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

101–200 of 538

ModerateFDA (Devices)·Z-0553-2026·2025-11-26
Sodium fluoride microtubes recalled over an inadequate quality system
ASP Global is recalling 2,100 SAFE-T-FILL micro capillary blood collection tubes, 200 microlitres with sodium fluoride, over an inadequate quality system.
Product
SAFE-T-FILL Micro Capillary Blood Collection, 200 ¿L; Prepared with Sodium Fluoride; Gray Model/Catalog Number: 07 7340 Product Description: The SAFE-T-FILL Capillary Blood Collection System is a collection device used to draw capillary blood from the finger or heelstick.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0177-2026·2025-11-26
Antiperspirant spray recalled over contamination found elsewhere at the facility
DermaRite Industries is recalling 37,379 spray bottles of UltraSure Anti-Perspirant & Deodorant because it was made at the same facility where other products were found contaminated.
Product
UltraSure Anti-Perspirant & Deodorant, Aluminum Sesquichlorohydrate 15%, 118 mL (4 fl. oz.), DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-266-04
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0559-2026·2025-11-26
Untreated blood gas tubes recalled over an inadequate quality system
ASP Global is recalling 77,500 SAFE-T-FILL plastic blood gas capillary tubes, 150 microlitres untreated, over an inadequate quality system.
Product
SAFE-T-FILL Plastic Blood Gas Capillary Tubes, 150 ¿L; Untreated. Model 06 0199 Product Description: A clear, plastic capillary blood collection tube
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0536-2026·2025-11-26
Shoulder reamer 46mm recalled after release without completed performance testing
Exactech is recalling one Equinoxe Ergo Adjustable Angle rTSA Reamer, 46mm, because it was released before design updates and performance testing were completed.
Product
Brand Name: Equinoxe Ergo Product Name: Adjustable Angle rTSA Reamer, 46mm Model/Catalog Number: 321-59-46 Software Version: N/A Product Description: rTSA Reamer, 46mm Component: Not a component
Category
Medical Device
Distribution
1 state
ModerateFDA (Drugs)·D-0174-2026·2025-11-26
Zinc oxide barrier cream recalled over contamination found at the facility
DermaRite Industries is recalling 37,272 tubes of Renew PeriProtect because it was made at the same facility where other products and lots were found to be contaminated.
Product
Renew PeriProtect, Zinc Oxide 12%, Dimethicone 1%, 113g (4 oz.) per tube, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-435-04
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0163-2026·2025-11-26
Antiseptic lotion soap recalled over contamination found at the manufacturing facility
DermaRite Industries is recalling 7,736 tubes of DermaKleen antiseptic lotion soap because it was made at the same facility where other products were found contaminated.
Product
DermaKleen, Health Care Antiseptic Lotion Soap with Vitamin E, Chloroxylenol 0.2%, packaged in a) 222 mL (7.5 fl. oz.) per tube (NDC 61924-092-08), b) 800 mL (27 fl. oz.) per bag (NDC 61924-092-27), and c 1000 mL (34 fl. oz.) per bag (NDC 61924-092-34), DermaRite Industries LLC,
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0158-2026·2025-11-26
Niacin extended release tablets recalled after failing dissolution specifications
Golden State Medical Supply is recalling 24,869 bottles of Niacin Extended-Release Tablets USP 1,000 mg for failed dissolution specifications.
Product
NIACIN — NIACIN (NIACIN)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0557-2026·2025-11-26
Blood gas capillary tubes recalled over an inadequate quality system
ASP Global is recalling 397,000 SAFE-T-FILL plastic blood gas capillary tubes, 150 microlitres, because they were manufactured under an inadequate quality system with unvalidated processes.
Product
SAFE-T-FILL Plastic Blood Gas Capillary Tubes, 150 ¿L; Prepared with Balanced Heparin Model 06 0186 Product Description: A clear, plastic capillary blood collection tube coated with Heparin
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0169-2026·2025-11-26
Dry skin therapy cream recalled over contamination found at the facility
DermaRite Industries is recalling 8,378 containers of Lantiseptic Dry Skin Therapy because it was made at the same facility where other products were found contaminated.
Product
Lantiseptic, Dry Skin Therapy, Lanolin USP 30%, packaged in a) 5 g (0.17 oz) (NDC 61924-504-05), b) 4 oz (NDC 61924-504-04), and c)14 oz (NDC 61924-710-14) tubes, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0175-2026·2025-11-26
Skin repair cream recalled over contamination found at the manufacturing facility
DermaRite Industries is recalling 57,041 units of Renew Skin Repair Cream because it was made at the same facility where other products and lots were found to be contaminated.
Product
Renew Skin Repair Cream, Dimethicone 1.5%, packaged in a) 5g tube (NDC 61924-405-05), b) 4 oz tube (NDC 61924-405-04), and c) 800 mL (NDC 61924-405-27), DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0172-2026·2025-11-26
Perineal antiseptic recalled over contamination found at the manufacturing facility
DermaRite Industries is recalling 16,006 units of PeriGiene health care antiseptic because it was made at the same facility where other products were found contaminated.
Product
PeriGiene, Health Care Antiseptic, Chloroxylenol 0.5%, 222mL (7.5 fl. oz.) bottle, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-198-08
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0560-2026·2025-11-26
Sodium heparin capillary tubes recalled over an inadequate quality system
ASP Global is recalling 1,000 SAFE-T-FILL plastic blood gas capillary tubes, 115 microlitres with sodium heparin, over an inadequate quality system.
Product
SAFE-T-FILL Plastic Blood Gas Capillary Tubes, 115 ¿L; Prepared with Sodium Heparin Model/Catalog Number: 06 0005 Product Description: A clear, plastic capillary blood collection tube
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0556-2026·2025-11-26
Untreated hematocrit tubes recalled over an inadequate quality system
ASP Global is recalling 209,000 SAFE-T-FILL microhematocrit capillary tubes, 50 microlitres untreated, over an inadequate quality system with unvalidated processes.
Product
SAFE-T-FILL MicroHematocrit Capillary Tubes, 50 ¿L; Untreated, Blue Markings Model/Catalog Number: 06 0508 Product Description: A clear, plastic capillary blood collection tube
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0159-2026·2025-11-26
Bromocriptine capsules recalled after an out of specification impurity result
Zydus Pharmaceuticals is recalling 36,624 bottles of Bromocriptine Mesylate Capsules USP 5 mg after an out of specification result for the 2-Bromoergine impurity.
Product
BROMOCRIPTINE MESYLATE — BROMOCRIPTINE MESYLATE (BROMOCRIPTINE MESYLATE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0171-2026·2025-11-26
McKesson skin protectant recalled over contamination found at the manufacturing facility
DermaRite Industries is recalling 5,876 units of McKesson Skin Protectant with lanolin because it was made at the same facility where other products were found contaminated.
Product
SKIN PROTECTANT WITH LANOLIN — SKIN PROTECTANT WITH LANOLIN (LANOLIN)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0161-2026·2025-11-26
Moisturizing skin cream recalled over contamination found at the manufacturing facility
DermaRite Industries is recalling DermaCerin Skin Protectant Moisturizing Cream because it was made at the same facility where other products and lots were found to be contaminated.
Product
DermaCerin, Skin Protectant Moisturizing Cream (petrolatum 33%), packaged in a) 106 g (3.75 oz.) per tube (NDC 61924-174-04) and b) 454 g (16 oz.) per jar (NDC 61924-174-16), DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0176-2026·2025-11-26
Alcohol hand foam recalled over contamination found at the manufacturing facility
DermaRite Industries is recalling 15,465 cartridges of San-E-Foam alcohol hand sanitiser because it was made at the same facility where other products were found contaminated.
Product
San-E-Foam, Alcohol 67%, 1000 mL (34 fl. oz.) per cartridge, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-107-34
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0546-2026·2025-11-26
Serum separator microtubes recalled over unvalidated manufacturing processes
ASP Global is recalling 64,850 SAFE-T-FILL micro capillary blood collection tubes, 300 microlitres with clot activator and serum separator gel, over an inadequate quality system.
Product
SAFE-T-FILL Micro Capillary Blood Collection, 300 ¿L; Prepared with Clot Activator and Serum Separator Gel; Red Model/Catalog Number: 07 7121 Product Description: The SAFE-T-FILL Capillary Blood Collection System is a collection device used to draw capillary blood from the f
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0554-2026·2025-11-26
Amber clot activator microtubes recalled over an inadequate quality system
ASP Global is recalling 1,500 SAFE-T-FILL micro capillary blood collection tubes, 200 microlitres with clot activator in an amber microtube, over an inadequate quality system.
Product
SAFE-T-FILL Micro Capillary Blood Collection, 200 ¿L; Prepared with Clot Activator; Amber Microtube, Red Model/Catalog Number: 07 7450 Product Description: The SAFE-T-FILL Capillary Blood Collection System is a collection device used to draw capillary blood from the finger o
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0173-2026·2025-11-26
Petrolatum barrier ointment recalled over contamination found at the manufacturing facility
DermaRite Industries is recalling 381,619 units of PeriGuard Ointment because it was made at the same facility where other products and lots were found to be contaminated.
Product
PeriGuard Ointment, Petrolatum 49.9%, packaged in a) 5g (NDC 61924-205-05), b) 3.5oz (NDC 61924-205-04), and c) 7oz (NDC 61924-205-07) tubes, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047.
Category
Drug
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0538-2026·2025-11-26
Fecal occult blood controls recalled over a wrong expiration date printed
Polymedco is recalling 403 units of OC-Auto FOBT-CHEK Negative Controls because the kit box and vial labels state an expiration date of 2026-01-16 instead of 2027-01-17.
Product
OC-Auto FOBT-CHEK Negative Controls is the negative hemoglobin control materials designed to monitor FOBT (Fecal Occult Blood Test)
Category
Medical Device
Distribution
47 states
SevereNHTSA·25V816000·2025-11-25
Rivian delivery van driver seat belt pretensioner cable can be damaged
Rivian is recalling certain 2022-2025 EDV vehicles because the driver's seat belt pretensioner cable may become damaged and fail to restrain the occupant as intended in a crash.
Product
RIVIAN — RIVIAN EDV
Category
Vehicle
Distribution
Distributed nationwide
SevereNHTSA·25V817000·2025-11-25
International truck control units can lose ABS and stability control
International is recalling certain 2016-2026 trucks with Bendix control units because electrical noise may cause the ECU to misprocess commands or stop working, disabling ABS and stability control.
Product
INTERNATIONAL — INTERNATIONAL 7600, RH, MV, LT
Category
Vehicle
Distribution
Distributed nationwide
HighNHTSA·25V819000·2025-11-25
2026 Cadillac Vistiq Electric Vehicles Missing Owner's Manual
General Motors is recalling certain 2026 Cadillac Vistiq electric vehicles because the radio may not have been configured to download the electronic owner's manual during production. Without access to the manual, owners may not know how to safely use and operate the vehicle.
Product
CADILLAC — CADILLAC VISTIQ
Category
Vehicle
Distribution
Distributed nationwide
HighNHTSA·25V818000·2025-11-25
Volvo Recalls XC60 Models Due to Improperly Tightened Front Seat Bolts
Volvo is recalling 2018, 2025, and 2026 XC60 vehicles because front seat bolts may be loose. This defect could prevent seats from restraining occupants during a crash.
Product
VOLVO — VOLVO XC60MHEV, XC60
Category
Vehicle
Distribution
Distributed nationwide
ModerateNHTSA·25V815000·2025-11-25
2026 Chevrolet Silverado 1500, 2500, 3500 Missing Owner Manuals
General Motors is recalling certain 2026 Chevrolet Silverado 1500, 2500, and 3500 vehicles because some may not have received an owner's manual during production. Without the manual, owners may not know how to safely use child restraint anchorages, increasing crash injury risk.
Product
CHEVROLET — CHEVROLET SILVERADO 1500, SILVERADO 2500, SILVERADO 3500
Category
Vehicle
Distribution
Distributed nationwide
SevereNHTSA·25V811000·2025-11-24
Bentley Recalls 2023 Bentayga Hybrid Vehicles Due to Battery Overheating Risk
Bentley is recalling 2023 Bentayga Hybrid vehicles because the high-voltage battery may overheat while charging, increasing the risk of a fire.
Product
BENTLEY — BENTLEY BENTAYGA HYBRID
Category
Vehicle
Distribution
Distributed nationwide
SevereNHTSA·25V812000·2025-11-24
Newell Recalls 2022 P50 Coaches Due to Seat Mounting Defect
Newell Coach Corp. is recalling 2022 P50 coaches because improperly welded pedestal mounting plates may cause seat assemblies to detach, increasing crash injury risk.
Product
NEWELL — NEWELL P50
Category
Vehicle
Distribution
Distributed nationwide
SevereNHTSA·25V813000·2025-11-24
Foretravel Recalls Realm and Realm 450 Vehicles for Seat Weld Defect
Foretravel is recalling 2020-2022 Realm and 2022 Realm 450 vehicles because a seat mounting plate may be improperly welded, allowing the seat to detach.
Product
FORETRAVEL — FORETRAVEL REALM, REALM 450
Category
Vehicle
Distribution
Distributed nationwide
HighNHTSA·25V814000·2025-11-24
nuCamp Trailers Recalled for Incorrect Weight Labels
Pleasant Valley is recalling 2025-2026 nuCamp trailers because incorrect weight information on labels may lead to unintentional overloading and increased crash risk.
Product
NUCAMP — NUCAMP TAB 320, TAB 360, TAG, TAB 400
Category
Vehicle
Distribution
Distributed nationwide
ModerateNHTSA·25T020000·2025-11-24
Achilles ATR Sport 2 Tires Recalled for Tire Identification Marking Defect
PT. Multistrada Arah Sarana, Tbk is recalling Achilles ATR Sport 2 tires because the Tire Identification Number is too long to register, failing federal safety standards.
Product
TIRES:MARKINGS recall
Category
Vehicle
Distribution
Distributed nationwide
SevereNHTSA·25E079000·2025-11-21
Lippert Recalls Hydraulic Pump Brackets on Forest River and Sunseeker Vehicles
Lippert is recalling hydraulic pump brackets on Forest River Forester and Sunseeker vehicles because they may fracture and detach, creating a road hazard.
Product
STRUCTURE:CRITICAL FASTENERS recall
Category
Vehicle
Distribution
Distributed nationwide
SevereNHTSA·25V810000·2025-11-21
Altec Recalls 2019-2024 AT Series Vehicles Due to Emergency Stop Defect
Altec is recalling 2019-2024 AT Series vehicles because the lower emergency stop may not function when the upper control is selected, increasing the risk of death or serious injury.
Product
ALTEC — ALTEC AT SERIES
Category
Vehicle
Distribution
Distributed nationwide
SevereCPSC·26103·2025-11-20
Riding lawn mowers recalled after 15 reports of unexpected bouncing
About 650 model year 2025 Spartan SRT-XD and KGZ-XD riding mowers are being recalled because incorrectly installed steering arm dampers can cause bouncing and loss of control.
Product
Model Year 2025 Spartan SRT-XD and KGZ-XD riding lawn mowers
Category
Consumer Product
Distribution
Distributed nationwide
SevereNHTSA·25V805000·2025-11-20
Cemen Tech Recalls Volumetric Mixer Trucks Due to Separation Risk
Cemen Tech is recalling specific volumetric mixer trucks because mounting plates may crack, allowing the mixer to separate from the vehicle and create a road hazard.
Product
CEMEN TECH — CEMEN TECH C60T VOLUMETRIC MIXER, C60E VOLUMETRIC MIXER, C60 VOLUMETRIC MIXER, M60 VOLUMETRIC MIXER
Category
Vehicle
Distribution
Distributed nationwide
SevereNHTSA·25V806000·2025-11-20
International trucks may stay in gear with the parking brake applied
International is recalling certain 2023-2026 LT and RH vehicles because the auto neutral function may not recognise that the parking brake has been applied, leaving the transmission in gear.
Product
INTERNATIONAL — INTERNATIONAL RH, LT
Category
Vehicle
Distribution
Distributed nationwide
SevereCPSC·26096·2025-11-20
Folding learning towers recalled after 14 reports of the platform collapsing
About 9,780 Grow 'N Stow Folding Learning Towers are being recalled because the platform inside the tower can collapse; 14 collapses have been reported including one child with bruises.
Product
Grow 'N Stow Folding Learning Tower
Category
Consumer Product
Distribution
Distributed nationwide
HighCPSC·26104·2025-11-20
Magnet fidget spinner sets recalled over loose high powered magnets
About 490 Anzmtosn Magnet Fidget Spinner Sets are being recalled because the sets contain loose magnets, posing an ingestion hazard to children.
Product
Anzmtosn Magnet Fidget Spinner Sets
Category
Consumer Product
Distribution
Distributed nationwide
HighNHTSA·25V807000·2025-11-20
Nissan Sentra windshields may have visible air bubbles obscuring visibility
Nissan is recalling certain 2025 Sentra vehicles because the windshield glass may have visible air bubbles, which can obscure the driver's visibility. This fails FMVSS 205.
Product
NISSAN — NISSAN SENTRA
Category
Vehicle
Distribution
Distributed nationwide
HighCPSC·26102·2025-11-20
Ethanol fuel bottles recalled for lacking required flame mitigation devices
About 18,200 MoonSoll and Magic Chems fuel bottles are being recalled because they lack the flame mitigation devices required under the Portable Fuel Container Safety Act.
Product
MoonSoll and Magic Chems Fuel Bottles
Category
Consumer Product
Distribution
Distributed nationwide
HighCPSC·26094·2025-11-20
Convertible baby strollers recalled because the restraint system can fail
About 15 4-in-1 Baby Safety Cart Carriage strollers are being recalled because the restraint system can fail, posing a risk of serious injury or a deadly fall.
Product
4-in-1 Baby Safety Cart Carriage
Category
Consumer Product
Distribution
Distributed nationwide
HighCPSC·26099·2025-11-20
Play yards recalled over entrapment risk under and beside the mattress
About 70 play yards with a bear print are being recalled because infants can become entrapped under the mattress or between the mattress and the side.
Product
Play Yards
Category
Consumer Product
Distribution
Distributed nationwide
HighCPSC·26095·2025-11-20
Baby loungers recalled over low sides and wide openings at the foot
About 300 Bearlala baby loungers are being recalled because the sides are too low to contain an infant, the foot openings are too wide, and the loungers have no stand.
Product
Bearlala Baby Loungers
Category
Consumer Product
Distribution
Distributed nationwide
HighCPSC·26101·2025-11-20
Children's pajama sets recalled for violating sleepwear flammability standards
About 2,100 Mallimoda children's pajama sets are being recalled because they violate the mandatory flammability standards for children's sleepwear.
Product
Mallimoda Children's Pajama Sets
Category
Consumer Product
Distribution
Distributed nationwide
HighCPSC·26106·2025-11-20
Fabric drawer dressers recalled over tip over and entrapment hazards
About 2,015 Romorgniz fabric 12- and 13-drawer dressers are being recalled because they are unstable when not anchored to a wall and violate the STURDY Act standard.
Product
Romorgniz Fabric 12- and 13-Drawer Dressers
Category
Consumer Product
Distribution
Distributed nationwide
HighNHTSA·25V803000·2025-11-20
Mack Trucks Recalls 2025-2026 Models for Automatic High Beam Defect
Mack Trucks is recalling 2025-2026 Pioneer and 2026 Anthem vehicles because automatic high beams may fail to switch to low beams, increasing crash risk.
Product
MACK — MACK ANTHEM AN (4), PIONEER PR (4)
Category
Vehicle
Distribution
Distributed nationwide
HighNHTSA·25V809000·2025-11-20
2025 Hyundai Tucson and Related Models Recalled for Improper Side Curtain Airbag Installation
Hyundai is recalling certain 2025 and 2026 vehicles because side curtain airbags may not have been installed properly and could fail to deploy in a crash. Dealers will reinstall the airbags free of charge.
Product
HYUNDAI — HYUNDAI, GENESIS SANTA FE HYBRID, SANTA CRUZ, TUCSON, GV70
Category
Vehicle
Distribution
Distributed nationwide
HighNHTSA·25V808000·2025-11-20
Hyundai Santa Fe rearview camera wiring may be damaged on installation
Hyundai is recalling certain 2024-2025 Santa Fe and Santa Fe Hybrid vehicles because the rearview camera may not have been installed properly, damaging the wiring harness so the image does not display.
Product
HYUNDAI — HYUNDAI SANTA FE, SANTA FE HYBRID
Category
Vehicle
Distribution
Distributed nationwide
HighNHTSA·25V804000·2025-11-20
Volvo VNL and VNR Trucks Automatic High Beam Lighting Failure Recall
Volvo Trucks is recalling certain 2024–2026 VNL and 2026 VNR trucks because their automatic high beam headlights may fail to switch to low beam, violating federal lighting standards and increasing crash risk.
Product
VOLVO — VOLVO VNR (4), VNL (4)
Category
Vehicle
Distribution
Distributed nationwide
HighNHTSA·25V802000·2025-11-20
2025 Volvo VNL Trucks Load Lock Clamp Loosening Recall
Volvo Trucks is recalling certain 2024–2026 VNL (4) trucks because load lock clamps on the cab back may loosen, allowing cargo to shift or fall and create a crash hazard.
Product
VOLVO — VOLVO VNL (4)
Category
Vehicle
Distribution
Distributed nationwide
HighNHTSA·25V801000·2025-11-20
Mack Recalls 2025-2026 Pioneer Trucks for Loose Load Lock Clamps
Mack is recalling 2025-2026 Pioneer vehicles because load lock clamps may loosen, causing cargo loss and increasing crash risk.
Product
MACK — MACK PIONEER PR (4)
Category
Vehicle
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-0448-2026·2025-11-19
Urology and hip pinning kits recalled over cracked anesthesia circuit tubing
Medline is recalling ortho spine, urology minor, set up and hip pinning convenience kits after complaints of anesthesia circuit leaks from cracked tubing. The FDA classified it Class I.
Product
Convenience Kits: DYNJ901048N ORTHO SPINE ST CLAIR DYNJ909123F UROLOGY MINOR DYNJ909132F SET UP DYNJ909308D HIP PINNING
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-0449-2026·2025-11-19
Expandable anesthesia circuits recalled over cracks causing leaks in tubing
Medline is recalling the 120-inch latex-free ExtendFlex anesthesia circuit after complaints of leaks caused by cracks in the expandable tubing. The FDA has classified it Class I.
Product
Anesthesia circuit kit; CIRCUIT,ANES,EXTENDFLEX,120,LF DYNJAA10230
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Food)·H-0190-2026·2025-11-19
Macaroni salad recalled over potential Listeria monocytogenes contamination in New York
Made Fresh Salads is recalling 100 pounds of LO-BOY Foods macaroni salad in 5 lb tubs distributed in New York over potential Listeria monocytogenes. The FDA classified it Class I.
Product
LO-BOY FOODS; MACARONI SALAD; packaged in 5lb white plastic tubs
Category
Food
Distribution
1 state
CriticalFDA (Devices)·Z-0446-2026·2025-11-19
Laparoscopy and cysto kits recalled over cracked anesthesia circuit tubing
Medline is recalling robotic gastric sleeve, cysto and general laparoscopy kits after complaints of anesthesia circuit leaks from cracks in the 120-inch expandable tubing. The FDA classified it Class I.
Product
DYNJ909119G ROBOTIC GASTRIC LAP SLEEVE-LF DYNJ909127F CYSTO DYNJ909129D GENERAL LAPAROSCOPY-LF
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-0434-2026·2025-11-19
Detachable brain aneurysm coils recalled because they may fail to detach
Cerenovus is recalling 12,004 CEREPAK Detachable Coil System units because the coils may fail to detach, which could result in hemorrhagic and ischemic stroke. The FDA classified it Class I.
Product
CEREPAK Detachable Coil System - Name/REF: UNIFORM 2MM X 2.5 CM/FCX100202, UNIFORM 2.5MM X 3.3 CM/FCX100253, UNIFORM 3MM X 5.4 CM/FCX100305, UNIFORM 3.5MM X 6.6 CM/FCX100356, UNIFORM 4MM X 7.5 CM/FCX100407, UNIFORM 4MM X 11.5 CM/FCX100412, UNIFORM 5MM X 9.7 CM/FCX100509, UNIFORM
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Food)·H-0178-2026·2025-11-19
Peanut butter candy bars recalled over an undeclared cashew allergen
Zingerman's Coffee Company is recalling 156 units of its 2 oz Peanut Butter Crush Candy Bar over undeclared cashew. The FDA has classified the recall as Class I.
Product
Zingerman's Peanut Butter Crush Candy Bar net wt 2oz UPC 844397005237
Category
Food
Distribution
2 states
CriticalFDA (Devices)·Z-0443-2026·2025-11-19
Breathing kits recalled over cracks in the expandable anesthesia tubing
Medline is recalling the latex-free Breathing Kit DYNJ10550 after complaints of anesthesia circuit leaks caused by cracks in the 120-inch expandable tubing. The FDA classified it Class I.
Product
Anesthesia Circuit Kits and other various kits that contain Anesthesia Circuits; BREATHING KIT-LF DYNJ10550
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Food)·H-0175-2026·2025-11-19
Iceless Italian parsley recalled over potential Salmonella contamination
Pacific International Marketing is recalling 4 cases of iceless conventional Italian parsley over potential Salmonella contamination. The FDA has classified the recall as Class I.
Product
Carton Label: PACIFIC FRESH VEGETABLES PACIFIC INTERNATIONAL MARKETING SALINAS, CA 93912 Carton Sticker Label: Conv Italian Parsley 60 Ct Iceless Pacific Product of USA Distributed By: Dynasty Farms Salinas, CA 93905 UPC 40695 80125 Twist Tie (for bunches) Label: FLAT PARSLEY P
Category
Food
Distribution
8 states
CriticalFDA (Food)·H-0176-2026·2025-11-19
Thirty count parsley cases recalled over potential Salmonella contamination
Pacific International Marketing is recalling 2 cases of 30-count iceless conventional Italian parsley over potential Salmonella. The FDA has classified the recall as Class I.
Product
Carton Label: PACIFIC FRESH VEGETABLES PACIFIC INTERNATIONAL MARKETING SALINAS, CA 93912 PRODUCE OF U.S.A. Sticker Label: Conv Italian Parsley 30 Ct Iceless Pacific Product of USA Distributed By: Dynasty Farms Salinas, CA 93905 Twist Tie (for bunches) Label: FLAT PARSLEY PLU #4
Category
Food
Distribution
8 states
CriticalFDA (Food)·H-0187-2026·2025-11-19
Red Bali kratom powder recalled over potential Salmonella contamination
Lotus Vaping Technologies is recalling Monarch Premium Kratom Red Bali powder in three sizes because the product may be contaminated with Salmonella. The FDA classified it Class I.
Product
Monarch Premium Kratom Red Bali powder is packaged in seal mylar pouches: Monarch Premium Kratom Red Bali, 4oz powder (112g), UPC 851006008442 Monarch Premium Kratom Red Bali, 8oz powder (224g), UPC 706970483859 Monarch Premium Kratom Red Bali, 2oz powder (56g), UPC 8510060084
Category
Food
Distribution
Distributed nationwide
CriticalFDA (Food)·H-0189-2026·2025-11-19
Tuna salad recalled over potential Listeria monocytogenes contamination in New York
Made Fresh Salads is recalling 60 pounds of LO-BOY Foods Tuna Deluxe in 5 lb tubs distributed in New York over potential Listeria monocytogenes. The FDA classified it Class I.
Product
LO-BOY FOODS; TUNA DELUXE; packaged in 5lb white plastic tubs
Category
Food
Distribution
1 state
CriticalFDA (Food)·H-0179-2026·2025-11-19
Cashew candy bars recalled over an undeclared peanut allergen
Zingerman's Coffee Company is recalling 78 units of its 2 oz Ca$hew Cow Candy Bar over undeclared peanut. The FDA has classified the recall as Class I.
Product
Zingerman's Ca$hew Cow Candy Bar net wt 2oz UPC 844397000157
Category
Food
Distribution
2 states
CriticalFDA (Food)·H-0185-2026·2025-11-19
Bali Gold kratom powder recalled over potential Salmonella contamination
Lotus Vaping Technologies is recalling Monarch Premium Kratom Bali Gold powder in 4 oz and 8 oz sizes because the product may be contaminated with Salmonella. The FDA classified it Class I.
Product
Monarch Premium Kratom Bali Gold powder is packaged in seal mylar pouches: Monarch Premium Kratom Bali Gold, 4oz powder (112g), UPC 851006008428 Monarch Premium Kratom Bali Gold, 8oz powder (224g), UPC 706970483712
Category
Food
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-0450-2026·2025-11-19
Robotic surgery kits recalled over cracked anesthesia circuit tubing
Medline is recalling GYN Robotic and Robotic Prostate convenience kits after complaints of anesthesia circuit leaks caused by cracks in the 120-inch expandable tubing. The FDA classified it Class I.
Product
Convenience kits; DYNJ901046M GYN ROBOTIC DYNJ909120D ROBOTIC PROSTATE
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Food)·H-0188-2026·2025-11-19
White Elephant kratom powder recalled over potential Salmonella contamination
Lotus Vaping Technologies is recalling Monarch Premium Kratom White Elephant powder in three sizes because the product may be contaminated with Salmonella. The FDA classified it Class I.
Product
Monarch Premium Kratom White Elephant powder is packaged in seal mylar pouches: Monarch Premium Kratom, White Elephant, 4oz powder (112g), UPC 851006008480 Monarch Premium Kratom, White Elephant, 0.5oz powder (14g), UPC 851006008756 Monarch Premium Kratom, White Elephant, 8oz p
Category
Food
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-0431-2026·2025-11-19
MRI upgrade recalled over ice blockage in helium venting paths
Siemens Medical Solutions is recalling four MAGNETOM Cima.X Upgrade systems because an ice blockage may form in the magnet's helium venting paths. The FDA has classified it Class I.
Product
MAGNETOM Cima.X Upgrade. Model Number: 11689304.
Category
Medical Device
Distribution
1 state
CriticalFDA (Food)·H-0200-2026·2025-11-19
Clamshell peach salsa recalled over Listeria risk from supplied peaches
JFE Franchising is recalling 177 units, 154.88 pounds, of 16 oz peach salsa in clamshells because the peaches supplied by Moonlight Peaches are potentially contaminated with Listeria.
Product
Peach Salsa - $5.99-16 oz 639123940636 packaged in clear plastic clamshells Sell by 11/3/2025 Sell by 11/4/2025
Category
Food
Distribution
18 states
CriticalFDA (Devices)·Z-0447-2026·2025-11-19
Surgical convenience kits recalled over cracked anesthesia circuit tubing
Medline is recalling 96,406 breast and hernia convenience kits after complaints of anesthesia circuit leaks caused by cracks in the 120-inch expandable tubing. The FDA classified it Class I.
Product
Convenience Kit, BREAST HERNIA DYNJ909125G
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-0451-2026·2025-11-19
Orthopedic and spine kits recalled over cracked anesthesia circuit tubing
Medline is recalling ortho spine, total joint and kyphoplasty convenience kits after complaints of anesthesia circuit leaks from cracks in the 120-inch expandable tubing. The FDA classified it Class I.
Product
Convenience kits; DYNJ901047R ORTHO SPINE FUMICH DYNJ902308K TOTAL JOINT DYNJ909111F DR SALMA'S SPINE DYNJ909117G PATTERSON TOTAL JOINT DYNJ909113F KYPHOPLASTY
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Food)·H-0177-2026·2025-11-19
Bagged Italian parsley recalled over potential Salmonella contamination
Pacific International Marketing is recalling 160 cases of bagged conventional Italian parsley over potential Salmonella. The FDA has classified the recall as Class I.
Product
Carton Label: PACIFIC STRAIGHT FROM THE FIELDS FRESH HERBS 4/24 BUNCH ITALIAN PARSLEY BAGS PRODUCE OF U.S.A. PACIFIC INTERNATIONAL MARKETING SALINAS, CA 93912 Carton Sticker Label: Conv Italian Parsley 4/24 CT Display Pacific Product of USA Distributed By: Dynasty Farms Salinas
Category
Food
Distribution
8 states
CriticalFDA (Devices)·Z-0444-2026·2025-11-19
Open heart and vascular kits recalled over cracked anesthesia circuit tubing
Medline is recalling open heart supplement and vascular kits containing anesthesia circuits after complaints of leaks from cracks in the 120-inch expandable tubing. The FDA classified it Class I.
Product
Anesthesia Circuit Kits and other various kits that contain Anesthesia Circuits; OPEN HEART SUPPLEMENT DYNJ909116D; VASCULAR DYNJ909124F
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-0445-2026·2025-11-19
Airway procedure kits recalled over cracks in anesthesia circuit tubing
Medline is recalling ENT and laryngoscopy-bronchoscopy kits containing anesthesia circuits after complaints of leaks from cracks in the 120-inch expandable tubing. The FDA classified it Class I.
Product
Anesthesia Circuit Kits and other various kits that contain Anesthesia Circuits; ENT DYNJ909128I; LARYNGOSCOPY - BRONCHOSCOPY DYNJ909114D
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Food)·H-0186-2026·2025-11-19
Green Maeng Da kratom powder recalled over potential Salmonella contamination
Lotus Vaping Technologies is recalling Monarch Premium Kratom Green Maeng Da powder in three sizes because the product may be contaminated with Salmonella. The FDA classified it Class I.
Product
Monarch Premium Kratom Green Maeng Da powder is packaged in seal mylar pouches: Monarch Premium Kratom Green Maeng Da, 4oz powder (112g), UPC 851006008466 Monarch Premium Kratom Green Maeng Da, 0.5oz powder (14g), UPC 851006008770 Monarch Premium Kratom Green Maeng Da, 2
Category
Food
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-0442-2026·2025-11-19
Adult anesthesia circuit kits recalled over cracked expandable tubing
Medline is recalling multiple adult 120-inch expandable anesthesia circuits after complaints of leaks caused by cracks in the tubing. The FDA has classified it Class I.
Product
Anesthesia Circuit Kits and other various kits that contain Anesthesia Circuits; Product description/Product numbers: ADULT 120 EXPANDABLE W/MASK DYNJAA10591; ANES CIRC 120IN EXP-LF DYNJAA6555G; ANES CIRCUIT ADULT 120"-LF DYNJAA10817; ANESTHESIA 120" ADLT-LF DYNJAA10
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Food)·H-0199-2026·2025-11-19
Peach salsa recalled over Listeria in peaches from one supplier
GBC Food Services is recalling 154.88 pounds of 14 oz peach salsa because the peaches supplied by Moonlight Peaches are potentially contaminated with Listeria. The FDA classified it Class I.
Product
Peach Salsa; UPC 85006540364 14oz (397g); Use by 10/12/2025 to 10/29/2025
Category
Food
Distribution
10 states
CriticalFDA (Food)·H-0191-2026·2025-11-19
Strawberry ice cream cones recalled over an undeclared peanut allergen
Seoul Trading is recalling 78 cases of PIGGY Lotte Crispy Crunch strawberry ice cream cones over undeclared peanut. The FDA has classified the recall as Class I.
Product
Item IL1014A, PIGGY Lotte Crispy Crunch Ice Cream Cone, Strawberry flavor, Keep Frozen, (4/5/160ML), UPC 8801118255045. Product of Korea. The label of recalled product declared: Ingredients: Cone snack, Strawberry syrup, Biscuit, Chocolate spray, Topping Chocolate, Ice cream mix
Category
Food
Distribution
2 states
CriticalFDA (Food)·H-0174-2026·2025-11-19
Italian parsley recalled over potential Salmonella contamination in eight states
Pacific International Marketing is recalling 308 cases of conventional Italian parsley over potential Salmonella contamination. The FDA has classified the recall as Class I.
Product
Carton Label: PACIFIC FRESH VEGETABLES PACIFIC INTERNATIONAL MARKETING SALINAS, CA 93912 Carton Sticker Label: Conv Italian Parsley 60 Ct Ctn Pacific Product of USA Distributed By: Dynasty Farms Salinas, CA 93905 UPC 40695 80125 Twist Tie (for bunches) Label: FLAT PARSLEY PLU #
Category
Food
Distribution
8 states
SevereNHTSA·25V799000·2025-11-19
2026 Tiffin Open Trail Motorhomes Recalled Due to Incorrect Cargo Capacity Labels
Tiffin Motorhomes, Inc. is recalling certain 2026 Open Trail motorhomes because the cargo carrying capacity labels may be incorrect, which could lead to vehicle overloading.
Product
TIFFIN — TIFFIN OPEN TRAIL
Category
Vehicle
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0501-2026·2025-11-19
Positive control serum recalled over negative recovery of the HBsAg analyte
Techno-Path is recalling 76 units of Multichem ID-B positive control serum because of potential negative recovery of the HBsAg analyte on the Alinity i platform.
Product
Multichem ID-B. Model/Catalog Number: SR103B Intended for use as an unassayed positive qualitative quality control serum to monitor the precision of laboratory testing procedures for the determination of anti-HIV-1 IgG, anti-HBc IgG, anti-HTLV-I IgG, anti-HCV IgG, HBs antigen
Category
Medical Device
Distribution
17 states
HighFDA (Devices)·Z-0468-2026·2025-11-19
Curved large jaw sealers recalled over residual material that may dislodge
Medline is recalling one reprocessed LigaSure Impact Curved Large Jaw sealer/divider because certain areas of the device can trap residual material that may become dislodged.
Product
Medline Renewal LigaSure Impact Curved Large Jaw Sealer/Divider, Compatible with FT10 Generator, FT10 SW Version 4.0.1.15 or lower; Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0458-2026·2025-11-19
Spinal cord stimulators recalled over loss of programmer communication
Abbott Medical is recalling 20,715 Eterna spinal cord stimulation implantable pulse generators because the devices may lose communication with the clinician programmer or patient controller.
Product
Eterna SCS IPG (Implantable Pulse Generator), Model Number 32400
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0467-2026·2025-11-19
LigaSure Exact dissectors recalled over residual material that may dislodge
Medline is recalling 4,226 reprocessed LigaSure Exact dissectors, 21 cm, because certain areas of the device can trap residual material that may become dislodged.
Product
Medline Renewal LigaSure Exact, Dissector without Nano-Coating 21cm FT10 SW Version 4.0.1.15 or lower; Electrosurgical Cutting And Coagulation Device
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0474-2026·2025-11-19
Blunt tip sealers 44 cm recalled over trapped residual material
Medline is recalling 1,446 reprocessed LigaSure Blunt Tip sealer/dividers, 44 cm, because certain areas of the device can trap residual material that may become dislodged.
Product
Medline Renewal Ligasure Blunt Tip Sealer/Divider NanoCoated, Compatible with FT10 Generator 44cm FT10 SW Version 4.0.1.15 or lower; Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0482-2026·2025-11-19
Electrosurgical snares recalled over small holes compromising package sterility
Olympus is recalling 48,208 Single Use Electrosurgical Snares SD-400 because sterility may be compromised by small holes formed during packaging or transportation.
Product
Brand Name: Olympus Single Use Electrosurgical Snare SD-400 Product Name: Single Use Electrosurgical Snare Model/Catalog Number: SD-400U-10 Product Description: These instruments have been designed to be used with an Olympus endoscope for the removal and/or cauterization of di
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0473-2026·2025-11-19
Blunt tip sealers recalled over residual material trapped inside the device
Medline is recalling 60,917 reprocessed LigaSure Blunt Tip sealer/dividers, 37 cm, because certain areas of the device can trap residual material that may become dislodged.
Product
Medline Renewal Ligasure Blunt Tip Sealer/Divider NanoCoated, Compatible with FT10 Generator 37 cm FT10 SW Version 4.0.1.15 or lower; Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0485-2026·2025-11-19
Surgical staplers recalled over a malformed cover tube press
Covidien is recalling 3,263 Signia Small Diameter Curved Tip Intelligent Reloads because a manufacturing issue can allow internal components to move during firing, risking uncontrolled motion.
Product
Covidien Signia" Small Diameter Curved Tip Intelligent Reload (45mm Vascular/Thin); CFN: SIGSDL45CTVT;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·H-0181-2026·2025-11-19
Nutra Calm supplement recalled because it contains magnesium salicylate
Professional Botanicals is recalling 452 bottles of Nutra Calm capsules because the product contains magnesium salicylate.
Product
Product Name: Nutra Calm Package: 175cc HDPE Bottle. Type: Vegetable Capsule Count: 90, Dose: 2 Capsules. Product Sku: PB248
Category
Food
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0472-2026·2025-11-19
Short blunt tip sealers recalled over residual material that may dislodge
Medline is recalling 65 reprocessed LigaSure Blunt Tip sealer/dividers, 23 cm, because certain areas of the device can trap residual material that may become dislodged.
Product
Medline RenewalLigasure Blunt Tip Sealer/Divider, NanoCoated Compatible with FT10 Generator 23 cm FT10 SW Version 4.0.1.15 or lower; Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0453-2026·2025-11-19
Patient monitors recalled over batteries that can lose backup power
GE Healthcare is recalling 3,271 Carescape B450 patient monitors because certain batteries can lose the ability to hold charge, causing a loss of patient monitoring.
Product
Carescape B450, Model no. 5805686 - shipped with potentially affected batteries or affected batteries installed as a spare part Monitor, Physiological, Patient (With Arrhythmia Detection or Alarms Record updated 3/19/26 to include: CARESCAPE B450 MBA313 2095800-001 CARESCAPE M
Category
Medical Device
Distribution
Distributed nationwide
HighNHTSA·25V800000·2025-11-19
McNeilus Recalls 2024-2025 Volterra ZSL Trucks Due to Software Error
McNeilus is recalling 2024-2025 Volterra ZSL side loader garbage trucks because a software error may cause grabber fingers to move without operator input, posing a risk of injury or crash.
Product
MCNEILUS — MCNEILUS VOLTERRA ZSL
Category
Vehicle
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0476-2026·2025-11-19
Reprocessed vessel sealers recalled over residual material that may dislodge
Medline is recalling 57,244 reprocessed LigaSure Maryland Jaw sealer/dividers because certain areas of the device can trap residual material that may, in rare cases, become dislodged.
Product
Medline Renewal LigaSure Maryland Jaw Sealer/Divider NanoCoated, Compatible w/FT10 37 cm FT10 SW Version 4.0.1.15 or lower; Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·H-0173-2026·2025-11-19
Artisan English muffins recalled over an undeclared milk allergen
Blue Oven Bakery is recalling about 4,500 bags of Blue Oven Artisan Bakery English Muffins sold in Indiana, Kentucky and Ohio over undeclared milk.
Product
Blue Oven Artisan Bakery English Muffins, Net Wt. 13.4 oz (380g), packaged as a 4-pack in a clear plastic bag, UPC 198715684322
Category
Food
Distribution
3 states
HighFDA (Food)·H-0172-2026·2025-11-19
Cinnamon powder recalled over elevated levels of lead and chromium
Singh Trading, doing business as Roshni Foods, is recalling 48 cases of Roshni Cinnamon Powder 3.5 oz because it may contain elevated levels of lead and chromium.
Product
Roshni Cinnamon Powder, 3.5 oz (100g). This product is packaged in clear plastic pouches.
Category
Food
Distribution
5 states
HighFDA (Devices)·Z-0478-2026·2025-11-19
Spinal fixation screws recalled for not meeting performance standards
Orthofix is recalling 624 Virata preassembled polyaxial screws used in the Virata Spinal Fixation System because the screws do not meet performance standards.
Product
Virata Preassembled Polyaxial Screw, utilized in the Virata Spinal Fixation System. The following sizes are affected: 1. POLYAXIAL SCREW, CC, 5.5mm X 30mm; Item Number: TL1-10755030. 2. POLYAXIAL SCREW, CC, 5.5mm X 35mm; Item Number: TL1-10755035. 3. POLYAXIAL SCREW, CC
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0459-2026·2025-11-19
Deep brain stimulators recalled over loss of programmer communication
Abbott Medical is recalling 722 Liberta RC deep brain stimulation implantable pulse generators because the devices may lose communication with the clinician programmer or patient controller.
Product
Liberta RC DBS IPG (Implantable Pulse Generator), Model Number 62400
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0493-2026·2025-11-19
Food allergen panels recalled over barcodes causing wrong tube scanning order
Siemens Healthcare Diagnostics is recalling 28 units of Food Panel 3 Specific Allergen because barcode orientation causes the instrument to misread tube positions in the holder wedge.
Product
Food Panel 3 Specific Allergen; Siemens Material Number (SMN): 10385891; Catalog Number: FP3L4;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0481-2026·2025-11-19
Oxygen concentrator batteries recalled over a chip that can stop oxygen
Philips Respironics is recalling 56 SimplyGo Mini standard battery kits because a defective chip can make the battery fail, shutting down the concentrator and stopping oxygen delivery.
Product
SimplyGo Mini, Standard Battery Kit; Product code: 1116816; The affected battery kits are sold as accessories for the SimplyGo Mini: SimplyGo Mini Portable Oxygen Concentrator Product code: 1113600
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·H-0209-2026·2025-11-19
California rolls recalled over wheat and soy missing from allergen statement
Hana Group is recalling 373 packages of Mai California Roll because wheat and soy are missing from the product's Contains statement.
Product
Mai California Roll WR - UPC 840031402639 5.9 oz (167g) Plastic tray with plastic lid
Category
Food
Distribution
8 states
HighFDA (Devices)·Z-0456-2026·2025-11-19
Portrait vital signs monitors recalled over batteries losing backup power
GE Healthcare is recalling 5,990 Portrait VSM patient monitors because certain batteries can lose the ability to hold charge, causing a loss of patient monitoring.
Product
Portrait VSM Model nos. 6660000-666 Monitor, Physiological, Patient (With Arrhythmia Detection or Alarms
Category
Medical Device
Distribution
Distributed nationwide

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