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.

14076–14100 of 53090

HighFDA (Devices)·Z-1175-2023·2023-03-08
Novafil Sutures Recalled for Sterile Barrier Breach Risk
Covidien is recalling 48,492 units of Novafil Monofilament Polybutester Sutures due to a sterile barrier breach in the breather pouch that may increase the risk of infection or vision loss during ophthalmic procedures.
Product
Novafil Monofilament Polybutester Suture Product Description: 8886 4002-41 NOVAFIL 3-0 BLU 90CM C14 8886 4400-13 NOVAFIL 6-0 BLU 45CM SBE2 8886 4400-23 NOVAFIL 5-0 BLU 45CM SBE2 8886 440123 NOVAFIL 5-0 BLU 45CM SBE3 8886 4402-33 NOVAFIL 4-0 BLU 45CM SBE4 8886 4403-33…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0394-2023·2023-03-08
Drizzilicious Mini Rice Cake Bites Recalled for Undeclared Peanut Residue
Snack Innovations Inc. is recalling Drizzilicious Mini Rice Cake bites due to undeclared peanut residue that may be present. Consumers with peanut allergies are at risk.
Product
Drizzilicious Mini Rice Cake bites Net Wt. 4oz and/or .74oz Bags Cookies & Cream UPC: 857900005167 and 857900005181 Packaged in a plastic bags Product also packed in the Drizzilicious mini rice cakes 32-ct Variety box
Category
Food
Distribution
10 states
HighFDA (Devices)·Z-1179-2023·2023-03-08
Surgipro Monofilament Polypropylene Sutures Recalled for Sterile Barrier Breach
Surgipro Monofilament Polypropylene Sutures are recalled due to a sterile barrier breach in the breather pouch, which may cause infection or vision loss during ophthalmic procedures.
Product
Surgipro Monofilament Polypropylene Sutures Product Description CP-535 SURGIPRO* 1 BLU 100CM GS24 X36 CP-824 SURGIPRO* 1 BLU 150CM GS26 X24 CP-825 SURGIPRO* 2 BLU 150CM GS26 X24 VP-543 SURGIPRO* 2-0 BLU 120CM V20 DA
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0382-2023·2023-03-08
Winter Mint Chocolate Premier Protein Shake Recalled for Processing Defect
Niagara Bottling is recalling Limited Edition Winter Mint Chocolate Premier Protein Shake 11.5oz because the product did not meet pre-kill step processing specifications and may become spoiled.
Product
Limited Edition Winter Mint Chocolate Premier Protein 30g Protein High Protein Shake 11.5oz (340mL) UPC 00643843801498 packaged in plastic bottles in full wrap lithographpacked in a cardboard case, 12 packages per case
Category
Food
Distribution
1 state
HighFDA (Devices)·Z-1170-2023·2023-03-08
Bone fixation plates recalled due to product packaging mix-up
Wright Medical Technology is recalling ORTHOLOC 3DSi CLAW II bone fixation plates due to packaging mix-up in specific lots. Packages contained incorrect product codes.
Product
ORTHOLOC 3DSi CLAW II 4 HOLE Plate, Size 25MM, REF 40241425, Bone fixation device
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0406-2023·2023-03-08
FDA Recalls Rosuvastatin Tablets Due to Manufacturing Practice Deviations
Accord Healthcare is recalling Rosuvastatin 20 mg tablets distributed in the US, Puerto Rico, and Canada due to Current Good Manufacturing Practice (CGMP) deviations. The deviations could affect product quality and safety.
Product
ROSUVASTATIN — ROSUVASTATIN (ROSUVASTATIN)
Category
Drug
Distribution
1 state
HighFDA (Devices)·Z-1200-2023·2023-03-08
CustomEyes kits recalled due to potential sterility compromise
Beaver Visitec International is recalling 4640 units of CustomEyes kits because packaging may contain open seals that could compromise product sterility. Affected units were distributed to 26 U.S. states and internationally.
Product
CustomEyes kits
Category
Medical Device
Distribution
27 states
HighNHTSA·23V153000·2023-03-08
2023 International MV and HV Vehicles Recalled for Driveshaft Separation Risk
Navistar is recalling certain 2023 International HV and 2023-2024 International MV vehicles due to incorrectly installed rear axle wedge shims that can cause driveshaft separation and loss of drive power. This increases the risk of a crash.
Product
INTERNATIONAL — INTERNATIONAL MV, HV
Category
Vehicle
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0408-2023·2023-03-08
Prescription Drug Simvastatin Recalled for Manufacturing Deviations
Accord Healthcare is recalling Simvastatin 5 mg tablets distributed in the United States, Puerto Rico, and Canada. The recall follows an FDA inspection that identified manufacturing practice deviations.
Product
SIMVASTATIN — SIMVASTATIN (SIMVASTATIN)
Category
Drug
Distribution
1 state
HighFDA (Drugs)·D-0423-2023·2023-03-08
FDA Recalls Pravastatin Sodium Tablets Due to Manufacturing Deviations
Accord Healthcare is recalling Pravastatin Sodium Tablets USP 40 mg due to manufacturing compliance deviations identified during an FDA inspection. The recall affects 120 bottles distributed in the United States, Puerto Rico, and Canada.
Product
PRAVASTATIN SODIUM — PRAVASTATIN SODIUM (PRAVASTATIN SODIUM)
Category
Drug
Distribution
1 state
HighFDA (Drugs)·D-0362-2023·2023-03-08
Phenylephrine injection recalled due to lack of sterility assurance
Nephron Sterile Compounding Center is recalling Phenylephrine HCl injection nationwide due to lack of assurance of sterility. Lot PS2008A with expiration 03/07/2023 is affected.
Product
Phenylephrine HCl in 0.9% Sodium Chloride Injection, USP, 50 mg/250 mL (200 mcg/mL), 250 mL Single-Dose Container bottle, packaged in 15 x 1 IV Bottles per carton, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC 69374-321-25.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1204-2023·2023-03-08
Med-Riser MR600 Patient Lift Boom Pivot Failure Risk Recall
Med-Mizer, Inc. is recalling the Med-Riser MR600 Patient Lift due to risk that the boom pivot may fail if the securing nut loosens and the bolt becomes unsecured. Contact the manufacturer for instructions.
Product
Med-Riser MR600 Patient Lift
Category
Medical Device
Distribution
0 states
HighFDA (Food)·F-0393-2023·2023-03-08
Drizzilicious Mini Rice Cake Bites Recalled for Undeclared Peanut Residue
Snack Innovations Inc. is recalling Drizzilicious Mini Rice Cake bites Cinnamon Swirl due to potential undeclared peanut residue. Individuals with peanut allergies should not consume this product.
Product
Drizzilicious Mini Rice Cake bites Net Wt.4oz and or .74oz Bags Cinnamon Swirl UPC: 857900005167 and UPC:857900005181 Packaged in a plastic bags Product also packed in the Drizzilicious mini rice cakes 32-ct Variety box
Category
Food
Distribution
10 states
HighFDA (Drugs)·D-0361-2023·2023-03-08
Phenylephrine HCl Injection Recalled for Sterility Assurance Deficiency
Nephron is recalling 24,870 Phenylephrine HCl Injection vials nationwide due to lack of sterility assurance. No illnesses have been reported.
Product
Phenylephrine HCl Injection, USP, 0.8 mg/10 mL (80 mcg/mL), 10 mL Single-Dose Vial, packaged in 30 x 10 mL Single-Dose Vials per carton, 12 x 30 Vials Carton per case, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC 69374-301-10.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0364-2023·2023-03-08
Sterile Water for Injection Recalled Due to Manufacturing Quality Deviations
Nephron Sc Inc recalls 325,080 vials of Sterile Water for Injection due to manufacturing quality deviations that could result in product carryover. Affected lots expire December 31, 2023.
Product
STERILE WATER — STERILE WATER (STERILE WATER)
Category
Drug
Distribution
0 states
HighFDA (Devices)·Z-1192-2023·2023-03-08
Alaris PC Unit 8015 wireless network connectivity failure affecting infusion pump management
Certain Alaris PC Unit 8015 infusion pump computers with specific wireless network cards may lose network connectivity, preventing remote infusion programming and data transfer. Manual programming of infusions may be required.
Product
Alaris PC Unit 8015 utilizing 802.11 b/g or 802.11 a/b/g wireless network cards, with IP addresses from x.x.x.224 to x.x.x.255
Category
Medical Device
Distribution
50 states
HighFDA (Drugs)·D-0365-2023·2023-03-08
Aripiprazole tablets recalled due to manufacturing process deviations
Accord Healthcare is recalling 747,464 bottles of Aripiprazole 2mg tablets due to manufacturing process deviations discovered during an FDA inspection. The affected medication was distributed in the United States, Puerto Rico, and Canada.
Product
ARIPIPRAZOLE — ARIPIPRAZOLE (ARIPIPRAZOLE)
Category
Drug
Distribution
1 state
HighFDA (Drugs)·D-0373-2023·2023-03-08
Atorvastatin Calcium tablets recalled due to manufacturing practice deviations
Accord Healthcare is recalling 147,736 bottles of Atorvastatin Calcium 40 mg tablets due to manufacturing practice deviations discovered during an FDA inspection.
Product
ATORVASTATIN CALCIUM — ATORVASTATIN CALCIUM (ATORVASTATIN CALCIUM)
Category
Drug
Distribution
1 state
HighFDA (Food)·F-0386-2023·2023-03-08
Lobster Ball Product Recalled for Incomplete Shellfish Allergen Labeling
Lobster Ball frozen seafood is recalled for inadequate shellfish allergen labeling. The product contains shellfish but is labeled as 'may contain shellfish,' failing to properly warn consumers with shellfish allergies.
Product
Lobster Ball***Ingredients: Surimi; Nemipterus Spp. (contain Egg), Palm Shortening, Water, Acetylated Tapioca Starch (E1420), Cellulose (E460(i)), Soy Protein, Flying Fish Roe, Permitted Flavour Enhancer***Salt, Sugar, Milk Powder, Emulsifiers, Flavouring***
Category
Food
Distribution
1 state
HighFDA (Food)·F-0399-2023·2023-03-08
Snack Day Vanilla Kettle Corn Recalled for Undeclared Peanut Residue
Snack Innovations Inc. is recalling 1,660 cases of Snack Day by Lidl Vanilla Flavored Kettle Corn due to potential undeclared peanut residue. The product was distributed to retailers in 10 U.S. states.
Product
Snack Day by Lidl Vanilla Flavored Kettle Corn Drizzled with Rainbow Sprinkles Net Wt. 5 oz (141g) Packaged in a plastic bags.
Category
Food
Distribution
10 states
HighFDA (Devices)·Z-1180-2023·2023-03-08
Surgipro II Surgical Sutures recalled for sterile barrier breach
Covidien is recalling Surgipro II Monofilament Polypropylene Sutures due to a sterile barrier breach in the breather pouch that may cause infection or vision loss in ophthalmic procedures with direct patient contact.
Product
Surgipro II Monofilament Polypropylene Sutures Product Description Model Number VP-421X SURGIPRO*II 4-0 90CM V20 DA7P VP421X VP-435-X SURGIPRO II 4-0 90CM KV5 DA7P VP435X VP-541X SURGIPRO*II 4-0 BLU 120CM V20DA VP541X VP-542-X SURGIPRO II 3-0 BLU 120CM V20DA VP542X…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0372-2023·2023-03-08
Atorvastatin Calcium tablets recalled due to manufacturing practice deviations
Accord Healthcare is recalling Atorvastatin Calcium 20 mg tablets due to manufacturing practice deviations found during an FDA inspection. The affected products were distributed in the United States, Puerto Rico, and Canada.
Product
ATORVASTATIN CALCIUM — ATORVASTATIN CALCIUM (ATORVASTATIN CALCIUM)
Category
Drug
Distribution
1 state
HighFDA (Devices)·Z-1197-2023·2023-03-08
Contact Lenses Recalled for Misaligned Axis Causing Poor Vision
CooperVision is recalling Biofinity XR Toric contact lenses due to misaligned axis in manufacturing that results in incorrect lens power. Users may experience poor visual acuity.
Product
Biofinity XR Toric 6-pack- Soft (hydrophilic) Contact Lens (extended wear)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0366-2023·2023-03-08
Accord Healthcare Recalls Aripiprazole Tablets Due to Manufacturing Deviations
Accord Healthcare is recalling approximately 1.1 million bottles of Aripiprazole 5mg tablets due to Good Manufacturing Practice deviations identified during an FDA inspection. No illnesses or injuries have been reported.
Product
ARIPIPRAZOLE — ARIPIPRAZOLE (ARIPIPRAZOLE)
Category
Drug
Distribution
1 state
HighFDA (Devices)·Z-1194-2023·2023-03-08
Vascular diagnostic devices recalled due to air embolism misconnection risk
Unetixs Vascular recalls MultiLab Series II vascular diagnostic devices worldwide due to a design flaw where air lines can be misconnected to IV lines, potentially causing air embolism.
Product
MultiLab Series II LHS TI & ERGO non-invasive vascular diagnostic device, Model Number 11949-0000-01
Category
Medical Device
Distribution
Distributed nationwide