The Recall Desk

Agency

U.S. Food and Drug Administration

The FDA regulates food, drugs, biologics, medical devices, and tobacco. We aggregate Class I, II, and III enforcement actions across its three recall streams.

Visit the official FDA site →

About FDA recalls

The FDA is the single biggest source of US product recalls by volume. Its enforcement workload splits into three streams — Foods (everything from infant formula to leafy greens to nutritional supplements), Drugs (prescription medicines, over-the-counter products, and active pharmaceutical ingredients), and Medical Devices (everything from implants to home blood-pressure monitors). The Recall Desk ingests all three from the openFDA enforcement endpoint every six hours.

FDA classifies every recall as Class I, II, or III. Class I means there is a reasonable probability that using the product will cause serious health consequences or death — these are the recalls you should treat as urgent. Class II means the product may cause temporary or medically reversible harm. Class III means the product is unlikely to cause adverse health consequences but still violates FDA rules. We map these classifications into our 1–5 severity score using the rubric on the methodology page.

Medical-device recalls are the highest-volume stream by far — software-update letters, calibration corrections, and IFU updates all show up in enforcement reports alongside genuine hazard recalls. We try to surface the severe ones first, but when in doubt, click through to the FDA notice itself for the clinical detail.

1551–1575 of 88106

  • ModerateFDA (Devices)·Z-2701-2026·2026-07-15

    EMPOWR 3D KNEE insertion instruments recalled for incorrect product size packaging

    Encore Medical is recalling EMPOWR 3D KNEE insertion instruments because some packages contain incorrect product sizes due to a packaging discrepancy.

    Product
    Brand Name: EMPOWR 3D KNEE Product Name: EMPOWR 3D KNEE INS, 11L 14MM, VE Model/Catalog Number: 341-14-711 Product Description: Enovis knee devices are for knee arthroplasty.
    Category
    Medical Device
    Distribution
    13 states
  • ModerateFDA (Drugs)·D-0666-2026·2026-07-15

    Gasco Isopropyl Alcohol 70% recalled nationwide for subpotency

    Gasco Industrial Corp. is recalling Gasco Isopropyl Alcohol 70% (1 US Gallon) nationwide due to subpotency. The voluntary recall affects specific lot numbers manufactured before the expiration date.

    Product
    Gasco Isopropyl Alcohol 70%, Net Contents: 1 US Gallon (3.78 L), Manufactured by: Gasco Industrial Corp., PO Box 1360, Gurabo, PR 00778, Made in USA
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2677-2026·2026-07-15

    Aquacel Ag Surgical SP Surgical Dressing Recalled for Out-of-Specification Thickness

    ConvaTec is recalling Aquacel Ag Surgical SP dressings (Lot 5G00809) that were manufactured with greater-than-specified thickness. The dressing is used in surgical wound care.

    Product
    Aquacel Ag Surgical SP REF: 413556 9cm x 15cm/3.5 in. x 6 in., Sterile R
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·H-1146-2026·2026-07-15

    Wise Onion Rings recalled for undeclared food color additives

    Wise Foods Inc is recalling Wise Onion Rings, 3.75 oz packages, because they contain undeclared Yellow 5 and 6, Blue 1, and unapproved Red 3 food colorings that are not listed on the label.

    Product
    Wise Onion Rings, 3.75 oz, metalized film in cardboard cartons, 14 bags per case,
    Category
    Food
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-2695-2026·2026-07-15

    Medline Anesthesia Kit Peds Contains Defective Temperature Probes

    Medline Industries is recalling Anesthesia Kit Peds (Model DYNJAP10125A, Lot 24JBR072) nationwide because they contain Covidien Mon-a-Therm temperature probes affected by a distribution control error.

    Product
    Medline Convenience Kits: 1) ANESTHESIA KIT PEDS 90-LF, Model Number: DYNJAP10125A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2697-2026·2026-07-15

    Medline Open Heart Peds Pack Convenience Kits Temperature Probe Recall

    Medline Industries is recalling specific lots of Open Heart Peds Pack Convenience Kits containing Covidien Mon-a-Therm temperature probes due to a distribution control process error.

    Product
    Medline Convenience Kits: 1) OPEN HEART PEDS PACK, Model Number: DYNJ88569; 2) OPEN HEART PEDS PACK, Model Number: DYNJ88569A; 3) OPEN HEART PEDS PACK, Model Number: DYNJ88569B; 4) OPEN HEART PEDS PACK, Model Number: DYNJ88569C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0691-2026·2026-07-15

    Clomiphene Citrate USP Active Pharmaceutical Ingredient Recalled for cGMP Deviations

    Shimoga Chemicals is voluntarily recalling Clomiphene Citrate USP active pharmaceutical ingredient in three package sizes due to current good manufacturing practice (cGMP) deviations. The product was distributed in California and Florida.

    Product
    Clomiphene Citrate USP Active Pharmaceutical Ingredient (CAS : 50-41-9), Net Weight a)1 KG (NDC 84849-000-01), b) 500 g (NDC 84849-000-02), (c) 100 g (NDC 84849-000-03), Rx Only, Shimoga Chemicals Address -W-57A, MIDC Kupwad Samgli, Maharashtra, 416436, India.
    Category
    Drug
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-2699-2026·2026-07-15

    KL Owen Custom Orthodontic Solution bracket placement defect

    Klowen Braces is recalling 3 units of the KL Owen Custom Orthodontic Solution (model CIAS-800033) due to a product error that may cause incorrect bracket placement.

    Product
    KL Owen Custom Orthodontic Solution, model/catalog number CIAS-800033,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0667-2026·2026-07-15

    Gasco Isopropyl Alcohol 70% recalled for subpotent drug content

    Gasco Industrial Corp. is recalling Gasco Isopropyl Alcohol 70% (32 oz bottles, Lot 250218B3) distributed nationwide because the product is subpotent—containing less active ingredient than labeled.

    Product
    Gasco Isopropyl Alcohol 70%, 32 oz (946 mL) Gasco Industrial Corp., PO Box 1360, Gurabo PR 00778, UPC 7 87302 12363 6.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2676-2026·2026-07-15

    Olympus Single Use Distal Cover MAJ-2315 Duodenovideoscope Replacement

    Olympus Corporation of the Americas is replacing the previous design of its Single Use Distal Cover (MAJ-2315) with a newly designed version for use with EVIS EXERA III Duodenovideoscopes.

    Product
    Olympus Single Use Distal Cover, Catalog Number MAJ-2315, Used with: EVIS EXERA III Duodenovideoscope TJF-Q190V- designed to be attached to Olympus duodenovideoscopes to cover the distal end of the insertion tube and around the forceps elevator; duodenoscope and accessories…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2713-2026·2026-07-15

    GSP Neonatal GALT Kit in vitro diagnostic test equipment

    WALLAC OY is recalling GSP Neonatal GALT Kit units due to reduced on-board stability that may increase run-QC failures and delay patient test results.

    Product
    GSP Neonatal GALT Kit. Product Codes: 3303-001U, 3303-0010. in vitro diagnostic. Used in FLUORESCENT PROC. (QUAL), GALACTOSE-1-PHOSPHATE URIDYL TRANSFERASE.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0664-2026·2026-07-15

    Methohexital Sodium 100 mg/10 mL Compounded Drug Recalled Nationwide

    QuVa Pharma is recalling Methohexital Sodium 100 mg/10 mL compounded drug vials due to failed impurities and degradation specifications. The recall affects multiple lot numbers distributed nationwide.

    Product
    Methohexital Sodium, 100 mg/10 mL (10 mg/mL), Total Volume: 10 mL, Rx only, Compounded drug, QuVa Pharma, 1075 W Park One Dr, Suite 100, Sugar Land, TX 77478, Product code: 70092-1310-46.
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2604-2026·2026-07-08

    Omnipod DASH Pod insulin pump affected by external cannula damage

    Insulet Corporation is recalling Omnipod DASH Pods worldwide due to external soft cannula damage during manufacturing that can cause insulin to leak around the pod instead of being delivered. This may lead to high blood glucose levels and, in severe cases, diabetic ketoacidosis or death.

    Product
    Omnipod DASH Pod. Includes the below Model/REF Numbers: 1. POD-BLE-I1-525 (5-Pack), POD-BLE-I1-520 (Single Pod). 2. POD-BLE-I1-529 (10-Pack), POD-BLE-I1-520 (Single Pod). 3. BLE-I1-529 (10-Pack), BLE-I1-520 (Single Pod). 4. BLE-C1-529 (10-Pack), BLE-C1-520…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0644-2026·2026-07-08

    PurPrep Povidone Iodine and Isopropyl Alcohol Applicators Recall

    CareFusion 213, LLC is recalling PurPrep sterile applicators distributed nationwide because unsterilized units intended for further processing were distributed to customers outside the intended channel.

    Product
    PURPREP — PURPREP (POVIDONE IODINE AND ISOPROPYL ALCOHOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2640-2026·2026-07-08

    Cyberknife Treatment Delivery System Collimator Docking Failure Risk

    Accuray Incorporated is recalling Cyberknife Treatment Delivery Systems equipped with the Xchange Robotic Collimator Changer due to a risk that the collimator may not fully dock and could fall from the housing if the in-room control pendant is used.

    Product
    Cyberknife Treatment Deliver System equipped with the Xchange Robotic Collimator Changer; Linear Accelerator
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2603-2026·2026-07-08

    Omnipod 5 Insulin Infusion Pods Recalled for External Cannula Damage

    Insulet Corporation is recalling approximately 4.9 million Omnipod 5 insulin pods due to external soft cannula damage during manufacturing that can cause insulin leakage and under-delivery, potentially leading to high blood glucose and serious diabetic complications.

    Product
    Omnipod 5 Pods. Includes the below Model/REF Numbers: 1. POD-OMNI-I1-6720. 2. POD-OMNI-I1-6220. 3. OMNI-I1-6729 (10-Pack), OMNI-I1-6720 (Single Pod). 4. OMNI-I1-6220. 5. OMNI-I1-6720. 6. BLE-H1-529 (10-Pack), BLE-H1-520 (Single Pod).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0645-2026·2026-07-08

    ChloraPrep One-Step Applicators Recalled Due to Sterility Assurance Failure

    CareFusion 213, LLC is recalling ChloraPrep One-Step applicators nationwide because unsterilized units intended for further processing were distributed to customers outside the intended distribution channel, lacking sterility assurance.

    Product
    CHLORAPREP ONE-STEP — CHLORAPREP ONE-STEP (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2463-2026·2026-07-08

    Ventilator breathing circuit sets may obstruct exhalation valve

    Hamilton Medical AG is recalling coaxial breathing circuit sets used with three ventilator models because membranes may stick to the expiratory valve body, preventing proper gas exhalation and potentially causing inadequate ventilation.

    Product
    Breathing circuit set, coaxial: REF: 260127, 260128, 260167, 260168 used with HAMILTON-C1, HAMILTON-T1 and HAMILTON-MR1 ventilators.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2672-2026·2026-07-08

    GORE TAG Thoracic Branch Endoprosthesis Side Branch Component Recall

    W. L. Gore & Associates is recalling 467 GORE TAG Thoracic Branch Endoprosthesis Side Branch Components worldwide due to risk of catheter separation during deployment.

    Product
    GORE¿ TAG¿ Thoracic Branch Endoprosthesis Side Branch Component Catalog Numbers (by Region) United States (includes Puerto Rico) and Canada: TSB080806A, TSB081006A, TSB081206A, TSB081506A, TSB081706A, TSB121506A, TSB121706A, TSB122006A EMEA Countries, Australia, New…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2607-2026·2026-07-08

    Medline Convenience Kits with Swan-Ganz Catheters Recalled for Defects

    Medline is recalling convenience kits containing Swan-Ganz catheters due to failures of the proximal injectate lumen hub that can cause leaks, lumen damage, and breakage, potentially resulting in infection, medication loss, or blood loss.

    Product
    Medline Convenience kits containing recalled Swan-Ganz Catheters CARDIAC MAJOR DYNJ901328G HEART A DYNJ903465K OPEN HEART DYNJ909090G SILVER CROSS OPEN HEART DYNJ906102M VPH OPEN HEART DYNJ902664M DYNJ902664N
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0649-2026·2026-07-08

    ChloraPrep One-Step Applicators Recalled for Lack of Sterility Assurance

    CareFusion 213, LLC is recalling ChloraPrep One-Step applicators distributed nationwide because unsterilized units intended for further processing were shipped to customers outside the intended distribution channel.

    Product
    CHLORAPREP ONE-STEP — CHLORAPREP ONE-STEP (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0676-2026·2026-07-08

    Cinacalcet Hydrochloride Tablets Recalled for Elevated Impurity Levels

    Cipla USA, Inc. is recalling Cinacalcet Hydrochloride 90 mg tablets (Lot #5PB0563, expiring 4/30/2027) distributed nationwide due to the presence of N-nitroso-cinacalcet above acceptable daily intake levels, a manufacturing deviation.

    Product
    CINACALCET — CINACALCET (CINACALCET)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·H-1125-2026·2026-07-08

    First Street Dark Chocolate Raisins recalled for undeclared peanuts

    Western Mixers Produce & Nuts, Inc. is recalling First Street Dark Chocolate Raisins (9 oz, UPC 797565011830, Lot 260562) because they contain undeclared peanuts, a major allergen not listed on the label.

    Product
    FIRST STREET Dark Chocolate Raisins Net Wt. 9 oz. (255g) UPC 797565011830 INGREDIENTS: DARK CHOCOLATE (SUGAR, CHOCOLATE LIQUOR, COCOA BUTTER, MILK FAT, SOY LECITHIN - AN EMULSIFIER, NATURAL VANILLA FLAVOR), RAISINS, TAPIOCA DEXTRIN, CONFECTIONERS GLAZE. CONTAINS: MILK, SOY…
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Devices)·Z-2615-2026·2026-07-08

    Reprocessed Electrophysiology Catheters Recalled for Residual Particles

    Medline Industries is recalling reprocessed electrophysiology and ultrasound catheters with residual particles that may cause inflammation, infection, or blood clots if contacted with blood or the heart.

    Product
    Reprocessed Electrophysiology Catheters and Ultrasound Catheters Item no. 401206RH, St. Jude Medical Response" Diagnostic Electrophysiology Catheter 4 Elec. 10mm; Item no. 401305RH, St. Jude Medical Response" Diagnostic Electrophysiology Catheter 10 Elec. 2-5-2mm.
    Category
    Medical Device
    Distribution
    Distributed nationwide