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.

21001–21025 of 50413

HighFDA (Devices)·Z-0981-2021·2021-02-17
Aomori Olympus Recalls KD-650U Electrosurgical Snare Due to Seal Defects
Aomori Olympus Co., Ltd. is recalling KD-650U Electrosurgical Snare units because inspection found some sterile packages have inadequate seals, posing an infection risk.
Product
KD-650U ELECTROSURGICAL SNARE, model no. KD-650U - 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-1102-2021·2021-02-17
Baxter IV Catheter Extension Set Recalled for Tubing Separation
Baxter Healthcare is recalling 66,800 units of ONE-LINK Non-DEHP Y-Type Microbore Catheter Extension Sets due to reports of tubing separation from the Male Luer Lock Adaptor.
Product
Baxter ONE-LINK Non-DEHP Y-Type Microbore Catheter Extension Set, Bonded Needle-free IV Connector, Neutral Fluid Displacement, 5.7 " (14 cm), REF 7N8370K - Product Usage: intended for single patient use with a vascular access device for the administration of drugs and solutions…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0987-2021·2021-02-17
Aomori Olympus Electrosurgical Snare Recalled for Inadequate Package Seals
Aomori Olympus is recalling SD-230U-20 electrosurgical snares because some sterile packages have inadequate seals, posing an infection risk.
Product
SD-230U-20 ELECTROSURGICAL SNARE, model no. SD-230U-20 - Product Usage: Used with endoscopes to electrosurgically resect tissue within the digestive tract.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0284-2021·2021-02-17
Pero Family Farms Recalls Butternut Squash Spirals Due to Listeria Risk
Pero Family Farms is recalling Butternut Veggie Spirals trays because they may be contaminated with Listeria monocytogenes.
Product
Butternut Veggie Spirals Tray, 10oz, Keep Refrigerated
Category
Food
Distribution
0 states
HighFDA (Devices)·Z-1071-2021·2021-02-17
Aomori Olympus Crescent Snare Recalled for Inadequate Package Seals
Aomori Olympus is recalling Crescent Snare devices due to inadequate package seals that may compromise sterility, posing an infection risk.
Product
CRESCENT SNARE, model no. SD-221U-25 - Product Usage: Used with endoscopes to electrosurgically resect tissue within the digestive tract.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1035-2021·2021-02-17
Aomori Olympus Recalls NeedleMaster Endoscopic Injection Needles Due to Seal Defects
Aomori Olympus is recalling NeedleMaster endoscopic needles because some sterile packages have inadequate seals, posing a risk of infection if used.
Product
NEEDLEMASTER 3MMx 23G LOWER, model no. NM-610L-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-1085-2021·2021-02-17
Cardinal Health Recalls Isolation Gowns Due to Potential Rips and Holes
Cardinal Health is recalling isolation gowns and lab coats due to potential defects like rips, holes, and open seams that may compromise barrier protection.
Product
Gown Isolation W/Ties Univ Ylw, SKU 1100PG, V1100PG, 2100PG, V2100PG, 2150PG, V2100PG 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…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1017-2021·2021-02-17
Aomori Olympus Endoscopic Injector Recall Due to Inadequate Package Seals
Aomori Olympus is recalling INJECTOR FORCEMAX LOWER 23G 4MM devices because inspection found some sterile packages have inadequate seals, posing an infection risk.
Product
INJECTOR FORCEMAX LOWER 23G 4MM, model no. NM-400U-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-1024-2021·2021-02-17
Aomori Olympus ForceMax Injector Recalled for Inadequate Package Seals
Aomori Olympus is recalling ForceMax injectors because some sterile packages have inadequate seals, posing a risk of infection if non-sterile equipment is used.
Product
INJECTOR FORCEMAX SIF 270CM 23G 4MM, model no. NM-401L-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-1100-2021·2021-02-17
Arjo Flat Dynamic Positioning System Recalled for Sling Clip Breakage Risk
Arjohuntleigh Magog is recalling 3,390 Arjo Flat Dynamic Positioning Systems due to a risk of sling clip breakage during use.
Product
Arjo Flat Dynamic Positioning System (DPS) - Product Usage: used in conjunction with passive clip slings is designed for resident transfer in a homecare setting, at nursing homes and other assisted living centers. Please note that the DPS can be utilized only if affixed to…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1104-2021·2021-02-17
Draegar Infinity Acute Care System Recall for Random Reboot Defect
Draegar Medical Systems is recalling Infinity Acute Care System monitors that may randomly reboot due to a memory error, potentially interrupting patient monitoring.
Product
Infinity Acute Care System (IACS) Monitoring Solution: The IACS is intended for multi-parameter, physiologic patient monitoring of adult, pediatric and neonatal patients in environments where patient care is provided by trained healthcare professionals.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1041-2021·2021-02-17
Aomori Olympus Recalls NeedleMaster Endoscopic Injection Needles Due to Seal Defects
Aomori Olympus is recalling NeedleMaster 3mm x 26G Lower needles because some sterile packages have inadequate seals, posing a risk of infection.
Product
NEEDLEMASTER 3MMx 26G LOWER, model no. NM-610U-0326 - 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-0992-2021·2021-02-17
Aomori Olympus Recalls SNAREMASTER PLUS Hot/Cold Snare Due to Seal Defects
Aomori Olympus is recalling SNAREMASTER PLUS Hot/Cold snares because inspection found some sterile packages have inadequate seals, posing an infection risk.
Product
SD-400U-15 SNAREMASTER PLUS Hot/Cold 15m, model no. SD-400U-15 - 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-1052-2021·2021-02-17
Aomori Olympus Recalls Guide Sheath Kits Due to Seal Defects
Aomori Olympus is recalling K-203 Guide Sheath Kits because some sterile packages have inadequate seals, posing a risk of infection if non-sterile equipment is used.
Product
K-203 GUIDE SHEATH KIT 2.6MM, model no. K-203 - Product Usage: Used with endoscopes to collect cells or tissue specimens in the respiratory organs.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1030-2021·2021-02-17
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 4MMx 21G UPPER, model no. NM-610L-0421 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in the GI tract.
Category
Medical Device
Distribution
Distributed nationwide
HighNHTSA·21V083000·2021-02-17
Blue Bird Recalls 2021-2022 School Buses Due to Electronic Stability Control Defect
Blue Bird is recalling 2021-2022 Vision and 2022 All American school buses because the hydraulic brake control unit may be programmed incorrectly, causing electronic stability control to malfunction.
Product
BLUE BIRD — BLUE BIRD VISION SCHOOL BUS, ALL AMERICAN SCHOOL BUS
Category
Vehicle
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0965-2021·2021-02-17
Aomori Olympus Recalls B7-2Q Balloon Catheters Due to Seal Defects
Aomori Olympus is recalling B7-2Q Balloon Catheters because some sterile packages have inadequate seals, posing a risk of infection if non-sterile equipment is used.
Product
B7-2Q BALLOON CATHETER 13MM DIA 3.2, model no. B7-2Q -Product Usage: Used with endoscopes for injection of contrast medium or other medical fluid into the biliary or pancreatic tract.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1051-2021·2021-02-17
Aomori Olympus Recalls Guide Sheath Kits Due to Seal Defects
Aomori Olympus is recalling K-202 Guide Sheath Kits because some sterile packages have inadequate seals, posing an infection risk.
Product
K-202 GUIDE SHEATH KIT 2.0MM, model no. K-202 - Product Usage: Used with endoscopes to collect cells or tissue specimens in the respiratory organs.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0983-2021·2021-02-17
Aomori Olympus Recalls Electrosurgical Snare Due to Inadequate Package Seals
Aomori Olympus is recalling KD-655U electrosurgical snares because some sterile packages have inadequate seals, posing a risk of infection if non-sterile equipment is used.
Product
KD-655U ELECTROSURGICAL SNARE, model no. KD-655U - 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-1031-2021·2021-02-17
Aomori Olympus Recalls NeedleMaster Endoscopic Injection Needles Due to Seal Defects
Aomori Olympus is recalling NeedleMaster endoscopic needles because some sterile packages have inadequate seals, posing an infection risk.
Product
NEEDLEMASTER 4MMx 23G UPPER, model no. NM-610L-0423 - 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-1070-2021·2021-02-17
Aomori Olympus Recalls Crescent Snare Due to Inadequate Package Seals
Aomori Olympus Co., Ltd. is recalling Crescent Snare models due to inadequate package seals that may compromise sterility and increase infection risk.
Product
CRESCENT SNARE, model no. SD-221L-25 - Product Usage: Used with endoscopes to electrosurgically resect tissue within the digestive tract.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0994-2021·2021-02-17
Aomori Olympus ForceMax Injector Recall Due to Package 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 UP 2.8MMCH 23G 4MM, model no. NM-400L-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-1032-2021·2021-02-17
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 4MMx 25G UPPER, model no. NM-610L-0425 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in the GI tract.
Category
Medical Device
Distribution
Distributed nationwide
HighNHTSA·21V078000·2021-02-17
2020-2021 Audi Q7 recalled for premature air bag deployment hazard
The air bag control module in certain 2020-2021 Audi Q7 vehicles may deploy the second stage of the front passenger air bag too quickly when an unbelted child is in the seat, increasing injury risk. Audi will update the module at no cost.
Product
AUDI — AUDI Q7
Category
Vehicle
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0997-2021·2021-02-17
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.
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