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.

2776–2800 of 21732

HighFDA (Food)·H-0327-2026·2025-12-31
[pending] Zen Cleanse Blend herbal tea; .95 oz (27g) pouch; 18 pouches/box UPC: 819005011504
Pending LLM rewrite. Source: FDA_FOOD H-0327-2026.
Product
Zen Cleanse Blend herbal tea; .95 oz (27g) pouch; 18 pouches/box UPC: 819005011504
Category
Food
Distribution
3 states
HighFDA (Devices)·Z-0967-2026·2025-12-31
[pending] Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails M
Pending LLM rewrite. Source: FDA_DEVICE Z-0967-2026.
Product
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509320 Software Version: N/A Product Description: Affixus 9 mm, Length 320 mm, Right, Trochanteric Nail Component: N/A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0968-2026·2025-12-31
[pending] Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails M
Pending LLM rewrite. Source: FDA_DEVICE Z-0968-2026.
Product
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509340 Software Version: N/A Product Description: Affixus 9 mm, Length 340 mm, Right, Trochanteric Nail Component: N/A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0972-2026·2025-12-31
[pending] Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails M
Pending LLM rewrite. Source: FDA_DEVICE Z-0972-2026.
Product
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509420 Software Version: N/A Product Description: Affixus 9 mm, Length 420 mm, Right, Trochanteric Nail Component: N/A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0981-2026·2025-12-31
[pending] Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails M
Pending LLM rewrite. Source: FDA_DEVICE Z-0981-2026.
Product
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609440 Software Version: N/A Product Description: Affixus 9 mm, Length 440 mm, Left, Trochanteric Nail Component: N/A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0994-2026·2025-12-31
[pending] Ring Transjugular Intrahepatic Access Sets, Reference Part Numbers: 1) RTPS-100; 2) RTPS-100-10
Pending LLM rewrite. Source: FDA_DEVICE Z-0994-2026.
Product
Ring Transjugular Intrahepatic Access Sets, Reference Part Numbers: 1) RTPS-100; 2) RTPS-100-10.0; The Ring Transjugular Intrahepatic Access Set is intended for transjugular liver access in diagnostic and interventional procedures.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0987-2026·2025-12-31
[pending] Brand Name: Diasol Product Name: 100225-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non
Pending LLM rewrite. Source: FDA_DEVICE Z-0987-2026.
Product
Brand Name: Diasol Product Name: 100225-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·H-0329-2026·2025-12-31
[pending] Ritz Peanut Butter Cracker Sandwiches, Net Wt. 27.6 oz.- 20 Count (20 x 1.38-oz. 6-pack carton)
Pending LLM rewrite. Source: FDA_FOOD H-0329-2026.
Product
Ritz Peanut Butter Cracker Sandwiches, Net Wt. 27.6 oz.- 20 Count (20 x 1.38-oz. 6-pack carton)
Category
Food
Distribution
8 states
HighFDA (Devices)·Z-0965-2026·2025-12-31
[pending] LifeShield Drug Library Management (DLM); LifeShield Infusion Safety Software Suite v2.2 List Nu
Pending LLM rewrite. Source: FDA_DEVICE Z-0965-2026.
Product
LifeShield Drug Library Management (DLM); LifeShield Infusion Safety Software Suite v2.2 List Number 17003-02
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0978-2026·2025-12-31
[pending] Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails M
Pending LLM rewrite. Source: FDA_DEVICE Z-0978-2026.
Product
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609380 Software Version: N/A Product Description: Affixus 9 mm, Length 380 mm, Left, Trochanteric Nail Component: N/A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·H-0337-2026·2025-12-31
[pending] 1) Wegmans Deluxe Mixed Nuts, Unsalted, Net Wt. 34 oz. (964g), packaged in a plastic tub with UPC 07
Pending LLM rewrite. Source: FDA_FOOD H-0337-2026.
Product
1) Wegmans Deluxe Mixed Nuts, Unsalted, Net Wt. 34 oz. (964g), packaged in a plastic tub with UPC 077890421314, packed 6 tubs per case 2) Wegmans Deluxe Mixed Nuts, Unsalted, Net Wt. 11.5 oz. (326g), packaged in a plastic bag with UPC 077890421352, packed 12 bags per case
Category
Food
Distribution
2 states
HighFDA (Devices)·Z-0969-2026·2025-12-31
[pending] Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails M
Pending LLM rewrite. Source: FDA_DEVICE Z-0969-2026.
Product
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509360 Software Version: N/A Product Description: Affixus 9 mm, Length 360 mm, Right, Trochanteric Nail Component: N/A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·H-0339-2026·2025-12-31
[pending] Choceur Cookie Butter Holiday Bark. Standup Pouch Bag. 5 oz. (142g). UPC: 4069365095690. Wholesale u
Pending LLM rewrite. Source: FDA_FOOD H-0339-2026.
Product
Choceur Cookie Butter Holiday Bark. Standup Pouch Bag. 5 oz. (142g). UPC: 4069365095690. Wholesale unit is split case, with 9 of each item per case.
Category
Food
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0988-2026·2025-12-31
[pending] Brand Name: Diasol Product Name: 100125-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non
Pending LLM rewrite. Source: FDA_DEVICE Z-0988-2026.
Product
Brand Name: Diasol Product Name: 100125-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·H-0342-2026·2025-12-31
[pending] Baby Soothe Herbal Supplement, Promotes rest, helps ease colic, upset stomach, and teething discomfo
Pending LLM rewrite. Source: FDA_FOOD H-0342-2026.
Product
Baby Soothe Herbal Supplement, Promotes rest, helps ease colic, upset stomach, and teething discomfort, Contains: Catnip, Chamomile, Vegetable Glycerin, water; packaged in a 2 oz. glass dropper bottle
Category
Food
Distribution
12 states
HighFDA (Food)·H-0331-2026·2025-12-31
[pending] Product: Zimi Puff Pastry French Style (frozen) Package Size and quantity per case: 700 g paper car
Pending LLM rewrite. Source: FDA_FOOD H-0331-2026.
Product
Product: Zimi Puff Pastry French Style (frozen) Package Size and quantity per case: 700 g paper carton - 12/case UPC: 5201592020017. Frozen.
Category
Food
Distribution
10 states
HighFDA (Food)·H-0344-2026·2025-12-31
[pending] Chaga Mushroom Herbal Supplement, 1:5 Alcohol Double Extract, Supports a healthy immune system with
Pending LLM rewrite. Source: FDA_FOOD H-0344-2026.
Product
Chaga Mushroom Herbal Supplement, 1:5 Alcohol Double Extract, Supports a healthy immune system with anti-cancer properties; packaged in a 2 oz. glass dropper bottle, UPC 284588087831
Category
Food
Distribution
12 states
HighFDA (Devices)·Z-0991-2026·2025-12-31
[pending] Brand Name: Diasol Product Name: 100325-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non
Pending LLM rewrite. Source: FDA_DEVICE Z-0991-2026.
Product
Brand Name: Diasol Product Name: 100325-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0923-2026·2025-12-31
[pending] Brand name: AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic Common Name: DR 800
Pending LLM rewrite. Source: FDA_DEVICE Z-0923-2026.
Product
Brand name: AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic Common Name: DR 800
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0997-2026·2025-12-31
[pending] BECKMAN COULTER BICARBONATE REF: OSR6137 OSR6237 OSR6637 OSR6x37 Bicarbonate is a system reage
Pending LLM rewrite. Source: FDA_DEVICE Z-0997-2026.
Product
BECKMAN COULTER BICARBONATE REF: OSR6137 OSR6237 OSR6637 OSR6x37 Bicarbonate is a system reagent for the quantitative determination of Bicarbonate in human serum and plasma on Beckman Coulter AU analyzers.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·H-0330-2026·2025-12-31
[pending] Publix Raspberry Coffee Cake, Net Wt. 15 oz. (425g), packaged in an aluminum foil tray and clear pla
Pending LLM rewrite. Source: FDA_FOOD H-0330-2026.
Product
Publix Raspberry Coffee Cake, Net Wt. 15 oz. (425g), packaged in an aluminum foil tray and clear plastic clamshell lid with wraparound label, UPC 0-41415-54691-2, Distributed By Publix Supermarkets, Inc. Lakeland, FL 33802, packed 12 per case Case label reads, in part: Maple Wal
Category
Food
Distribution
1 state
HighFDA (Devices)·Z-0990-2026·2025-12-31
[pending] Brand Name: Diasol Product Name: 100230-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non
Pending LLM rewrite. Source: FDA_DEVICE Z-0990-2026.
Product
Brand Name: Diasol Product Name: 100230-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·H-0332-2026·2025-12-31
[pending] Product: Zimi Kunefe Ready to eat (Frozen) Package Size and quantity per case: 380 g paper carton/tr
Pending LLM rewrite. Source: FDA_FOOD H-0332-2026.
Product
Product: Zimi Kunefe Ready to eat (Frozen) Package Size and quantity per case: 380 g paper carton/tray - 9/case UPC: 5201592015822
Category
Food
Distribution
10 states
HighFDA (Food)·H-0346-2026·2025-12-31
[pending] Organic Ginger Root Herbal Supplement, Natural anti-inflammatory properties, supports gut, increases
Pending LLM rewrite. Source: FDA_FOOD H-0346-2026.
Product
Organic Ginger Root Herbal Supplement, Natural anti-inflammatory properties, supports gut, increases circulation, 50 capsules/560 mg, packaged in a plastic bag
Category
Food
Distribution
12 states
HighFDA (Devices)·Z-0963-2026·2025-12-31
[pending] The Stryker CranialMask Tracker is a single-use device consisting of a flexible printed circuit boar
Pending LLM rewrite. Source: FDA_DEVICE Z-0963-2026.
Product
The Stryker CranialMask Tracker is a single-use device consisting of a flexible printed circuit board (PCB) with 31 infrared (IR) light-emitting diodes (LEDs) as well as an electronics control unit for the LEDs which includes its own battery power supply. The measured LED positio
Category
Medical Device
Distribution
Distributed nationwide