Severity 4 of 5

Severe recalls

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

What “severe” means here

Severity 4 (Severe) recalls have a real, documented risk of significant injury, hospitalization, or property damage even if no deaths have been reported. The agency classification is FDA Class II with hospitalization reports, USDA Class I, or a structural vehicle defect. These need attention quickly — not five-alarm urgency but not something to put off. Examples include allergen mislabeling on common allergens for products eaten by children, drug potency out of specification by a margin that could cause measurable harm, and vehicle defects affecting braking or steering.

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.

751–775 of 29054

SevereFDA (Devices)·Z-1879-2026·2026-04-29
Medline Convenience Kits with Syringes Recalled for Unapproved Design Changes
Medline Industries, LP is recalling Medline 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 worldwide.
Product
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes BIOPSY PACK DYNJ38587A, DYNJ38587B BIOPSY/DRAINAGE TRAY-LF DYNJ30078D W LINQ PACK DYNJ59108B
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1837-2026·2026-04-29
Medline PICC Tray Model DYNJ41648A regulatory clearance rescinded
Medline Industries has recalled its PICC Tray (Model DYNJ41648A) because the 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded by FDA.
Product
Medline Kits: 1) PICC TRAY, Model Number: DYNJ41648A
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1886-2026·2026-04-29
Medline Polycarbonate Syringes Recalled for Unapproved Design Changes
Medline Industries is recalling select Convenience Kits containing 10mL polycarbonate colored syringes (Eye Pack and Heart Cath Pack) due to unapproved design changes made outside of FDA 510(k) clearance.
Product
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes EYE PACK DYNJ35056A HEART CATH PACK DYNJ69318A
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1869-2026·2026-04-29
Soft-Vu Angiographic Catheter Recalled Due to Manufacturing Defect
Angiodynamics, Inc. is recalling Soft-Vu Angiographic Catheter (Straight Art, Non-Braided) units due to a manufacturing defect that may prevent guidewires from passing through the catheter hub's inner diameter.
Product
Soft-Vu Angiographic Catheter, Straight Art, Non-Braided; SOFT-VU STR ART 4F X 65CM 035 NB 0SH; Catalog No.: 10731401; Product/UPN No.: H787107314015 (Box), H787107314010 (Pouch); Box Quantity: 5 pouches;
Category
Medical Device
Distribution
Distributed nationwide
SevereNHTSA·26V274000·2026-04-29
Storyteller Overland Recalls 2023 AWD Vehicles for Coolant Line Defect
Storyteller Overland is recalling 2023 Stealth, Classic, and Beast Mode AWD vehicles because improperly routed coolant lines may cause engine overheating and loss of drive power.
Product
STORYTELLER OVERLAND — STORYTELLER OVERLAND BEAST MODE, STEALTH, CLASSIC
Category
Vehicle
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1867-2026·2026-04-29
Soft-Vu Angiographic Catheter Soft-Vu SO1 recalled for manufacturing defect
Angiodynamics is recalling the Soft-Vu Angiographic Catheter, Sos Omni Selective (1), Non-Braided due to a manufacturing defect that may prevent guidewires from passing through the catheter hub.
Product
Soft-Vu Angiographic Catheter, Sos Omni Selective (1), Non-Braided; SOFT-VU SO1 4F X 80CM 038 NB 0SH; Catalog No.: 10714024; Product/UPN No.: H787107140245 (Box), H787107140240 (Pouch); Box Quantity: 5 pouches;
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0495-2026·2026-04-29
Sterile Water for Injection bags recalled due to sterility concerns
B. Braun Medical Inc. is recalling Sterile Water for Injection USP 3000 mL bags (24,928 units) distributed nationwide due to lack of assurance of sterility and potential leakage from the diaphragm port.
Product
STERILE WATER — STERILE WATER (WATER)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Food)·H-0682-2026·2026-04-29
Kirkland Signature madeleines contain undeclared hazelnut and soy lecithin
Kirkland Signature Traditional Madeleines are being recalled because packages were filled with heart madeleines containing undeclared hazelnut and soy lecithin. 92 units are affected.
Product
Kirkland Signature Traditional Madeleines 12 Count/net wt. 18oz., Item #2000012, UPC 000020000127. Plastic clamshell container is packed with 9 pieces of Filled Heart Madeleines. Distributed by Costco Wholesale Corp. Seattle, WA. Label of recalled package is read in part: TRAD
Category
Food
Distribution
10 states
SevereFDA (Devices)·Z-1876-2026·2026-04-29
Medline 10mL Polycarbonate Syringes in Convenience Kits recalled
Medline Industries is recalling Medline Convenience Kits containing 10mL polycarbonate colored syringes due to unapproved design changes made outside of FDA 510(k) clearance. The kits were distributed nationwide in the US and to Canada, Panama, and Barbados.
Product
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes JUDKINS PACK DYNJ51126 ANGIO PACK DYNJ32555C, DYNJ66631 ANGIO TRAY DYNJ46153B ANGIOGRAPHY PACK DYNJ26855F ANGIOGRAPHY PACK-M-LF DYNJ24530I ANGIOGRAPHY TRAY-LF DYNJ022088
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1843-2026·2026-04-29
Control Syringes and Related Devices FDA Regulatory Clearances Rescinded
Medline Industries has recalled Control Syringes (Model DNSC89369 and DYNJSYR10C), Guidewires, and High-Pressure Tubing after their FDA 510(k) regulatory clearances were rescinded. The devices were distributed nationwide.
Product
Medline Kits: 1) SYR CONTROL 8ML ROTATING, Model Number: DNSC89369; 2) SYRINGE 10ML CONTROL MLL, Model Number: DYNJSYR10C
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0489-2026·2026-04-29
Harrow Eye FRESHKOTE Lubricant Eyedrops Sterile 10mL Recall
Harrow Eye LLC is recalling FRESHKOTE Lubricant Eyedrops because the manufacturer cannot guarantee the product remains sterile. Affected lots are 1X68 and 1X69, with an expiration date of 05/31/2027.
Product
FRESHKOTE LUBRICANT EYEDROPS, Sterile, 0.33 FL OZ (10mL), Harrow Eye LLC, Nashville, TN USA.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1892-2026·2026-04-29
Medline Convenience Kits with Polycarbonate Syringes Recalled for Unapproved Design Changes
Medline Industries is recalling Convenience Kits containing 10mL polycarbonate colored syringes because the products were modified in ways not approved by the FDA. The kits were distributed nationwide and internationally.
Product
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes ENSEMBLE GYNECO SCOPIE-LF DYNJ53744B LAVH GRH-LF DYNJ41792G
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1932-2026·2026-04-29
IV Start Kit with Non-Sterile Alcohol Prep Pads Recalled
LSL Healthcare is recalling IV Start Kits containing Webcol Large Alcohol Prep Pads due to non-sterility concerns. The affected kits were distributed nationwide in Maryland, Illinois, and Minnesota.
Product
LSL Healthcare, IV Start Kit, Model/Catalog Number: 3131
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1842-2026·2026-04-29
Medline Surgical Kits Recalled Due to Rescinded Regulatory Clearances
Medline Industries is recalling 41 different surgical kit models nationwide because regulatory clearances for certain control syringes, guidewires, and high-pressure tubing have been rescinded. Affected facilities should stop use and contact Medline.
Product
Medline Kits: 1) NEWBORN ADMISSION, Model Number: DYKB1038; 2) DRAINAGE TRAY, Model Number: DYNDA3188; 3) VA ORLANDO SHOULDER PACK, Model Number: DYNJG001027B; 4) TUMESCENT SYRINGE KIT, Model Number: DYNJTUMSYR; 5) OMC PTCA PACK, Model Number: DYNJT3719; 6) PORT PACK,
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0496-2026·2026-04-29
Dextrose Injection USP recalled due to sterility assurance concerns
B. Braun Medical Inc. is recalling Dextrose Injection USP 70% in 2000 mL bags nationwide due to lack of assurance of sterility and potential leakage from the diaphragm port after foil removal.
Product
DEXTROSE — DEXTROSE (DEXTROSE)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Food)·H-0666-2026·2026-04-29
Salute Seasonings ground allspice may be contaminated with Salmonella
Salute Seasonings Ground All Spice is being recalled because the product may be contaminated with Salmonella. The action covers 330 units across three lots.
Product
SALUTE SEASONINGS; Ground All Spice; Net Wt 16oz; Unistel Industries 650 Blossom Road Rochester, NY 14610; UPC: 7 69203 01617 0
Category
Food
Distribution
3 states
SevereNHTSA·26E024000·2026-04-29
Dorman Recalls Transmission Gearshift Cables Due to Bushing Detachment Risk
Dorman is recalling specific transmission gearshift cables where the bushing may detach, preventing the vehicle from shifting into Park and increasing the risk of a crash.
Product
POWER TRAIN:SHIFT LINKAGE/CABLE/ROD recall
Category
Vehicle
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1891-2026·2026-04-29
Medline Convenience Kits containing 10mL Polycarbonate Colored Syringes recalled
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 multiple product SKUs distributed nationwide and internationally.
Product
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes ARTERIOGRAM TRAY 00-402001T, 00-402001U CATH LAB-VEIN PROCEDURES DYNJ60329A CENTRAL VENOUS ACCESS PACK-LF CVI5070 FISTULAGRAM PACK DYNJ66259 INVASIVE LINE INSERTION DYNJ44123
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1931-2026·2026-04-29
LSL Healthcare Infant Central Line Dressing Change Kit Recalled
LSL Healthcare is recalling its Infant Central Line Dressing Change Kit (Model 2925H) distributed nationwide because it contains Webcol Large Alcohol Prep Pads that were recalled for non-sterility.
Product
LSL Healthcare, Infant Central Line Dressing Change Kit, Model/Catalog Number: 2925H
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1890-2026·2026-04-29
Medline Convenience Kits with 10mL Polycarbonate Colored Syringes Recalled
Medline Industries is recalling multiple 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 ADD A ENDOVASCULAR PACK-LF DYNJ0429339L, DYNJ0429339M ANGIO ARTERIOGRAM PACK-LF DYNJ0774026K ANGIO KIT PACK DYNJ83746B ANGIO TRAY NO LIDO DYNJ85557A ANGIOGRAPHY PACK II DYNJ1
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1844-2026·2026-04-29
Medline medical device kits recalled for regulatory compliance rescission
Medline Industries has recalled six medical device kits (arthrogram trays, angiography packs, and neuro packs) because their 510(k) regulatory clearances have been rescinded by the FDA.
Product
Medline Kits: 1) ARTHROGRAM TRAY, Model Number: DYNJ07425; 2) TOL NEURO ANGIO PACK, Model Number: DYNJ38610I 3) ANGIOGRAPHY PACK, Model Number: DYNJ45234A 4) C.I.C.N. ANGIO PACK, Model Number: DYNJ53064B 5) DR. ALLEYNE NEURO PACK, Model Number: DYNJ63779A 6) NEURO CTM IR P
Category
Medical Device
Distribution
Distributed nationwide
SevereNHTSA·26V269000·2026-04-28
Lode-King Recalls Trailers With Missing Rear Impact Guard Welds
Lode-King is recalling 2019-2026 trailers because missing welds on the rear impact guard reduce structural strength, increasing injury risk in rear-end crashes.
Product
LODE KING — LODE KING SDG53-3, SDF53-3, SDF50-3
Category
Vehicle
Distribution
Distributed nationwide
SevereNHTSA·26V268000·2026-04-28
Ford Ranger and Bronco front seat pivot bolts may dislodge
Ford is recalling certain 2024-2026 Ranger and Bronco vehicles because the front seat frame height-adjust pivot bolt may be loose or dislodged. 179,698 vehicles are affected.
Product
FORD — FORD RANGER, BRONCO
Category
Vehicle
Distribution
Distributed nationwide
SevereNHTSA·26V266000·2026-04-24
Audi Q5 front seat belts may fail to restrain occupants
Audi is recalling certain 2025 Q5, Q5 Sportback, SQ5 and SQ5 Sportback vehicles because the driver and front passenger seat belts may have been manufactured incorrectly.
Product
AUDI — AUDI Q5, Q5 SPORTBACK, SQ5, SQ5 SPORTBACK
Category
Vehicle
Distribution
Distributed nationwide
SevereNHTSA·26V264000·2026-04-23
REV Recalls 2026 Motorhomes Due to Unexpected Generator Activation
REV is recalling 2026 Fleetwood and Holiday Rambler motorhomes because a furnace defect may turn on the generator unexpectedly, posing a carbon monoxide risk.
Product
FLEETWOOD — FLEETWOOD, HOLIDAY RAMBLER FORTIS, VACATIONER, ADMIRAL, FLAIR
Category
Vehicle
Distribution
Distributed nationwide