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.

14451–14475 of 53090

HighFDA (Food)·F-0334-2023·2023-02-08
Ube Spanish Bread Recalled Due to Undeclared Wheat Allergen
Joy Joys Bakery LLC recalls Ube Spanish Bread because the label lists 'flour' without specifying it is wheat flour, failing to disclose a major allergen. The product was distributed in Washington and Oregon.
Product
Ube Spanish Bread, UPC 36897113. Product is packaged in plastic clear clamshell container and there are 6 pieces per container. Ingredients: Ube Flavoring, Butter, Egg, Flour, Water, Milk, Sugar, Salt, Yeast. Joy Joy s Bakery contact information: (253) 507-5259, 11107 Pacific…
Category
Food
Distribution
2 states
HighFDA (Food)·F-0331-2023·2023-02-08
Frozen burritos recalled for undeclared milk allergen
THE MISO BROTHERS INC is recalling Alpha Plant-Based Burrito (Pizza, 5.5 oz) because the product contains undeclared milk. Consumers with milk allergies should not consume this product.
Product
Alpha Plant-Based Burrito - Pizza 5.5 oz UPC 855099007016 Frozen
Category
Food
Distribution
0 states
HighFDA (Devices)·Z-1024-2023·2023-02-08
Affinity Fusion Oxygenator temperature monitoring adapter may loosen during cardiac surgery
The temperature monitoring adapter on Medtronic's Affinity Fusion Oxygenator may come loose during cardiopulmonary bypass procedures. The manufacturer has received multiple complaints about this issue.
Product
Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, OXY/CVR COMBO BB841 FUSION W/BALANCE 26L, REF BB841. Used in Cardiopulmonary bypass.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0328-2023·2023-02-08
Frozen Plant-Based Breakfast Sandwich Recalled for Undeclared Milk Allergen
THE MISO BROTHERS INC is recalling Alpha Plant-Based Breakfast Sandwiches because they contain milk that is not listed on the label. Consumers with milk allergies may experience allergic reactions.
Product
Alpha Plant-Based Breakfast Sandwich - Meatless Spicy Chorizo, Plant-Based Egg & Cheeze 5 oz UPC 810070350109 Frozen
Category
Food
Distribution
0 states
HighFDA (Food)·F-0336-2023·2023-02-08
Ube Roll bakery product recall due to undeclared wheat allergen
Joy Joys Bakery is recalling Ube Roll packages because the label lists 'flour' but does not specify it is wheat flour, creating an allergen risk for consumers with wheat sensitivity.
Product
Ube Roll UPC 35961092. Product is packaged in plastic clear clamshell container and there are 3 pieces per container. Ingredients: Ube Flavoring, Butter, Flour, Sugar, Salt, Yeast, Egg, Milk, Water. Joy Joy s Bakery contact information: (253) 507-5259, 11107 Pacific HWY SW…
Category
Food
Distribution
2 states
HighFDA (Devices)·Z-1051-2023·2023-02-08
Bard Catheter Repair Kits Recalled for Hardened, Unusable Adhesive
Bard Peripheral Vascular is recalling multiple catheter repair kits because the adhesive may be hardened or coagulated, rendering the kits unusable. Approximately 7,520 units were distributed worldwide.
Product
Catalog Number / Product Description 0601600 2.7F Broviac CV Catheter Repair Kit 0601610 4.2 Fr Broviac CV Catheter Repair Kit 0601620 6.6F Broviac CV Catheter Repair Kit 0601630 9.6F Hickman CV Catheter Repair Kit 0601680 Hickman / Leonard CV Catheter Repair Kit (all…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0318-2023·2023-02-08
DR SNACK Crystal Ginger recalled for undeclared sulfites
DR SNACK Crystal Ginger was recalled because the product contains undeclared sulfites. Affected products were distributed in the Northeast U.S.
Product
DR SNACK brand Crystal Ginger; Net Wt. 7.00 oz (0.20kg); Net 6oz; and Net 10 oz.
Category
Food
Distribution
7 states
HighFDA (Food)·F-0346-2023·2023-02-08
Organic jackfruit recalled for undeclared sulfites in Florida
Organic jackfruit produced by Food Castle, Inc. is being recalled due to undeclared sulfites not listed on the product label. Sulfite-sensitive consumers face potential allergic reaction risk.
Product
ORGANIC JACKFRUIT Nutty and Fruity Brand UNSWEETENED AND UNSULFURED NET WT. 3.5 oz. (100g) USDA ORGANIC UPC: 819496021426 8 units per case Distributed by: Food Castle Inc. Vernon, CA 90058 PRODUCT OF SRI LANKA
Category
Food
Distribution
1 state
HighFDA (Devices)·Z-1045-2023·2023-02-08
MEDLINE UNITE Foot and Ankle Screw Recall: Intra-Operative Failure
MEDLINE INDUSTRIES is recalling 420 units of UNITE Foot and Ankle surgical screws (Lot 810304) due to observed intra-operative failure when pre-drilled and implanted with excessive torque.
Product
MEDLINE UNITE FOOT & ANKLE Screw, Non-Locking, Mini T8 (2.0x8mm), REF MMSN2008
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1023-2023·2023-02-08
Medtronic Affinity Fusion Oxygenator: Temperature Monitoring Adapter May Detach
Medtronic is recalling 2,937 Affinity Fusion Oxygenators used in cardiac surgery because the Temperature Monitoring Adapter may detach during setup or disassembly.
Product
Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, Custom Packs, REF BB811. Used in Cardiopulmonary bypass.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0335-2023·2023-02-08
Ube Ensaymada recalled for undeclared wheat allergen
Joy Joys Bakery LLC is recalling Ube Ensaymada sold in Washington and Oregon due to undeclared wheat. The product label lists flour but does not specify wheat flour.
Product
Ube Ensaymada, UPC 6658266481. Product is packaged in plastic clear clamshell container and there are 4 pieces per container. Ingredients: Cream Cheese, Cheese, Butter, Milk, Sugar, Salt, Water, Yeast, Flour, Egg. Joy Joy s Bakery contact information: (253) 507-5259, 11107…
Category
Food
Distribution
2 states
HighFDA (Drugs)·D-0259-2023·2023-02-08
Hand Sanitizer Recalled Due to Manufacturing Practice Deviations
Frenda Corporation has recalled Global Care Antibacterial Hand Sanitizer due to manufacturing practice deviations. The recall affects 124 bottles with lot number C013121 distributed in Puerto Rico.
Product
Global Care Antibacterial Hand Sanitizer Alcohol Etilico 70% Original, 1 Gallon (128 FL OZ) 3785.41 mL, Dist. by Target Price, Inc. Catano, PR, UPC 8 70373 01326 2
Category
Drug
Distribution
1 state
HighFDA (Devices)·Z-1044-2023·2023-02-08
Biopsy Medium for In Vitro Fertilization Recalled Due to Product Contamination
CooperSurgical is recalling a lot of Biopsy Medium used in IVF procedures because the product may contain an incorrect medium that could degrade embryos. No illnesses have been reported.
Product
BIOPSY MEDIUM 10ML, Reference Number 10620010 A, used for blastomere biopsy of cleavage stage embryos for Pre-implantation Genetic Diagnosis (PGD)
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1039-2023·2023-02-08
Non-Invasive Patient Tracker Verification Failure During Image-Guided Surgery
Medtronic is recalling AxiEM Non-Invasive Patient Trackers due to increasing complaints that users cannot verify their navigation instruments work properly during image-guided surgery. The verification failure affects approximately 1,867 devices worldwide.
Product
AxiEM" Non-Invasive Patient Tracker
Category
Medical Device
Distribution
41 states
HighFDA (Devices)·Z-1037-2023·2023-02-08
Turbett Surgical Container TS1200 Recalled Due to Potential Weld Failures
Turbett Surgical Container TS1200 units may have weld failures that could breach the sterile barrier, potentially allowing unsterile instruments to be used in medical procedures and risking infection.
Product
Turbett Surgical Container, TS1200: Indicated for enclosing other medical devices that are to be sterilized by a healthcare provider
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1028-2023·2023-02-08
Medtronic Perfusion Oxygenator Temperature Monitoring Adapter Detachment Recall
Medtronic has recalled Custom Pack Perfusion Tubing Packs used in cardiopulmonary bypass procedures. The Temperature Monitoring Adapter on the oxygenator may detach during setup or disassembly.
Product
Custom Pack Perfusion Tubing Packs containing Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, REF CB811. Used in Cardiopulmonary bypass.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1042-2023·2023-02-08
Vanguard Knee System Prosthesis Components Incorrectly Labeled for Size and Side
Biomet is recalling 157 units of Vanguard Knee System prosthesis components incorrectly labeled as different sizes or surgical sides. Surgeons relying on labels could implant the wrong size or side, requiring corrective surgery.
Product
(1) Vanguard Knee System PS Open Box Femoral; Right; 60 mm. Intended for knee joint replacement prostheses. Item Number: 183104 (2) Vanguard Knee System PS Open Box Femoral; Right; 62.5 mm Item Number: 183106 (3) Vanguard Knee System PS Open Box Femoral; Right; 65 mm Item…
Category
Medical Device
Distribution
6 states
HighFDA (Food)·F-0327-2023·2023-02-08
Frozen breakfast sandwiches and burritos recalled for undeclared milk allergen
The Miso Brothers Inc. is recalling frozen breakfast sandwiches and breakfast burritos containing undeclared milk, affecting approximately 31,092 units distributed throughout US retail locations. This poses a risk to consumers with milk allergies.
Product
Alpha Plant-Based Breakfast Sandwich - Meatless Sausage, Plant-Based Egg & Cheeze 5 oz. UPC 810070350093 Frozen
Category
Food
Distribution
0 states
HighFDA (Devices)·Z-1032-2023·2023-02-08
Non-sterile procedural trays with potential sterile packaging breach
Medline Industries is recalling non-sterile procedural trays containing sterile blades that may damage sterile packaging due to blade puncture risk. Lot 22IBQ980. No illnesses reported.
Product
Non-sterile procedural trays labeled as MAJOR/MINOR, 3 per case
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0326-2023·2023-02-08
Plant-based breakfast burritos recalled for undeclared milk allergen
THE MISO BROTHERS INC is recalling 31,092 units of frozen Alpha Plant Based Breakfast Burritos due to undeclared milk. The product may contain milk, a common allergen.
Product
Alpha Plant Based Breakfast Burrito - Meatless Sausage SCRAMBLE 5.5 oz UPC 855099007733 Frozen
Category
Food
Distribution
0 states
HighFDA (Devices)·Z-1048-2023·2023-02-08
GORE CARDIOFORM Septal Occluder Recalled for Incomplete Quality Documentation
W L Gore & Associates is recalling 14 units of the GORE CARDIOFORM Septal Occluder (GSX0030A) due to incomplete quality test documentation. The missing verification of device release could pose a potential risk of device failure and serious complications.
Product
GORE CARDIOFORM Septal Occluder, REF: GSX0030A
Category
Medical Device
Distribution
Distributed nationwide
HighUSDA FSIS·PHA-02082023-01·2023-02-08
Goulart's Smoked Linguica Links Recalled for Undeclared Milk Allergen
USDA FSIS issued a public health alert for Goulart's Smoked Linguica Links due to undeclared milk. Consumers with dairy allergies should not consume these products.
Product
Goulart's Sausage Co. — FSIS Issues Public Health Alert for Ready-To-Eat Pork Sausage Products Due to Misbranding and an Undeclared Allergen
Category
Food
Distribution
1 state
HighFDA (Drugs)·D-0262-2023·2023-02-08
Diltiazem Hydrochloride extended-release capsules recalled due to failed quality specifications
Sun Pharmaceutical is recalling Diltiazem Hydrochloride Extended-Release Capsules (360 mg) due to failed impurity specifications and dissolution testing found during FDA laboratory evaluation. The recall affects five lot numbers distributed nationwide.
Product
DILTIAZEM HYDROCHLORIDE — DILTIAZEM HYDROCHLORIDE (DILTIAZEM HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1022-2023·2023-02-08
SynCardia Total Artificial Heart System Recalled for Cannula Tears
SynCardia Systems is recalling its Total Artificial Heart System due to reported tears in the cannula caused by wear and tear stress. Approximately 1,732 systems worldwide are affected.
Product
SynCardia Total Artificial Heart System (70CC): 500101-001 SynCardia Total Artificial Heart System (50CC): 570500-000
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1038-2023·2023-02-08
Turbett Surgical Container TS1000 may have weld failures breaching sterile barrier
Turbett Surgical Container TS1000 may have weld failures that breach the sterile barrier, potentially resulting in unsterile instruments being used in medical procedures and risking patient infection or injury.
Product
Turbett Surgical Container, TS1000: Indicated for enclosing other medical devices that are to be sterilized by a healthcare provider
Category
Medical Device
Distribution
Distributed nationwide