The Recall Desk

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.

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18151–18175 of 27833

  • HighFDA (Devices)·Z-1644-2023·2023-06-07

    EarlyVue VS30 Vital Signs Monitor lacks calibration alarm, risking inaccurate CO2 readings

    Philips EarlyVue VS30 vital signs monitors lack a calibration alarm, potentially causing inaccurate CO2 measurements. This could prevent clinicians from detecting changes in patient condition.

    Product
    EARLYVUE VS30 VITAL SIGNS MONITOR Software Version A.00.02 and A.00.01 Product Number: 863359
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0810-2023·2023-06-07

    Hydrocortisone and Acetic Acid Otic Solution Recalled Due to Manufacturing Deviations

    Akorn, Inc. is recalling all lots of Hydrocortisone and Acetic Acid Otic Solution, USP (10 mL bottles) nationwide due to manufacturing deviations. The company ceased business and could not complete required stability studies to verify product quality.

    Product
    Hydrocortisone and Acetic Acid Otic Solution, USP, 10 mL bottles, Rx Only, Distributed by: Akorn, Inc., Gurnee, IL 60031. ALL NDCs
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0815-2023·2023-06-07

    Lactulose Solution Recall Due to Manufacturing Practice Deviations

    Akorn, Inc. has recalled all lots of Lactulose Solution, USP 30 mL Unit Dose Cups nationwide due to the company's inability to continue stability studies after ceasing operations.

    Product
    Lactulose Solution, USP (For oral or rectal administration), 30 mL Unit Dose Cups, Rx Only, Distributed by: Akorn, Inc., Gurnee, IL 60031. ALL NDCs
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0845-2023·2023-06-07

    Sodium Chloride Ophthalmic Solution Recalled Due to Incomplete Stability Studies

    Akorn Operating Company is recalling all lots of Sodium Chloride Ophthalmic Solution (5%, 50mg/mL) nationwide because the firm went out of business and could not complete required stability studies to verify product safety and effectiveness.

    Product
    Sodium Chloride Ophthalmic Solution, USP, 5%, 50mg/mL, 15 mL bottles, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0956-2023·2023-06-07

    Trader Joe's Cold Brew Coffee Recalled for Glass Particles

    Trader Joe's Instant Cold Brew Coffee may contain glass particles. Regal Trading is recalling 14,112 cases distributed in eight states. No illnesses have been reported.

    Product
    Trader Joes Instant Cold Brew Coffee, 3.5 oz.(99g), 24 jars per case.
    Category
    Food
    Distribution
    7 states
  • HighFDA (Drugs)·D-0784-2023·2023-06-07

    FDA Recalls Apraclonidine Ophthalmic Solution Due to Manufacturing Compliance Failures

    Akorn Inc. is recalling all lots of Apraclonidine Ophthalmic Solution 0.5% due to manufacturing compliance deviations. The firm went out of business and could not complete required stability studies.

    Product
    Apraclonidine Ophthalmic Solution 0.5%, packaged in a) 5mL and b) 10 mL bottles, Rx only, Sterile, For Topical Ophthalmic Use Only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1658-2023·2023-06-07

    QUADROX-iD Pediatric Oxygenator Recalled Due to Packaging Sterile Barrier Defect

    Maquet Medical Systems USA recalls 5,022 QUADROX-iD Pediatric Oxygenators distributed nationwide due to small pinholes in product packaging that may compromise the sterile barrier, potentially exposing patients to non-sterile devices.

    Product
    QUADROX-iD Pediatric, Oxygenator used during cardiopulmonary bypass Model Item No. BEQ-HMOD30000-USA 701070397 BEQ-HMOD30000-USA 701050330
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0858-2023·2023-06-07

    Calcitriol Injection 2 mcg/mL Recalled Due to CGMP Deviations by Akorn, Inc.

    Akorn recalled all lots of Calcitriol Injection 2 mcg/mL nationwide due to CGMP deviations and inability to complete stability studies after the firm went out of business.

    Product
    Calcitriol Injection 2 mcg/mL, 1 mL ampules Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0846-2023·2023-06-07

    Akorn Recalls All Lots of Sodium DIURIL Injectable Due to CGMP Deviations

    Akorn Operating Company recalls all lots of Sodium DIURIL (chlorothiazide sodium) 0.5g/vial due to Current Good Manufacturing Practice deviations. The manufacturer was unable to complete required stability studies after the firm ceased operations.

    Product
    Sodium DIURIL (chlorothiazide sodium), 0.5g/vial, Single-dose vial Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1674-2023·2023-06-07

    LINK SymphoKnee System Femoral Augment Recalled for Incorrect Implant in Packaging

    Linkbio Corp. is recalling 11 units of the LINK SymphoKnee System L-Shaped Femoral Augment because the packaging contains the opposite side of the implant. This error could result in implantation of the wrong component if not detected.

    Product
    LINK SymphoKnee System L-Shaped Femoral Augment, Medial-Right/Lateral-Left, Sz 5-6 Tilastan, cemented. Intended for primary and revision total knee replacement. Item Number: 880-325/13
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0852-2023·2023-06-07

    Trihexyphenidyl Hydrochloride Oral Solution Recalled for Unverified Stability

    All lots of Trihexyphenidyl Hydrochloride Oral Solution (2mg/5mL) distributed nationwide have been recalled. The manufacturer went out of business and could not complete stability studies needed to verify the drug's safety over time.

    Product
    Trihexyphenidyl Hydrochloride Oral Solution, USP, 2mg/5mL, 473 mL bottles, Rx only, Distributed by: VersaPharm, Inc. - An Akorn Company- Lake Forest, IL 60045. ALL NDCs
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1659-2023·2023-06-07

    QUADROX-i Adult Oxygenator Recalled for Packaging Defects Compromising Sterility

    Maquet is recalling QUADROX-i Adult Oxygenators used in cardiopulmonary bypass surgery due to packaging defects that may compromise the sterile barrier. Contact with non-sterile devices could cause infection, sepsis, or ischemia.

    Product
    QUADROX-i Adult, Oxygenator used during cardiopulmonary bypass Model Item No. HMO 70000-USA 701067820 HMO 71000-USA 701067823 BEQ-HMO 71000-USA 701067829
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0804-2023·2023-06-07

    Fluticasone Propionate Nasal Spray Recalled Due to Manufacturing Quality Concerns

    Akorn, Inc. is recalling all lots of Fluticasone Propionate Nasal Spray, 50mcg due to manufacturing deviations and inability to verify product stability.

    Product
    Fluticasone Propionate Nasal Spray, 50mcg, 16 g bottles, Manufactured by: HI-TECH PHARMACAL CO., INC., Amiy. ALL NDCs
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0961-2023·2023-06-07

    Fresh Location Garden Salad Recalled for Potential Metal Contamination

    The H.T. Hackney Company is recalling Fresh Location Garden Salad with Ranch due to potential metal fragments in the product, which may pose a choking and injury risk.

    Product
    Fresh location Garden Salad with Ranch, 7.25oz clear plastic container, UPC 8 55110 00811 4
    Category
    Food
    Distribution
    4 states
  • HighFDA (Devices)·Z-1636-2023·2023-06-07

    FDA Recalls QUADROX-i Small Oxygenator Due to Packaging Integrity Issues

    Maquet Medical Systems USA is recalling 1,784 QUADROX-i Small Oxygenators due to packaging defects that may compromise the sterile barrier, risking infection and other serious complications.

    Product
    BEQ-HMO 50000-USA/ QUADROX-i Small, Oxygenator used during cardiopulmonary bypass Item no. 701067905
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1647-2023·2023-06-07

    Philips Azurion X-ray Systems May Lose Imaging Capability When Storage Full

    Philips Azurion X-ray imaging systems may suddenly lose X-ray functionality when disk storage capacity is reached, potentially interrupting medical procedures.

    Product
    Philips Azurion System with software versions: R2.2.O, R2.2.1, R2.2.3, R2.2.5 and R2.2.6. Models/Model Number: (1) Azurion 3M12: 722063, 722221; (2) Azurion 3M15: 722064, 722222; (3) Azurion SM12: 722227; (4) Azurion SM20: 722228; (5) Azurion 7B12/12: 722067, 722225; (6)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0849-2023·2023-06-07

    Timolol Maleate Ophthalmic Solution Recalled for Manufacturing and Stability Testing Defects

    Akorn, Inc. has recalled all lots of Timolol Maleate Ophthalmic Solution 0.5% nationwide due to manufacturing quality deviations and inability to complete stability studies.

    Product
    Timolol Maleate Ophthalmic Solution, USP 0.5%, packaged in a) 2.5mL bottles, b) 5mL bottles, c) 10 mL bottles, and d)15mL bottles, Rx only, Manufactured by: Akorn , Inc, Lake Forest, IL 60045. ALL NDCs
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1635-2023·2023-06-07

    Oxygenator devices recalled due to packaging damage compromising sterile barrier

    Maquet Medical Systems USA recalls 15,880 QUADROX-iD oxygenators nationwide due to packaging damage that may compromise sterile barriers, potentially exposing patients to infection.

    Product
    BEQ-HMOD70000-USA/QUADROX-iD, Oxygenator used during cardiopulmonary bypass Item no. 701067859
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0814-2023·2023-06-07

    Akorn Lactulose Solution Recalled Due to Incomplete Stability Studies

    Akorn, Inc. is recalling all lots of Lactulose Solution USP (Oral), 10g/15mL, distributed nationwide in the USA and Puerto Rico, due to the manufacturer's inability to complete required stability studies following company closure.

    Product
    Lactulose Solution, USP (Oral), 10g/15 mL, packaged in a) 15mL bottles, b) 30 mL bottles, c) 473 mL bottles, and d) 946 mL bottles, Rx Only, Distributed by: Akorn, Inc., Gurnee, IL 60031. ALL NDCs
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0847-2023·2023-06-07

    Sufenta Injection Recalled Due to Manufacturing Compliance Deviations

    Akorn Inc. is recalling all lots of Sufenta (Sufentanil Citrate Injection) distributed nationwide. The manufacturer ceased operations and could not complete required stability studies to verify drug safety and effectiveness over time.

    Product
    Sufenta (Sufentanil Citrate Injection, USP) 50 mcg/mL, packaged in a)1 mL ampules, b) 2mL ampules, c) 5mL ampules, For Intravenous and Epidural Use, Rx only, Manufactured by: Akorn Inc., Lake Forest, IL 60045. ALL NDCs
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0840-2023·2023-06-07

    Rifampin Capsules Recalled Due to Incomplete Stability Studies

    Akorn, Inc. is recalling all lots of Rifampin Capsules USP 150 mg distributed nationwide due to manufacturing deviations. The company ceased business before completing required stability studies to verify the drug remains safe and effective throughout its shelf life.

    Product
    Rifampin Capsules USP, 150 mg, 30-count bottles, Rx Only, Sterile, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0816-2023·2023-06-07

    Levetiracetam Oral Solution Recalled Nationwide for Incomplete Stability Testing

    Akorn, Inc. is recalling Levetiracetam Oral Solution nationwide after closing and failing to complete required FDA stability studies. The Class II recall affects all lots distributed in the United States and Puerto Rico.

    Product
    Levetiracetam Oral Solution 100 mg/mL (100 mg/mL), 473 mL, Rx Only, Distributed by: Akorn, Inc., Gurnee, IL 60031. ALL NDCs
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1642-2023·2023-06-07

    Venous Hardshell Cardiotomy Reservoirs recalled for sterile packaging defects

    Maquet Medical Systems USA is recalling Venous Hardshell Cardiotomy Reservoirs for cardiopulmonary bypass due to sterile packaging defects. Exposure to non-sterile product could result in infection, sepsis, or ischemia.

    Product
    Venous Hardshell Cardiotomy Reservoir, used during cardiopulmonary bypass Model Item No. VKMO 10000-USA 701070441 VKMO 11000-USA 701070445
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1671-2023·2023-06-07

    Smith & Nephew Knee Prosthesis Recalled Due to Higher-Than-Expected Revision Rate

    Smith & Nephew is recalling 1,596 units of its ENGAGE Cementless Partial Knee System due to complaint data indicating higher revision rates than comparable devices. Patients should consult their surgeon.

    Product
    Smith&Nephew ENGAGE Cementless Partial Knee System, Tibial Anchor Stem, Part Numbers: a) REF 1-10011-100 (SIZE 1-2), b) REF 1-10011-200 (SIZE 3-4), c) REF 1-10011-300 (SIZE 5-6); Unicondylar knee prothesis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0965-2023·2023-06-07

    Ready-to-eat salmon roll recalled for undeclared sesame allergen

    Origami Catering has recalled Multigrain Spicy Salmon Avocado Roll products due to an undeclared sesame allergen. Sesame seeds are visible on the product but sesame is not listed in the allergen declaration statement.

    Product
    Multigrain Spicy Salmon Avocado Roll, net wt. 7 oz., Ready to Eat, perishable and refrigerated product. UPC 8 51016 00244 7. Manufactured by Origami Catering 828 N Killingsworth St., Portland, OR 97217. The Ingredients statement is read in part: Multigrain Sushi Rice ***, Salmon
    Category
    Food
    Distribution
    0 states