Recalls

All US Product Recalls

Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.

How to read this listing

Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means deaths or serious injuries are reported, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.

The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.

Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.

Agency

All agencies FDA (Food)FDA (Drugs)FDA (Devices)USDA FSIS CPSC NHTSA EPA

1201–1225 of 39824

HighFDA (Devices)·Z-1870-2026·2026-04-29
Soft-Vu Angiographic Catheter Omni Flush Non-Braided Defect Recall
Angiodynamics is recalling Soft-Vu Angiographic Catheters (Omni Flush, Non-Braided) due to a manufacturing defect that may prevent guidewires from passing through the catheter hub.
Product
Soft-Vu Angiographic Catheter, Omni Flush, Non-Braided; SOFT-VU OF 4F X 65CM 035 NB 6SH; Catalog No.: 10732301; Product/UPN No.: H787107323015 (Box), H787107323010 (Pouch); Box Quantity: 10 units;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1868-2026·2026-04-29
Soft-Vu Angiographic Catheter Headhunter recalled due to manufacturing defect
Angiodynamics is recalling Soft-Vu Angiographic Catheter, Headhunter (1), Non-Braided devices because a manufacturing defect may prevent guidewires from passing through the catheter hub.
Product
Soft-Vu Angiographic Catheter, Headhunter (1), Non-Braided; SOFT-VU HH1 4F X 100CM 038 NB 0SH; Catalog No.: 10714040; Product/UPN No.: H787107140405 (Box), H787107140400 (Pouch); Box Quantity: 5 pouches;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1862-2026·2026-04-29
Soft-Vu Angiographic Catheter, Kumpe, Non-Braided manufacturing defect
Angiodynamics is recalling Soft-Vu Angiographic Catheter, Kumpe, Non-Braided devices due to a manufacturing defect that may prevent guidewires from passing through the catheter hub.
Product
Soft-Vu Angiographic Catheter, Kumpe, Non-Braided; SOFT-VU KMP 4F X 65CM 038 NB 0SH; Catalog No.: 10714014; Product/UPN No.: H787107140145 (Box), H787107140140 (Pouch); Box Quantity: 5 pouches;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1907-2026·2026-04-29
OER-ELITE Endoscope Reprocessor Connecting Tubes Lock Failure Recall
Olympus Corporation of the Americas is recalling OER-ELITE Endoscope Reprocessor Connecting Tubes (Model MAJ-2119) due to potential premature failure of the Version 2 reprocessor connecting tube lock levers.
Product
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2119.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1853-2026·2026-04-29
Olympus Thunderbeat II shears 35 cm may shed a distal tip component
Olympus is recalling Thunderbeat II Shears with Ultrasonic Mode, 5 mm and 35 cm, because a distal tip component may detach during use. 3,360 units are affected.
Product
Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 35cm. Model Number: TB2-0535FC.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1866-2026·2026-04-29
Angiodynamics Soft-Vu Angiographic Catheter Guidewire Blockage Risk
Angiodynamics is recalling the Soft-Vu Angiographic Catheter, Kumpe, Non-Braided due to a manufacturing defect that may prevent guidewires from passing through the catheter hub.
Product
Soft-Vu Angiographic Catheter, Kumpe, Non-Braided; SOFT-VU KMP 4F X 100CM 038 NB 0SH; Catalog No.: 10714021; Product/UPN No.: H787107140215 (Box), H787107140210 (Pouch); Box Quantity: 5 pouches;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1940-2026·2026-04-29
Diversatek Viper balloon dilator tags may show incorrect inflation parameters
Diversatek Viper 3-Stage Wire Guided Balloon Dilators are being recalled because the catheter inflation tag may show an incorrect part number with wrong balloon diameters and pressures.
Product
Diversatek Healthcare Viper¿ 3-Stage Wire Guided Balloon Dilator, 15mm-16.5mm-18mm, REF 1205-18
Category
Medical Device
Distribution
19 states
HighFDA (Devices)·Z-1875-2026·2026-04-29
AccuVu Angiographic Catheter recalled for guidewire passage defect
Angiodynamics is recalling the AccuVu Angiographic Catheter (Pigtail, Non-Braided) due to a manufacturing defect that may prevent a properly sized guidewire from passing through the catheter hub's inner diameter.
Product
AccuVu Angiographic Catheter, Pigtail, Non-Braided, With 21 R/O Markers; ACCU-VU PT 4F X 70CM 035 NB 10SH 21 R/O 1CM; Catalog No.: 13709804; Product/UPN No.: H787137098045 (Box), H787137098040 (Pouch); Box Quantity: 5 pouches;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1938-2026·2026-04-29
Diversatek Healthcare Viper Balloon Dilator Inflation Tag Labeling Error
Diversatek Healthcare is recalling Viper 3-Stage Fixed Wire Balloon Dilators because the catheter inflation tag may contain incorrect part numbers and balloon diameter and pressure specifications.
Product
Diversatek Healthcare Viper¿ 3-Stage Fixed Wire Balloon Dilator, 6mm-7mm-8mm, REF 1204-08
Category
Medical Device
Distribution
19 states
HighFDA (Devices)·Z-1904-2026·2026-04-29
Olympus OER-ELITE Endoscope Reprocessor Connecting Tubes Recall
Olympus Corporation of the Americas is recalling OER-ELITE Endoscope Reprocessor Connecting Tubes (Model MAJ-2116) because the Version 2 reprocessor connecting tube lock levers may fail prematurely.
Product
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2116.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1882-2026·2026-04-29
Medline Polycarbonate Colored Syringes Kits Recalled for Unapproved Design Changes
Medline Industries is recalling Convenience Kits containing 10mL Polycarbonate Colored Syringes due to unapproved design changes made outside of FDA clearance. The recall affects 270,311 units distributed nationwide and internationally.
Product
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes FACE/RHINOPLASTY PACK DYNJ80343C PLASTIC HEAD-NECK PACK DYNJ86639
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1848-2026·2026-04-29
Medline D and C Pack Kits Recalled Due to Rescinded Regulatory Clearances
Medline Industries is recalling D and C Pack kits (Model DYNJ41254B) nationwide because regulatory clearances for certain Control Syringes, Guidewires, and High-Pressure Tubing have been rescinded.
Product
Medline Kits: 1) D AND C PACK, Model Number: DYNJ41254B
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1937-2026·2026-04-29
Protocol Configuration Tool software v1.3.0 for Hamilton AutoLys STAR
Foundation Medicine is recalling Protocol Configuration Tool (PCT) software v1.3.0 for Hamilton AutoLys STAR used within FoundationOneCDx due to potential spontaneous closures of Hamilton HxRunControl software during protocol execution.
Product
Protocol Configuration Tool (PCT) software v1.3.0 for Hamilton AutoLys STAR used within FoundationOneCDx (F1CDx) installed on Research Triangle Park laboratory Equipment IDs 01342, 01591, 01989, 01990, 01994, 01995.
Category
Medical Device
Distribution
2 states
ModerateFDA (Devices)·Z-1889-2026·2026-04-29
Medline Convenience Kits with Polycarbonate Syringes Recalled
Medline Industries is recalling Medline Convenience Kits containing 10mL polycarbonate colored syringes due to unapproved design changes made outside of FDA clearance.
Product
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes E P DRAPE PACK-LF DYNJ0373061J
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1883-2026·2026-04-29
Medline convenience kits recalled over unapproved syringe design changes
Medline is recalling convenience kits containing select 10 mL polycarbonate colored syringes because of unapproved design changes made outside the 510(k) clearance. 270,311 units are affected.
Product
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes BASIC CL PACK-LF DYNJ87052 BASIC PACK DYNJ83976 BASIC SET UP PACK DYNJ80700 CORONARY ANGI
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1905-2026·2026-04-29
Olympus OER-ELITE Endoscope Reprocessor Connecting Tubes Recall
Olympus Corporation of the Americas is recalling OER-ELITE Endoscope Reprocessor Connecting Tubes (Model MAJ-2117) because the Version 2 reprocessor connecting tube lock levers may fail prematurely.
Product
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2117.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1884-2026·2026-04-29
Medline Convenience Kits with 10mL Syringes Recalled for Unapproved Design
Medline Industries is recalling certain convenience kits containing 10mL polycarbonate colored syringes because of unapproved design changes made outside of FDA 510(k) clearance. The affected kits were distributed nationwide and to Canada, Panama, and Barbados.
Product
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes ANGIO KIT PACK DYNJ50783B ANGIO PHC DYNJ37485C C.I.C.N. ANGIO PACK DYNJ53064B FHT P NEURO PACK DYNJ39931D NEURO ARTERIOGRAM PACK-LF DYNJ0948060F NEURO KIT NAM0003
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1924-2026·2026-04-29
Flamingo Funnel Small surgical device recalled for sterilization defect
SurgiSmoke Solutions is recalling certain lots of the Flamingo Funnel Small (Model SQ20012-01) due to a manufacturing issue involving use of a non-gamma sterilization compatible drape.
Product
Flamingo Funnel Small, Model Number SQ20012-01
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1897-2026·2026-04-29
nanOss 3D Bone Graft Substitute Incorrectly Labeled with Five-Year Shelf Life
XTANT Medical Holdings is recalling nanOss 3D Advanced Bone Graft Substitute products due to incorrect labeling showing a 5-year shelf life when the approved shelf life is four years.
Product
nanOss 3D Advanced Bone Graft Substitute nanOss 3D Plus Advanced Bone Graft Substitute 90-300-251008: nanOss 3D Advanced Bone Graft Substitute, 25x100x8mm, 20cc 90-300-25508: nanOss 3D Advanced Bone Graft Substitute, 25x50x8mm, 10cc 90-300-251004: nanOss 3D Advanced Bone Gr
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1832-2026·2026-04-29
Medline Angio Cath Pack regulatory clearance rescinded nationwide
Medline Industries is recalling certain Angio Cath Pack kits (Model DYNJ24517D, Lot 25CBA224) because their regulatory 510(k) clearances have been rescinded by the FDA.
Product
Medline Kits: 1) ANGIO CATH PACK-MARY IMMACULAT, Model Number: DYNJ24517D
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1899-2026·2026-04-29
OER-ELITE Endoscope Reprocessor Connecting Tubes Lock Lever Failure
Olympus is recalling OER-ELITE Endoscope Reprocessor Connecting Tubes (Model MAJ-2111) because the Version 2 reprocessor connecting tube lock levers may fail prematurely.
Product
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2111
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1909-2026·2026-04-29
OER-ELITE Endoscope Reprocessor Connecting Tubes Lock Levers Failure Risk
Olympus Corporation is recalling OER-ELITE Endoscope Reprocessor Connecting Tubes (Model MAJ-2330) because the Version 2 reprocessor connecting tube lock levers may fail prematurely.
Product
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2330.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1880-2026·2026-04-29
Medline Convenience Kits with Polycarbonate Syringes Recalled for Unapproved Design Changes
Medline Industries is recalling Convenience Kits containing 10mL Polycarbonate Colored Syringes due to unapproved design changes made outside of FDA 510(k) clearance. The recall affects approximately 270,311 units distributed in the US and internationally.
Product
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes MINOR ENT SINUS PACK-LF DYNJ0101278F DYNJ0101278G DYNJ0101278I SINUS PACK DYNJ56262
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1908-2026·2026-04-29
Olympus OER-ELITE Endoscope Reprocessor Connecting Tubes Recall
Olympus is recalling OER-ELITE Endoscope Reprocessor Connecting Tubes (Model MAJ-2138) due to potential premature failure of the Version 2 reprocessor connecting tube lock levers. The defect could affect proper tube attachment during endoscope reprocessing.
Product
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2138.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1926-2026·2026-04-29
Flamingo Funnel Large surgical smoke evacuation device recall
SurgiSmoke Solutions is recalling certain lots of the Flamingo Funnel Large (Model SQ20012-03) surgical device due to a manufacturing nonconformance involving use of a non-gamma sterilization compatible drape.
Product
Flamingo Funnel Large, Model Number SQ20012-03
Category
Medical Device
Distribution
Distributed nationwide

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1201–1225 of 39824