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.

1251–1275 of 52929

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-1933-2026·2026-04-29
LSL Healthcare Wound Closure Tray Model 7554 Recalled for Non-Sterility
LSL Healthcare is recalling its Wound Closure Tray (Model 7554) distributed nationwide to Maryland, Illinois, and Minnesota because the kits contained non-sterile Webcol Large Alcohol Prep Pads.
Product
LSL Healthcare Wound Closure Tray, Model/Catalog Number: 7554
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1941-2026·2026-04-29
Diversatek Viper Wire Guided Balloon Dilator Inflation Tag Incorrect
Diversatek Healthcare is recalling Viper 3-Stage Wire Guided Balloon Dilators because the attached inflation tag may contain an incorrect part number with wrong balloon diameter sizes and inflation pressures.
Product
Diversatek Healthcare Viper¿ 3-Stage Wire Guided Balloon Dilator, 18mm-19mm-20mm, REF 1205-20
Category
Medical Device
Distribution
19 states
HighNHTSA·26V273000·2026-04-29
Newmar Recalls 2026 Freedom Aire Motorhomes for Incorrect Weight Labels
Newmar is recalling 2026 Freedom Aire motorhomes because the Cargo Carrying Capacity label may display an incorrect weight value, potentially allowing the vehicle to be overloaded.
Product
NEWMAR — NEWMAR FREEDOM AIRE
Category
Vehicle
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1874-2026·2026-04-29
AccuVu Angiographic Catheter, Omni Flush, Non-Braided Defect Recall
Angiodynamics recalls AccuVu Angiographic Catheters due to a manufacturing defect that may prevent guidewires from passing through the catheter hub. The affected devices were distributed worldwide.
Product
AccuVu Angiographic Catheter, Omni Flush, Non-Braided, With 21 R/O Markers; ACCU-VU OF 4F X 70CM 035 NB 6SH 21 R/O 1CM; Catalog No.: 13709704; Product/UPN No.: H787137097045 (Box), H787137097040 (Pouch); Box Quantity: 5 pouches;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1922-2026·2026-04-29
Beckman Coulter Access Total T4 Calibrator Recalled for Inaccurate Results
Beckman Coulter is recalling Access Total T4 Calibrator lots because they produce falsely low patient results on DxI 600/800 instruments, potentially leading to unnecessary testing, delayed treatment for thyroid disorders, and incorrect dosing in pregnant patients.
Product
Access Total T4 Calibrator, Catalog No. 33805
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-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
HighFDA (Devices)·Z-1896-2026·2026-04-29
Avitene Ultrafoam Microfibrillar Collagen Hemostat Recalled for Foreign Matter
Davol, Inc. is recalling Avitene Ultrafoam Microfibrillar Collagen Hemostat (Catalog Number 1050030) because the product may contain foreign matter, confirmed to be inspect fragments.
Product
Avitene Ultrafoam Microfibrillar Collagen Hemostat - 8cm x 6.25cm x 1cm. Catalog Number: 1050030.
Category
Medical Device
Distribution
Distributed nationwide
HighNHTSA·26V271000·2026-04-29
Roadtrek recreational vehicle pop-top latches may disengage during transit
Roadtrek is recalling certain recreational vehicles because the pop-top latch may disengage during transit, causing the pop-top to lift. 312 vehicles are affected.
Product
ROADTREK — ROADTREK ZION SLUMBER, WESTFALIA WAVE SL, PLAY+SLUMBER, PLAY SLUMBER
Category
Vehicle
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1929-2026·2026-04-29
LSL Healthcare Central Line Dressing Change Kit Recalled for Non-Sterility
LSL Healthcare is recalling its Standard Central Line Dressing Change Kit (Model 2717J) because the included Webcol Large Alcohol Prep Pads were found to be non-sterile.
Product
LSL Healthcare, Standard Central Line Dressing Change Kit, Model/Catalog Number: 2717J
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·H-0674-2026·2026-04-29
El Mexicano agua fresca de horchata contains undeclared milk
EL MEXICANO agua fresca de horchata Instant Horchata Drink is being recalled because of undeclared milk. The action covers 405,136 packages distributed across a large number of states.
Product
EL MEXICANO agua fresca de horchata Instant Horchata Drink NET WT 12oz (340g) INGREDIENTS: *** MILK SUBSTITUTE (WHEY *** LACTOSE *** DISTRIBUTED BY MARQUEZ BROTHERS INTERNATIONAL, INC. San Jose CA 95138 UPC: 042743190204 Item: 102279
Category
Food
Distribution
29 states
HighFDA (Devices)·Z-1872-2026·2026-04-29
AccuVu Angiographic Catheter recall due to manufacturing defect
Angiodynamics is recalling AccuVu Angiographic Catheters due to a manufacturing defect that may prevent a guidewire from passing through the catheter hub. The defect could interfere with proper device function during medical procedures.
Product
AccuVu Angiographic Catheter, Omni Flush, Non-Braided, With 2 R/O Markers; ACCU-VU OF 4F X 70CM 035 NB 6SH 2 R/O 2CM; Catalog No.: 13709005; Product/UPN No.: H787137090055 (Box), H787137090050 (Pouch); Box Quantity: 5 pouches;
Category
Medical Device
Distribution
Distributed nationwide
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-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-1857-2026·2026-04-29
Soft-Vu Angiographic Catheter Kumpe Non-Braided manufacturing defect recall
Angiodynamics is recalling Soft-Vu Angiographic Catheter Kumpe units 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 40CM 038 NB 0SH; Catalog No.: 10710013; Product/UPN No.: H787107100135 (Box), H787107100130 (Pouch); Box Quantity: 5 pouches;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1863-2026·2026-04-29
Soft-Vu Angiographic Catheter Berenstein Non-Braided Device Recall
Angiodynamics is recalling Soft-Vu Angiographic Catheters (Berenstein, Non-Braided) due to a manufacturing defect that may prevent the guidewire from passing through the catheter hub. The defect affects 1,030 units distributed worldwide.
Product
Soft-Vu Angiographic Catheter, Berenstein, Non-Braided; SOFT-VU BER 4F X 100CM 038 NB 0SH; Catalog No.: 10714016; Product/UPN No.: H787107140165 (Box), H787107140160 (Pouch); Box Quantity: 5 pouches;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1877-2026·2026-04-29
Medline Convenience Kits With 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 270,311 units distributed nationwide and internationally.
Product
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes ADULT CATH PACK-LF DYNJ38395G ANGIO DRAPE PACK (ADLUG)642-LF DYNJ47665F DYNJ47665G ANGIO KIT PACK DYNJ83746 DYNJ83746A ANGIO PACK DYNJ30565G DYNJ51239C DYNJ66631A DYNJ6920
Category
Medical Device
Distribution
Distributed nationwide
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 (Food)·H-0671-2026·2026-04-29
Spice powder recalled after lead level exceeded the New York standard
A 4 oz spice powder is being recalled because its lead level was higher than the New York State Department of Agriculture and Markets standard. 20 cases are affected.
Product
Spice Powder, 4 oz, Plastic Bag
Category
Food
Distribution
8 states
HighFDA (Devices)·Z-1854-2026·2026-04-29
Olympus Thunderbeat II Shears Ultrasonic Mode distal tip detachment risk
Olympus is recalling Thunderbeat II Shears (5mm, 45cm) because the distal tip component may detach during use, potentially causing patient harm.
Product
Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 45cm. Model Number: TB2-0545FC.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1851-2026·2026-04-29
Olympus Thunderbeat II Shears recall due to distal tip detachment
Olympus Corporation of the Americas is recalling Olympus Thunderbeat II Shears (Model TB2-0520FC) because the distal tip component may detach during use.
Product
Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 20cm. Model Number: TB2-0520FC.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1894-2026·2026-04-29
LeadCare Plus Blood Lead Test Kit Recalled for Unexpectedly Elevated Results
Magellan Diagnostics is recalling LeadCare Plus Blood Lead Test Kits (Catalog Number 82-0004) because they may produce falsely elevated lead results when used with certain third-party micro-collection devices, potentially causing delayed testing and unnecessary follow-up testing.
Product
LeadCare¿ Plus Blood Lead Test Kit; Catalog Number: 82-0004; The LeadCare¿ Plus kit is provided with the following materials: " Sensors (4 containers of 24 each; 96 tests) " Treatment Reagent Tubes (4 packages of 24 each; 96 tests) " Calibration Button (1 @) " Lead Contro
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