December 2025 recalls

744 recalls were announced in December 2025.

What the numbers show

Critical: 102
Severe: 54
High: 363
Moderate: 217
Low: 8

Of the 744 recalls this month scored against our rubric, 14% are Critical, 7% are Severe.

Which agencies issued them

701–744 of 744

HighFDA (Devices)·Z-0685-2026·2025-12-03
IV set 490312 recalled over medication backflow between IV containers
B. Braun Medical is recalling 226,632 units iv administration sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.
Product
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMN SET W/15 DROP, ULTR
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0709-2026·2025-12-03
Outlook set 354212 recalled over piggyback backflow and occlusion risk
B. Braun Medical is recalling 162,648 units outlook sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.
Product
Outlook set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. OUTLOOK IV SET 15DROP W/2 CARESITE; C
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0697-2026·2025-12-03
IV set 480231 recalled over backflow from secondary piggyback containers
B. Braun Medical is recalling 85,176 units iv administration sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.
Product
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET W/15 DROPS/ML,
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0716-2026·2025-12-03
Outlook set 354214 recalled over backflow and inability to prime
B. Braun Medical is recalling Outlook set catalog number 354214 over the potential for medication backflow from secondary piggyback containers and an inability to prime.
Product
Outlook set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. OUTLOOK IV SET 15DR W/2 CARESITE FILT
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0583-2026·2025-12-03
Skin cancer aid recalled because it may not meet specifications
DermaSensor is recalling nine affected units of its software-aided diagnostic device because it may not meet specifications, risking incorrect results or a delayed referral.
Product
DermaSensor. Model/Catalog Number: 10101. Software Version: 3.0.2. Software-aided adjunctive diagnostic device for use by physicians on lesions suspicious for skin cancer
Category
Medical Device
Distribution
8 states
HighFDA (Devices)·Z-0663-2026·2025-12-03
IV set 490400 recalled over backflow and inability to prime
B. Braun Medical is recalling 19,104 IV administration sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.
Product
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET W/CARESITE EXT
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0620-2026·2025-12-03
Blood set 480233 recalled over backflow from piggyback containers
B. Braun Medical is recalling 5,448 blood administration sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.
Product
Blood Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. Y-TYPE BLOOD SET W/ 170¿
Category
Medical Device
Distribution
0 states
HighFDA (Food)·H-0206-2026·2025-12-03
Cinnamon whiskey pecans recalled over undeclared cashews in the product
Nat's Nuts is recalling 50 cases, 600 units, of Cinnamon Whiskey Pecans 4 oz because the product contains undeclared cashews.
Product
Nat's Nuts Cinnamon Whiskey Pecans, 4 oz.
Category
Food
Distribution
9 states
HighFDA (Food)·H-0207-2026·2025-12-03
Ice cream bars recalled over undeclared wheat and soy allergens
Jeni's Splendid Ice Creams is recalling 3,767 cases of Passion Fruit Dreamsicle Ice Cream Bars over undeclared wheat and soy.
Product
Jeni's Passion Fruit Dreamsicle Ice Cream Bars, 3 FL OZ (89 ML)/9 FL OZ (266 ML), packaged 3 bars per retail carton with Item UPC: 850060644122, packed 8 retail cartons per case with Case UPC: 10850060644129
Category
Food
Distribution
10 states
HighFDA (Food)·H-0208-2026·2025-12-03
Cinnamon powder recalled after lead measured at 2.92 milligrams per kilogram
Homeneeds is recalling 7 cases of DEVI brand Cinnamon Powder after an FDA sample of the ground cinnamon was found to contain 2.92 mg/kg of lead.
Product
DEVI brand Cinnamon Powder (Dalchini Powder), net wt.: 3.5 oz (100 g), packaged in flexible plastic bag. UPC 6 09595 11904 5. Imported and Distributed by Homeneeds Inc. Bellevue, WA 98007; Product of India
Category
Food
Distribution
1 state
HighFDA (Devices)·Z-0641-2026·2025-12-03
IV set 490357 recalled over backflow from secondary piggyback containers
B. Braun Medical is recalling 98,688 IV administration sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.
Product
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET W/ 10 DROPS/ML
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-0656-2026·2025-12-03
Bronchoscopy robots recalled because the user manual was password protected
Noah Medical is recalling 47 Galaxy Systems because users did not have access to the Instructions for Use and User Manual, which was password protected.
Product
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET W/15 DROPS/ML
Category
Medical Device
Distribution
0 states
ModerateFDA (Drugs)·D-0189-2026·2025-12-03
Shimmery sun lotion recalled over current good manufacturing practice deviations
CA Botana International is recalling 805 tubes of Doctor D. Schwab Shimmery Sun Lotion Sunscreen SPF 30 for CGMP deviations.
Product
Doctor D. Schwab Shimmery Sun Lotion Sunscreen SPF 30, Titanium Dioxide 5% and Octinoxate 4%, 4 oz./113.4 g per tube, Doctor D. Schwab, A division of CA BOTANA, San Diego, CA 92121. NDC: 35192-012-02
Category
Drug
Distribution
5 states
ModerateFDA (Drugs)·D-0184-2026·2025-12-03
Tinted moisturizer SPF 50 recalled over manufacturing practice deviations
CA Botana International is recalling 1,401 tubes of Doctor D. Schwab Flawless Skin Fluid Tinted Moisturizer SPF 50 for CGMP deviations.
Product
Doctor D. Schwab Flawless Skin Fluid Tinted Moisturizer SPF 50, Zinc Oxide 21%, 2.1 oz/61 g per tube, Manufactured by CA BOTANA, San Diego, CA 92121. NDC: 35192-043-17
Category
Drug
Distribution
5 states
ModerateFDA (Drugs)·D-0186-2026·2025-12-03
Benzoyl peroxide cream recalled over current good manufacturing practice deviations
CA Botana International is recalling 470 tubes of Doctor D. Schwab Controlling Cream with Benzoyl Peroxide 2.7% for CGMP deviations.
Product
Doctor D. Schwab Controlling Cream, Benzoyl Peroxide 2.7%, 1 FL OZ/ 30 ML per tube, Doctor D. Schwab, A division of CA BOTANA, San Diego, CA 92123. NDC: 35192-017-05
Category
Drug
Distribution
5 states
ModerateFDA (Drugs)·D-0191-2026·2025-12-03
Daily moisturizer recalled over current good manufacturing practice deviations
CA Botana International is recalling 1,492 tubes of Karina Daily Moisturizer SPF 25 for CGMP deviations.
Product
Karina Daily Moisturizer SPF 25, Octinoxate 7.5% and Zinc Oxide 7.0%, Net WT. 5 oz/ 141.7 g per tube, Dist. By: Beauty4Pros LLC, Palm Desert, CA 92211. NDC: 35192-033-16, UPC 8 18204 02572 5
Category
Drug
Distribution
5 states
ModerateFDA (Drugs)·D-0194-2026·2025-12-03
Elixir tinted sunscreen recalled over manufacturing practice deviations
CA Botana International is recalling Elixir by Coco March Tinted Mineral Sunscreen SPF 50 for CGMP deviations.
Product
Elixir by Coco March Tinted Mineral Sunscreen SPF 50, Zinc Oxide 21%, 2.1 oz (62g) per bottle, Distributed by: VitaTienda Co U.S.A., San Juan, PR 00646. NDC: 35192-050-17, UPC 6 7229 99913 8
Category
Drug
Distribution
5 states
ModerateFDA (Drugs)·D-0195-2026·2025-12-03
CLEARSTEM sunscreen recalled over current good manufacturing practice deviations
CA Botana International is recalling 4,890 bottles of CLEARSTEM You Are Sunshine SPF 50 for CGMP deviations.
Product
CLEARSTEM YOU ARE SUNSHINE SPF 50, Zinc Oxide 21%, 2.1 oz/61g per bottle, Distributed by: CLEARSTEM Skincare, clearstemskincare.com. NDC: 35192-046-17
Category
Drug
Distribution
5 states
ModerateFDA (Drugs)·D-0193-2026·2025-12-03
Mineral sunscreen recalled over current good manufacturing practice deviations
CA Botana International is recalling 3,295 bottles of Elixir by Coco March Mineral Sunscreen SPF 50 for CGMP deviations.
Product
Elixir by Coco March Mineral Sunscreen SPF 50, Zinc Oxide 21%, 2.1 oz (62g) per bottle, Distributed by: VitaTienda Co U.S.A., San Juan, PR 00646. NDC: 35192-048-17, UPC 8 10145 82007 0
Category
Drug
Distribution
5 states
ModerateFDA (Drugs)·D-0196-2026·2025-12-03
Menthol pain relief gel recalled over manufacturing practice deviations
CA Botana International is recalling 4,890 bottles of Dr. Bump Natural Pain Relief Gel with Menthol 5% for CGMP deviations.
Product
Dr. Bump Natural Pain Relief Gel, Menthol 5%, NET WT 4 FL OZ/118 ML per bottle, Distr. by 1Beauty US LLC, Palm Desert, CA 92211. NDC: 35192-052-18, UPC 8 18204 02513 8
Category
Drug
Distribution
5 states
ModerateFDA (Drugs)·D-0192-2026·2025-12-03
Tinted mineral sunscreen recalled over manufacturing practice deviations
CA Botana International is recalling 2,090 tubes of Sugared+Bronzed Tinted Mineral Sunscreen SPF 50 for CGMP deviations.
Product
Sugared+Bronzed Tinted Mineral Sunscreen SPF 50, Zinc Oxide 21%, Net WT 3.3 OZ (93 G) per tube, Dist. By: Sugared+Bronzed, 929 Montana Ave, Santa Monica, CA 90403. NDC: 35192-055-18, UPC 8 50047 92223 6
Category
Drug
Distribution
5 states
ModerateFDA (Drugs)·D-0185-2026·2025-12-03
Tea tree balm recalled over current good manufacturing practice deviations
CA Botana International is recalling 555 tubes of Doctor D. Schwab Controlling Balm with Tea Tree Oil for CGMP deviations.
Product
Doctor D. Schwab Controlling Balm with Tea Tree Oil, Salicyclic Acid 0.8%, 1 FL OZ/ 30 ML per tube, Doctor D. Schwab, A division of CA BOTANA, San Diego, CA 92123. NDC: 35192-016-05
Category
Drug
Distribution
5 states
ModerateFDA (Devices)·Z-0719-2026·2025-12-03
Interventional imaging systems recalled over ceiling rail movement that may fail
Philips is recalling 172 Azurion 7M20 systems with FlexArm because motorized longitudinal movement of the stand may be inconsistent and eventually become unavailable.
Product
Philips Azurion 7M20 systems with FlexArm ceiling-mounted system. Model Number: 722234;
Category
Medical Device
Distribution
28 states
ModerateFDA (Drugs)·D-0187-2026·2025-12-03
Mineral sunscreen recalled over current good manufacturing practice deviations
CA Botana International is recalling 874 tubes of Sea Enzyme Ultra Umbrella Sunscreen SPF 30 for CGMP deviations.
Product
Sea Enzyme Ultra Umbrella Sunscreen SPF 30, Titanium Dioxide 4%, Octinoxate 4%, 4 oz./113.4 g per tube, Manufactured by CA BOTANA, San Diego, CA 92121. NDC: 35192-011-02
Category
Drug
Distribution
5 states
ModerateFDA (Devices)·Z-0577-2026·2025-12-03
Cancer test reports recalled for omitting the companion diagnostic claims page
Foundation Medicine is recalling 59 FoundationOne CDx reports that were sent to customers without the companion diagnostic Claims Page.
Product
FoundationOne CDx (F1CDx), RAL-0003 version 31.0
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0585-2026·2025-12-03
Culture media recalled over contamination that may darken the broth
Remel is recalling cation-adjusted Mueller Hinton broth and Brucella broth because the products may contain contamination, which may result in a darker or brown media color.
Product
1. CAMHB W/LHB, MANUAL, 11ML, 10/BOX YCP112-10 2. BRUCELLA BROTH, 11ML, 10/BOX YT3450
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0666-2026·2025-12-03
Liquid biopsy reports recalled for omitting the companion diagnostic claims page
Foundation Medicine is recalling 18 FoundationOne Liquid CDx reports that were sent to customers without the companion diagnostic Claims Page.
Product
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET W/15 DROPS/ML,
Category
Medical Device
Distribution
0 states
ModerateFDA (Drugs)·D-0183-2026·2025-12-03
Schwab mineral sunscreen recalled over manufacturing practice deviations at Botana
CA Botana International is recalling 1,167 tubes of Doctor D. Schwab Mineral Sunscreen SPF 50 for CGMP deviations.
Product
Doctor. D. Schwab Mineral Sunscreen SPF 50, Zinc Oxide 21%, 4 oz./ 113.4 g per tube, Manufactured by CA Botana, San Diego, CA 92123. NDC: 35192-042-02
Category
Drug
Distribution
5 states
ModerateFDA (Drugs)·D-0190-2026·2025-12-03
Gabriel mineral sunscreen recalled over manufacturing practice deviations
CA Botana International is recalling 1,617 tubes of Gabriel Mineral Sunscreen SPF 50 for CGMP deviations.
Product
Gabriel Mineral Sunscreen SPF 50, Zinc Oxide 21%, 2.1 oz, Net 61 g per tube, Dist. By: Gabriel Cosmetics, Inc., Redmond, WA USA 98052, NDC: 35192-044-01, UPC 7 07060 9592 1
Category
Drug
Distribution
5 states
ModerateFDA (Drugs)·D-0188-2026·2025-12-03
Menthol arnica gel recalled over current good manufacturing practice deviations
CA Botana International is recalling 810 tubes of Doctor D. Schwab Clinical Weh Weh Natural Pain Relief Gel with Menthol and Arnica for CGMP deviations.
Product
Doctor D. Schwab Clinical Weh Weh Natural Pain Relief Gel with Menthol and Arnica, Menthol 5%, 4.2 oz./120 g per tube, Doctor D. Schwab, A division of CA BOTANA, San Diego, CA 92121. NDC: 35192-020-02
Category
Drug
Distribution
5 states
ModerateFDA (Devices)·Z-0724-2026·2025-12-03
Tuberculosis test cartridges recalled after failing expected stability criteria
Cepheid is recalling 9,880 Xpert MTB/RIF cartridges from one lot because product testing did not meet expected stability criteria.
Product
Xpert MTB/RIF. Model Number: GXMTB/RIF-US-10.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0581-2026·2025-12-03
Vitrectomy probe packs recalled with no reason stated in the record
Alcon Research is recalling 28,323 Constellation UltraVit 10K and HyperVit 20K vitrectomy probe packs; the enforcement record does not state a reason.
Product
CONSTELLATION ULTRAVIT 10K and CONSTELLATION HYPERVIT 20K, Description/REF: 25+ TOTALPLUS CP PAK 20K CPM BWV .9 IU/ 8065000093; 25+ TOTALPLUS CP PAK 20K CPM BV .9 IU/ 8065000095; 27+ TOTALPLUS CP PAK 20K CPM BV .9 IU/ 8065000096; 23GA BEVEL ULTRAVIT 10,000 CPM/ 8065752413; 25+ B
Category
Medical Device
Distribution
Distributed nationwide
HighNHTSA·25V834000·2025-12-02
Zero Recalls 2023 DSR/X Motorcycles Due to Motor Controller Defect
Zero Motorcycles is recalling 2023 DSR/X motorcycles because incorrect fasteners in the motor controller may cause a loss of drive power, increasing crash risk.
Product
ZERO — ZERO DSR/X
Category
Vehicle
Distribution
Distributed nationwide
SevereNHTSA·25V824000·2025-12-01
2019 Ram Trucks Recalled for Side Curtain Air Bag Inflator Defect
Chrysler is recalling 2019 Ram 1500, 2500, and 3500 vehicles because side curtain air bag inflators may rupture, potentially sending metal fragments into the cabin.
Product
RAM — RAM 1500, 2500, 3500
Category
Vehicle
Distribution
Distributed nationwide
SevereNHTSA·25V828000·2025-12-01
Ford Recalls 2025 Maverick for Cylinder Head Manufacturing Defect
Ford is recalling 2025 Maverick vehicles with defectively manufactured cylinder heads that can leak oil. The leak increases the risk of fire and engine failure.
Product
FORD — FORD, LINCOLN EXPLORER, MUSTANG, MAVERICK, CORSAIR
Category
Vehicle
Distribution
Distributed nationwide
SevereNHTSA·25V827000·2025-12-01
Ford Recalls 2016-2019 Lincoln MKT for Detaching B-Pillar Trim
Ford is recalling 2016-2019 Lincoln MKT vehicles because the B-pillar door trim may detach while driving, creating a road hazard and increasing crash risk.
Product
LINCOLN — LINCOLN MKT
Category
Vehicle
Distribution
Distributed nationwide
SevereNHTSA·25V832000·2025-12-01
Virnig Recalls 2025 Trailers Due to Bearing Lock Nut Failure Risk
Virnig is recalling 2025 TR-HDD-1414 and TR-RHDD-1409 trailers because improperly installed bearing lock nuts may fail, causing the tire to detach and increasing crash risk.
Product
VIRNIG — VIRNIG TR-RHDD-1409, TR-HDD-1414
Category
Vehicle
Distribution
Distributed nationwide
HighNHTSA·25V826000·2025-12-01
2025-2026 RAM Pickup Trucks: Blank Instrument Panel Display Software Error
Chrysler is recalling 2025-2026 RAM pickup trucks (1500, 2500, 3500, 4500, 5500) because a software error causes the instrument panel display to go blank, preventing drivers from seeing critical warning lights and gear selection.
Product
RAM — RAM 1500, 2500, 3500, 4500
Category
Vehicle
Distribution
Distributed nationwide
HighNHTSA·25V825000·2025-12-01
KTM and Husqvarna motorcycles recalled for engine control software stalling defect
KTM and Husqvarna are recalling certain 2024-2025 motorcycles because faulty engine control software may cause the engine to stall at low RPMs, creating a risk of crashes.
Product
KTM — KTM, HUSQVARNA 390 SMC R, 390 ENDURO R, 390 ADVENTURE X, VITPILEN 401
Category
Vehicle
Distribution
Distributed nationwide
HighNHTSA·25V830000·2025-12-01
Mercedes-Benz Recalls 2024-2025 AMG EQE SUV for Pedestrian Warning Sound Defect
Mercedes-Benz is recalling 2024-2025 AMG EQE SUV 4MATIC vehicles because a software error may prevent the pedestrian warning sound from increasing in volume with speed.
Product
MERCEDES-BENZ — MERCEDES-BENZ AMG EQE SUV 4MATIC
Category
Vehicle
Distribution
Distributed nationwide
HighNHTSA·25V823000·2025-12-01
2025 Ford Expedition and Other Models Recalled for Brake Booster Malfunction
Ford is recalling 679 2025 Expedition, Ranger, F-150, Bronco, and Navigator vehicles due to a potential Electronic Brake Booster malfunction that can cause loss of power brake assist, increasing crash risk.
Product
FORD — FORD, LINCOLN F-150, EXPEDITION, BRONCO, RANGER
Category
Vehicle
Distribution
Distributed nationwide
HighNHTSA·25V831000·2025-12-01
2025 Lincoln Navigator Rear Lightbar Cracks May Disable Reverse Lights
Ford is recalling certain 2025 Lincoln Navigator vehicles. The rear lightbar may develop cracks allowing moisture accumulation, potentially disabling reverse lights and reducing visibility when backing up.
Product
LINCOLN — LINCOLN NAVIGATOR
Category
Vehicle
Distribution
Distributed nationwide
HighNHTSA·25V833000·2025-12-01
Genesis G90 Models: Highway Drive Assist Braking Malfunction Recall
Hyundai is recalling 2023-2026 Genesis G90 vehicles because the Highway Drive Assist radar may falsely detect another vehicle, causing sudden braking that increases crash risk.
Product
GENESIS — GENESIS G90
Category
Vehicle
Distribution
Distributed nationwide
HighNHTSA·25V829000·2025-12-01
2025 Ford Escape liftgate hinge covers may detach, creating crash risk
Ford is recalling certain 2025 Escape vehicles because liftgate hinge covers may not be properly secured and can detach. Detached covers can create a distraction or road hazard, increasing crash risk.
Product
FORD — FORD ESCAPE
Category
Vehicle
Distribution
Distributed nationwide

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