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.

20976–21000 of 50413

HighFDA (Devices)·Z-1029-2021·2021-02-17
Aomori Olympus ForceMax Injector Recall Due to Inadequate Package Seals
Aomori Olympus is recalling ForceMax Up injectors because some sterile packages have inadequate seals, posing a risk of infection if non-sterile equipment is used.
Product
INJECTOR FORCEMAX UP 2MM CH 25G 6MM, model no. NM-401L-0625 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1023-2021·2021-02-17
Aomori Olympus ForceMax Injector Recalled for Inadequate Package Seals
Aomori Olympus is recalling ForceMax injectors because some sterile packages have partial heat seals, which could allow non-sterile equipment to be used and cause infection.
Product
INJECTOR FORCEMAX SIF 270CM 23G 4MM, model no. NM-400Y-0423 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1014-2021·2021-02-17
Aomori Olympus Endoscopic Injector Recall Due to Package Seal Defects
Aomori Olympus is recalling specific endoscopic injectors because inspection found some sterile packages have inadequate seals, posing a risk of infection if non-sterile equipment is used.
Product
INJECTOR FORCEMAX UP 2.8MMCH 25G 5MM, model no. NM-400L-0525 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0977-2021·2021-02-17
Aomori Olympus Recalls KD-620LR Electrosurgical Snare Due to Seal Defects
Aomori Olympus Co., Ltd. is recalling KD-620LR Electrosurgical Snare units because inspection found some sterile packages have inadequate seals, posing an infection risk.
Product
KD-620LR ELECTROSURGICAL SNARE, model no. KD-620LR - Product Usage: Used with endoscopes and electrosurgical units to cut tissue using high-frequency current within the upper digestive tract.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1013-2021·2021-02-17
Aomori Olympus ForceMax Injector Recalled for Inadequate Package Seals
Aomori Olympus is recalling ForceMax injectors because some sterile packages have partial heat seals, creating a risk of infection if non-sterile equipment is used.
Product
INJECTOR FORCEMAX UP 2.8MMCH 25G 4MM, model no. NM-400L-0425 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1008-2021·2021-02-17
Aomori Olympus Recalls ForceMax Injectors Due to Package Seal Defects
Aomori Olympus is recalling ForceMax injectors because some sterile packages have inadequate seals, which could allow non-sterile equipment to be used and cause infection.
Product
INJECTOR FORCEMAX SIF 270CM 23G 4MM, model no. NM-400Y-0423 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0991-2021·2021-02-17
Aomori Olympus Recalls SNAREMASTER PLUS Hot/Cold Snare Due to Seal Defects
Aomori Olympus is recalling SNAREMASTER PLUS Hot/Cold snares because some sterile packages have inadequate seals, posing a risk of infection.
Product
SD-400U-10 SNAREMASTER PLUS Hot/Cold 10m, model no. SD-400U-10 - Product Usage: Used with endoscopes for the removal and/or cauterization of diminutive polyps, sessile polyps, pedunculated polyps and tissue from within the GI tract.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0996-2021·2021-02-17
Aomori Olympus ForceMax Injector Recalled for Inadequate Package Seals
Aomori Olympus is recalling ForceMax UP injectors because some sterile packages have inadequate seals, posing a risk of infection if non-sterile equipment is used.
Product
INJECTOR FORCEMAX UP 2.8MMCH 23G 5MM, model no. NM-400L-0523 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1068-2021·2021-02-17
Aomori Olympus Recalls MAJ-247 Replacement Baskets Due to Seal Defects
Aomori Olympus is recalling MAJ-247 replacement baskets for the BML-3Q Mechanical Lithotripter because some sterile packages have inadequate seals, posing an infection risk.
Product
MAJ-247 SINGLE USE 30MM REPLACEMENT BASKET, model no. MAJ-247 - Product Usage: REPLACEMENT BASKET for BML-3Q Mechanical Lithotripter.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0988-2021·2021-02-17
Aomori Olympus Electrosurgical Snare Recalled for Inadequate Package Seals
Aomori Olympus is recalling SD-240U-10 electrosurgical snares because inspection found inadequate package seals. Non-sterile equipment use may lead to patient infection.
Product
SD-240U-10 ELECTROSURGICAL SNARE, model no. SD-240U-10 - Product Usage: Used with endoscopes to electrosurgically resect tissue within the digestive tract.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1063-2021·2021-02-17
Aomori Olympus Biliary Stent Recalled for Inadequate Package Seals
Aomori Olympus is recalling biliary stents because inspection found some sterile packages had inadequate seals, posing a risk of infection if non-sterile equipment is used.
Product
PBD-203-0703 BILIARY STENT, model no. PBD-203-0703 - Product Usage: Used with endoscopes for endoscopic retrograde biliary drainage.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1025-2021·2021-02-17
Aomori Olympus Endoscopic Injector Recall Due to Package Seal Defects
Aomori Olympus is recalling specific endoscopic injectors because inspection found some sterile packages had inadequate seals, posing a risk of infection if used.
Product
INJECTOR FORCEMAX UP 2MM CH 25G 4MM, model no. NM-401L-0425 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1064-2021·2021-02-17
Aomori Olympus Recalls Biliary Stents Due to Inadequate Package Seals
Aomori Olympus is recalling biliary stents because inspection found some sterile packages had inadequate seals, posing a risk of infection if non-sterile equipment is used.
Product
PBD-203-0704 BILIARY STENT, model no. PBD-203-0704 -Product Usage: Used with endoscopes for endoscopic retrograde biliary drainage.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1006-2021·2021-02-17
Aomori Olympus Recalls ForceMax Endoscopic Injectors Due to Seal Defects
Aomori Olympus is recalling ForceMax endoscopic injectors because some sterile packages have inadequate seals, posing a risk of infection.
Product
INJECTOR FORCEMAX LOWER 23G 6MM, model no. NM-400U-0623 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1009-2021·2021-02-17
Aomori Olympus ForceMax Injector Recalled for Inadequate Package Seals
Aomori Olympus is recalling ForceMax UP injectors because inspection found some sterile packages have inadequate seals, posing a risk of infection if non-sterile equipment is used.
Product
INJECTOR FORCEMAX UP 2.8MMCH 21G 4MM, model no. NM-400L-0421 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1101-2021·2021-02-17
GE Healthcare Precision 600FP Monitor Suspension Recall
GE Healthcare is recalling 113 Precision 600FP systems due to a potential monitor suspension defect that could cause injury.
Product
GE Healthcare Precision 600FP, Classical R&F (radiographic and fluoroscopic) System - Product Usage: Intended for use by a qualified/trained doctor or technologist on both adult and pediatric subjects taking diagnostic radiographic and fluoroscopic exposures of the whole body…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1018-2021·2021-02-17
Aomori Olympus Recalls ForceMax Injectors Due to Seal Defects
Aomori Olympus is recalling ForceMax injectors because some sterile packages have inadequate seals, posing a risk of infection if non-sterile equipment is used.
Product
INJECTOR FORCEMAX 25G 2.5MM, model no. NM-400U-0425 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1012-2021·2021-02-17
Aomori Olympus Recalls ForceMax UP Injectors Due to Seal Defects
Aomori Olympus is recalling ForceMax UP injectors because some sterile packages have inadequate seals, posing an infection risk if used.
Product
INJECTOR FORCEMAX UP 2.8MMCH 23G 6MM, model no. NM-400L-0623 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1011-2021·2021-02-17
Aomori Olympus ForceMax Injector Recalled for Inadequate Package Seals
Aomori Olympus is recalling ForceMax injectors because inspection found some sterile packages have inadequate seals, posing an infection risk.
Product
INJECTOR FORCEMAX UP 2.8MMCH 23G 5MM, model no. NM-400L-0523 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0286-2021·2021-02-17
Glanbia Recalls think! Oatmeal Bowls Due to Undeclared Nuts
Glanbia Performance Nutrition is recalling think! Protein + Fiber Oatmeal bowls because they contain undeclared pecans and almonds.
Product
think! Protein + Fiber Oatmeal, Farmer's Market Berry Crumble bowl 1.76 oz. individual unit UPC 753656711836 also sold in retail 6 pack with UPC 753656712338
Category
Food
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1105-2021·2021-02-17
BEMER Therapy Systems Recalled for Potential Interference with Pacemakers and Insulin Pumps
BEMER International AG is recalling Bemer-Set and Pro-Set therapy systems because electromagnetic fields may cause technical defects in insulin pumps or pacemaker malfunctions.
Product
Bemer-Set/ Pro-Set for the following models: REF. 410201 (BEMER Pro-Set), REF. 420201 (B.BOX Professional), REF. 420100 (B.BOX CLASSIC), REF. 410100 (BEMER Classic-Set), REF. 420200 (B.BOX Professional), and REF. 410200 (BEMER Pro - Set)
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1050-2021·2021-02-17
Aomori Olympus Recalls Guide Sheath Kits Due to Seal Defects
Aomori Olympus is recalling K-201 Guide Sheath Kits because some sterile packages have inadequate seals, posing an infection risk if used.
Product
K-201 GUIDE SHEATH KIT 2.0MM, model no. K-201 - Product Usage: Used with endoscopes to collect cells or tissue specimens in the respiratory organs.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1067-2021·2021-02-17
Aomori Olympus Recalls MAJ-244 Replacement Baskets Due to Seal Defects
Aomori Olympus is recalling MAJ-244 replacement baskets for the BML-3Q Mechanical Lithotripter because some sterile packages have inadequate seals, posing an infection risk.
Product
MAJ-244 SINGLE USE 30MM REPLACEMENT BASKET, model no. MAJ-244 - Product Usage: REPLACEMENT BASKET for BML-3Q Mechanical Lithotripter.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1036-2021·2021-02-17
Aomori Olympus Recalls NeedleMaster Endoscopic Injection Needles Due to Seal Defects
Aomori Olympus is recalling NeedleMaster endoscopic injection needles because some sterile packages have inadequate seals, posing an infection risk.
Product
NEEDLEMASTER 5MMx 25G UPPER, model no. NM-610L-0525 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in the GI tract.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1038-2021·2021-02-17
Aomori Olympus Recalls NeedleMaster Endoscopic Injection Needles Due to Seal Defects
Aomori Olympus is recalling NeedleMaster 6mm x 23G Upper needles because some sterile packages have inadequate seals, posing an infection risk.
Product
NEEDLEMASTER 6MMx 23G UPPER, model no. NM-610L-0623 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in the GI tract.
Category
Medical Device
Distribution
Distributed nationwide