Severity 3 of 5

High recalls

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

What “high” means here

Severity 3 (High) recalls have a known hazard but no confirmed illness, injury, or property damage in the source text. The risk is theoretical-but-real: a pathogen pre-emptively pulled from shelves before anyone got sick, an allergen mislabeling on an uncommon allergen, a precautionary correction on a device that hasn't yet malfunctioned in the field. Most allergen recalls land here, as do most preventive food recalls based on routine sampling. You should still stop using the product, but you don't need to panic.

The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.

32076–32100 of 50502

HighFDA (Devices)·Z-2258-2017·2017-06-14
Arrow International Recalls Central Venous Catheter Kits Due to Needlestick Risk
Arrow International is recalling 43,394 central venous catheter kits because the packaged BD Eclipse Needle may disengage, posing a needlestick injury risk.
Product
Pressure Injectable Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter The Arrow(r) CVC is indicated to provide short-term (<30 days) central venous access for treatment of diseases or conditions requiring central venous access including, but not…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2305-2017·2017-06-14
Arrow International Recalls Central Venous Catheter Kits Due to Needlestick Risk
Arrow International is recalling specific central venous catheter kits because the packaged BD Eclipse Needle may disengage, posing a needlestick injury risk.
Product
ARROWg+ard Blue PLUS(R) Two-Lumen Central Venous Catheterization Kit The Arrow(r) CVC is indicated to provide short-term ( < 30 days) central venous access for treatment of diseases or conditions requiring central venous access including, but not limited to: multiple infusions…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2262-2017·2017-06-14
Arrow PICC Kit Recall Due to Needlestick Injury Risk
Arrow International is recalling specific PICC kits because the packaged BD Eclipse Needle has a safety cover that may disengage, posing a needlestick injury risk.
Product
Pressure Injectable ARROW(R) PICC Kit with Chlorag+ard(R) Technology The ArrowEVOLUTIONTM Pressure injectable P1CC with chlorag+ard Antimicrobial and Antithrombogenic Technology is indicated for short-term or long-term peripheral access to the central venous system for…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2274-2017·2017-06-14
Arrow International Recalls Central Venous Catheter Kits Due to Needlestick Risk
Arrow International is recalling specific central venous catheter kits because the packaged BD Eclipse Needle safety cover may disengage, posing a needlestick injury risk.
Product
Pressure Injectable ARROWg+ard Blue PLUS(R) Two-Lumen Central Venous Catheterization Kit The ARROWg+ard Blue Plus" antimicrobial catheter is indicated in the short-term ( < 30 days) treatment of diseases or conditions requiring central venous access including, but not limited…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2243-2017·2017-06-14
ConvaTec Recalls Pediatric Non-Rebreather Oxygen Masks Due to Defects
ConvaTec is voluntarily recalling specific lots of pediatric non-rebreather oxygen masks with tubing. The recall was initiated by the firm and is currently terminated.
Product
Non-Rebreather Oxygen Mask, Pediatric with Tubing, Product Code 86-3226E, Product Code PMD06009, Product Code PMD06106
Category
Medical Device
Distribution
14 states
HighNHTSA·17V379000·2017-06-14
BMW Recalls 2013-2015 7 Series Vehicles for Incorrect Taillights
BMW is recalling certain 2013-2015 7 Series and ActiveHybrid 7 vehicles because incorrect left rear taillight assemblies may reduce visibility to other drivers.
Product
BMW — BMW 750I, ACTIVE HYBRID 7, 740LXI, 740I
Category
Vehicle
Distribution
Distributed nationwide
HighFDA (Food)·F-2312-2017·2017-06-14
Aunt Jemima Thick French Toast Recalled for Listeria Risk
Pinnacle Foods is recalling Aunt Jemima Thick French Toast nationwide due to a potential for Listeria monocytogenes contamination.
Product
Aunt Jemima(R) Thick French toast, 72 COUNT, NET WT 10.7 LBS, UPC 001960043560
Category
Food
Distribution
Distributed nationwide
HighFDA (Food)·F-2313-2017·2017-06-14
Pinnacle Foods Recalls Waffles for Potential Listeria Contamination
Pinnacle Foods is recalling specific Aunt Jemima, Mrs. Butterworth's, and Hilltop Hearth waffle products due to potential Listeria monocytogenes contamination.
Product
Waffles packaged as follows: a) Aunt Jemima(R) Waffles, 144 COUNT, NET WT 7.88 LBS, UPC 001960043575 b) Aunt Jemima(R) Jumbo Square Waffles, 144 COUNT, NET WT 11.4 LBS, UPC 001960043573 c) Aunt Jemima(R) Waffles, 144 COUNT, NET WT 7.88 LBS, UPC 001960043575 d) Mrs.…
Category
Food
Distribution
Distributed nationwide
HighFDA (Food)·F-2338-2017·2017-06-14
Fourth Street Barbeque Recalls Chicken and Waffle Sandwiches for Listeria Risk
Fourth Street Barbeque is recalling Pick 5 Chicken & Waffle Sandwiches due to potential Listeria monocytogenes contamination. The product was distributed nationwide by Save-A-Lot.
Product
Pick 5 Chicken & Waffle Sandwich; Mix & Match, Keep Frozen; Net Wt. 14.4 oz.; Distributed by: Save-A-Lot Food Stores, Ltd., Earth City, MO 63045; UPC: 051933353664
Category
Food
Distribution
Distributed nationwide
HighFDA (Food)·F-2298-2017·2017-06-14
Aunt Jemima Buttermilk Pancakes Recalled for Listeria Risk
Pinnacle Foods is recalling Aunt Jemima Buttermilk Pancakes due to potential Listeria monocytogenes contamination.
Product
AUNT JEMIMA(R) 12 BUTTERMILK PANCAKES, NET WT 14.8oz UPC 019600068204
Category
Food
Distribution
Distributed nationwide
HighFDA (Food)·F-2316-2017·2017-06-14
Hilltop Hearth Waffles Recalled for Potential Listeria Contamination
Pinnacle Foods is recalling Hilltop Hearth Waffles nationwide due to the potential for Listeria monocytogenes contamination.
Product
Hilltop HEARTH WAFFLES, 18 BOLSAS CON 8 PIEZAS, PESO NETO 11LB 6.4 oz, UPC075810843855
Category
Food
Distribution
Distributed nationwide
HighFDA (Food)·F-2311-2017·2017-06-14
Pinnacle Foods Recalls Aunt Jemima French Toast for Listeria Risk
Pinnacle Foods is recalling Aunt Jemima Original Thin French Toast nationwide due to a potential for Listeria monocytogenes contamination.
Product
Aunt Jemima(R) Original Thin French toast, 144 COUNT, NET WT 13.5 LBS, UPC 001960005870
Category
Food
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2303-2017·2017-06-14
Arrow International Recalls Large-Bore CVC Kits Due to Needlestick Risk
Arrow International is recalling specific large-bore central venous catheter kits because the packaged BD Eclipse Needle safety cover may disengage, posing a needlestick injury risk.
Product
ARROWg+ard Blue Large-Bore Multi-Lumen CVC Kit The large-bore multiple-lumen catheter permits venous access to the central circulation for rapid fluid administration. It may be inserted into the jugular, subclavian, or femoral veins
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-2340-2017·2017-06-14
Alaska Pasta Company Recalls Gluten-Free Fettuccine for Undeclared Soy Lecithin
Alaska Pasta Company is recalling refrigerated gluten-free fettuccine because it contains undeclared soy lecithin from cooking spray.
Product
Fettuccine Gluten Free. Product is made refrigerated. Product is packaged in plastic containers. The plastic containers are marked on the side of the container with the customer name (middle top), date of production (bottom left), and weight of product in lbs (bottom right).…
Category
Food
Distribution
1 state
HighFDA (Food)·F-2351-2017·2017-06-14
Alaska Pasta Company Recalls Ravioli Orso for Undeclared Soy Lecithin
Alaska Pasta Company is recalling Ravioli Orso because it contains undeclared soy lecithin from canola oil cooking spray. The product was distributed in Alaska.
Product
Ravioli Orso. Product is made refrigerated. Product is packaged in plastic containers. The plastic containers are marked on the side of the container with the customer name (middle top), date of production (bottom left), and weight of product in lbs (bottom right). Some…
Category
Food
Distribution
1 state
HighFDA (Devices)·Z-2241-2017·2017-06-14
ConvaTec Recalls Non-Rebreathing Masks Due to Potential Valve Defects
ConvaTec, Inc. is voluntarily recalling specific lots of Non-Rebreathing Masks with tubing. The recall is classified as Class II by the FDA.
Product
Non-Rebreathing Mask, Reservoir Bag, Check Valve, Two Side Valves, with Tubing, Product Code 3230MM
Category
Medical Device
Distribution
14 states
HighFDA (Devices)·Z-2223-2017·2017-06-14
Roche Cobas Connection Module Recalled for Vibration and Contamination Risk
Roche Diagnostics is recalling three Cobas connection modules in Washington due to a gap that may cause rack vibration, posing operator injury and sample cross-contamination risks.
Product
Cobas connection module (CCM) - OUTPUT UNIT The module CCM enables a unidirectional connection of the pre-analytical systems cobas p 612/ p 512 to analysis instruments from Roche Diagnostics, Hitachi or Sysmex by means of the Aloka transportation system
Category
Medical Device
Distribution
1 state
HighFDA (Food)·F-2352-2017·2017-06-14
Alaska Pasta Company Recalls Ravioli Spinach Due to Undeclared Soy Lecithin
Alaska Pasta Company is recalling refrigerated Ravioli Spinach because it contains undeclared soy lecithin from cooking spray. The product was distributed in Alaska.
Product
Ravioli Spinach. Product is made refrigerated. Product is packaged in plastic containers. The plastic containers are marked on the side of the container with the customer name (middle top), date of production (bottom left), and weight of product in lbs (bottom right). Some…
Category
Food
Distribution
1 state
HighFDA (Food)·F-2301-2017·2017-06-14
Pinnacle Foods Recalls Aunt Jemima Cinnamon French Toast for Listeria Risk
Pinnacle Foods is recalling Aunt Jemima Cinnamon French Toast due to potential Listeria monocytogenes contamination. The recall covers 22,172 units distributed nationwide.
Product
AUNT JEMIMA(R) CINNAMON FRENCH TOAST, 6 COUNT, NET WT 12.5oz, UPC 019600058908
Category
Food
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2242-2017·2017-06-14
ConvaTec Recalls Infant High Concentration Non-Rebreather Oxygen Masks
ConvaTec is recalling specific lots of infant high concentration non-rebreather oxygen masks due to a Class II safety concern.
Product
Oxygen Mask, Standard (Under the Lip) Infant, High Concentration Non-Rebreather, 7 ft. (2.1 m) Oxygen Tubing w/FITS-All Oxygen Connector Check Valve, Two Side Valves, Product Code 3266-E
Category
Medical Device
Distribution
14 states
HighFDA (Food)·F-2308-2017·2017-06-14
Pinnacle Foods Recalls Aunt Jemima Mini Pancakes for Listeria Risk
Pinnacle Foods is recalling Aunt Jemima Mini Pancakes, Blueberry Blast, due to potential Listeria monocytogenes contamination. The recall covers 5,371 units distributed nationwide.
Product
AUNT JEMIMA(R) MiNi pancakes, BLUEBERRY BLAST, NET WT 3.2 OZ, UPC 001960043567
Category
Food
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2239-2017·2017-06-14
ConvaTec Recalls Pediatric Oxygen Masks Due to Potential Defect
ConvaTec is voluntarily recalling specific lots of pediatric oxygen masks. The recall addresses a potential defect in the high-concentration rebreather devices.
Product
Oxygen Mask, Elongated (Under the Chin) Pediatric, High Concentration Rebreather, 7 ft. (2.1 m) Oxygen Tubing w/FITS-All Oxygen Connector, Product Code 3224-E and Product Code 3226-E
Category
Medical Device
Distribution
14 states
HighFDA (Food)·F-2339-2017·2017-06-14
Alaska Pasta Company Recalls Refrigerated Fettuccine for Undeclared Soy Lecithin
Alaska Pasta Company is recalling 447.2 lbs of refrigerated fettuccine because it contains undeclared soy lecithin from cooking spray.
Product
Fettuccine. Product is made refrigerated. Product is packaged in plastic containers. The plastic containers are marked on the side of the container with the customer name (middle top), date of production (bottom left), and weight of product in lbs (bottom right). Some…
Category
Food
Distribution
1 state
HighFDA (Food)·F-2302-2017·2017-06-14
Pinnacle Foods Recalls Aunt Jemima French Toast for Listeria Risk
Pinnacle Foods is recalling Aunt Jemima French Toast made with Whole Grain due to potential Listeria monocytogenes contamination.
Product
AUNT JEMIMA(R) FRENCH TOAST MADE WITH WHOLE GRAIN, 6 COUNT, NET WT 12.5oz, UPC 019600059684; Aunt Jemima(R) French toast made with Whole Grain, 72 COUNT, NET WT 11.25 LBS, UPC 001960043583
Category
Food
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2250-2017·2017-06-14
Circadiance Recalls SmartMonitor 2 PS/PSL Apnea Monitors for Nurse Call Defect
Circadiance LLC is recalling 1,242 SmartMonitor 2 PS/PSL apnea monitors because the nurse call feature may operate intermittently, potentially preventing alarm transmission.
Product
SmartMonitor 2 PS/PSL, Monitor, Apnea, Facility USE. Intended for use in the continuous monitoring of respiration, heart rate, and SP02 of infant, pediatric and adult patients.
Category
Medical Device
Distribution
Distributed nationwide