🏥 Medical Devices Class I - Dangerous
No 510(k) clearance
All Recalls
95,114 total recalls in our database
🏥 Medical Devices Class I - Dangerous
The polyester-based polyurethane (PE-PUR) foam may degrade into particles which may enter the device s the air pathway and be ingested or inhaled by the user, and the PE-PUR foam may off-gas certain chemicals.
🏥 Medical Devices Class I - Dangerous
GE Healthcare has recently become aware of an issue on the affected products listed below where the "Patient Orientation" button may inadvertently be clicked when intending to click on the "Save RX" button. This changes the prescribed patient orientation on the system prior to running the initial 3-Plane Localizer Scan (See Figure 1 for reference to buttons.) Selecting and saving a patient orientation that does not match the patient's actual position may result in incorrectly annotated and/or flipped images.
Unifine Pentips Plus, hypodermic needle - Product Usage: Pen needles with built in pen needle remover.
Owen Mumford USA
🏥 Medical Devices Class I - Dangerous
Mixed Up. Two (2) cases of Unifine Pentips Plus 4mm pen needles have been mixed into a packed configuration of Unifine Pentips Plus 8mm pen needles.
Lingen Disposable Virus Sampling Kit, Item MTM-04, 40 tubes/box.
Mercedes Medical
🏥 Medical Devices Class I - Dangerous
No 510(k) clearance
SIGNA Voyager, Nuclear Magnetic Resonance Imaging System
GE Healthcare
🏥 Medical Devices Class I - Dangerous
GE Healthcare has recently become aware of an issue on the affected products listed below where the "Patient Orientation" button may inadvertently be clicked when intending to click on the "Save RX" button. This changes the prescribed patient orientation on the system prior to running the initial 3-Plane Localizer Scan (See Figure 1 for reference to buttons.) Selecting and saving a patient orientation that does not match the patient's actual position may result in incorrectly annotated and/or flipped images.
Caldwell E-Max® Pro BT Earmuffs with rechargeable lithium battery packs
Unknown Manufacturer
🏠 Consumer Products Class I - Dangerous
The soldering within the lithium-battery pack housing can allow the wiring to detach and cause the unit to overheat, posing fire and burn hazards.
One Stop Gardens 15,000 and 30,000 BTU Tank Top Propane Heaters
Unknown Manufacturer
🏠 Consumer Products Class II - Moderate
In windy weather, the flame can be directed to the rear of the unit, which can melt the "tip switch" safety shut off feature at the rear of the heater. This poses a risk that the heater will not turn off if it tips over and poses a burn hazard to consumers.
Rechargeable handheld fans
Unknown Manufacturer
🏠 Consumer Products Class I - Dangerous
The fan's lithium ion battery can overheat while charging, posing a fire hazard.
Arroyo and Hideaway Wood Burning Fire Pits
Unknown Manufacturer
🏠 Consumer Products Class I - Dangerous
Wood stored under the unit can ignite, posing a fire hazard.
Firebird Artisan Mills Gluten Free Organic Brown Rice Flour, Net Wt: 50 lb / 22.7 kg. 500 North St W., Harvey, ND 58341
FO-ND, LLC. (dba Firebird Artisan Mills)
🍎 Food Class I - Dangerous
Organic Brown Rice Flour has the potential to be contaminated with Salmonella.
🍎 Food Class I - Dangerous
Firm testing found trace levels of yeast in the product. Further investigation found the presence of Candida pelliculosa.
🍎 Food Class I - Dangerous
Product may contain elevated levels of inorganic arsenic (above 100ppb)
Hatch Verde Salsa Medium Net Wt. 12 oz (340g) 6 jars per case packaged in clamshell container UPC Code: 810041591999
Heritage Family Specialty Foods
🍎 Food Class I - Dangerous
Potential to contain a foreign material
E6164J2 Taco Casa Green Salsa 8 x 4 lb (1.8 kg) pouches
Heritage Family Specialty Foods
🍎 Food Class I - Dangerous
Potential to contain a foreign material
JERSEY COOKIE MONSTER ICE CREAM 3 GALLONS (11.34 LITERS) MFG: GREENWOOD ICE CREAM CO LTD 4829 PEACHTREE ROAD, ATLANTA, GA 30341 UPC 0 12609 06378 0
Greenwood Ice Cream
🍎 Food Class I - Dangerous
During an FDA inspection the firm was notified that their ingredient statement does not include soy. Undeclared soy in ice cream
Milo's Sauce 5 gallon pails 24 pails per pallet
Southern Classic Food Group
🍎 Food Class I - Dangerous
Undeclared Fish Allergen
Topotecan Injection 4 mg/4mL (1 mg/mL), Single-Dose vial, Teva Pharmaceuticals USA, Inc. North Whales, PA 19454, Carton NDC# 0703-4714-01, Vial NDC# 0703-4714-71
Teva Pharmaceuticals USA
💊 Drugs Class I - Dangerous
Presence of Particulate Matter: Complaint received of a glass particle observed inside the vial. The vial was returned to Teva for further analysis where two other particulates were found and identified as one (1) grey silicone particle and one (1) translucent, colorless cotton fiber.
💊 Drugs Class I - Dangerous
Subpotent drug: Out of specification for assay of naloxone and buprenorphine (low)
💊 Drugs Class I - Dangerous
Low out of specification results for epinephrine assay.