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.

28001–28025 of 50462

HighFDA (Devices)·Z-2672-2018·2018-08-15
Howmedica Recalls Radial Head Implant Due to Higher Revision Rate
Howmedica Osteonics Corp. is recalling 690 Lateral Assembly, Radial Head Implant, Size 3 units because literature indicates a higher revision rate than other similar devices.
Product
Lateral Assembly, Radial Head Implant, Size 3. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2722-2018·2018-08-15
Howmedica Recalls Stryker Radial Head Implants Due to Performance Concerns
Howmedica Osteonics Corp. is recalling 607 Stryker rHead Radial Head implants because literature reviews indicate a higher revision rate than other similar devices.
Product
radial head implant #2 (Sterile packed). Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2701-2018·2018-08-15
Howmedica Recalls Radio Capitellum Orthopedic Implants Due to Performance Concerns
Howmedica Osteonics Corp. is recalling 225 Radio Capitellum, Recon Head, Size #3 orthopedic implants because literature reviews indicate a higher revision rate than other similar devices.
Product
Radio Capitellum, Recon Head, Size #3. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2715-2018·2018-08-15
Howmedica Recalls rHead Recon Stem Implants Due to Revision Rate Concerns
Howmedica Osteonics Corp. is recalling 90 rHead Recon Stem Implants because literature reviews indicate a higher revision rate than other similar devices.
Product
rHead Recon Stem Implant non-coated, Size 1. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2689-2018·2018-08-15
Howmedica Recalls rHead Recon Stem Implant Due to Higher Revision Rates
Howmedica Osteonics Corp. is recalling 265 rHead Recon Stem Implant 6mm Collar, Size 1 units because literature reviews indicate a higher revision rate than other similar devices.
Product
rHead Recon Stem Implant 6mm Collar,Size 1. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2671-2018·2018-08-15
Howmedica Recalls Stryker Radial Head Implant Due to Performance Concerns
Howmedica Osteonics Corp. is recalling 283 Stryker rHead Radial Head implants because literature suggests a higher revision rate than similar devices.
Product
Lateral Assembly, Radial Head Implant, Size 2. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2659-2018·2018-08-15
Leica M530 OHX Microscope System Recalled for Power Module Design Weakness
Leica Microsystems is recalling 123 M530 OHX Microscope Systems due to a design weakness in the power insert module.
Product
Leica M530 OHX Microscope System Supplied with 100 - 120 Vac.
Category
Medical Device
Distribution
22 states
HighFDA (Drugs)·D-1075-2018·2018-08-15
Mylan Recalls Dymista Nasal Spray Due to Potential Glass Contamination
Mylan Pharmaceuticals is recalling 20,780 bottles of Dymista nasal spray because glass fragments may be present in the neck area of the bottles.
Product
DYMISTA — DYMISTA (AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2679-2018·2018-08-15
Howmedica Recalls rHead Stem Implant Due to Higher Revision Rates
Howmedica Osteonics Corp. is recalling 320 rHead Stem Implant Plasma Coated, Size 3 units because literature reviews indicate higher revision rates than other similar devices.
Product
rHead Stem Implant Plasma Coated, Size 3. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2699-2018·2018-08-15
Howmedica Recalls Radial Head Implants Due to Higher Revision Rates
Howmedica Osteonics Corp. is recalling 107 Radial Head Assy Size #4 implants because literature review indicates higher revision rates than other devices.
Product
Radial Head Assy Size #4, Rad. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2684-2018·2018-08-15
Howmedica Recalls rHead Stem Implant 6mm Collar Size 4
Howmedica Osteonics Corp. is recalling 256 units of the rHead Stem Implant 6mm Collar, Size 4, because the revision rate is higher than other similar devices.
Product
rHead Stem Implant 6mm Collar, Size 4.Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2718-2018·2018-08-15
Howmedica Recalls Stryker rHead Radial Head Bipolar Stem Implants
Howmedica Osteonics Corp. is recalling 673 units of #3 Bipolar stem implants used in the Stryker rHead system due to a higher-than-expected revision rate.
Product
#3 Bipolar stem implant (Sterile packed). Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2669-2018·2018-08-15
Howmedica Recalls Radial Stem Implants Due to Higher Revision Rates
Howmedica Osteonics Corp. is recalling 230 Lat Assembly Rad Stem Implants because literature reviews indicate higher revision rates than other similar devices.
Product
Lat Assembly, Rad Stem Implant,Collar 6mm,Size 3. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2693-2018·2018-08-15
Howmedica Recalls Radio Capitellum Orthopedic Implants Due to Revision Rate
Howmedica Osteonics Corp. is recalling 170 Radio Capitellum Large, Left orthopedic implants because literature reviews indicate a higher revision rate than other similar devices.
Product
Radio Capitellum Large, Left Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2680-2018·2018-08-15
Howmedica Recalls rHead Stem Implant Due to Higher Revision Rates
Howmedica Osteonics Corp. is recalling 301 rHead Stem Implant Plasma Coated, Size 4 units because literature reviews indicate higher revision rates than other similar devices.
Product
rHead Stem Implant Plasma Coated, Size 4. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2670-2018·2018-08-15
Howmedica Radial Head Implant Recall Due to Higher Revision Rates
Howmedica Osteonics Corp. is recalling 175 Lat Assembly Rad Stem Implants because literature reviews indicate higher revision rates than other similar devices.
Product
Lat Assembly, Rad Stem Implant,Collar 6mm,Size 4. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-1790-2018·2018-08-15
Pepperidge Farm Goldfish Crackers Recalled for Potential Salmonella
Pepperidge Farm is recalling Goldfish crackers because an ingredient supplier reported potential Salmonella in the whey powder used in the seasoning.
Product
Pepperidge Farm Goldfish Baked Snack Crackers Baked with Whole Grain Xtra Cheddar. Net Wt. 6.6 oz. (187g) bag, UPC 14100-04654
Category
Food
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2691-2018·2018-08-15
Howmedica Recalls rHead Recon Stem Implant Due to Higher Revision Rates
Howmedica Osteonics Corp. is recalling 298 units of the rHead Recon Stem Implant 6mm Collar, Size 3, because literature reviews indicate a higher revision rate than other similar devices.
Product
rHead Recon Stem Implant 6mm Collar, Size 3. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2711-2018·2018-08-15
Howmedica Recalls 605 Bipolar Radial Head Implants Due to Revision Rate
Howmedica Osteonics Corp. is recalling 605 sterile bipolar radial head implants because literature reviews indicate a higher revision rate than other similar devices.
Product
#2 Bipolar radial head Implant (Sterile packed). Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2687-2018·2018-08-15
Howmedica Recalls rHead Recon Stem Implant Due to Higher Revision Rate
Howmedica Osteonics Corp. is recalling 396 rHead Recon Stem Implant Plasma Coated, Size 3 units because literature reviews indicate a higher revision rate than other similar devices.
Product
rHead Recon Stem Implant Plasma Coated, Size 3. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2604-2018·2018-08-15
New Era Orthopaedics Recalls Modera Pedicle Screw Shank Insertion Instrument
New Era Orthopaedics is recalling 6 shank insertion instruments for the Modera Modular Pedicle Screw System due to a laser weld failure reported after excessive force was applied.
Product
Modera Modular Pedicle Screw System Shank Insertion Instrument, 3-107-07
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-2702-2018·2018-08-15
Howmedica Recalls Radio Capitellum Orthopedic Implants Due to Performance Concerns
Howmedica Osteonics Corp. is recalling 124 Radio Capitellum, Recon Head, Size #4 orthopedic implants because the revision rate is higher than other similar devices.
Product
Radio Capitellum, Recon Head, Size #4. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-1819-2018·2018-08-15
FUSIA Spicy Mongolian Noodle Bowl Recalled for Undeclared Peanuts
Marketing Concepts Group is recalling FUSIA Spicy Mongolian Noodle Bowls because the inner packaging contains undeclared peanuts.
Product
FUSIA Asian Inspirations Spicy Mongolian Noodle Bowl, NET WT 8.5 OZ (240g) Heat and Serve UPC# 041498135461 PRODUCT OF CHINA
Category
Food
Distribution
1 state
HighFDA (Devices)·Z-2700-2018·2018-08-15
Howmedica Recalls 163 Orthopedic Radial Head Implants Due to Performance Concerns
Howmedica Osteonics Corp. is recalling 163 Radio Capitellum, Recon Head implants because literature reviews indicate a higher revision rate than other similar devices.
Product
Radio Capitellum, Recon Head, Size #2. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2732-2018·2018-08-15
Howmedica Recalls rHead Radial Implant Due to Higher Revision Rate
Howmedica Osteonics Corp. is recalling 286 units of the rHead Radial Implant 6 mm Collar, Size 4, because literature reviews indicate a higher revision rate than other similar devices.
Product
rHead, Radial Implant 6 mm Collar, Size 4. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
Category
Medical Device
Distribution
Distributed nationwide