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.

21051–21075 of 50413

HighFDA (Devices)·Z-0984-2021·2021-02-17
Aomori Olympus Electrosurgical Snare Recalled for Inadequate Package Seals
Aomori Olympus is recalling SD-210U-10 electrosurgical snares because inspection found some sterile packages have inadequate seals, posing an infection risk.
Product
SD-210U-10 ELECTROSURGICAL SNARE, model no. SD-210U-10 - Product Usage: Used with endoscopes to electrosurgically resect tissue within the digestive tract.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1057-2021·2021-02-17
Aomori Olympus Recalls Aspiration Needles Due to Inadequate Package Seals
Aomori Olympus is recalling NA-411D-1521 aspiration needles because some sterile packages have inadequate seals, posing a risk of infection if non-sterile equipment is used.
Product
NA-411D-1521 ASPIRATION NEEDLE, model no. NA-411D-1521 - Product Usage: Used with endoscopes to collect cells or tissue specimens in the respiratory organs.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0989-2021·2021-02-17
Aomori Olympus Electrosurgical Snare Recalled for Inadequate Package Seals
Aomori Olympus is recalling SD-240U-15 electrosurgical snares because some sterile packages have inadequate seals, posing an infection risk.
Product
SD-240U-15 ELECTROSURGICAL SNARE, model no. SD-240U-15 - Product Usage: Used with endoscopes to electrosurgically resect tissue within the digestive tract.
Category
Medical Device
Distribution
Distributed nationwide
HighCPSC·21083·2021-02-17
Anker Play Recalls Science Kits Due to Lead Paint Violation
Anker Play Products is recalling 10-in-1 Incredible Inventions Science Kits because the red and blue magnet contains lead paint exceeding federal limits.
Product
10-in-1 Incredible Inventions Science Kits
Category
Consumer Product
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0995-2021·2021-02-17
Aomori Olympus ForceMax Injector Recalled for Inadequate Package Seals
Aomori Olympus is recalling ForceMax injectors because some sterile packages have inadequate seals, posing an infection risk 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-1005-2021·2021-02-17
Aomori Olympus Recalls Endoscopic Injectors Due to Inadequate Package Seals
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 LOWER 25G 5MM, model no. NM-400U-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 (Food)·F-0288-2021·2021-02-17
Bickel's Butter Flavored Popcorn Recalled for Undeclared Milk
Bickel's Snack Foods Inc. is recalling 8-ounce bags of Butter Flavored Popcorn due to undeclared milk caused by mislabeling.
Product
Butter Flavored Popcorn Artificially Flavored 8oz. UPC:7017306021
Category
Food
Distribution
9 states
HighFDA (Devices)·Z-0973-2021·2021-02-17
Aomori Olympus Recalls K-204 Guide Sheath Kits Due to Seal Defects
Aomori Olympus is recalling K-204 Guide Sheath Kits because some sterile packages have inadequate seals, posing a risk of infection if non-sterile equipment is used.
Product
K-204 GUIDE SHEATH Kit 2.6MM, model no K-204 - Product Usage: Used with endoscopes to collect cells or tissue specimens in the respiratory organs.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1093-2021·2021-02-17
Cardinal Health Recalls Lab Coats and Gowns Due to Manufacturing Defects
Cardinal Health is recalling approximately 29.8 million lab coats and isolation gowns due to potential rips, holes, or foreign material that may compromise barrier protection.
Product
Lab Coats SMS Large White, SKU 2302LC Cardinal Health Isolation Gown, Lab Coat, and Kendall" Gowns are intended to provide minimal barrier protection to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate…
Category
Medical Device
Distribution
Distributed nationwide
HighNHTSA·21V084000·2021-02-17
Blue Bird Recalls 2022 All American Buses Due to Electronic Stability Control Defect
Blue Bird is recalling 2022 All American buses because a programming error in the hydraulic brake control unit may cause the electronic stability control to malfunction.
Product
BLUE BIRD — BLUE BIRD ALL AMERICAN TRANSIT BUS
Category
Vehicle
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0962-2021·2021-02-17
Aomori Olympus Recalls B5-2C Balloon Catheters Due to Seal Defects
Aomori Olympus is recalling B5-2C balloon catheters because some sterile packages have inadequate seals, posing a risk of infection if used.
Product
B5-2C BALLOON CATHETER 11MM DIA 2.0; Model No. B5-2C - Product Usage: Used with endoscopes to inject contrast medium or other medical fluid into the bile duct, pancreatic duct, and respiratory organs.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1061-2021·2021-02-17
Aomori Olympus Recalls ViziShot Aspiration Needles Due to Seal Defects
Aomori Olympus is recalling ViziShot 22G aspiration needles because some sterile packages have inadequate seals, posing an infection risk.
Product
NA-201SX-4022-B ASPIRATION NEEDLE ViziShot 22G, model no. NA-201SX-4022-B - Product Usage: Used with ultrasound endoscopes for ultrasound guided fine needle aspiration of submucosal and extramural lesions of the tracheobronchial tree and esophagus.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1066-2021·2021-02-17
Aomori Olympus Recalls Biliary Stents Due to Inadequate Package Seals
Aomori Olympus is recalling biliary stents because inspection found some sterile packages have inadequate seals, posing a risk of infection if non-sterile equipment is used.
Product
PBD-203-0710 BILIARY STENT, model no. PBD-203-0710 -Product Usage: Used with endoscopes for endoscopic retrograde biliary drainage.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1033-2021·2021-02-17
Aomori Olympus NeedleMaster Endoscopic Injection Needles Recalled for Seal Defects
Aomori Olympus is recalling NeedleMaster endoscopic injection needles because inspection found inadequate package seals, posing a risk of infection if non-sterile equipment is used.
Product
NEEDLEMASTER 4MMx 26G UPPER, model no. NM-610L-0426 - 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-1045-2021·2021-02-17
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 a risk of infection.
Product
NEEDLEMASTER 3MMx 23G LOWER, model no. NM-610U-0523 - 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-0974-2021·2021-02-17
Aomori Olympus Recalls KD-611L Electrosurgical Knives Due to Seal Defects
Aomori Olympus is recalling KD-611L electrosurgical knives because some sterile packages have inadequate seals, posing a risk of infection if non-sterile equipment is used.
Product
KD-611L ELECTROSURGICAL KNIFE, model no. KD-611L - 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-1027-2021·2021-02-17
Aomori Olympus ForceMax Injector Recalled for Inadequate Package Seals
Aomori Olympus is recalling ForceMax injectors because some sterile packages have inadequate seals, posing an infection risk if non-sterile equipment is used.
Product
INJECTOR FORCEMAX UP 2MM CH 25G 5MM, model no. NM-401L-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-0961-2021·2021-02-17
Aomori Olympus Recalls B5-2Q Balloon Catheters Due to Seal Defects
Aomori Olympus is recalling B5-2Q Balloon Catheters because some sterile packages have inadequate seals, posing a risk of infection if non-sterile equipment is used.
Product
B5-2Q BALLOON CATHETER, Model No. B5-2Q - Product Usage: Used with endoscopes to inject contrast medium or other medical fluid into the bile duct, pancreatic duct, and respiratory organs.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1004-2021·2021-02-17
Aomori Olympus Recalls ForceMax Endoscopic Injectors Due to Seal Defects
Aomori Olympus is recalling ForceMax endoscopic injectors because inspection found some sterile packages have inadequate seals, posing a risk of infection.
Product
INJECTOR FORCEMAX LOWER 23G 5MM, model no. NM-400U-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-0979-2021·2021-02-17
Aomori Olympus Recalls KD-640L Electrosurgical Snare Due to Seal Defects
Aomori Olympus is recalling KD-640L electrosurgical snares because some sterile packages have inadequate seals, posing a risk of infection if used.
Product
KD-640L ELECTROSURGICAL SNARE, model no. KD-640L - 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-0968-2021·2021-02-17
Aomori Olympus Recalls 3-Lumen Extraction Balloon V Due to Seal Defects
Aomori Olympus is recalling 3-Lumen Extraction Balloon V devices because some sterile packages have inadequate seals, posing a risk of infection if used.
Product
B-V443Q-A 3-LUMEN EXTRACTION BALLOON V, model no. B-V443Q-A - Product Usage: Used with endoscopes to endoscopically remove stones such as calculi, pancreatic and common bile duct stones.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0966-2021·2021-02-17
Aomori Olympus Recalls 3-Lumen Extraction Balloon V Due to Seal Defects
Aomori Olympus is recalling 3-Lumen Extraction Balloon V devices because some sterile packages have inadequate seals, posing a risk of infection if used.
Product
B-V233P-A 3-LUMEN EXTRACTION BALLOON V, model no. B-V233P-A - Product Usage: Used with endoscopes to endoscopically remove stones such as calculi, pancreatic and common bile duct stones.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1049-2021·2021-02-17
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 a risk of infection.
Product
NEEDLEMASTER 1.8MMx 26G LOWER, model no. NM-610U-1826 - 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-1007-2021·2021-02-17
Aomori Olympus ForceMax Endoscopic Injectors Recalled for Seal Defects
Aomori Olympus is recalling ForceMax endoscopic injectors because some sterile packages have inadequate seals, posing an infection risk if non-sterile equipment is used.
Product
INJECTOR FORCEMAX LOWER 25G 6MM, model no. NM-400U-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-1044-2021·2021-02-17
Aomori Olympus Recalls NeedleMaster Endoscopic Injection Needles for Seal Defects
Aomori Olympus is recalling NeedleMaster endoscopic injection needles because some sterile packages have inadequate seals, posing an infection risk.
Product
NEEDLEMASTER 4MMx 26G LOWER, model no. NM-610U-0426 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in the GI tract.
Category
Medical Device
Distribution
Distributed nationwide