Recalls

All US Product Recalls

Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.

How to read this listing

Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means deaths or serious injuries are reported, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.

The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.

Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.

Agency

All agencies FDA (Food)FDA (Drugs)FDA (Devices)USDA FSIS CPSC NHTSA EPA

14326–14350 of 31492

HighFDA (Drugs)·D-0399-2024·2024-04-03
FDA Recalls Fentanyl and Bupivacaine Injection Due to Sterility Concerns
SCA Pharmaceuticals is recalling 324 syringes of fentanyl/bupivacaine epidural injection nationwide due to lack of sterility assurance. Patients should contact their healthcare provider if affected.
Product
fentaNYL 100 mcg/50 mL, Bupivacaine HCl 0.125% in 0.9% Sodium Chloride 50 mL Injection (fentaNYL Concentration = 2 mcg/mL), EPIDURAL USE ONLY, 50 mL fill Syringe, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd, Windsor, CT 06095, NDC 70004-0231-22, Bar Code 70004023122
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1361-2024·2024-04-03
Thermalon Sinus Compress Recalled for Potential Mold and Mildew
Bruder Healthcare Company is recalling 1,416 units of Thermalon Sinus Compress (Item Number 24332) due to potential mold and mildew growth from excessive moisture exposure. Affected lot numbers are M053160 and M053570.
Product
Thermalon Sinus Compress, Item Number 24332
Category
Medical Device
Distribution
Distributed nationwide
HighNHTSA·23V169000·2024-04-03
Keystone Cougar travel trailers recalled for missing emergency exit window
Keystone is recalling certain 2022-2023 Cougar travel trailers that may lack a required emergency exit window, creating a safety hazard in emergency situations. Owners should contact Keystone customer service for a free inspection and replacement if needed.
Product
KEYSTONE — 2022 KEYSTONE COUGAR
Category
Vehicle
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1365-2024·2024-04-03
Thermalon Stye Compress recalled due to potential mold and mildew
Bruder Healthcare Company is recalling Thermalon Stye Compress (Item Number 24352) in certain lots due to potential mold and mildew growth from excessive moisture exposure. No illnesses have been reported.
Product
Thermalon Stye Compress, Item Number 24352
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-1103-2024·2024-04-03
German Home Bakery Apple Coffee Cake Recalled for Undeclared Wheat and Yellow #5
German Home Bakery Apple Coffee Cake is being recalled due to undeclared wheat and Yellow #5 food coloring. Consumers with wheat allergies or Yellow #5 sensitivity should not consume this product.
Product
German Home Bakery Apple Coffee Cake, 16 oz, clear poly bag
Category
Food
Distribution
1 state
HighFDA (Devices)·Z-1378-2024·2024-04-03
Baxter Supple Peri-Guard Repair Patch Recall Due to Endotoxin Contraindication
Baxter is recalling Supple Peri-Guard Repair Patch units due to elevated endotoxin levels that may exceed allowable limits for cerebrospinal fluid-contacting devices. The product should not be used in neurosurgery.
Product
Baxter Supple Peri-Guard Repair Patch (legacy product codes): a) PC0404SNBIO, b) PC0608NSBIO, c) PC0814SNBIO, d) PC1016SNBIO
Category
Medical Device
Distribution
5 states
HighNHTSA·23V174000·2024-04-03
Honda Odyssey Rearview Mirror Glass May Detach, Reducing Visibility
Honda is recalling certain 2020-2022 model year Odyssey, Passport, Pilot, and Ridgeline vehicles because heating pads behind the side-view mirrors may not be bonded properly, allowing mirror glass to detach and reduce visibility.
Product
HONDA — 2022 HONDA ODYSSEY
Category
Vehicle
Distribution
Distributed nationwide
HighNHTSA·22V197000·2024-04-03
2022 Hyundai Santa Fe and Santa Cruz Turbocharger Oil Pipe Fire Risk Recall
Hyundai is recalling 2022 Santa Fe and Santa Cruz vehicles because the turbocharger oil supply pipe may crack, causing an oil leak that could increase fire risk in the engine compartment.
Product
HYUNDAI — 2022 HYUNDAI SANTA FE
Category
Vehicle
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0419-2024·2024-04-03
Pharmaceutical Injection Recalled Due to Lack of Sterility Assurance
SCA Pharmaceuticals is recalling PHENYLephrine HCl 40 mg injection nationwide due to lack of sterility assurance. Patients should contact their healthcare provider and not use this product.
Product
PHENYLephrine HCl 40 mg in 0.9% Sodium Chloride Injection, (Concentration = 160 mcg/mL), 250 mL Bag, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0825-40, Bar Code 70004082540.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1372-2024·2024-04-03
Laboratory performance verifier recalled for mismatched diluent assembly
Ortho-Clinical Diagnostics is recalling 10,911 units of VITROS Performance Verifier I worldwide due to mismatched diluent components that could cause inaccurate quality control test results.
Product
VITROS Performance Verifier I
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1369-2024·2024-04-03
Cystatin C Calibrator Series CVS 2699 Recalled for Calibration Bias
Randox Laboratories is recalling Cystatin C Calibrator Series CVS 2699 because it runs with negative bias compared to other methods, which could affect test accuracy on automated analyzers.
Product
Cystatin C Calibrator - In vitro diagnostic (IVD) use in the calibration of the Randox Cystatin C assay on automated analysers Catalog Number: CVS 2699
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1390-2024·2024-04-03
Boston Scientific iSLEEVE Expandable Introducer Sets Recalled for Hemostatic Valve Leak
Boston Scientific is recalling specific batches of the iSLEEVE Expandable Introducer Set due to hemostatic valve leaks affecting 4,060 devices. The devices are distributed in the US, Canada, and worldwide.
Product
Boston Scientific iSLEEVE EXPANDABLE Introducer Set REF H74939349140, facilitates femoral access to the vascular system
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0407-2024·2024-04-03
Hydromorphone Injection Recalled Due to Lack of Sterility Assurance
SCA Pharmaceuticals recalls 1,023 syringes of Hydromorphone Injection nationwide due to lack of sterility assurance. No illnesses have been reported.
Product
HYDROmorphone HCl 10 mg/50 mL in 0.9% Sodium Chloride Injection (Concentration = 0.2 mg/ml) 50 mL fill Syringe, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0300-22, Bar Code 70004030022
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1396-2024·2024-04-03
Certain OptiCross Coronary Imaging Catheters recalled for manufacturing defect
Boston Scientific recalls certain batches of OptiCross Coronary Imaging Catheters manufactured with an incorrect voltage setting that may cause decreased image brightness.
Product
OptiCross Coronary Imaging Catheter, REF H749518080120
Category
Medical Device
Distribution
0 states
HighFDA (Drugs)·D-0422-2024·2024-04-03
FDA Recalls Sodium Citrate Injectable Solution Due to Sterility Concerns
SCA Pharmaceuticals recalls Sodium Citrate 4% injectable solution syringes (9,624 units) distributed nationwide due to lack of assurance of sterility.
Product
Sodium Citrate 4% 3 mL, Anticoagulation Solution Injection (Concentration = 40/mg/mL) 3mL fill Syringe, Repackaged by SCA Pharma, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0900-25, Bar Code 70004090025
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1379-2024·2024-04-03
Baxter Peri-Guard Repair Patch Contraindication Added for Neurosurgery
Baxter Healthcare has added a contraindication to Peri-Guard Repair Patch instructions, restricting use in neurosurgery because endotoxin levels may exceed allowable limits for cerebrospinal fluid-contacting devices.
Product
Baxter Peri-Guard Repair Patch (new product codes): a) PG0404, b) PG0608, c) PG0814, d) PG1016, e) PG1225
Category
Medical Device
Distribution
5 states
HighFDA (Drugs)·D-0412-2024·2024-04-03
Injectable midazolam HCl recalled due to sterility assurance failure
SCA Pharmaceuticals is recalling Midazolam HCl 100 mg/100 mL injectable nationwide because the manufacturer cannot assure sterility of the product. Users should consult their healthcare provider regarding affected lot numbers.
Product
Midazolam HCl 100 mg/100 mL in 0.9% Sodium Chloride Injection, (Concentration = 1mg/mL) 100 mL Bag, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0411-59, Bar Code 70004041159
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1358-2024·2024-04-03
Bio-Rad QXDx BCR-ABL diagnostic kit recalled for calibration errors
Bio-Rad Laboratories is recalling a diagnostic test kit due to incorrect calibrations and controls that may produce inaccurate test results. Patients and healthcare providers should contact the manufacturer.
Product
Bio-Rad, REF: 12005660, QXDx BCR-ABL %IS Kit
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-1109-2024·2024-04-03
Nordic Naturals Baby Vitamin D3 Liquid Recalled for Elevated Levels
Nordic Naturals has recalled its Baby's Vitamin D3 dietary supplement liquid due to elevated vitamin D3 levels. The recall affects approximately 5,564 bottles with lot number 234909.
Product
Nordic Naturals Baby s Vitamin D3 liquid, 400 IU (10 mcg) D3, 0.76 fl oz (22.5 mL) DIETARY SUPPLEMENT, dark glass bottle
Category
Drug
Distribution
28 states
HighFDA (Drugs)·D-0418-2024·2024-04-03
Phenylephrine HCl Injectable Recalled Nationwide for Lack of Sterility Assurance
SCA Pharmaceuticals is recalling Phenylephrine HCl Injectable (400 mcg/10 mL) distributed nationwide due to lack of sterility assurance. Affected lot numbers have expiration dates through May 2024.
Product
PHENYLephrine HCl 400 mcg/10 mL in 0.9% Sodium Chloride Injection, (Concentration = 40 mcg/mL), 10 mL fill 12 mL Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0811-12, Bar Code 70004081112.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1362-2024·2024-04-03
Thermalon Back Wrap Recalled for Potential Mold and Mildew Growth
Certain lots of Thermalon Back Wrap may have been exposed to excessive moisture, potentially resulting in mold and mildew growth. The product is distributed nationwide in the US and Canada.
Product
Thermalon Back Wrap, Item Number 24312
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1384-2024·2024-04-03
SOLTIVE Pro SuperPulsed Laser recalled for non-compliant power cord
Olympus Corporation recalls the SOLTIVE Pro SuperPulsed Laser (TFL-SLS) due to a non-compliant power cord with incompatible plug configurations for the regions where affected units were distributed.
Product
SOLTIVE Pro SuperPulsed Laser (TFL-SLS )
Category
Medical Device
Distribution
0 states
HighFDA (Drugs)·D-0413-2024·2024-04-03
Neostigmine methylsulfate injection recalled nationwide due to sterility concerns
SCA Pharmaceuticals is recalling 1,122 syringes of neostigmine methylsulfate injection nationwide due to inability to assure product sterility. The affected lot is 1223048138 (expiration 1/31/24).
Product
neostigmine methylsulfate 5 mg/5 mL Injection, (Concentration = 1mg/mL), 5 mL fill 6 mL Syringe, Rx Only, SCA Pharma, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0750-09, Bar Code 70004075009
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0408-2024·2024-04-03
HYDROmorphone Injectable Recalled Due to Sterility Assurance Failure
SCA Pharmaceuticals is recalling HYDROmorphone HCl injections due to lack of assurance of sterility. Patients who received the affected lot should contact their healthcare provider.
Product
HYDROmorphone HCl 25 mg/25 mL in 0.9% Sodium Chloride Injection, (Concentration = 1mg/mL), 25 mL fill 30 mL Syringe, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0303-17, Bar Code 7004030317
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0397-2024·2024-04-03
Fentanyl-Bupivacaine Epidural Injection Recalled for Sterility Assurance Failure
SCA Pharmaceuticals is recalling 242 bags of fentanyl-bupivacaine epidural injection due to lack of assurance of sterility. The affected lot may not meet required sterility standards.
Product
fentaNYL 200 mcg/100 mL, Bupivacaine HCl 0.125% in 0.9% Sodium Chloride 100 mL Injection (fentaNYL Concentration = 2 mcg/mL), EPIDURAL USE ONLY, 100 mL Bag, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0231-32, Bar Code 70004023132
Category
Drug
Distribution
Distributed nationwide

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14326–14350 of 31492