
Lot/product code:
Serial Numbers: 11281 11611 11918 11790 12040 11991 12218 11950 11795 11533 11635 12054 11610 11453 11753 11539 11990 12298 11774 11541 11981 11788 11834 12005 11907 11524 12237 11246 12154 12104 12299 12176 11711 11420 12153 12177 12074 11405 11303 12039 11250 11336 12137 12075
Recalling firm:
Sysmex America, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 15, 2025

Brand Name: Broselow Product Name: BROSELOW" FILLED BROSELOW ORGANIZER Model/Catalog Number: 7730IALS Software Version: Not Applicable Product Description: The Broselow Tape is a length- and weight-based reference tool specifically designed for pediatric emergency care. Component: no

Product contains potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine.

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

Recall #:
98208
Lot/product code:
Lot Code: Lot/Serial Number(s) 0004317699 0004333171 0004333593 UDI-DI Each-10889483589205 Case-30889483589209
Recalling firm:
SunMed Holdings, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 15, 2025

ICU Medical Plum Duo Precision IV Pump, List Numbers: 400020403 (US), 400021003 (Philippines)

Plum Solo and Duo Infusion pumps include a feature, that when selected, automatically flushes the downstream line after a piggyback therapy. The programmed flush volume is delivered from the primary line container at the piggyback therapy rate after the piggyback therapy is complete. In certain cases, as described below, the clinician may receive an Upper Hard Limit (UHL) or Lower Hard Limit (LHL) Violation message when programming a piggyback flush, which prevents the flush from being programmed.

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

Recall #:
98128
Lot/product code:
400020403 (US), Software Versions: 1.2.2; 400021003 (Philippines), Software Versions: 1.2.0
Recalling firm:
ICU Medical, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 15, 2025

Asserachrom HPIA. Model/Catalog Number: 00615. The Asserachrom HPIA kit is intended for the qualitative detection in plasma or serum of the anti-heparin-platelet factor 4 (PF4) antibodies generated during the type II heparin-induced thrombocytopenia (HIT type II) by ELISA.

Potential for defect for Asserachrom HPIA lot 271288, which can affect every well in the impacted strip and produce negative results.

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

Recall #:
98163
Lot/product code:
Reference Number: 00615. UDI: (01)03607450006155(11)240531(17)260531(10)271288(241)00615. Lot Number: 271288.
Recalling firm:
Diagnostica Stago, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 14, 2025

Brand Name: Elekta Medical Linear Accelerator Product Name: Elekta Synergy, Elekta Harmony, Elekta Infinity, Versa HD Software Version: N/A Product Description: Digital Linear Accelerator Component: No

Due to a manufacturing issue and electrical grounding of systems.

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

Recall #:
97958
Lot/product code:
Lot Code: 05060191071550 (NFB) Elekta Synergy 05060191071505 (FB) 05060191071543 (NFB) Elekta Infinity 05060191071512 (FB) 05060191071574 (NFB) Versa HD 05060191071529 (FB) 05060191071581 Harmony 05060191071604 Harmony Pro 07340201503461 Elekta Evo
Recalling firm:
Elekta, Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
FoodForeign materialRecalled December 13, 2025

Tom Bumble Nutty Peanut Butter Flake Candy with Peanut & Chocolate GF V. Product is shelf stable, gold foil wrapping with paper label and cardboard outer box in some cases. Oregon Bark 2630 NE Sandy Blvd. Portland, Oregon 97232 2 Bars Boxes marked 50/50 or Nutty 4 Bars Boxes marked 50/50 or NUTTY 24 count boxes labeled Nutty UPC 852905007024 (1.2oz) UPC 852905007055 (2.2oz) UPC 852905007031 (4.5oz)

Foreign material.

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

Recall #:
H-0391-2026
Lot/product code:
Best By dates between 5/21/26 - 6/9/26.
Recalling firm:
Tom Bumble LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 12, 2025

Medline medical procedure convenience kits labeled as: 1) WATKINS SPINE PACK-LF, Kit SKU DYNJ0275635M; 2) SM-SPINE PACK-LF, Kit SKU DYNJ0395037X; 3) TOTAL HIP PACK, Kit SKU DYNJ04809N; 4) MAIN/LAMINECTOMY PACK-LF, Kit SKU DYNJ0565499AN; 5) SCC/SPOC HAND & FOOT PACK, Kit SKU DYNJ27164Q; 6) ORTHO SPINE, Kit SKU DYNJ40221G; 7) URO GYN PACK, Kit SKU DYNJ45311J; 8) LAMINECTOMY PACK, Kit SKU DYNJ46330C; 9) DJ ORTHO SPINE, Kit SKU DYNJ48980M; 10) CERVICAL PACK, Kit SKU DYNJ52995F; 11) NORTH BACK FUSION PACK-LF, Kit SKU DYNJ56483L; 12) KNEE ARTHROSCOPY CHRISTUS, Kit SKU DYNJ61200B; 13) KNEE ARTHROSCOPY PACK-LF, Kit SKU DYNJ66150; 14) HIP PACK, Kit SKU DYNJ66630; 15) OHNS FREE FLAP A PACK, Kit SKU DYNJ69065F; 16) LUMBAR PACK, Kit SKU DYNJ69113C; 17) LAMINECTOMY PACK, Kit SKU DYNJ69401D; 18) LAMINECTOMY PACK, Kit SKU DYNJ81013D; 19) HIP/SHOULDER ARTHROSCOPY PACK, Kit SKU DYNJ84275A; 20) FLASC ACL PACK, Kit SKU DYNJ88971; 21) SPINE PACK MERCY GALENA, Kit SKU DYNJ89943; 22) SPINAL FUSION MT CARMEL, Kit SKU DYNJ900173J; 23) HAND, Kit SKU DYNJ904945G; 24) LAMINECTOMY, Kit SKU DYNJ909505D; 25) SHOULDER SPLIT, Kit SKU DYNJ910543F; 26) SHOULDER SPLIT, Kit SKU DYNJ910543G; 27) CRANIOTOMY PACK, Kit SKU DYNJT4724; 28) SPINE PACK, Kit SKU DYNJT5184.

Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to complaints that the butyrate tubing cracked during actuation of the vials of MASTISOL Liquid Adhesive.

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

Recall #:
98226
Lot/product code:
Medline Kit SKU DYNJ0275635M: UDI/DI 10198459464799 (EA) 40198459464790 (CS), Lot Number 25KMH120; Medline Kit SKU DYNJ0395037X: UDI/DI 10198459600555 (EA) 40198459600556 (CS), Lot Number 25LMB119; Medline Kit SKU DYNJ04809N: UDI/DI 10198459440908 (EA) 40198459440909 (CS), Lot Number 25KMF969; Medline Kit SKU DYNJ0565499AN: UDI/DI 10195327318352 (EA) 40195327318353 (CS), Lot Number 25JMF339; Medline Kit SKU DYNJ0565499AN: UDI/DI 10195327318352 (EA) 40195327318353 (CS), Lot Number 25LMB019; Medline Kit SKU DYNJ27164Q: UDI/DI 10198459138102 (EA) 40198459138103 (CS), Lot Number 25KMJ742; Medline Kit SKU DYNJ40221G: UDI/DI 10198459448515 (EA) 40198459448516 (CS), Lot Number 25KME669; Medline Kit SKU DYNJ45311J: UDI/DI 10198459255670 (EA) 40198459255671 (CS), Lot Number 25KMI080; Medline Kit SKU DYNJ46330C: UDI/DI 10889942490066 (EA) 40889942490067 (CS), Lot Number 25KMD795; Medline Kit SKU DYNJ48980M: UDI/DI 10195327533694 (EA) 40195327533695 (CS), Lot Number 25KMC459; Medline Kit SKU DYNJ52995F: UDI/DI 10195327639778 (EA) 40195327639779 (CS), Lot Number 25KME064; Medline Kit SKU DYNJ56483L: UDI/DI 10195327518141 (EA) 40195327518142 (CS), Lot Number 25LMB049; Medline Kit SKU DYNJ61200B: UDI/DI 10195327604264 (EA) 40195327604265 (CS), Lot Number 25KBE867; Medline Kit SKU DYNJ66150: UDI/DI 10193489317558 (EA) 40193489317559 (CS), Lot Number 25KMC057; Medline Kit SKU DYNJ66630: UDI/DI 10193489368284 (EA) 40193489368285 (CS), Lot Number 25KMG435; Medline Kit SKU DYNJ69065F: UDI/DI 10198459226618 (EA) 40198459226619 (CS), Lot Number 25KMI293; Medline Kit SKU DYNJ69113C: UDI/DI 10198459170225 (EA) 40198459170226 (CS), Lot Number 25JMJ726; Medline Kit SKU DYNJ69401D: UDI/DI 10198459183676 (EA) 40198459183677 (CS), Lot Number 25KMJ106; Medline Kit SKU DYNJ81013D: UDI/DI 10198459547706 (EA) 40198459547707 (CS), Lot Number 25LDA122; Medline Kit SKU DYNJ84275A: UDI/DI 10198459240171 (EA) 40198459240172 (CS), Lot Number 25LMB546; Medline Kit SKU DYNJ88971: UDI/DI 10198459222269 (EA) 40198459222260 (CS), Lot Number 25KMH340; Medline Kit SKU DYNJ89943: UDI/DI 10198459299483 (EA) 40198459299484 (CS), Lot Number 25KMB583; Medline Kit SKU DYNJ900173J: UDI/DI 10198459292170 (EA) 40198459292171 (CS), Lot Number 25JDB487; Medline Kit SKU DYNJ904945G: UDI/DI 10198459518317 (EA) 40198459518318 (CS), Lot Number 25LBC198; Medline Kit SKU DYNJ909505D: UDI/DI 10198459594229 (EA) 40198459594220 (CS), Lot Number 25LMB637; Medline Kit SKU DYNJ910543F: UDI/DI 10198459554971 (EA) 40198459554972 (CS), Lot Number 25KMH376; Medline Kit SKU DYNJ910543G: UDI/DI 10198459588204 (EA) 40198459588205 (CS), Lot Number 25LMA619; Medline Kit SKU DYNJT4724: UDI/DI 10198459457913 (EA) 40198459457914 (CS), Lot Number 25KMI923; Medline Kit SKU DYNJT5184: UDI/DI 10198459467592 (EA) 40198459467593 (CS), Lot Number 25KMG240.
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 12, 2025

Broviac 4.2 Fr Single-Lumen CV Catheter Cutdown Tray with SureCuff Tissue Ingrowth Cuff Cat 60060

Due to damage to outer tray that can potentially compromise the sterile barrier

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

Recall #:
98222
Lot/product code:
Product Name: Broviac 4.2 Fr Single-Lumen CV Catheter Cutdown Tray with SureCuff Tissue Ingrowth Cuff Product Catalog Number: 600060 UDI code: (01)00801741051692(17)300728(10)HUKV0547 Lot Number: HUKV0547 Product Name: Broviac 6.6 Fr Single-Lumen CV Catheter Cutdown Tray with SureCuff Tissue Ingrowth Cuff Product Catalog Number: 600100 UDI code: (01)00801741051708(17)300628(10)HUKU0307 (01)00801741051708(17)300828(10)HUKW1312 Lot Number: HUKU0307 HUKW1312 Product Name: Broviac 6.6 Fr Single-Lumen CV Catheter Cutdown Tray (Short External Length) with SureCuff Tissue Ingrowth Cuff Product Catalog Number: 600120 UDI code: (01)00801741051715(17)300628(10)HUKU0274 Lot Number: HUKU0274 Product Name: Hickman 7 Fr Dual-Lumen CV Catheter, Cutdown Tray with SureCuff Tissue Ingrowth Cuff Product Catalog Number: 600310 UDI code: (01)00801741051739(17)300428(10)HUKS0783 (01)00801741051739(17)300628(10)HUKU0250 (01)00801741051739(17)300628(10)HUKU0310 Lot Number: HUKS0783 HUKU0250 HUKU0310 Product Name: Hickman 12 Fr Dual-Lumen CV Catheter, Cutdown Tray with SureCuff Tissue Ingrowth Cuff Product Catalog Number: 600350 UDI code: (01)00801741051777(17)300428(10)HUKR1359 (01)00801741051777(17)300428(10)HUKS0811 (01)00801741051777(17)300628(10)HUKU0316 Lot Number: HUKR1359 HUKS0811 HUKU0316 Product Name:Broviac 4.2 Fr Single-Lumen CV Catheter Peel-Apart Introducer Kit with SureCuff Tissue Ingrowth Cuff Product Catalog Number: 600520 UDI code: (01)00801741051807(17)270528(10)HUKS1468 (01)00801741051807(17)270528(10)HUKU0246 (01)00801741051807(17)270528(10)HUKU0278 (01)00801741051807(17)270528(10)HUKU0289 (01)00801741051807(17)270528(10)HUKU0305 (01)00801741051807(17)270528(10)HUKU0327 (01)00801741051807(17)270528(10)HUKU0338 (01)00801741051807(17)270528(10)HUKU0353 (01)00801741051807(17)270528(10)HUKW0164 (01)00801741051807(17)280328(10)HUKW1278 (01)00801741051807(17)280328(10)HUKW1285 Lot Number: HUKS1468 HUKU0246 HUKU0278 HUKU0289 HUKU0305 HUKU0327 HUKU0338 HUKU0353 HUKW0164 HUKW1278 HUKW1285 Product Name:Broviac 6.6 Fr Single-Lumen CV Catheter Peel-Apart Introducer Kit with SureCuff Tissue Ingrowth Cuff Product Catalog Number: 600540 UDI code: (01)00801741051821(17)290428(10)HUKR0064 (01)00801741051821(17)290628(10)HUKR0065 (01)00801741051821(17)290628(10)HUKR0067 (01)00801741051821(17)300128(10)HUKU0252 (01)00801741051821(17)300128(10)HUKU0270 (01)00801741051821(17)300128(10)HUKU0279 (01)00801741051821(17)300128(10)HUKU0308 (01)00801741051821(17)300128(10)HUKU0334 (01)00801741051821(17)300328(10)HUKV0359 (01)00801741051821(17)300328(10)HUKV0550 (01)00801741051821(17)300328(10)HUKV0560 (01)00801741051821(17)300328(10)HUKW0156 (01)00801741051821(17)300328(10)HUKW0159 Lot Number: HUKR0064 HUKR0065 HUKR0067 HUKU0252 HUKU0270 HUKU0279 HUKU0308 HUKU0334 HUKV0359 HUKV0550 HUKV0560 HUKW0156 HUKW0159 Product Name:Hickman 9.6 Fr Single-Lumen CV Catheter, Peel-Apart Introducer Kit with SureCuff Tissue Ingrowth Cuff Product Catalog Number: 600560 UDI code: (01)00801741051845(17)290828(10)HUKS0776 (01)00801741051845(17)290828(10)HUKS0816 (01)00801741051845(17)290928(10)HUKS1220 (01)00801741051845(17)290928(10)HUKU0302 (01)00801741051845(17)290928(10)HUKU0311 (01)00801741051845(17)300128(10)HUKU0345 (01)00801741051845(17)300128(10)HUKU0350 (01)00801741051845(17)300128(10)HUKV0376 (01)00801741051845(17)300128(10)HUKV0555 Lot Number: HUKS0776 HUKS0816 HUKS1220 HUKU0302 HUKU0311 HUKU0345 HUKU0350 HUKV0376 HUKV0555 Product Name:Hickman 7 Fr Dual-Lumen CV Catheter, Peel-Apart Introducer Kit with SureCuff Tissue Ingrowth Cuff Product Catalog Number: 600570 UDI code: (01)00801741051869(17)290628(10)HUKR1342 (01)00801741051869(17)290628(10)HUKR1344 (01)00801741051869(17)300128(10)HUKR1346 (01)00801741051869(17)290628(10)HUKR1347 (01)00801741051869(17)300128(10)HUKR1348 (01)00801741051869(17)300128(10)HUKR1356 (01)00801741051869(17)290628(10)HUKR1363 (01)00801741051869(17)290628(10)HUKR1367 (01)00801741051869(17)300128(10)HUKR1368 (01)00801741051869(17)300128(10)HUKS0774 (01)00801741051869(17)300128(10)HUKU0238 (01)00801741051869(17)300128(10)HUKU0242 (01)00801741051869(17)300128(10)HUKU0247 (01)00801741051869(17)300128(10)HUKU0253 (01)00801741051869(17)300128(10)HUKU0254 (01)00801741051869(17)300128(10)HUKU0266 (01)00801741051869(17)300128(10)HUKU0280 (01)00801741051869(17)300128(10)HUKU0283 (01)00801741051869(17)300128(10)HUKU0284 (01)00801741051869(17)300128(10)HUKU0290 (01)00801741051869(17)300128(10)HUKU0293 (01)00801741051869(17)300128(10)HUKU0294 (01)00801741051869(17)300128(10)HUKU0298 (01)00801741051869(17)300128(10)HUKU0312 (01)00801741051869(17)300128(10)HUKU0339 (01)00801741051869(17)300328(10)HUKU0340 (01)00801741051869(17)300128(10)HUKU0344 (01)00801741051869(17)300128(10)HUKU0354 (01)00801741051869(17)300328(10)HUKV0549 (01)00801741051869(17)300328(10)HUKV0569 (01)00801741051869(17)300328(10)HUKV0576 (01)00801741051869(17)300328(10)HUKV0581 (01)00801741051869(17)300328(10)HUKW0148 Lot Number: HUKR1342 HUKR1344 HUKR1346 HU… (truncated, 13979 characters total — see the official FDA record for the full value)
Recalling firm:
Bard Peripheral Vascular Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 12, 2025

Medline medical procedure convenience kits labeled as: CIRCUMCISION PACK, Kit SKU DYNJ16826O

Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to complaints that the butyrate tubing cracked during actuation of the vials of MASTISOL Liquid Adhesive.

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

Recall #:
98226
Lot/product code:
Medline Kit SKU DYNJ16826O: UDI/DI 10195327412067 (EA) 40195327412068 (CS), Lot Number 25LMA655; Medline Kit SKU DYNJ16826O: UDI/DI 10195327412067 (EA) 40195327412068 (CS), Lot Number 25KMC911.
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
Class IIModerate risk
FoodAllergenSoyUndeclaredRecalled December 12, 2025

1972 Banana Pudding Ice Cream, 3 GAL, UPC 0 75196 00556 6

Not listed on the label soy lecithin

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

Recall #:
H-0384-2026
Lot/product code:
Lot numbers: 22236, 23175, 24019, 24051, 25070, 25247
Recalling firm:
House Of Flavors, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 12, 2025

Medline medical procedure convenience kits labeled as: 1) DRAWER 1 AIRWAY, Kit SKU ACC010270A; 2) DRAWER 2, Kit SKU ACC010690; 3) DRAWER 3 SYR/DRS/MON/NG 1 OF 3, Kit SKU ACC011073; 4) HYPOSPADIUS PACK, Kit SKU DYNJ00282Q; 5) SJ NEURO PACK RFID-LF, Kit SKU DYNJ0101360K; 6) CENTRAL LINE PACK-LF, Kit SKU DYNJ0220136S; 7) SPINE PACK-LF, Kit SKU DYNJ0376635Q; 8) ORTHO SPINAL PACK-LF, Kit SKU DYNJ0460768T; 9) W.C. MINOR LAPAROTOMY PK-LF, Kit SKU DYNJ0509186J; 10) NEURO SHUNT PACK-LF, Kit SKU DYNJ0578815W; 11) ANCILLARY SPINE PACK-LF, Kit SKU DYNJ0610290T; 12) MINOR LAPAROTOMY PACK-LF, Kit SKU DYNJ0753436P; 13) KNEE SCOPE PACK-LF, Kit SKU DYNJ0890502R; 14) PEDIATRIC PACK-LF, Kit SKU DYNJ28212L; 15) ANTERIOR CERVICAL PACK, Kit SKU DYNJ31341P; 16) PEDIATRIC MINOR PROCEDURE PACK, Kit SKU DYNJ37615J; 17) LAPAROSCOPY PACK, Kit SKU DYNJ39215N; 18) MAJOR LAP VCH, Kit SKU DYNJ39217P; 19) NEURO PACK, Kit SKU DYNJ39220N; 20) CAS HAND PK, Kit SKU DYNJ39468G; 21) RFT ISC NOBLES MINOR PACK, Kit SKU DYNJ43954B; 22) PED OPEN HEART PACK, Kit SKU DYNJ45373G; 23) MAJOR GENERAL PACK-LF, Kit SKU DYNJ51436F; 24) MINOR PK-LF, Kit SKU DYNJ51437C; 25) VEIN ABLATION & EXCISION ASC, Kit SKU DYNJ52586C; 26) SHOULDER PACK, Kit SKU DYNJ56889B; 27) LAP CHOLE PACK, Kit SKU DYNJ57206F; 28) TRANSGENDER MASTECTOMY 2, Kit SKU DYNJ58257I; 29) SHOULDER ARTH PACK, Kit SKU DYNJ58410D; 30) MAJOR PACK, Kit SKU DYNJ58528J; 31) PACK BREAST, Kit SKU DYNJ60157F; 32) CH TRANSPHENOIDAL PACK, Kit SKU DYNJ61696I; 33) RR-SPINE PACK, Kit SKU DYNJ62643B; 34) MINOR PACK, Kit SKU DYNJ64238D; 35) PBMS NECK PACK-LF, Kit SKU DYNJ64961C; 36) BREAST PACK, Kit SKU DYNJ64988C; 37) MINOR PACK 180110, Kit SKU DYNJ65447C; 38) PACK,V-P SHUNT, Kit SKU DYNJ65472C; 39) BASIC PACK, Kit SKU DYNJ65996D; 40) MINOR SS, Kit SKU DYNJ66094A; 41) CRMC ROBOTIC GENERAL PACK, Kit SKU DYNJ66613D; 42) PEDIATRIC GENERAL PACK, Kit SKU DYNJ66644F; 43) URO/GYN PACK, Kit SKU DYNJ66675F; 44) SHOULDER SCOPE PACK, Kit SKU DYNJ68707B; 45) SPECIALTY FACIAL PLASTICS PACK, Kit SKU DYNJ68844B; 46) SPECIALTY FACIAL PLASTICS PACK, Kit SKU DYNJ68844C; 47) ACF PACK, Kit SKU DYNJ69112C; 48) SM OR-DR. YEH PACK-LF, Kit SKU DYNJ69705C; 49) SHOULDER ARTHROSCOPY PACK, Kit SKU DYNJ81752C; 50) C BIRTH SET UP PACK, Kit SKU DYNJ81994C; 51) TRIAL PACK, Kit SKU DYNJ82770A; 52) PROSTATE ROBOTIC PACK, Kit SKU DYNJ84120C; 53) HAND PACK, Kit SKU DYNJ85033A; 54) ARTHROSCOPY PACK, Kit SKU DYNJ85197A; 55) GU-GYN-LITHO PACK, Kit SKU DYNJ86013A; 56) DBD-ARTHROSCOPY PACK, Kit SKU DYNJ86963A; 57) BREAST PACK, Kit SKU DYNJ87587A; 58) PACK,PEDIATRIC MINOR, Kit SKU DYNJ88718; 59) UNIVERSAL-ASC, Kit SKU DYNJ900071C; 60) BASIC, Kit SKU DYNJ905869G; 61) PACK,PEDIATRIC MAJOR, Kit SKU DYNJ906888F; 62) HAND/FOOT PACK, Kit SKU DYNJT3131A; 63) SHOULDER PACK, Kit SKU DYNJT3266; 64) LUMBAR PACK, Kit SKU DYNJT4178; 65) CVS ICU PACK, Kit SKU PHS41728D; 66) SINGLE TAP BLOCK TRAY, Kit SKU SPEC0156A.

Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to complaints that the butyrate tubing cracked during actuation of the vials of MASTISOL Liquid Adhesive.

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

Recall #:
98226
Lot/product code:
Medline Kit SKU ACC010270A: UDI/DI 10889942219827 (EA) 40889942219828 (CS), Lot Number 25LDA153; Medline Kit SKU ACC010690: UDI/DI 10195327433307 (EA) 40195327433308 (CS), Lot Number 25LDA088; Medline Kit SKU ACC011073: UDI/DI 10198459569333 (EA) 40198459569334 (CS), Lot Number 25LDA072; Medline Kit SKU DYNJ00282Q: UDI/DI 10195327412029 (EA) 40195327412020 (CS), Lot Number 25KMC904; Medline Kit SKU DYNJ00282Q: UDI/DI 10195327412029 (EA) 40195327412020 (CS), Lot Number 25LMA071; Medline Kit SKU DYNJ0101360K: UDI/DI 10195327662066 (EA) 40195327662067 (CS), Lot Number 25KMC709; Medline Kit SKU DYNJ0220136S: UDI/DI 10198459566073 (EA) 40198459566074 (CS), Lot Number 25KMB403; Medline Kit SKU DYNJ0220136S: UDI/DI 10198459566073 (EA) 40198459566074 (CS), Lot Number 25JMF503; Medline Kit SKU DYNJ0376635Q: UDI/DI 10198459422591 (EA) 40198459422592 (CS), Lot Number 25KMH121; Medline Kit SKU DYNJ0376635Q: UDI/DI 10198459422591 (EA) 40198459422592 (CS), Lot Number 25KMF780; Medline Kit SKU DYNJ0460768T: UDI/DI 10198459466809 (EA) 40198459466800 (CS), Lot Number 25KMH789; Medline Kit SKU DYNJ0509186J: UDI/DI 10198459117626 (EA) 40198459117627 (CS), Lot Number 25KME895; Medline Kit SKU DYNJ0578815W: UDI/DI 10198459466892 (EA) 40198459466893 (CS), Lot Number 25JMJ695; Medline Kit SKU DYNJ0610290T: UDI/DI 10198459021558 (EA) 40198459021559 (CS), Lot Number 25KMC723; Medline Kit SKU DYNJ0753436P: UDI/DI 10198459466854 (EA) 40198459466855 (CS), Lot Number 25KMJ740; Medline Kit SKU DYNJ0890502R: UDI/DI 10198459431098 (EA) 40198459431099 (CS), Lot Number 25KME522; Medline Kit SKU DYNJ28212L: UDI/DI 10193489322118 (EA) 40193489322119 (CS), Lot Number 25KBE916; Medline Kit SKU DYNJ31341P: UDI/DI 10198459069352 (EA) 40198459069353 (CS), Lot Number 25KMA795; Medline Kit SKU DYNJ37615J: UDI/DI 10195327560881 (EA) 40195327560882 (CS), Lot Number 25KDB706; Medline Kit SKU DYNJ39215N: UDI/DI 10198459102240 (EA) 40198459102241 (CS), Lot Number 25KMH027; Medline Kit SKU DYNJ39217P: UDI/DI 10198459102356 (EA) 40198459102357 (CS), Lot Number 25LMA409; Medline Kit SKU DYNJ39220N: UDI/DI 10198459102387 (EA) 40198459102388 (CS), Lot Number 25KMJ608; Medline Kit SKU DYNJ39468G: UDI/DI 10198459408595 (EA) 40198459408596 (CS), Lot Number 25KMD121; Medline Kit SKU DYNJ43954B: UDI/DI 10193489509168 (EA) 40193489509169 (CS), Lot Number 25KMD726; Medline Kit SKU DYNJ45373G: UDI/DI 10198459254635 (EA) 40198459254636 (CS), Lot Number 25JMH775; Medline Kit SKU DYNJ51436F: UDI/DI 10198459004315 (EA) 40198459004316 (CS), Lot Number 25KMG978; Medline Kit SKU DYNJ51437C: UDI/DI 10198459005114 (EA) 40198459005115 (CS), Lot Number 25JMJ673; Medline Kit SKU DYNJ52586C: UDI/DI 10195327596521 (EA) 40195327596522 (CS), Lot Number 25KMH637; Medline Kit SKU DYNJ56889B: UDI/DI 10198459490088 (EA) 40198459490089 (CS), Lot Number 25KBE707; Medline Kit SKU DYNJ57206F: UDI/DI 10195327682958 (EA) 40195327682959 (CS), Lot Number 25KMG080; Medline Kit SKU DYNJ58257I: UDI/DI 10198459565526 (EA) 40198459565527 (CS), Lot Number 25LMA492; Medline Kit SKU DYNJ58410D: UDI/DI 10198459366468 (EA) 40198459366469 (CS), Lot Number 25KBF113; Medline Kit SKU DYNJ58528J: UDI/DI 10198459322815 (EA) 40198459322816 (CS), Lot Number 25JBW494; Medline Kit SKU DYNJ60157F: UDI/DI 10198459343445 (EA) 40198459343446 (CS), Lot Number 25KMI064; Medline Kit SKU DYNJ61696I: UDI/DI 10198459208713 (EA) 40198459208714 (CS), Lot Number 25KMF819; Medline Kit SKU DYNJ62643B: UDI/DI 10198459164446 (EA) 40198459164447 (CS), Lot Number 25KMB841; Medline Kit SKU DYNJ64238D: UDI/DI 10198459068447 (EA) 40198459068448 (CS), Lot Number 25KME422; Medline Kit SKU DYNJ64961C: UDI/DI 10198459569777 (EA) 40198459569778 (CS), Lot Number 25KMD570; Medline Kit SKU DYNJ64988C: UDI/DI 10198459373008 (EA) 40198459373009 (CS), Lot Number 25LMB275; Medline Kit SKU DYNJ65447C: UDI/DI 10198459605222 (EA) 40198459605223 (CS), Lot Number 25LMA822; Medline Kit SKU DYNJ65472C: UDI/DI 10198459168727 (EA) 40198459168728 (CS), Lot Number 25KMD067; Medline Kit SKU DYNJ65996D: UDI/DI 10198459376726 (EA) 40198459376727 (CS), Lot Number 25KMJ550; Medline Kit SKU DYNJ66094A: UDI/DI 10198459462689 (EA) 40198459462680 (CS), Lot Number 25LMB276; Medline Kit SKU DYNJ66613D: UDI/DI 10198459504488 (EA) 40198459504489 (CS), Lot Number 25KMI271; Medline Kit SKU DYNJ66644F: UDI/DI 10198459574160 (EA) 40198459574161 (CS), Lot Number 25KMD640; Medline Kit SKU DYNJ66675F: UDI/DI 10198459574108 (EA) 40198459574109 (CS), Lot Number 25LMA853; Medline Kit SKU DYNJ68707B: UDI/DI 10198459001734 (EA) 40198459001735 (CS), Lot Number 25KBE843; Medline Kit SKU DYNJ68844B: UDI/DI 10198459232428 (EA) 40198459232429 (CS), Lot Number 25KMF829; Medline Kit SKU DYNJ68844C: UDI/DI 10198459608360 (EA) 40198459608361 (CS), Lot Number 25LMA922; Medline Kit SKU DYNJ69112C: UDI/DI 10198459176128 (EA) 40198459176129 (CS), Lot Number 25KME071; Medline Kit SKU DYNJ69705C: U… (truncated, 6847 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 December 12, 2025

Conductivity Standard Solution Catalog/Model Numbers: 10001, 10011, 10021, 10032, 10040, 10040c, and 10041 Conductivity Standard Solutions are a secondary standard solution used for the calibration of conductivity cells together with conductivity meters

Due to a defect associated with the conductivity values of the solution used to calibrate meters and result in the reporting of incorrect conductivity values for dialysate.

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

Recall #:
98030
Lot/product code:
Catalog/Model Numbers/ Lot Numbers / UDI codes: 10001 14250616-1019106 (01) 0 0850016 97600 0 (17) 251030 (10) SHOWCASE 10011 14250616-1019107 (01) 0 0850016 97609 3 (17) 251030 (10) SHOWCASE 10040c 50250624-1019120 (01) 0 0850016 97636 9 (17) 251030 (10) SHOWCASE 10040 50250624-1019119 (01) 0 0850016 97635 2 (17) 251030 (10) SHOWCASE 10032 14250616-1019108 (01) 0 0850016 97631 1 (17) 251030 (10) SHOWCASE 10041 50250522-1018643 (01) 0 0850016 97637 6 (17) 251030 (10) SHOWCASE 10041 50250624-1019121 (01) 0 0850016 97637 6 (17) 251030 (10) SHOWCASE 10021 15F250603-1018834 (01) 0 0850016 97619 2 (17) 251030 (10) SHOWCASE
Recalling firm:
NIPRO Technical Services, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 12, 2025

ThinPrep CytoLyt Solution. Buffered Cell Wash Solution.

Fungal contamination of affected lot with Parengyodontium album.

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

Recall #:
98058
Lot/product code:
Catalog number: 0236004; UDI: (01)25420045508405(17)270303(10)5062EC; UDI-DI: 25420045508405; Lot number: 5062EC.
Recalling firm:
Hologic, Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 12, 2025

Philips Smart-hopping 2.0 AP 1.4 GHz. Patient Monitor.

It was found that the MX40 device could not reconnect to the PIC iX when moving between Radiohead and Trident 1.4 GHz access points if the signal strength changed quickly.

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

Recall #:
98158
Lot/product code:
Model No. 867216; UDI [Serial No.]: , (01)00884838099876(21)DK32800791[DK32800791], (01)00884838099876(21)DK32800825[DK32800825], (01)00884838099876(21)DK32800918[DK32800918], (01)00884838099876(21)DK32800947[DK32800947], (01)00884838099876(21)DK32801055[DK32801055], (01)00884838099876(21)DK32801076[DK32801076], (01)00884838099876(21)DK32801098[DK32801098], (01)00884838099876(21)DK32801120[DK32801120], (01)00884838099876(21)DK32801188[DK32801188], (01)00884838099876(21)DK32801197[DK32801197], (01)00884838099876(21)DK32801225[DK32801225], (01)00884838099876(21)DK32801235[DK32801235], (01)00884838099876(21)DK32801252[DK32801252], (01)00884838099876(21)DK32801306[DK32801306], (01)00884838099876(21)DK32801338[DK32801338], (01)00884838099876(21)DK33402127[DK33402127], (01)00884838099876(21)DK33402141[DK33402141], (01)00884838099876(21)DK33402210[DK33402210], (01)00884838099876(21)DK33402281[DK33402281], (01)00884838099876(21)DK33402309[DK33402309], (01)00884838099876(21)DK33402345[DK33402345], (01)00884838099876(21)DK33402358[DK33402358], (01)00884838099876(21)DK33402363[DK33402363], (01)00884838099876(21)DK33402364[DK33402364], (01)00884838099876(21)DK33402437[DK33402437], (01)00884838099876(21)DK33402526[DK33402526], (01)00884838099876(21)DK33402553[DK33402553], (01)00884838099876(21)DK33402569[DK33402569], (01)00884838099876(21)DK33402630[DK33402630], (01)00884838099876(21)DK33402653[DK33402653], (01)00884838099876(21)DK33402657[DK33402657], (01)00884838099876(21)DK33402737[DK33402737], (01)00884838099876(21)DK33402805[DK33402805], (01)00884838099876(21)DK33402894[DK33402894], (01)00884838099876(21)DK33402955[DK33402955], (01)00884838099876(21)DK33403058[DK33403058], (01)00884838099876(21)DK33403144[DK33403144], (01)00884838099876(21)DK33403145[DK33403145], (01)00884838099876(21)DK33403209[DK33403209], (01)00884838099876(21)DK33403222[DK33403222], (01)00884838099876(21)DK33403235[DK33403235], (01)00884838099876(21)DK33603488[DK33603488], (01)00884838099876(21)DK33603527[DK33603527], (01)00884838099876(21)DK33603582[DK33603582], (01)00884838099876(21)DK33603584[DK33603584], (01)00884838099876(21)DK33603673[DK33603673], (01)00884838099876(21)DK33603678[DK33603678], (01)00884838099876(21)DK33603746[DK33603746], (01)00884838099876(21)DK33603796[DK33603796], (01)00884838099876(21)DK33603971[DK33603971], (01)00884838099876(21)DK33603989[DK33603989], (01)00884838099876(21)DK33603999[DK33603999], (01)00884838099876(21)DK33604020[DK33604020], (01)00884838099876(21)DK33604046[DK33604046], (01)00884838099876(21)DK33604057[DK33604057], (01)00884838099876(21)DK33604109[DK33604109], (01)00884838099876(21)DK33604128[DK33604128], (01)00884838099876(21)DK33604162[DK33604162], (01)00884838099876(21)DK33604229[DK33604229], (01)00884838099876(21)DK33604235[DK33604235], (01)00884838099876(21)DK33604249[DK33604249], (01)00884838099876(21)DK33604252[DK33604252], (01)00884838099876(21)DK33604424[DK33604424], (01)00884838099876(21)DK33604425[DK33604425], (01)00884838099876(21)DK33604524[DK33604524], (01)00884838099876(21)DK33604571[DK33604571], (01)00884838099876(21)DK33604588[DK33604588], (01)00884838099876(21)DK33604612[DK33604612], (01)00884838099876(21)DK33904737[DK33904737], (01)00884838099876(21)DK33904802[DK33904802], (01)00884838099876(21)DK33904818[DK33904818], (01)00884838099876(21)DK33904830[DK33904830], (01)00884838099876(21)DK33904834[DK33904834], (01)00884838099876(21)DK33904949[DK33904949], (01)00884838099876(21)DK33904961[DK33904961], (01)00884838099876(21)DK33905053[DK33905053], (01)00884838099876(21)DK33905076[DK33905076], (01)00884838099876(21)DK33905149[DK33905149], (01)00884838099876(21)DK34305222[DK34305222], (01)00884838099876(21)DK34305227[DK34305227], (01)00884838099876(21)DK34305256[DK34305256], (01)00884838099876(21)DK34405461[DK34405461], (01)00884838099876(21)DK34405464[DK34405464], (01)00884838099876(21)DK34405673[DK34405673], (01)00884838099876(21)DK34405777[DK34405777], (01)00884838099876(21)DK34405778[DK34405778], (01)00884838099876(21)DK34405795[DK34405795], (01)00884838099876(21)DK34706009[DK34706009], (01)00884838099876(21)DK34706048[DK34706048], (01)00884838099876(21)DK34706100[DK34706100], (01)00884838099876(21)DK34706116[DK34706116], (01)00884838099876(21)DK34706181[DK34706181], (01)00884838099876(21)DK34706271[DK34706271], (01)00884838099876(21)DK34706308[DK34706308], (01)00884838099876(21)DK34706385[DK34706385], (01)00884838099876(21)DK34706394[DK34706394], (01)00884838099876(21)DK34706485[DK34706485], (01)00884838099876(21)DK40306620[DK40306620], (01)00884838099876(21)DK40306621[DK40306621], (01)00884838099876(21)DK40306622[DK40306622], (01)00884838099876(21)DK40306681[DK40306681], (01)00884838099876(21)DK40306690[DK40306690], (01)00884838099876(21)DK40306709[DK40306709], (01)00884838099876(21)DK40306749[DK40306749], (01)00884838099876(21)DK40306765[DK40306765], (01)00884838099876(21)DK40306766[DK40306766], (01)00884838099876(21)DK40306781[DK40306781], (01)00884838099876(21)DK40306796[DK40306… (truncated, 17700 characters total — see the official FDA record for the full value)
Recalling firm:
Philips North America Llc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 12, 2025

Codman Microsensor Basic Kit. Catalog Number: 626631US. Use of the CODMAN MICROSENSOR Basic Kit is indicated when direct ICP monitoring is required. The kit is indicated for use in both subdural and intraparenchymal pressure monitoring applications only.

Potential corrosion stains on the surface of the 14-gauge Tuohy Needle that is included in the Microsensor and Cerelink ICP Kits.

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

Recall #:
98091
Lot/product code:
Catalog Number: 626631US. UDI-DI: 10381780514473. Lot Numbers: 7288007, 7288040, 7294017, 7305988, 7305989, 7305990, 7305991, 7307683, 7325489, 7336088, 7336089, 7336090, 7305992, 7346223, 7391752, 7391751, 7406650, 7406651, 7406652, 7408825, 7408826, 7408827, 7456174, 7456175, 7456176, 7456179, 7478039, 7478040, 7480073, 7480072, 7482162, 7503704, 7507495, 7503608, 7510153, 7510155, 7510154, 7534856, 7535008, 7535009, 7411809.
Recalling firm:
Integra LifeSciences Corp. (NeuroSciences)
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UnclassifiedRisk not yet known
Medical deviceRecalled December 12, 2025

Brand Name: Leksell GammaPlan Product Name: Radionuclide RT Treatment planning system Software Version: 11,3, 11.4 Product Description: Leksell GammaPlan is a computer-based system designed for Leksell Gamma Knife treatment planning.

Due to an error when defining a new stereotactic reference that users fail to first change an already defined obsolete reference to a pre-plan reference. This may result in a treatment plan that potentially irradiates the incorrect patient location if the error is not detected by users.

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

Recall #:
98212
Lot/product code:
Lot Code: 07340048311878 (LGP 11.3) 07340201502136 (LGP 11.4)
Recalling firm:
Elekta, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 12, 2025

Codman CereLink ICP Sensor Basic Kit. Catalog Number: 826850. The Codman CereLink ICP Sensor Basic Kit consists of the CereLink ICP Sensor (ICP Sensor) and a 14-gauge Tuohy needle with stylet. The ICP Sensor is a nylon tube with a microminiature strain gauge pressure transducer (sensing element) mounted at one end and an electrical connector at the other end. It is designed for use with a Codman intracranial pressure monitoring device. The ICP Sensor Basic Kit is designed for use with the Codman Cranial Hand Drill. The drill facilitates access to the intraparenchymal area. The drill is also available as a component of the Codman Cranial Access Kit. Use of the ICP Sensor Basic Kit is indicated when direct ICP monitoring is required. The kit is indicated for use in both subdural and intraparenchymal pressure monitoring applications only.

Potential corrosion stains on the surface of the 14-gauge Tuohy Needle that is included in the Microsensor and Cerelink ICP Kits.

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

Recall #:
98091
Lot/product code:
Catalog Number: 826850. UDI-DI: 10381780520672. Lot Numbers: 7261958, 7266691, 7266692, 7288060, 7293837, 7293836, 7306040, 7306041, 7306042, 7306043, 7306044, 7306045, 7306046, 7306047, 7306050, 7306051, 7306052, 7307670, 7307671, 7307672, 7325482, 7307675, 7325481, 7325483, 7325484, 7307673, 7307674, 7325485, 7325486, 7336611, 7336612, 7336614, 7336623, 7336613, 7336615, 7336616, 7336618, 7336619, 7336620, 7336621, 7336622, 7306048, 7306049, 7336626, 7336627, 7336629, 7347166, 7336628, 7346295, 7346297, 7346299, 7346301, 7365434, 7365435, 7392019, 7396607, 7396608, 7396609, 7396610, 7392034, 7392067, 7405790, 7405791, 7405792, 7405793, 7406633, 7406634, 7406636, 7406637, 7406639, 7406640, 7406641, 7406642, 7406635, 7406638, 7408813, 7408815, 7408818, 7408814, 7408816, 7468726, 7468727, 7411801, 7411802, 7414641, 7414642, 7468731, 7468732, 7468745, 7468746, 7468741, 7468742, 7468743, 7468744, 7468771, 7468769, 7468770, 7468773, 7468774, 7468775, 7482179, 7482180, 7482181, 7482182, 7482183, 7482184, 7482185, 7482186, 7468772, 7482154, 7482155, 7482156, 7482157, 7468801, 7468804, 7468805, 7468806, 7482136, 7468802, 7468803, 7482132, 7482134, 7482135, 7482137, 7482159, 7482158, 7482160, 7482161, 7495593, 7495594, 7495596, 7495597, 7495598, 7495599, 7482212, 7495600, 7495601, 7495602, 7495603, 7495604, 7495605, 7495606, 7495607, 7495608, 7495635, 7495636, 7495637, 7495638, 7495639, 7495640, 7495641, 7495642, 7495643, 7495666, 7495644, 7495664, 7482213, 7495667, 7503597, 7503598, 7503599, 7503659, 7510140, 7510141, 7510142, 7503600, 7503601, 7517716, 7517708, 7503627, 7503628, 7503630, 7503631, 7503632, 7503633, 7503629, 7503664, 7503657, 7503662, 7503663, 7503602, 7503624, 7510156, 7517703, 7517704, 7517706, 7517707, 7517709, 7517710, 7517711, 7517712, 7517714, 7517715, 7408817, 7411797, 7411798, 7411799, 7411800, 7414643, 7414644, 7414645, 7414646, 7414647, 7414648, 7414649, 7417938, 7417940, 7417942, 7417944, 7417946, 7417948, 7417950, 7417952, 7417955, 7417957, 7417959, 7503625.
Recalling firm:
Integra LifeSciences Corp. (NeuroSciences)
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 12, 2025

Medline medical procedure convenience kits labeled as: 1) CATH LAB PACEMAKER PACK-LF, Kit SKU DYNJ64837C; 2) LOOP RECOVERY PACK, Kit SKU DYNJT7034;

Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to complaints that the butyrate tubing cracked during actuation of the vials of MASTISOL Liquid Adhesive.

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

Recall #:
98226
Lot/product code:
Medline Kit SKU DYNJ64837C: UDI/DI 10198459139482 (EA) 40198459139483 (CS), Lot Number 25KMJ193; Medline Kit SKU DYNJT7034: UDI/DI 10198459592591 (EA) 40198459592592 (CS), Lot Number 25KMI766;.
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 12, 2025

Medline medical procedure convenience kits labeled as: 1) PACER / CATH LAB PACK-LF, Kit SKU DYNJ0972604A; 2) PACEMAKER/ICD PACK, Kit SKU DYNJ33822L; 3) VENOUS ACCESS PACK, Kit SKU DYNJ45640B; 4) PACEMAKER SET UP, Kit SKU DYNJ63377D; 5) PACK PACEMAKER CUSTOM,9909178, Kit SKU DYNJ65011D; 6) HEART BASIC OPEN PACK, Kit SKU DYNJ69143C; 7) SCC VEIN PACK, Kit SKU DYNJ69313; 8) CV PACK, Kit SKU DYNJ86007B.

Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to complaints that the butyrate tubing cracked during actuation of the vials of MASTISOL Liquid Adhesive.

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

Recall #:
98226
Lot/product code:
Medline Kit SKU DYNJ0972604A: UDI/DI 10889942403905 (EA) 40889942403906 (CS), Lot Number 25KMD144; Medline Kit SKU DYNJ33822L: UDI/DI 10198459385582 (EA) 40198459385583 (CS), Lot Number 25KMD419; Medline Kit SKU DYNJ45640B: UDI/DI 10193489494983 (EA) 40193489494984 (CS), Lot Number 25KMD793; Medline Kit SKU DYNJ63377D: UDI/DI 10198459514579 (EA) 40198459514570 (CS), Lot Number 25KMI988; Medline Kit SKU DYNJ65011D: UDI/DI 10198459017018 (EA) 40198459017019 (CS), Lot Number 25KMH161; Medline Kit SKU DYNJ69143C: UDI/DI 10198459478505 (EA) 40198459478506 (CS), Lot Number 25LMB211; Medline Kit SKU DYNJ69313: UDI/DI 10193489931822 (EA) 40193489931823 (CS), Lot Number 25KMJ489; Medline Kit SKU DYNJ86007B: UDI/DI 10198459260452 (EA) 40198459260453 (CS), Lot Number 25KDB551.
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 12, 2025

Medline medical procedure convenience kits labeled as: 1) BREAST-HERNIA-PORT CDS-LF, Kit SKU CDS984853L; 2) BREAST BIOPSY PACK, Kit SKU DYNJ45641B; 3) DERMATOLOGY PACK, Kit SKU DYNJT3658A.

Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to complaints that the butyrate tubing cracked during actuation of the vials of MASTISOL Liquid Adhesive.

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

Recall #:
98226
Lot/product code:
Medline Kit SKU CDS984853L: UDI/DI 10198459293535 (EA) 40198459293536 (CS), Lot Number 25KMI898; Medline Kit SKU DYNJ45641B: UDI/DI 10193489494921 (EA) 40193489494922 (CS), Lot Number 25KMH748; Medline Kit SKU DYNJT3658A: UDI/DI 10198459354007 (EA) 40198459354008 (CS), Lot Number 25KME009.
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 12, 2025

Medline medical procedure convenience kits labeled as: 1) MIDDLE EAR CDS, Kit SKU CDS984347O; 2) HEAD AND NECK CDS-LF, Kit SKU CDS984857N; 3) NECK PACK-LF, Kit SKU DYNJ0966130K; 4) NECKLINE PACK-LF, Kit SKU DYNJ51440B; 5) THYROID PACK, Kit SKU DYNJ58742J; 6) ENT I, Kit SKU DYNJ63781B; 7) NECK PACK, Kit SKU DYNJ82751B; 8) NOSE PACK, Kit SKU DYNJ82753C; 9) WMC COCHLEAR IMPLANT ADD ON, Kit SKU DYNJ907206G.

Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to complaints that the butyrate tubing cracked during actuation of the vials of MASTISOL Liquid Adhesive.

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

Recall #:
98226
Lot/product code:
Medline Kit SKU CDS984347O: UDI/DI 10198459311451 (EA) 40198459311452 (CS), Lot Number 25KMD733; Medline Kit SKU CDS984347O: UDI/DI 10198459311451 (EA) 40198459311452 (CS), Lot Number 25KMC147; Medline Kit SKU CDS984857N: UDI/DI 10198459359705 (EA) 40198459359706 (CS), Lot Number 25KMJ151; Medline Kit SKU DYNJ0966130K: UDI/DI 10198459442117 (EA) 40198459442118 (CS), Lot Number 25LMB220; Medline Kit SKU DYNJ0966130K: UDI/DI 10198459442117 (EA) 40198459442118 (CS), Lot Number 25KME804; Medline Kit SKU DYNJ51440B: UDI/DI 10198459004230 (EA) 40198459004231 (CS), Lot Number 25KMI445; Medline Kit SKU DYNJ58742J: UDI/DI 10198459254710 (EA) 40198459254711 (CS), Lot Number 25KMC534; Medline Kit SKU DYNJ63781B: UDI/DI 10198459549595 (EA) 40198459549596 (CS), Lot Number 25KMB410; Medline Kit SKU DYNJ82751B: UDI/DI 10198459039157 (EA) 40198459039158 (CS), Lot Number 25LMB068; Medline Kit SKU DYNJ82751B: UDI/DI 10198459039157 (EA) 40198459039158 (CS), Lot Number 25KMI309; Medline Kit SKU DYNJ82753C: UDI/DI 10198459446887 (EA) 40198459446888 (CS), Lot Number 25KMC126; Medline Kit SKU DYNJ907206G: UDI/DI 10198459368028 (EA) 40198459368029 (CS), Lot Number 25KBL336.
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 12, 2025

Medline medical procedure convenience kits labeled as: 1) SMJ LAP CHOLE PACK-LF, Kit SKU DYNJ19974P; 2) DEPAUL ABDOMINAL ENDOSCOPY-LF, Kit SKU DYNJ20027K; 3) LAPAROSCOPY PACK-LF, Kit SKU DYNJ20468J; 4) SMJ LAPAROSCOPY PACK, Kit SKU DYNJ25763N; 5) SMJ LAPAROSCOPY PACK, Kit SKU DYNJ25763O; 6) BWNBORO LAP CHOLE PACK-LF, Kit SKU DYNJ32836B; 7) MINOR SET UP PACK, Kit SKU DYNJ43272K; 8) PK, GEN LAPAROSCOPIC CHOLE, Kit SKU DYNJ43976C; 9) GV LAP CHOLE PACK, Kit SKU DYNJ46939Q; 10) LAP CHOLE PACK, Kit SKU DYNJ49688C; 11) GENERAL ROBOTIC LAP, Kit SKU DYNJ51347N; 12) LAP CHOLE PACK, Kit SKU DYNJ54081F; 13) PEDIATRIC MOSES, Kit SKU DYNJ58864B; 14) LAPAROTOMY PACK, Kit SKU DYNJ59313B; 15) CRMC LAP CHOLE DIAG LAP-LF, Kit SKU DYNJ61095F; 16) LAP GASTRIC PACK, Kit SKU DYNJ62065A; 17) MINOR PACK, Kit SKU DYNJ64174A; 18) GENERAL SURGERY PACK, Kit SKU DYNJ64258I; 19) GENERAL LAP SHARED-LF, Kit SKU DYNJ64786D; 20) CHOLE PACK, Kit SKU DYNJ67686B; 21) GEN SURG MINOR PACK, Kit SKU DYNJ69142F; 22) LAP CHOLE PACK, Kit SKU DYNJ81695B; 23) GENERAL LAPAROSCOPY, Kit SKU DYNJ900901K; 24) GEN MINOR, Kit SKU DYNJ900906L; 25) ROBOTIC GENERAL, Kit SKU DYNJ906861D; 26) RMC GENERAL LAPAROSCOPIC, Kit SKU DYNJ907087C; 27) LAP CHOLE LMC CDS, Kit SKU DYNJ911116A; 28) MINOR GENERAL PACK, Kit SKU DYNJT3884; 29) GENERAL LAPAROSCOPY PACK, Kit SKU DYNJT4504; 30) MINOR SURGERY PACK-LF, Kit SKU PHS109062D.

Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to complaints that the butyrate tubing cracked during actuation of the vials of MASTISOL Liquid Adhesive.

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

Recall #:
98226
Lot/product code:
Medline Kit SKU DYNJ19974P: UDI/DI 10198459138195 (EA) 40198459138196 (CS), Lot Number 25KMB830; Medline Kit SKU DYNJ19974P: UDI/DI 10198459138195 (EA) 40198459138196 (CS), Lot Number 25KMB831; Medline Kit SKU DYNJ20027K: UDI/DI 10198459228957 (EA) 40198459228958 (CS), Lot Number 25KMG395; Medline Kit SKU DYNJ20027K: UDI/DI 10198459228957 (EA) 40198459228958 (CS), Lot Number 25KMH132; Medline Kit SKU DYNJ20468J: UDI/DI 10195327024338 (EA) 40195327024339 (CS), Lot Number 25KMF540; Medline Kit SKU DYNJ25763N: UDI/DI 10198459138218 (EA) 40198459138219 (CS), Lot Number 25KMH134; Medline Kit SKU DYNJ25763O: UDI/DI 10198459603655 (EA) 40198459603656 (CS), Lot Number 25KMI209; Medline Kit SKU DYNJ32836B: UDI/DI 10195327037369 (EA) 40195327037360 (CS), Lot Number 25KBF167; Medline Kit SKU DYNJ43272K: UDI/DI 10198459257131 (EA) 40198459257132 (CS), Lot Number 25KME892; Medline Kit SKU DYNJ43976C: UDI/DI 10193489806694 (EA) 40193489806695 (CS), Lot Number 25KMG962; Medline Kit SKU DYNJ46939Q: UDI/DI 10198459404047 (EA) 40198459404048 (CS), Lot Number 25JDA437; Medline Kit SKU DYNJ46939Q: UDI/DI 10198459404047 (EA) 40198459404048 (CS), Lot Number 25LDA059; Medline Kit SKU DYNJ49688C: UDI/DI 10198459155017 (EA) 40198459155018 (CS), Lot Number 25KMG180; Medline Kit SKU DYNJ51347N: UDI/DI 10198459386428 (EA) 40198459386429 (CS), Lot Number 25JBW506; Medline Kit SKU DYNJ54081F: UDI/DI 10198459172410 (EA) 40198459172411 (CS), Lot Number 25KMB295; Medline Kit SKU DYNJ58864B: UDI/DI 10198459346965 (EA) 40198459346966 (CS), Lot Number 25JBW678; Medline Kit SKU DYNJ59313B: UDI/DI 10195327248338 (EA) 40195327248339 (CS), Lot Number 25JMJ736; Medline Kit SKU DYNJ61095F: UDI/DI 10198459228568 (EA) 40198459228569 (CS), Lot Number 25KMC402; Medline Kit SKU DYNJ62065A: UDI/DI 10193489273472 (EA) 40193489273473 (CS), Lot Number 25KMI773; Medline Kit SKU DYNJ64174A: UDI/DI 10198459076367 (EA) 40198459076368 (CS), Lot Number 25LMB281; Medline Kit SKU DYNJ64258I: UDI/DI 10198459031564 (EA) 40198459031565 (CS), Lot Number 25KMJ665; Medline Kit SKU DYNJ64786D: UDI/DI 10198459328671 (EA) 40198459328672 (CS), Lot Number 25JMJ978; Medline Kit SKU DYNJ67686B: UDI/DI 10198459383120 (EA) 40198459383121 (CS), Lot Number 25KMH683; Medline Kit SKU DYNJ69142F: UDI/DI 10198459478499 (EA) 40198459478490 (CS), Lot Number 25KMH891; Medline Kit SKU DYNJ81695B: UDI/DI 10198459023453 (EA) 40198459023454 (CS), Lot Number 25KMB850; Medline Kit SKU DYNJ900901K: UDI/DI 10198459272493 (EA) 40198459272494 (CS), Lot Number 25KBP907; Medline Kit SKU DYNJ900906L: UDI/DI 10198459408526 (EA) 40198459408527 (CS), Lot Number 25LMA386; Medline Kit SKU DYNJ906861D: UDI/DI 10198459293702 (EA) 40198459293703 (CS), Lot Number 25LMA703; Medline Kit SKU DYNJ907087C: UDI/DI 10198459201301 (EA) 40198459201302 (CS), Lot Number 25KMJ480; Medline Kit SKU DYNJ911116A: UDI/DI 10198459354274 (EA) 40198459354275 (CS), Lot Number 25KMH214; Medline Kit SKU DYNJ911116A: UDI/DI 10198459354274 (EA) 40198459354275 (CS), Lot Number 25KMJ766; Medline Kit SKU DYNJT3884: UDI/DI 10198459366840 (EA) 40198459366841 (CS), Lot Number 25JBX326; Medline Kit SKU DYNJT4504: UDI/DI 10198459456701 (EA) 40198459456702 (CS), Lot Number 25KMF188; Medline Kit SKU PHS109062D: UDI/DI 10889942716548 (EA) 40889942716549 (CS), Lot Number 25KMD005.
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 12, 2025

Medline medical procedure convenience kits labeled as: 1) C-SECTION PACK, Kit SKU DYNJ35494C; 2) SMJ C-SECTION PACK-LF, Kit SKU DYNJ38582O; 3) RR-L&D C-SECTION PACK-LF, Kit SKU DYNJ82084F.

Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to complaints that the butyrate tubing cracked during actuation of the vials of MASTISOL Liquid Adhesive.

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

Recall #:
98226
Lot/product code:
Medline Kit SKU DYNJ35494C: UDI/DI 10198459117879 (EA) 40198459117870 (CS), Lot Number 25KMD420; Medline Kit SKU DYNJ38582O: UDI/DI 10198459603709 (EA) 40198459603700 (CS), Lot Number 25KMI679; Medline Kit SKU DYNJ82084F: UDI/DI 10198459089206 (EA) 40198459089207 (CS), Lot Number 25KMD145.
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 12, 2025

Medline medical procedure convenience kits labeled as: NERVE BLOCK TRAY 2, Kit SKU DYNJRA2713

Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to complaints that the butyrate tubing cracked during actuation of the vials of MASTISOL Liquid Adhesive.

ALL 50 STATES
▸Full report

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

Recall #:
98226
Lot/product code:
UDI/DI 10198459565861 (EA) 40198459565862 (CS), Lot number 25KMD285
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)