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.

676–700 of 29054

SevereFDA (Food)·H-0712-2026·2026-05-13
French Broad chocolate assortment tasting guide misidentifies walnut bonbons
French Broad Chocolate bette's bake sale bonbon assortments are being recalled because the printed tasting guide misidentifies the Walnut Fudge and Peach Cobbler chocolates.
Product
french broad CHOCOLATE bette's bake sale (a multi-flavor bonbon assortment). 6-piece NET WT. 2.5 OZ (70.75G); 12-piece NET WT. 5 OZ (141.75G); and 24-piece NET WT. 10 OZ (283.5G), French Broad Chocolate Crafted in Asheville, NC 28801, USA
Category
Food
Distribution
41 states
SevereFDA (Devices)·Z-2064-2026·2026-05-13
Endoscopy Pump Tubing/Cap Set water aspiration risk recall
Erbe Medical is recalling ERBEFLO 2 Endoscopy Pump Tubing/Cap Sets due to a connector design that may allow unintended water flow, potentially leading to water aspiration and serious respiratory conditions.
Product
ERBEFLO 2, Endoscopy Pump Tubing/Cap Set, REF: 20325-222
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1855-2026·2026-05-13
Intuitive 8 mm SureForm 30 Gray Reloads Incomplete Staple Defect
Intuitive Surgical is recalling Intuitive 8 mm SureForm 30 Gray Reloads (Reference Numbers 48230M-05 and 48230M-06) because they may produce an incomplete staple line during curved-tipped stapler operations.
Product
Intuitive 8 mm SureForm 30 Gray Reloads Reference Numbers: 48230M-05 and 48230M-06
Category
Medical Device
Distribution
49 states
SevereFDA (Food)·H-0763-2026·2026-05-13
Raw Farm jalapeno raw cheddar linked to multistate E. coli outbreak
Raw Farm Raw Cheddar Jalapeno is being recalled in connection with a multi-state outbreak of E. coli O157:H7, covering the named batches and all prior batches and dates.
Product
RAW FARM RAW CHEDDAR Jalapeno NEVER WARMED ABOVE 102F (TRULY RAW) MADE WITH WHOLE RAW MILK MADE IN USA KEEP REFRIGERATED INGREDIENTS: whole raw milk, vegetable rennet, cultures, kosher sea salt, 100% organic chili powder jalapeno, air dried green jalapeno peppers Produced By: RAW
Category
Food
Distribution
10 states
SevereNHTSA·26V309000·2026-05-13
Lucid Air rear-wheel drive inverters may fail and cut drive power
Lucid is recalling certain 2024-2025 Air rear-wheel drive vehicles because the Gen 4 inverter may experience internal friction and become damaged, causing a loss of drive power.
Product
LUCID — LUCID AIR
Category
Vehicle
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0524-2026·2026-05-13
TPN Bag Recalled for Missing Insulin Formulation Error
Central Admixture Pharmacy Services is recalling a patient-specific TPN bag because it did not contain insulin as listed on the label. Patients relying on this product for the labeled insulin dosage may face serious health risks.
Product
TPN bag (patient specific), Rx# 11-4909703-0-1, Compound Volume 1660 mL per bag, Rx only, Single Dose Injection, Refrigerated Injection, Central Admixture Pharmacy Services, Los Angeles, 13128 Imperial Hwy, Santa Fe Spr., CA 90670
Category
Drug
Distribution
1 state
SevereFDA (Devices)·Z-1977-2026·2026-05-13
Halyard PERC TRAY Kit Syringe Adaptor Connection Risk Recall
The Halyard PERC TRAY kit (models SLPC34-01 and SLPC34-02) is being recalled due to risk that a Medline syringe rotating adaptor may unwind during use, causing a loose or full disconnection between the syringe and manifold.
Product
Halyard PERC TRAY kit. Model Numbers: SLPC34-01, SLPC34-02.
Category
Medical Device
Distribution
7 states
SevereFDA (Devices)·Z-1942-2026·2026-05-13
VOCSN V+Pro Ventilator System Respiratory Device Safety Recall
Ventec Life Systems is recalling VOCSN V+Pro ventilator units because they may not have been fully tested for high-pressure conditions, which could cause oxygen leaks and increase fire risk during use.
Product
VOCSN V+Pro package, REF: PRT-01198-000; VOCSN V+Pro unit, REF: PRT-01185-000
Category
Medical Device
Distribution
4 states
SevereFDA (Devices)·Z-1981-2026·2026-05-13
Coronary angio packs recalled over Medline syringe rotating adaptor defect
Coronary angio convenience kits are being recalled because they contain Medline Namic syringes whose rotating adaptor may unwind, risking disconnection from the manifold.
Product
Convenience kits containing Medline Namic Angiographic Control Syringes with Rotating Adaptor CORONARY ANGIO PACK Model numbers ANCA80AP ANCA80AQ
Category
Medical Device
Distribution
1 state
SevereFDA (Drugs)·D-0513-2026·2026-05-13
DELFLEX Peritoneal Dialysis Solution Recall Due to Potential Sterility Issues
Fresenius Medical Care is recalling DELFLEX Dextrose Peritoneal Dialysis Solution bags due to potential leaks from bag perforations that could compromise sterility. Affected patients should contact their healthcare provider immediately.
Product
DELFLEX, Dextrose Peritoneal Dialysis Solution with attached stay-safe Exchange Set for Intraperitoneal Dialysis Only, 2.5% DEX. LM/LC, 2L 5PK, Part Number 054-20222, Fresenius Medical Care North America, 920 Winter Street, Waltham, MA 02451.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Food)·H-0764-2026·2026-05-13
Raw Farm shredded raw cheddar linked to multistate E. coli outbreak
Raw Farm Raw Cheddar Simply Shredded Original in 8 oz packs is being recalled in connection with a multi-state outbreak of E. coli O157:H7.
Product
RAW FARM RAW CHEDDAR SIMPLY SHREDDED Original MADE WITH: WHOLE RAW MILK TRULY RAW - NEVER WARMED ABOVE 102F MADE IN THE USA KEEP REFRIGERATED INGREDIENTS: WHOLE RAW MILK, VEGETABLE RENNET, CULTURES, KOSHER SEA SALT Produced By: RAW FARM, LLC www.rawfarmusa.com 8 oz (227g) UPC: 8
Category
Food
Distribution
10 states
SevereFDA (Devices)·Z-2062-2026·2026-05-13
ERBEFLO CleverCap CO2 Tubing and Cap Sets for Endoscopes
Erbe Medical is recalling ERBEFLO CleverCap CO2 hybrid tubing and cap sets used with endoscopes because the distal connector may allow unintended water flow, potentially leading to water aspiration and serious respiratory complications.
Product
ERBEFLO CleverCap CO2: Hybrid CO2 Tubing/Cap Set for Olympus Scopes & CO2 Sources, REF: 20325-239; Hybrid CO2 Tubing/Cap Set for Olympus Scopes & UCR, REF: 20325-240; Hybrid CO2 Tubing/Cap Set for Olympus Scopes, REF: 20325-206; Hybrid CO2 Tubing/Cap Set for Pentax Scopes, REF: 2
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0523-2026·2026-05-13
Naproxen Oral Suspension Recalled for Lead and Lithium Contamination
Acella Pharmaceuticals is recalling Naproxen oral suspension due to the presence of lead and lithium above specification levels. The recall affects 6,336 bottles distributed nationwide.
Product
NAPROXEN — NAPROXEN (NAPROXEN)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0517-2026·2026-05-13
PurPrep Povidone-Iodine and Isopropyl Alcohol Solution Recalled for Sterility Assurance
CareFusion 213, LLC is recalling PurPrep sterile topical solution due to lack of assurance of sterility and potential product contamination. The affected product is a povidone-iodine and isopropyl alcohol solution distributed nationwide.
Product
PURPREP — PURPREP (POVIDONE IODINE AND ISOPROPYL ALCOHOL)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Food)·H-0765-2026·2026-05-13
Raw Farm bulk shredded cheddar linked to multistate E. coli outbreak
Raw Farm Shredded Raw Cheddar in 80 oz bulk format is being recalled in connection with a multi-state outbreak of E. coli O157:H7.
Product
RAW FARM SHREDDED RAW CHEDDAR 80 OZ [BULK ITEM] UPC: 835204000194
Category
Food
Distribution
10 states
SevereFDA (Food)·H-0766-2026·2026-05-13
Raw Farm bulk raw cheddar linked to multistate E. coli outbreak
Raw Farm Original Raw Cheddar in 80 oz bulk format is being recalled in connection with a multi-state outbreak of E. coli O157:H7.
Product
RAW FARM ORIGINAL RAW CHEDDAR 80 OZ [BULK ITEM] UPC: 835204001160
Category
Food
Distribution
10 states
SevereFDA (Devices)·Z-2106-2026·2026-05-13
Medline Convenience Kits recalled due to sterilization equipment calibration issues
Medline Industries is recalling four Convenience Kit models (892 units) nationwide because sterilization and packaging equipment calibration issues may have compromised the sterility assurance level of the devices.
Product
Medline Convenience Kits: 1) CHEST TUBE INSERTION TRAY, Model Number: DYNDA2941A; 2) CHEST/BREAST-LF, Model Number: DYNJ83950; 3) HERNIA REPAIR TOTE, Model Number: DYNJ908337A; 4) HERNIA REPAIR TOTE, Model Number: DYNJ908337C
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Food)·H-0698-2026·2026-05-13
Non-fat dried milk powder totes recalled over potential Salmonella contamination
Low Heat Non-Fat Dried Milk Powder supplied in plastic totes under five labels is being recalled over potential Salmonella contamination. The action covers 1,110,564 lbs.
Product
Low Heat Non-Fat Dried Milk Powder - plastic totes (NTE) 2200 lbs. (packed under 5 labels: Off Grade NFDM Variable; Grade A NFDM LH Basic; Grade A NFDM LH Green Loop rBST Free; Grade A NFDM LH Standard NC rBST Free; NFDM LH Variable Standard)
Category
Food
Distribution
0 states
SevereFDA (Devices)·Z-2091-2026·2026-05-13
Medline Convenience Kits Recalled for Sterilization Calibration Issues
Medline is recalling multiple convenience kits used in catheterization labs and surgical procedures due to calibration issues with sterilization equipment that may affect sterility assurance. The affected kits were distributed nationwide.
Product
Medline Convenience Kits: 1) ANGIO PROCEDURE PACK, Model Number:00-401824AA; 2) ENDO KIT W/SYRINGE, Model Number:DYKE1743; 3) BGMC ANGIOGRAPHY PACK-LF, Model Number:DYNJ0800934D; 4) GENERAL ENDO PACK-LF, Model Number:DYNJ0842873J; 5) ANGIO PROCEDURE PACK, Model Number:DY
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1979-2026·2026-05-13
Halyard VA Detroit Cath Lab Pack Kit Syringe Adaptor Disconnection Risk
Halyard VA Detroit Cath Lab Pack kits (Model VMCD029) are being recalled due to a potential risk that the Medline syringe rotating adaptor may unwind during use, causing a loose or full disconnection between the syringe and manifold.
Product
Halyard VA DETROIT CATH LAB PACK kit. Model Numbers: VMCD029.
Category
Medical Device
Distribution
7 states
SevereFDA (Devices)·Z-2114-2026·2026-05-13
Medline Surgical Convenience Kits recalled for sterilization calibration defect
Medline Industries is recalling multiple surgical convenience kits because equipment used to sterilize and package the devices had calibration issues that may have affected sterility assurance. The devices were processed through validated sterilization cycles but the calibration problems could impact their sterility.
Product
See RES for complete list. Medline Convenience Kits: 1) SPINAL CDS, Model Number: CDS940087AG; 2) SPINAL CDS, Model Number: CDS940087AI; 3) TOTAL HIP CDS-LF, Model Number: CDS980832Q; 4) TOTAL HIP CDS-LF, Model Number: CDS980832R; 5) TOTAL HIP CDS-LF, Model Number: CDS980832S; 6)
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0519-2026·2026-05-13
Octreotide Acetate Injectable Suspension Recalled Due to Sterility Assurance
Teva Pharmaceuticals USA, Inc. is recalling 2,200 kits of Octreotide Acetate for Injectable Suspension (30 mg) due to quality system deficiencies that affect sterility assurance. The recall affects all lots nationwide.
Product
OCTREOTIDE ACETATE — OCTREOTIDE ACETATE (OCTREOTIDE ACETATE)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1976-2026·2026-05-13
Halyard NEURO IR PERIPHERAL kit syringe adapter may disconnect
AVID Medical is recalling the Halyard NEURO IR PERIPHERAL (PS 64405) kit because the Medline syringe rotating adapter may unwind during use, causing a loose or full disconnection between the syringe and manifold.
Product
Halyard NEURO IR PERIPHERAL (PS 64405) kit. Model Number: UINR44-01.
Category
Medical Device
Distribution
7 states
SevereFDA (Devices)·Z-1971-2026·2026-05-13
Halyard CARDIAC CATH PACK SAN23CARDQ Kit Syringe Adapter Risk
AVID Medical is recalling Halyard CARDIAC CATH PACK SAN23CARDQ kits (Model DRCC36) due to a Medline syringe rotating adapter that may unwind during use, potentially causing loose or full disconnection between the syringe and manifold.
Product
Halyard CARDIAC CATH PACK SAN23CARDQ kit. Model Number: DRCC36.
Category
Medical Device
Distribution
7 states
SevereFDA (Devices)·Z-2007-2026·2026-05-13
Medical Action Industries Pack Cath BHH Catheter Kit Recall
Medical Action Industries is recalling Pack Cath BHH catheter kits because the rotating adapter may unwind during use, causing a loose or full disconnection between the syringe and manifold.
Product
Medical Action Industries Inc. Pack Cath BHH, REF: BHCA49K, Sterile EO, Rx Only, QTY: 5/Case
Category
Medical Device
Distribution
1 state