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.

16951–16975 of 53124

HighFDA (Food)·F-1296-2022·2022-06-22
Cedar Crest S'Mores Ice Cream recalled due to plastic foreign material
Cedar Crest Specialties, Inc. is recalling Cedar Crest WI Campfire S'Mores Ice Cream due to foreign plastic material in the product. Consumers should not consume the affected product.
Product
Cedar Crest WI Campfire S'Mores Ice Cream, Net Wt. 1.5 Quarts (1.41 L). UPC 20652-00768. Graham Flavored Ice Cream with Crushed Peanut Butter cups and Marshmallow Swirl. Cedar Crest Specialties, Inc. Cedarburg, WI 53012
Category
Food
Distribution
5 states
HighFDA (Drugs)·D-1143-2022·2022-06-22
Prefilled Syringes of Medroxyprogesterone Acetate Recalled for Lack of Sterility Assurance
Afaxys Pharma is recalling 79,339 prefilled syringes of medroxyprogesterone acetate because the manufacturer could not assure sterility. The syringes were distributed nationwide.
Product
medroxyPROGESTERone Acetate Injectable Suspension, USP, 1 mL Prefilled Syringe, 150 mg/mL, Rx only, Manufactured by: Sun Pharmaceutical Industries, Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India Distributed by: Afaxys Pharma, LLC, Charleston, SC, 29403, USA, Product…
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1259-2022·2022-06-22
Illumina MiSeq Dx Sequencing Instruments Recalled Due to Cybersecurity Vulnerability
Illumina is recalling approximately 1,014 MiSeq Dx sequencing instruments due to a cybersecurity vulnerability. The devices are distributed worldwide and throughout the United States.
Product
illumina REF DX-410-1001 Model: MiSeq Dx illumina REF 15036706 Model: MiSeq Dx illumina REF 20014053 Model: MiSeq Dx
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-1297-2022·2022-06-22
Cedar Crest Caramel Collision Ice Cream Recalled for Plastic Contamination
Cedar Crest Caramel Collision Ice Cream is being recalled due to the presence of plastic foreign material in the product. The affected product was distributed across IL, MI, MN, TX, and WI.
Product
Cedar Crest Caramel Collision Ice Cream, Net Wt. 1.5 Quarts (1.41 L). UPC 20652-00714. Caramel Ice Cream with a Caramel Swirl and Chocolate coated Caramel Mini Cups. Cedar Crest Specialties, Inc. Cedarburg, WI 53012
Category
Food
Distribution
5 states
HighFDA (Drugs)·D-1126-2022·2022-06-22
Homeopathic drug Bacillinum Pulmo recalled for manufacturing deviations
Washington Homeopathic Products recalled Bacillinum Pulmo homeopathic drug due to manufacturing practice deviations. The Class II recall, initiated in May 2022 and terminated in May 2023, affected nationwide distribution.
Product
Bacillinum Pulmo, Potency: 30C, 200C, Liquid Pellets, Rx only, Washington Homeopathic Products, 260 JR Hawvermale Way, Berkeley Springs, WV 25411
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1142-2022·2022-06-22
Alcohol Antiseptic Hand Sanitizer Recalled for Chemical Contamination
A.P. Nonweiler is recalling its 80% alcohol antiseptic hand sanitizer because FDA testing found acetaldehyde and acetal above safe specification limits. The product was distributed in Wisconsin and Virginia.
Product
Alcohol Antiseptic 80%, Topical Solution, Hand Sanitizer, Non-Sterile Solution, Packaged as (a) 250 U.S. gallons per tote, Product Code 9999D361-250: (b) 1 U.S. gallon, Product Code 9999D361-001: A.P. Nonweiler Co., Inc., 3321 County Road A, Oshkosh, WI 54901.
Category
Drug
Distribution
2 states
HighFDA (Food)·F-1298-2022·2022-06-22
Zesty Sweet Peppers Recalled Due to Potential Botulinum Contamination
Soul Cedar Farm's Zesty Sweet Peppers are being recalled due to potential contamination with Clostridium botulinum. Testing found a pH level of 5.57, which can support dangerous pathogen growth in shelf-stable foods.
Product
Zesty Sweet Peppers. Shelf stable product in glass container. Net wt. 8 oz (372 g). The label is read in parts: "***Zesty Sweet Peppers *** Ingredients: Sweet Peppers, Balsamic Vinegar (organic wine vinegar, organic concentrated grape must), Olive Oil, Onion, Lemon Juice…
Category
Food
Distribution
1 state
HighFDA (Devices)·Z-1267-2022·2022-06-22
Medtronic Cobalt ICD and CRT-D Telemetry Software Error Recall
Medtronic is recalling Cobalt and Crome ICDs and CRT-Ds due to a software telemetry error in the CareLink SmartSync Device Manager. The error may affect device communication and remote monitoring.
Product
Cobalt Models loaded with CareLink SmartSync Device Manager application software D00U005: a) Cobalt XT VR: DVPA2D1, DVPA2D4; b) Cobalt VR: DVPB3D1, DVPB3D4; c) Cobalt XT DR: DDPA2D1, DDPA2D4; d) Cobalt DR: DDPB3D1, DDPB3D4; e) Cobalt XT HF: DTPA2D4, DTPA2D1 f) Cobalt…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1270-2022·2022-06-22
Philips OmniWire guide wire recalled for potential sterilization failure
Volcano Corp is recalling 11 Philips OmniWire Pressure guide wires distributed in Washington, Wisconsin, and Canada due to a potential failed sterilization process.
Product
Philips OmniWire Pressure guide wire REF 89185J PN 300000252891
Category
Medical Device
Distribution
2 states
HighNHTSA·22V441000·2022-06-22
2023 Thomas Built Saf-T-Liner C2 School Buses Recalled for Emergency Exit Defect
Daimler Trucks North America is recalling 2023 Thomas Built Saf-T-Liner C2 school buses because they may lack sufficient emergency exits, increasing injury risk during emergencies.
Product
THOMAS BUILT BUSES — THOMAS BUILT BUSES SAF-T-LINER C2
Category
Vehicle
Distribution
Distributed nationwide
HighFDA (Food)·F-1376-2022·2022-06-22
Dawn's Campfire BBQ Beans Recalled for Metal Foreign Object
Morski Brands recalls 1,312 units of Dawn's Campfire BBQ Beans nationwide due to metal foreign objects. Consumers should not consume the product.
Product
Dawn's Campfire BBQ Beans, #90125, Net Wt 8 lb (3.63 kg) Keep Refrigerated UPC 0 32345 90125 4. Mfg By Morski Brands, Inc., Portage, WI 53901
Category
Food
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1146-2022·2022-06-22
Medroxyprogesterone acetate injectable suspension recalled for lack of sterility assurance
Sun Pharmaceutical is recalling medroxyprogesterone acetate injectable suspension (150 mg/mL) nationwide due to lack of assurance of sterility. Affected lots contain vials with expiration dates from December 2022 through September 2023.
Product
medroxyPROGESTERone Acetate Injectable Suspension, USP, 1 mL Single-Dose Vial, 150 mg/mL, Rx only, Manufactured for: Northstart Rx LLC, Memphis, TN, 38141, Manufactured by: Sun Pharmaceutical Industries Ltd., Halol Baroda Highway, Halol-389 350, Gujarat India , NDC…
Category
Drug
Distribution
Distributed nationwide
HighFDA (Food)·F-1312-2022·2022-06-22
Pedialyte Strawberry Lemonade Powder Recalled for Undeclared Wheat Allergen
Abbott Laboratories recalls one lot of Pedialyte Strawberry Lemonade powder because dextrose derived from wheat was not declared on the label. Lot code 287112S00.
Product
Pedialyte***Replaces Electrolytes***Great for Kids and Adults***Strawberry Lemonade Natural Flavor with Other Natural Flavor*** 6 0.6 OZ (17g) PACKETS/NET WT. 3.6 OZ (102g)***INGREDIENTS: ANHYDROUSE DEXTROSE, CITRIC ACID, POTASSIUM CITRATE***Manufactured for: Abbott Nutrition…
Category
Food
Distribution
12 states
HighFDA (Food)·F-1374-2022·2022-06-22
Ranch BLT Pasta Salad Recalled for Metal Foreign Objects
Morski Brands recalls Ranch BLT Pasta Salad nationwide due to possible metal fragments. The product was sold under Finest Traditions and Dawn's brands with a best-before date of 6-13-22.
Product
Ranch BLT Pasta Salad, Keep Refrigerated packaged in the following brands and plastic container sizes: 1. Finest Traditions, Net Wt. 2/5 lbs. (10 lbs) (4.54kg), Item 10406332. UPC 10 7 33147 11722 1. Distributed By: DBC Foods, St. Cloud, MN 56302. 2. Dawn's…
Category
Food
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1262-2022·2022-06-22
Olympus endoscope diopter ring adhesive failure may impair vision
Olympus endoscopes with defective diopter ring adhesive may cause vision loss and, in rare cases, urinary tract perforation.
Product
Olympus CYSTONEPHROFIBERSCOPE Model: CYF-5
Category
Medical Device
Distribution
9 states
HighFDA (Drugs)·D-1135-2022·2022-06-22
Homeopathic drug Proteus recalled for manufacturing quality control deviations
Washington Homeopathic Products is recalling Proteus homeopathic remedy in multiple potencies due to manufacturing process deviations. The firm initiated this voluntary recall in May 2022.
Product
Proteus, Potency: 7C, 8C, 9C, 12C, 15C, 16C, 20C, 30C, 200C, OTC, Liquid Pellets, Washington Homeopathic Products, 260 JR Hawvermale Way, Berkeley Springs, WV 25411
Category
Drug
Distribution
Distributed nationwide
HighNHTSA·22V443000·2022-06-22
2022 Freightliner Cascadia brake system may fail to engage
The emergency braking system on certain 2022 Freightliner Cascadia trucks may fail to engage, creating a risk of brake failure. Dealers will install a corrective valve at no cost.
Product
FREIGHTLINER — FREIGHTLINER CASCADIA
Category
Vehicle
Distribution
Distributed nationwide
HighFDA (Food)·F-1373-2022·2022-06-22
Steakhouse Potato Salad Recalled Due to Metal Contamination
Morski Brands is recalling Steakhouse Potato Salad products nationwide due to metal contamination. Affected brands include Finest Traditions and Dawn's.
Product
Steakhouse Potato Salad, Keep Refrigerated packaged in the following brands and plastic container sizes: 1. Finest Traditions, Net Wt. 10 lb (4.54kg), Item 1038364. UPC 10-73314710773-4. Mfg By Morski Brands, Inc., Portage, WI 53801. 2. Finest Traditions, Net Wt.…
Category
Food
Distribution
Distributed nationwide
HighFDA (Food)·F-1314-2022·2022-06-22
Thistle Tropical Limeade Cold-Pressed Juice recalled for hepatitis A
Thistle Health Inc. recalls 1,003 bottles of Thistle Tropical Limeade due to strawberries potentially contaminated with Hepatitis A. Affected product was distributed in California, Nevada, Oregon, and Washington.
Product
Thistle Tropical Limeade Cold-Pressed Organic Juice watermelon pineapple lime strawberry papaya activated charcoal 32 FL OZ (355 mL) Keep Refrigerated Distributed By: Thistle Health Inc. Vacaville, CA 95688
Category
Food
Distribution
4 states
HighFDA (Devices)·Z-1268-2022·2022-06-22
Medtronic Crome and Cobalt Cardiac Defibrillators Recalled Due to Telemetry Error
Medtronic recalls 3,944 Crome and Cobalt ICDs and CRT-Ds due to a potential telemetry error affecting device communication with external monitors.
Product
Crome Models loaded with CareLink SmartSync Device Manager application software D00U005: a) Crome VR: DVPC3D1, DVPC3D4; b) Crome DR: DDPC3D1, DDPC3D4; c) Crome HF: DTPC2D4, DTPC2D1; d) Crome HF Quad: DTPC2QQ, DTPC2Q1
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1261-2022·2022-06-22
FDA Recalls Axium Detachable Coil Systems for Incorrect Labeling
Micro Therapeutics is recalling Axium Detachable Coil Systems due to incorrect size and configuration labeling. The 96 affected units were distributed to China and the Republic of Korea.
Product
AXIUM DETACHABLE COIL SYSTEM REF QC-4-12-HELIX; Axium Detachable Coil System REF QC-10-30-3D;
Category
Medical Device
Distribution
0 states
HighFDA (Drugs)·D-1149-2022·2022-06-22
Hand Sanitizer Recalled for Acetaldehyde and Acetal Above Limits
Hand Sanitizer LLC is recalling Say Goodbye to Germs hand sanitizer bottles due to CGMP deviations. FDA testing found acetaldehyde and acetal levels above acceptable limits.
Product
HAND SANITIZER SAY GOODBYE TO GERMS Alcohol Antiseptic 80% Topical Non-Sterile Solution, 12 FL OZ (254 mL) bottles, Distributed by: Hand Cleansing Gel 850 Kaliste Saloom Rd. Suite 212 Lafayette, LA 70508 UPC 8 60003 62626 9
Category
Drug
Distribution
0 states
HighFDA (Food)·F-1313-2022·2022-06-22
Thistle Watermelon Berry Juice Recalled for Potential Hepatitis A Contamination
Thistle Health Inc is recalling Thistle Watermelon Berry Cold-Pressed Organic Juice (32 fl oz) due to potential Hepatitis A contamination in the strawberry ingredient. The recall affects 965 bottles distributed in California, Nevada, Oregon, and Washington.
Product
Thistle Watermelon Berry Cold-Pressed Organic Juice watermelon strawberry lime chia 32 FL OZ (355 mL) Keep Refrigerated Distributed By: Thistle Health, Inc., Vacaville, CA 95688
Category
Food
Distribution
4 states
HighFDA (Food)·F-1315-2022·2022-06-22
Rolls Recalled for Undeclared Milk Allergen from RoRo's
RoRo's Dinn-A-Rolls (10oz, UPC 86945900031) are being recalled because the label fails to declare milk as a sub-ingredient in butter. Consumers with milk allergies should not consume this product.
Product
RoRo's Dinn-A-Rolls, 10oz UPC: 86945900031 packaged in a pan and wrapped in plastic 4 pans per case
Category
Food
Distribution
1 state
HighFDA (Drugs)·D-1150-2022·2022-06-22
Zileuton Extended-Release Tablets recalled for failed dissolution specifications
Lupin Pharmaceuticals is recalling Zileuton Extended-Release Tablets, 600 mg, due to failed dissolution specifications found during stability testing that may affect medication efficacy.
Product
Zileuton Extended-Release Tablets, 600 mg, 120-count bottle, Rx only, Manufactured for Lupin Pharmaceuticals, Inc., Baltimore, MD 21202 by Lupin Limited, Nagpur-441108, India, NDC 68180-169-16
Category
Drug
Distribution
Distributed nationwide