November 2025 recalls

538 recalls were announced in November 2025.

What the numbers show

Critical: 62
Severe: 48
High: 306
Moderate: 118
Low: 4

Of the 538 recalls this month scored against our rubric, 12% are Critical, 9% are Severe.

Which agencies issued them

301–400 of 538

HighFDA (Devices)·Z-0432-2026·2025-11-12
Hip bipolar heads recalled over packaging that may compromise sterility
Total Joint Orthopedics is recalling 103 Klassic BiPolar Heads over a potential packaging issue that could compromise the sterile barrier and present a risk of infection if implanted.
Product
Brand Name: Klassic BiPolar Head Model/Catalog Number: 3205.41.022 Klassic BiPolar Head, 41 mm OD, 22 mm Head; 3205.42.022 Klassic BiPolar Head, 42 mm OD, 22 mm Head; 3205.43.022 Klassic BiPolar Head, 43 mm OD, 22 mm Head; 3205.44.028 Klassic BiPolar Head, 44 mm OD, 28…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·H-0165-2026·2025-11-12
Peeled tail on shrimp recalled over potential Cesium-137 contamination
AquaStar is recalling 2,916 cases of Publix Large Shrimp Peeled & Deveined Tail On 31/40 because the shrimp may be contaminated with Cesium-137.
Product
Publix Large Shrimp Peeled & Deveined Tail On 31/40, net wt. 1.5 lbs. UPC 041415067455. Product was sold at Publix.
Category
Food
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0433-2026·2025-11-12
Stereotactic frames recalled because paint flakes may enter the wound
Elekta is recalling 338 Leksell Vantage Stereotactic System components because paint flakes from the engravings may separate and could inadvertently enter the wound.
Product
Brand Name: Leksell Stereotactic System Product Name: Leksell Vantage Stereotactic System Software Version: n/a Product Description: The Intended Purpose of Leksell¿ Vantage" Stereotactic System is target localization and fixation of the patient head in a coordinate system in…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0418-2026·2025-11-12
Hip bearings recalled because size F packages contain size G implants
Zimmer is recalling 72 Dual Mobility Vivacit-E bearings labelled Size F 44 mm because the implant inside the package is a Size G 46 mm, and the reverse also occurred.
Product
Zimmer Biomet Dual Mobility Vivacit-E Highly Crosslinked Polyethylene, 28 mm I.D., 44 mm O.D., Size F, Bearing, Model/Catalog Number: 110031012; semi constrained hip prosthesis
Category
Medical Device
Distribution
20 states
HighFDA (Devices)·Z-0425-2026·2025-11-12
Straight extension catheter trays 24 cm recalled over header bag seals
Mozarc Medical is recalling 3,258 MAHURKAR acute high pressure triple lumen catheter trays with straight extensions and IC components, 12 Fr x 24 cm, over header bag seal integrity.
Product
MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Straight Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 24 cm;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·H-0169-2026·2025-11-12
Cinnamon powder recalled over potentially elevated levels of lead
TBC Distribution is recalling 5,598 units of Lucky Foods Cinnamon Powder 40g because the product may contain elevated levels of lead.
Product
Lucky Foods Cinnamon Powder; 40g
Category
Food
Distribution
11 states
HighFDA (Food)·H-0167-2026·2025-11-12
Bakery graham pieces recalled over foil fragments in brown sugar
Ice Cream Factory is recalling 255 ten-pound boxes of Bakery Graham Pieces after aluminum foil and packaging fragments were found in a brown sugar ingredient.
Product
Bakery Graham Pieces, 10 LB Label reads in part as "Ice Cream Factory, #10 Graham Pieces, Distributed by Ice Cream Factory, 1201 Ice Cream Way, Lebanon, MO 65536"
Category
Food
Distribution
29 states
HighFDA (Food)·H-0163-2026·2025-11-12
Easy peel deveined shrimp recalled over potential Cesium-137 contamination
AquaStar is recalling 1,800 cases of AquaStar 13/15 Raw Shrimp Easy Peel Deveined, sold at Publix, because the shrimp may be contaminated with Cesium-137.
Product
AquaStar 13/15 Raw Shrimp Easy Peel Deveined, net wt. 2 lbs. UPC 731149654051. Product was sold at Publix.
Category
Food
Distribution
Distributed nationwide
HighFDA (Food)·H-0157-2026·2025-11-12
Colossal EZ peel shrimp recalled over potential Cesium-137 contamination
AquaStar is recalling 5,400 cases of Kroger Raw Colossal EZ Peel Shrimp because the shrimp may be contaminated with Cesium-137.
Product
Kroger Raw Colossal EZ Peel Shrimp, net wt. 2lbs., UPC 20011110643906. Product is packaged in transparent printed bag with a blue band on the top with yellow and red details.
Category
Food
Distribution
Distributed nationwide
HighFDA (Food)·H-0160-2026·2025-11-12
Best Yet frozen shrimp recalled over potential Cesium-137 contamination
AquaStar is recalling 9,900 cases of Best Yet Frozen Raw EZ-Peel White Shrimp across multiple counts because the shrimp may be contaminated with Cesium-137.
Product
Best Yet Frozen Raw EZ-Peel White Shrimp 16/20 (net wt. 1 lbs/pkg; 10 pkgs per case). UPC 04218700282 Best Yet Frozen Raw EZ-Peel White Shrimp 21/25 (net wt. 1 lbs/pkg; 10 pkgs per case). UPC 04218700286 Best Yet Frozen Raw EZ-Peel White Shrimp 26/30 (net wt. 1 lbs/pkg; 10…
Category
Food
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0426-2026·2025-11-12
Straight extension catheter trays recalled over header bag seal integrity
Mozarc Medical is recalling 3,258 MAHURKAR acute high pressure triple lumen catheter trays with straight extensions, 12 Fr x 24 cm, over header bag seal integrity.
Product
MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Straight Extensions with IC Safety Components: 12 Fr/Ch (4.0 mm) x 24 cm;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·H-0158-2026·2025-11-12
Cooked peeled tail off shrimp recalled over potential Cesium-137 contamination
AquaStar is recalling 3,600 cases of Kroger Mercado Cooked Medium Peeled Tail-Off Shrimp because the shrimp may be contaminated with Cesium-137.
Product
Kroger Mercado Cooked Medium Peeled Tail-Off Shrimp, net wt. 2lbs. UPC 011110626196. Product is packaged in clear plastic bag and has a white label with green stripes on top of each bag.
Category
Food
Distribution
Distributed nationwide
HighFDA (Food)·H-0162-2026·2025-11-12
Frozen raw white shrimp recalled over potential Cesium-137 contamination
AquaStar is recalling 7,200 cases of AquaStar 16/20 Frozen Raw EZ-Peel White Shrimp, sold at WinCo, because the shrimp may be contaminated with Cesium-137.
Product
AquaStar 16/20 Frozen Raw EZ-Peel White Shrimp, net wt. 5 lbs. UPC 731149654075. Product was sold at WinCo.
Category
Food
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0424-2026·2025-11-12
Twenty centimetre straight catheter trays recalled over header bag seal integrity
Mozarc Medical is recalling 3,258 MAHURKAR acute high pressure triple lumen catheter trays with straight extensions, 12 Fr x 20 cm, over header bag seal integrity.
Product
MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Straight Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 20 cm;
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0435-2026·2025-11-12
Flex Focus ultrasound carts recalled over incomplete battery safety instructions
B-K Medical is recalling 4,426 1202 Flex Focus ultrasound systems because the user guide and service manual do not adequately state battery replacement intervals, end-of-life handling or safety precautions.
Product
1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Food)·H-0148-2026·2025-11-12
Crawfish stuffed potatoes recalled over undeclared Yellow 5 and Yellow 6
Quality Poultry & Seafood is recalling 342 cases of Specialty Stuft Meats Crawfish Stuft Potato over undeclared Yellow 5 and Yellow 6 colour additives.
Product
Specialty Stuft Meats Crawfish Stuft Potato, Net Wt .72 lbs, individually packaged in vacuum-sealed plastic, UPC 642176000172
Category
Food
Distribution
3 states
ModerateFDA (Devices)·Z-0439-2026·2025-11-12
bk3500 ultrasound systems recalled over incomplete battery safety instructions
B-K Medical is recalling 124 bk3500 ultrasound systems because the user guide and service manual do not adequately state battery replacement intervals, end-of-life handling or safety precautions.
Product
bk3500 Ultrasound System w/battery; Model No. 2300-41; System, Imaging, Pulsed Doppler, Ultrasonic
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0437-2026·2025-11-12
bkActiv ultrasound systems recalled over battery guidance missing from manuals
B-K Medical is recalling 567 Ultrasound System 2300 bkActiv units because the user guide and service manual do not adequately state battery replacement intervals, end-of-life handling or safety precautions.
Product
UUltrasound System 2300, bkActiv w/battery; Model No. 2300-11; System, Imaging, Pulsed Doppler, Ultrasonic
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0436-2026·2025-11-12
bkSpecto ultrasound systems recalled over battery guidance gaps in manuals
B-K Medical is recalling 1,697 Ultrasound System 1300 bkSpecto units because the user guide and service manual do not adequately state battery replacement intervals, end-of-life handling or safety precautions.
Product
Ultrasound System 1300, bkSpecto w/battery; Model No. 1300-21 or 1300-S1; System, Imaging, Pulsed Doppler, Ultrasonic
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0440-2026·2025-11-12
Ultrasound systems recalled over battery guidance missing from the manuals
B-K Medical is recalling 895 bk5000 ultrasound systems because the user guide and service manual do not adequately state battery replacement intervals, end-of-life handling or safety precautions.
Product
bk5000 Ultrasound System w/battery; Model No. 2300-61; System, Imaging, Pulsed Doppler, Ultrasonic
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0438-2026·2025-11-12
bk3000 ultrasound systems recalled over incomplete battery replacement guidance
B-K Medical is recalling 496 bk3000 ultrasound systems because the user guide and service manual do not adequately state battery replacement intervals, end-of-life handling or safety precautions.
Product
bk3000 Ultrasound System w/battery; Model No. 2300-66; System, Imaging, Pulsed Doppler, Ultrasonic
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0313-2026·2025-11-12
Dental X-ray systems recalled over a missing radiological certification statement
OSSTEM Implant is correcting labeling for its Dental X-Ray System T1 because the certification statement required under the radiological health regulations may have been omitted.
Product
Osstem Dental X-Ray System T1. Product Model Numbers T1-C and T1-CS.
Category
Medical Device
Distribution
0 states
LowFDA (Devices)·Z-0314-2026·2025-11-12
T2 dental X-ray systems recalled over an omitted certification statement
OSSTEM Implant is correcting labeling for its Dental X-Ray System T2 because the certification statement required under the radiological health regulations may have been omitted.
Product
Osstem Dental X-Ray System T2. Product Model Numbers T2-C and T2-CS.
Category
Medical Device
Distribution
0 states
LowFDA (Devices)·Z-0315-2026·2025-11-12
T2Plus dental X-ray systems recalled over a missing certification statement
OSSTEM Implant is correcting labeling for its Dental X-Ray System T2Plus because the certification statement required under the radiological health regulations may have been omitted.
Product
Osstem Dental X-Ray System T2Plus. Product Model Numbers T2-C-P and T2-CS-P.
Category
Medical Device
Distribution
0 states
HighNHTSA·25V774000·2025-11-11
Wabash Recalls 2025-2026 Stepdeck Trailers Due to Incorrect Rear Impact Guards
Wabash is recalling 2025-2026 Stepdeck trailers because incorrect rear impact guards may have been installed, potentially failing to protect following vehicles in crashes.
Product
WABASH — WABASH STEPDECK
Category
Vehicle
Distribution
Distributed nationwide
SevereNHTSA·25V771000·2025-11-10
Keystone Recalls 2024-2026 Voltage Trailers Due to Fuel Line Fire Risk
Keystone RV Company is recalling 2024-2026 Voltage recreational trailers because incorrectly installed generator fuel lines may cause a fire.
Product
KEYSTONE — KEYSTONE VOLTAGE
Category
Vehicle
Distribution
Distributed nationwide
HighNHTSA·25V773000·2025-11-10
Nova Bus Recalls 2024-2025 LFS Transit Buses for Seat Belt Defect
Nova Bus is recalling 2024-2025 LFS transit buses because the driver's seat belt may be pinched by the partition, preventing proper retraction and increasing injury risk.
Product
NOVA BUS — NOVA BUS LFS
Category
Vehicle
Distribution
Distributed nationwide
HighNHTSA·25V772000·2025-11-10
Coach and Equipment Recalls 2025 Phoenix Transit Buses with Wheelchair Restraint Defect
Coach and Equipment is recalling 2025 Phoenix transit buses because wheelchair restraints may fail to lock, increasing injury risk.
Product
COACH AND EQUIPMENT — COACH AND EQUIPMENT PHOENIX
Category
Vehicle
Distribution
Distributed nationwide
SevereNHTSA·25E074000·2025-11-07
AROW Emergency Exit Window Latch Failure Recall
AROW Global Corp is recalling emergency exit windows because the latch can fail during a crash, increasing the risk of passenger injury.
Product
STRUCTURE:EMERGENCY:ESCAPE/EGRESS/EXIT recall
Category
Vehicle
Distribution
Distributed nationwide
HighNHTSA·25V770000·2025-11-07
Micro Bird Recalls 2026 G5 School Buses With Wheelchair Restraint Defect
Micro Bird USA is recalling 2026 G5 school buses because wheelchair restraints may fail to lock, increasing injury risk during transit or crashes.
Product
MICRO BIRD — MICRO BIRD G5 SCHOOL BUS
Category
Vehicle
Distribution
Distributed nationwide
SevereCPSC·26068·2025-11-06
Prosecco bottles recalled after ten reports of shattering and one laceration
About 941,400 bottles of Kirkland Signature Valdobbiadene Prosecco DOCG are being recalled because the bottles can break or shatter; ten reports include one laceration injury.
Product
Kirkland Signature Valdobbiadene Prosecco DOCG bottles
Category
Consumer Product
Distribution
Distributed nationwide
SevereCPSC·26078·2025-11-06
Bicycle floor pumps recalled after a canister ejected and caused facial injuries
About 7,500 Lezyne Pressure Over Drive bicycle floor pumps are being recalled after one report of the canister ejecting from the base and causing serious facial injuries.
Product
Lezyne Pressure Over Drive Bicycle Floor Pumps
Category
Consumer Product
Distribution
Distributed nationwide
SevereNHTSA·25V764000·2025-11-06
GM Recalls 2014 Buick Verano and Chevrolet Cruze for Air Bag Defect
General Motors is recalling 2,099 vehicles because side roof-rail air bag inflators may rupture, potentially causing sharp metal fragments to enter the vehicle.
Product
BUICK — BUICK, CHEVROLET VERANO, CRUZE
Category
Vehicle
Distribution
Distributed nationwide
SevereNHTSA·25V766000·2025-11-06
Jeep Grand Cherokee and Wrangler 4XE vehicles engine debris recall
Chrysler is recalling certain 2023–2025 Jeep Grand Cherokee 4XE and 2024–2025 Jeep Wrangler 4XE vehicles due to debris inside the engine that may cause engine failure, loss of drive power, and engine compartment fire.
Product
JEEP — JEEP WRANGLER 4XE, GRAND CHEROKEE 4XE
Category
Vehicle
Distribution
Distributed nationwide
SevereCPSC·26070·2025-11-06
Children's scooters recalled after 18 reports of a front wheel detaching
About 50 three-wheeled children's scooters are being recalled after 18 reports of the left front wheel detaching during use, resulting in three injuries.
Product
Three-Wheeled Children's Scooter with Foot Brake
Category
Consumer Product
Distribution
Distributed nationwide
SevereNHTSA·25V769000·2025-11-06
GMC Recalls 2026 Hummer EV Models Due to Air Bag Wiring Defect
General Motors is recalling 2026 GMC Hummer EV Pickup and SUV vehicles because an improperly crimped wire may prevent the front passenger air bag from deploying.
Product
GMC — GMC HUMMER EV PICKUP, HUMMER EV SUV
Category
Vehicle
Distribution
Distributed nationwide
SevereNHTSA·25V768000·2025-11-06
GM Recalls 2019-2020 Chevrolet Silverado Medium Duty Trucks for Brake Wiring Defect
General Motors is recalling 2019-2020 Chevrolet Silverado 4500, 5500, and 6500 trucks because a brake jumper wire harness may lack protective tape, risking power brake assist failure.
Product
CHEVROLET — CHEVROLET SILVERADO 4500, SILVERADO 6500, SILVERADO 5500
Category
Vehicle
Distribution
Distributed nationwide
SevereNHTSA·25V765000·2025-11-06
RAM pickup trucks steering column control module air bag risk
Chrysler is recalling certain 2021–2022 RAM 1500, 2500, 3500, 4500, and 5500 vehicles because the steering column control module may prevent the driver's side air bag from deploying in a crash, increasing injury risk.
Product
RAM — RAM 3500, 2500, 4500, 1500
Category
Vehicle
Distribution
Distributed nationwide
SevereCPSC·26067·2025-11-06
Exercise bikes recalled after seat posts broke and riders fell
About 833,000 Peloton Original Series Bike+ units are being recalled after three reports of the seat post breaking and detaching during use, including two fall injuries.
Product
Peloton Original Series Bike+ Model PL02
Category
Consumer Product
Distribution
Distributed nationwide
HighNHTSA·25V767000·2025-11-06
2022-2024 Toyota Tundra and Lexus LX/GX Engine Failure Recall
Toyota is recalling certain 2022–2024 Tundra and Lexus LX/GX vehicles with V35A engines due to potential manufacturing debris contamination that can cause engine failure and loss of drive power, increasing crash risk.
Product
TOYOTA — TOYOTA, LEXUS TUNDRA, GX, LX
Category
Vehicle
Distribution
Distributed nationwide
HighCPSC·26073·2025-11-06
Children's cotton nightgowns recalled for violating sleepwear flammability standards
About 200 Umeyda children's cotton nightgowns are being recalled because they violate the mandatory flammability standards for children's sleepwear.
Product
Umeyda Nightgowns
Category
Consumer Product
Distribution
Distributed nationwide
HighCPSC·26075·2025-11-06
Plush alpaca toys recalled because the eyes can detach and choke
About 64,000 Inkari plush alpaca toys are being recalled because the eyes can detach, violating the small parts ban and posing a choking hazard to children.
Product
Inkari Plush Alpaca Toys
Category
Consumer Product
Distribution
Distributed nationwide
HighCPSC·26072·2025-11-06
Backpack blowers recalled because the fan wheel can break apart
About 47,800 STIHL BR 800 Magnum backpack blowers are being recalled because the fan wheel inside the blower can break apart, posing a laceration hazard.
Product
STIHL BR 800 Backpack Blower
Category
Consumer Product
Distribution
Distributed nationwide
HighCPSC·26079·2025-11-06
Bioethanol fuel containers recalled for lacking required flame mitigation devices
About 14,000 Y'all Can DIY bioethanol fireplace fuel containers are being recalled because they lack the flame mitigation devices required under the Portable Fuel Container Safety Act.
Product
Y'all Can DIY Liquid Bioethanol Fireplace Fuel Containers
Category
Consumer Product
Distribution
Distributed nationwide
HighNHTSA·25V763000·2025-11-06
International Recalls 2019-2020 CV Vehicles Due to Brake Harness Defect
International is recalling 2019-2020 CV vehicles because a brake pressure switch harness may lack protective material, potentially causing a short circuit and reduced brake performance.
Product
INTERNATIONAL — INTERNATIONAL CV
Category
Vehicle
Distribution
Distributed nationwide
HighCPSC·26077·2025-11-06
Adult portable bed rails recalled over entrapment and asphyxiation risk
About 3,294 Neaude adult portable bed rails are being recalled because users can become entrapped within the rail or between the rail and the mattress.
Product
Neaude Adult Portable Bed Rails
Category
Consumer Product
Distribution
Distributed nationwide
HighCPSC·26071·2025-11-06
Infant bath tubs recalled over accessible button cell batteries in thermometer
About 7,800 Napei collapsible infant bath tubs are being recalled because the built-in thermometer's button cell batteries can be accessed easily by children.
Product
Napei Collapsible Infant Bath Tubs
Category
Consumer Product
Distribution
Distributed nationwide
HighCPSC·26074·2025-11-06
Baby swings recalled for exceeding the incline limit for infant sleep
About 1,020 Vevor baby swings are being recalled because they were marketed for infant sleep with an incline angle greater than 10 degrees, posing a suffocation risk.
Product
Vevor Baby Swings
Category
Consumer Product
Distribution
Distributed nationwide
HighCPSC·26081·2025-11-06
WYBITNY children's bed rails recalled over multiple entrapment openings
About 120 WYBITNY children's portable bed rails are being recalled because a child can become entrapped in the enclosed openings and in openings beside and above the mattress.
Product
Children's WYBITNY Bed Rails
Category
Consumer Product
Distribution
Distributed nationwide
HighCPSC·26069·2025-11-06
Aftermarket crib and play yard mattresses recalled over deadly entrapment gaps
About 117,900 Criblike aftermarket play yard and non-full-sized crib mattresses are being recalled because they may not fit properly, posing a deadly entrapment hazard.
Product
Criblike aftermarket play yard and non-full sized crib mattresses
Category
Consumer Product
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-0163-2026·2025-11-05
MRI operating suites recalled over ice blockage in the magnet venting system
IMRIS is recalling the IMRIS iMRI 3T V Operating Suite because an ice blockage in the Siemens 3 Tesla magnet's venting system could rupture the helium containment system during a quench. The FDA classified it Class I.
Product
IMRIS Operating Suite, IMRIS iMRI 3T V, containing Siemens 3 Tesla MRI Magnet, vIDA
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-0161-2026·2025-11-05
Neuro operating suites recalled over ice blockage in magnet venting paths
IMRIS is recalling the Neuro III-SV iMRI and iMRX systems because an ice blockage in the Siemens 3 Tesla Verio magnet's venting system could rupture the helium containment system during a quench.
Product
IMRIS Operating Suite, Neuro III-SV iMRI System, iMRX System, containing Siemens 3 Tesla MRI Magnet, Verio
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Food)·H-0135-2026·2025-11-05
Christmas chocolate nonpareils recalled over an undeclared milk allergen
Weaver Nut Company is recalling 849 cases of semi-sweet chocolate nonpareils with Christmas seeds over an undeclared milk allergen. The FDA has classified the recall as Class I.
Product
47518 - Nonpareil, Semi-Sweet Chocolate (Christmas Seeds), 25lb Bulk Cases Packaged into Various Size Units After distribution.
Category
Food
Distribution
14 states
CriticalFDA (Food)·H-0136-2026·2025-11-05
Chocolate nonpareils recalled over an undeclared milk allergen in bulk cases
Weaver Nut Company is recalling 1,760 cases of semi-sweet chocolate nonpareils with white seeds over an undeclared milk allergen. The FDA has classified the recall as Class I.
Product
D2645 - Nonpareils, Semi-Sweet Chocolate (White Seeds), 25lb Bulk Cases Packaged into Various Size Units After distribution.
Category
Food
Distribution
14 states
CriticalFDA (Devices)·Z-0164-2026·2025-11-05
InVision operating suite recalled over ice blockage in magnet venting paths
IMRIS is recalling the InVision 3T Operating Suite because an ice blockage in the Siemens 3 Tesla Vida magnet's venting system could rupture the helium containment system during a quench.
Product
IMRIS Operating Suite, InVision 3T Operating Suite, containing Siemens 3 Tesla MRI Magnet, Vida
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-0162-2026·2025-11-05
MRI operating suites with Skyra magnet recalled over venting system blockage
IMRIS is recalling the IMRIS iMRI 3T S Operating Suite because an ice blockage in the Siemens 3 Tesla Skyra magnet's venting system could rupture the helium containment system during a quench.
Product
IMRIS Operating Suite, iMRI 3T S, containing Siemens 3 Tesla MRI Magnet, Skyra
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-0318-2026·2025-11-05
Glucose monitoring app recalled because it can terminate and miss alerts
Dexcom is recalling version 1.15.0 of the G6 and G6 Pro Android CGM app because a software defect can terminate the app, stopping glucose values, alarms and alerts. The FDA classified it Class I.
Product
Brand Name: Dexcom G6 Continuous Glucose Monitoring System Product Name: Dexcom G6 and G6 Pro Android US CGM App Model/Catalog Number: SW11678 Software Version: version 1.15.0 Product Description: Dexcom G6 and G6 Pro Android US CGM App SW11678 version 1.15.0 Component…
Category
Medical Device
Distribution
0 states
CriticalFDA (Food)·H-0137-2026·2025-11-05
Frozen carrot bundt cakes recalled over an undeclared wheat allergen
Doan's Dessert And Coffee is recalling its 4 lb Carrot Bundt Cake over an undeclared wheat allergen in ready-to-eat frozen cakes. The FDA has classified the recall as Class I.
Product
Carrot Bundt Cake - Net Weight 4 lbs Contains: Wheat, Soy, Milk, Eggs, Tree Nuts No UPC
Category
Food
Distribution
Distributed nationwide
CriticalFDA (Food)·H-0143-2026·2025-11-05
Veggie spring rolls recalled over undeclared shrimp in retail cartons
Tai Foong USA is recalling 1,261 cases of Fusia Asian Inspirations Veggie Spring Rolls over undeclared shrimp. The FDA has classified the recall as Class I.
Product
Fusia Asian Inspirations brand Veggie Spring Rolls. Net weight: 10 oz (283.5 g).) retail package identified by UPC 4099100222258. Type of packaging: Paperboard carton with inner poly bag; 12 ct corrugated master case. Responsible firm on label: ALDI Inc. Batavia, IL 60510…
Category
Food
Distribution
23 states
CriticalFDA (Food)·H-0168-2026·2025-11-05
Bulk frozen scrambled eggs recalled over potential Listeria monocytogenes contamination
Echo Lake Foods is recalling 824 cases, 23,072 pounds, of bulk cage free precooked scrambled eggs over potential Listeria monocytogenes contamination. The FDA classified it Class I.
Product
EchoLakeFoods MF 3067 CNFREE Cage Free Precooked IAF Scrambled Eggs Net Wt. 28 lbs. Bulk. Keep Frozen. Manufactured by: Echo Lake Foods, Inc., 2319 Raymond Ave. Franksville, WI 53126.
Category
Food
Distribution
1 state
CriticalFDA (Food)·H-0138-2026·2025-11-05
White chocolate coconut bundt cakes recalled over an undeclared wheat allergen
Doan's Dessert And Coffee is recalling its 3 lb 12 oz White Chocolate Coconut Bundt Cake over an undeclared wheat allergen. The FDA has classified the recall as Class I.
Product
White Chocolate Coconut Bundt Cake - Net Weight 3 lbs 12 oz Contains: Wheat, Soy, Milk, Eggs No UPC
Category
Food
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-0188-2026·2025-11-05
Distal access catheters recalled after coating material lifting inside the lumen
Balt USA is recalling 207 MEGA Ballast Distal Access Platform catheters over a manufacturing defect in which coating material lifts within the catheter's distal lumen. The FDA has classified it Class I.
Product
Brand Name: MEGA Ballast Distal Access Platform Product Name: Mega Ballast Model/Catalog Number: MEGABT09180, MEGABT09190, MEGABT091100, MEGABT091110 Software Version: N/A Product Description: The Mega Ballast 091 is designed with a semi-rigid proximal shaft and a highly…
Category
Medical Device
Distribution
12 states
SevereNHTSA·25E073000·2025-11-05
Bendix Recalls EC80 Electronic Control Units Due to Electrical Noise Issues
Bendix is recalling specific EC80 Electronic Control Units because electrical noise may cause the unit to malfunction, potentially disabling critical vehicle safety systems.
Product
SERVICE BRAKES, AIR:ANTILOCK:CONTROL UNIT/MODULE recall
Category
Vehicle
Distribution
Distributed nationwide
SevereNHTSA·25E072000·2025-11-05
Daimler Trucks Recalls One Tuftrac Gen 2 for Loose Suspension Fasteners
Daimler Trucks North America is recalling one Tuftrac Gen 2 truck because loose axle clamp fasteners may cause a loss of vehicle control.
Product
SUSPENSION:CRITICAL FASTENERS recall
Category
Vehicle
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0317-2026·2025-11-05
Magseed Pro 12 cm markers recalled over potential cotton fiber contamination
Endomagnetics is recalling 540 Magseed Pro 12 cm soft tissue markers because of the potential for contamination with cotton fibers.
Product
Magseed Pro 12 cm soft tissue marker. Model Number: MS2-17-1-12. Product Description: The Endomag Magseed Pro Magnetic Marker System is a sterile, single use device composed of a marker preloaded in a 17ga Needle Delivery System. The Endomag Magseed Pro Marker is indicated…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0331-2026·2025-11-05
Clave bag spikes recalled because port weld may separate and leak
ICU Medical is recalling 200 Clave Bag Spikes with ChemoLock port because the port weld of the drug transfer device may separate or break during use and leak.
Product
ICU Medical Clave Bag Spike w/ChemoLock Port REF: CL2150
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0329-2026·2025-11-05
Universal vented vial spikes recalled because port weld may separate and leak
ICU Medical is recalling 2,100 ChemoLock Universal Vented Vial Spikes because the port weld of the drug transfer device may separate or break during use and leak.
Product
ICU Medical Chemo Lock Universal Vented Vial Spike REF: CL-70-10
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·H-0146-2026·2025-11-05
Roasted mixed nuts recalled over hazelnuts missing from the allergen statement
Severn Peanut Company is recalling 528 cases of 8 oz Roasted No Salt Mixed Nuts after finding hazelnuts were not listed in the allergen statement.
Product
MIXED NUTS Roasted No Salt NET WT 8 OZ (227g) INGREDIENTS: ALMONDS, WALNUTS, PEANUTS***CASHEWS***HAZELNUTS, BRAZIL NUTS CONTAINS: ALMONDS, BRAZIL NUTS, CASHEWS, PEANUTS, WALNUTS UPC 8 10111 02237 8 DIST BY: HAMPTON FARMS 180 AVOCADO ST. SPRINGFIELD, MA 01104
Category
Food
Distribution
2 states
HighFDA (Drugs)·D-0136-2026·2025-11-05
Testosterone and triamcinolone 100 mg pellets recalled over metal particulate matter
FarmaKeio Outsourcing is recalling 103,444 sterile Testosterone / Triamcinolone Acetonide 100MG/20MCG pellets over the potential presence of metal particulate matter.
Product
Testosterone / Triamcinolone Acetonide Pellet (100MG/20MCG), 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0367-01
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0129-2026·2025-11-05
Testosterone 200 mg pellets recalled over potential metal particulate matter
FarmaKeio Outsourcing is recalling 14,329 sterile Testosterone Regular Release 200 mg pellets over the potential presence of metal particulate matter.
Product
Testosterone Regular Release 200 MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0402-01
Category
Drug
Distribution
Distributed nationwide
HighFDA (Food)·H-0139-2026·2025-11-05
Cheddar caramel popcorn recalled over peanuts missing from the ingredient statement
Jody's Inc. is recalling 8,244 units of Cabot Creamery Sea Salt Caramel Cheddar popcorn after two complaints that the product contains peanuts not listed in the ingredient statement.
Product
CaBOT CREAMERY SEA SALT CARAMEL CHEDDAR SWEET & CHEESY POPCORN 6.0oz bag CONTAINS: SOY & MILK UPC 8 50016 94430 6 MANUFACTURED FOR: VERMONT CHEESE PRODUCTS, INC 60 LAKE STREET, SUITE 2A BURLINGTON, VT 05401
Category
Food
Distribution
1 state
HighFDA (Drugs)·D-0131-2026·2025-11-05
Combination hormone pellets recalled over potential presence of metal particulate matter
FarmaKeio Outsourcing is recalling 36,924 sterile Testosterone / Triamcinolone Acetonide 25MG/5MCG pellets over the potential presence of metal particulate matter.
Product
Testosterone / Triamcinolone Acetonide 25MG/5MCG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0379-01
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0357-2026·2025-11-05
ChemoLock ports with Spiros recalled over port weld separation risk
ICU Medical is recalling 2,000 ChemoLock Ports with Spiros and red cap because the port weld of the drug transfer device may separate or break during use and leak.
Product
ICU Medical ChemoLock Port w/Spiros, Red Cap REF: CL-35
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0143-2026·2025-11-05
Sodium chloride injection bags recalled over potential flexible container leaks
Otsuka ICU Medical is recalling 509,360 100 mL bags of 0.9% Sodium Chloride Injection from one lot for lack of assurance of sterility due to potential flexible container leaks.
Product
SODIUM CHLORIDE — SODIUM CHLORIDE (SODIUM CHLORIDE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0099-2026·2025-11-05
Adalimumab prefilled syringes recalled for lack of sterility assurance
Samsung Bioepis is recalling 5,518 cartons, 11,036 prefilled syringes, of HADLIMA (adalimumab-bwwd) injection 40mg/0.8 mL from one lot for lack of assurance of sterility.
Product
HADLIMA (adalimumab-bwwd) injection, 40mg/0.8 mL, 2 Single-dose Prefilled Syringes per carton, Rx only, Manufactured for: Organon LLC, a subsidiary of ORGANON & Co, Jersey City, NJ 07302, Manufactured by: SAMSUN BIOEPIS Co., Ltd, Incheon, Republic of Korea, NDC 78206-183-01.
Category
Drug
Distribution
1 state
HighFDA (Devices)·Z-0311-2026·2025-11-05
Trocar sealing units recalled over silicone fragments detaching from sealing component
Aesculap is recalling 26 sealing units for 10/12mm trocars because silicone fragments may detach from the yellow sealing component.
Product
Brand Name: AESCULAP Product Name: SEALING UNIT FOR 10/12MM TROCARS Model/Catalog Number: EK086P Software Version: N/A Product Description: SEALING UNIT FOR 10/12MM TROCARS Component: N/A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0360-2026·2025-11-05
Graduated adapter extension sets recalled over port weld separation risk
ICU Medical is recalling 5,700 7.5-inch extension sets with a ChemoLock port and graduated adapter because the port weld may separate or break during use and leak.
Product
ICU Medical 7.5" (19 cm) Appx 1.5 ml, Ext Set w/ChemoLock" Port, Clamp, Graduated Adapter REF: CL3967
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0337-2026·2025-11-05
Oncology transfer kits recalled over port weld separation risk
ICU Medical is recalling 600 Oncology Transfer Kits with ChemoClave and ChemoLock ports because the port weld of the drug transfer device may separate or break during use and leak.
Product
ICU Medical Oncology Transfer Kit w/ChemoClave and ChemoLock Port; Spiros w/Red Cap; ChemoLock Port REF: CL4138
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0375-2026·2025-11-05
CT scanners recalled over six software faults affecting movement and dose
Philips Medical Systems is recalling 105 Incisive CT scanners on software versions 5.1.0.X and 5.1.1.X over six software issues, including unintentional gantry and couch movement.
Product
Model: Incisive CT; Product Code (REF): (1) 728143, (2) 728144; Software Versions: 5.1.0.X & 5.1.1.X;
Category
Medical Device
Distribution
18 states
HighFDA (Devices)·Z-0356-2026·2025-11-05
Syringe transfer sets recalled because port weld may separate and leak
ICU Medical is recalling 900 Syringe Transfer Sets with MicroClave and ChemoLock port because the port weld of the drug transfer device may separate or break during use and leak.
Product
ICU Medical Syringe Transfer Set w/MicroClave, ChemoLock Port REF: CL-34
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0348-2026·2025-11-05
Closed vial spikes with skirt recalled over port weld separation risk
ICU Medical is recalling 8,475 ChemoLock Closed Vial Spikes with Skirt because the port weld of the drug transfer device may separate or break during use and leak.
Product
ICU Medical ChemoLock Closed Vial Spike w/Skirt, 5 Units REF: CL-80S-5
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0336-2026·2025-11-05
Oncology kits with ChemoLock port recalled over port weld separation
ICU Medical is recalling 150 Oncology Kits with ChemoLock and ChemoLock Port because the port weld of the drug transfer device may separate or break during use and leak.
Product
ICU Medical Oncology Kit w/ChemoLock, ChemoLock Port REF: CL4136
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0341-2026·2025-11-05
Chemotherapy bag spikes recalled because port weld may separate and leak
ICU Medical is recalling 7,850 ChemoLock Bag Spikes because the port weld of the drug transfer device may separate or break during use and leak.
Product
ICU Medical ChemoLock Bag Spike REF: CL-10
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0123-2026·2025-11-05
Testosterone pellets recalled over potential presence of metal particulate matter
FarmaKeio Outsourcing is recalling 1,329 sterile Testosterone 25 mg pellets from one lot over the potential presence of metal particulate matter.
Product
Testosterone 25MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0389-01
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0110-2026·2025-11-05
Desipramine 75 mg tablets recalled over nitrosamine impurity above intake limit
Heritage Pharmaceuticals is recalling 2,418 bottles of Desipramine Hydrochloride Tablets USP 75 mg because N-Nitroso Desipramine exceeded the permissible acceptable daily intake level.
Product
DESIPRAMINE HYDROCHLORIDE — DESIPRAMINE HYDROCHLORIDE (DESIPRAMINE HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0104-2026·2025-11-05
Prazosin 1 mg capsules recalled over nitrosamine impurity above intake limit
Teva Pharmaceuticals USA is recalling 181,659 bottles of Prazosin Hydrochloride Capsules 1 mg because test results for N-nitroso Prazosin impurity C exceeded the acceptable intake limit.
Product
PRAZOSIN HYDROCHLORIDE — PRAZOSIN HYDROCHLORIDE (PRAZOSIN HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0343-2026·2025-11-05
Universal vented vial spikes recalled over port weld separation risk
ICU Medical is recalling 16,850 ChemoLock Universal Vented Vial Spikes because the port weld of the drug transfer device may separate or break during use and leak.
Product
ICU Medical ChemoLock Universal Vented Vial Spike REF: CL-70
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0305-2026·2025-11-05
Infusion line packs recalled over incomplete seals in sterile pouches
Alcon Research is recalling 25,778 accessory devices for Unity and Constellation surgical consoles because of incomplete seals in the pouch that provides the sterile barrier.
Product
Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and Constellation surgical consoles Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List' 8065750918 PAK,I/A LINE,NGVS 8065750957 ASSY,SHIP,CONSTELLATION VFC 8065750972…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0321-2026·2025-11-05
Surgical imaging software recalled over image layer misalignment in 2D fusion
Surgical Theater is recalling 50 units of its PE SNAP imaging platform because a software anomaly may misalign secondary image layers against the primary layer.
Product
Surgical Navigation Advanced Platform Patient Engagement (PE SNAP), software version SNP.3.12.0, imaging processing radiological system
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0378-2026·2025-11-05
Infusion pumps recalled over phantom touches on the touchscreen corner
Fresenius Kabi is recalling six Ivenix Infusion System large volume pumps over a potential issue causing the device to register phantom touches in the lower-left corner of the touchscreen.
Product
Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0415-2026·2025-11-05
Cardiac control material recalled over vial to vial troponin variability
Microgenics is recalling 4,462 units of Thermo Scientific MAS Omni CARDIO control after customers reported vial-to-vial variability with high sensitivity Troponin I assays.
Product
Thermo scientific MAS Omni CARDIO, Liquid Assayed Integrated Cardiac Control, Model/Catalog Number: OCRD-L, OCRD-101, OCRD-202, OCRD-303, OCRD-SP, OCRD-MP, OCRD-UL; Product Description: In Vitro Diagnostic external control
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0344-2026·2025-11-05
20mm vented vial spikes recalled over port weld separation risk
ICU Medical is recalling 11,200 ChemoLock Vented Vial Spikes, 20mm, because the port weld of the drug transfer device may separate or break during use and leak.
Product
ICU Medical ChemoLock Vented Vial Spike, 20mm REF: CL-70S
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0126-2026·2025-11-05
Testosterone 87.5 mg pellets recalled over potential metal particulate matter
FarmaKeio Outsourcing is recalling 529 sterile Testosterone 87.5 mg pellets from one lot over the potential presence of metal particulate matter.
Product
Testosterone 87.5 MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0386-01
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0100-2026·2025-11-05
Duloxetine capsules recalled over nitrosamine impurity above the safety assessment limit
Breckenridge Pharmaceutical is recalling 172,263 bottles of Duloxetine Delayed-Release Capsules 60 mg because N-nitroso-duloxetine was above the 12.5 ppm safety assessment limit.
Product
DULOXETINE — DULOXETINE (DULOXETINE HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0103-2026·2025-11-05
Unit dose prazosin 5 mg cartons recalled over nitrosamine impurity
Amerisource Health Services is recalling 3,410 unit dose cartons of Prazosin Hydrochloride Capsules 5 mg over N-nitroso Prazosin impurity C above the acceptable intake limit.
Product
PRAZOSIN HYDROCHLORIDE — PRAZOSIN HYDROCHLORIDE (PRAZOSIN HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0324-2026·2025-11-05
Augmented reality spine platform recalled over image layer misalignment in fusion
Surgical Theater is recalling three units of its SpineAR SyncAR SNAP orthopedic augmented reality platform because a software anomaly may misalign secondary image layers.
Product
SpineAR Surgical Navigation Advanced Platform Patient Engagement (SyncAR SNAP), software version SPR.1.2.0, orthopedic augmented reality
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0306-2026·2025-11-05
Surgical console accessories recalled over incomplete seals in sterile pouches
Alcon Research is recalling six accessory devices for Unity and Constellation surgical consoles because of incomplete seals in the pouch that provides the sterile barrier.
Product
Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and Constellation surgical consoles Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List' 8065000393 UNITY HP VISCOUS FLUID CONTROL VFC PACK Software Version: N/A Product…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0377-2026·2025-11-05
Brazil market CT scanner recalled over six software faults affecting movement
Philips Medical Systems is recalling one Incisive CT for Brazil SKD unit on software versions 5.1.0.X and 5.1.1.X over six software issues, including unintentional gantry and couch movement.
Product
Model: Incisive CT for Brazil SKD; Product Code (REF): 728146; Software Versions: 5.1.0.X & 5.1.1.X;
Category
Medical Device
Distribution
18 states
HighFDA (Drugs)·D-0109-2026·2025-11-05
Desipramine 50 mg tablets recalled over nitrosamine impurity above intake limit
Heritage Pharmaceuticals is recalling 5,880 bottles of Desipramine Hydrochloride Tablets USP 50 mg because N-Nitroso Desipramine exceeded the permissible acceptable daily intake level.
Product
DESIPRAMINE HYDROCHLORIDE — DESIPRAMINE HYDROCHLORIDE (DESIPRAMINE HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0319-2026·2025-11-05
Surgical planning software recalled over image layer misalignment in 2D fusion
Surgical Theater is recalling 45 units of its SuRgical Planner because a software anomaly may misalign secondary image layers against the primary layer.
Product
SuRgical Planner (SRP), software version SRP.7.12.0, imaging processing radiological system
Category
Medical Device
Distribution
Distributed nationwide

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