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.

26–50 of 27263

  • ModerateFDA (Devices)·Z-2700-2026·2026-07-15

    EMPOWR 3D Knee surgical device recalled due to packaging discrepancy

    Encore Medical, LP is recalling EMPOWR 3D KNEE surgical devices due to a packaging discrepancy where incorrect product sizes were mixed up in packaging.

    Product
    Brand Name: EMPOWR 3D KNEE Product Name: EMPOWR 3D KNEE INS, 11L 14MM, VE Model/Catalog Number: 342-19-703 Product Description: Enovis knee devices are intended for knee arthroplasty.
    Category
    Medical Device
    Distribution
    13 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 (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 (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-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-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, flex
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0663-2026·2026-07-15

    Medline Remedy Specialized Silicone Cream Recalled for Elevated Formaldehyde Levels

    Medline Remedy Specialized Silicone Cream is being recalled because formaldehyde levels exceeded the product specification. BioMed Laboratories is recalling approximately 509,652 tubes distributed nationwide.

    Product
    MEDLINE — MEDLINE (DIMETHICONE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2696-2026·2026-07-15

    Medline Convenience Kits containing temperature probes recalled

    Medline Industries is recalling Convenience Kits containing Covidien Mon-a-Therm General Purpose Temperature Probes due to an error in distribution control. The recall affects 75 kits distributed nationwide.

    Product
    Medline Convenience Kits: 1) OPEN HEART PEDS PACK, Model Number: DYNJ88569D; 2) ACCESSORY KIT, Model Number: DYNJ901348F
    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
  • 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 (Devices)·Z-2714-2026·2026-07-15

    OmniTract Surgical Retractor System sterilization instructions require extended dry time

    Integra LifeSciences is recalling the OmniTract Surgical Retractor System because the sterilization instructions require a longer dry time than stated in the current manual. The dry time must be extended to 90, 110, or 120 minutes depending on the sterilization cycle used.

    Product
    OmniTract Surgical Retractor System, which includes 633 of the firm s product codes.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0670-2026·2026-07-15

    Drogueria San Juan Isopropyl Alcohol 70% recalled for subpotency

    Gasco Industrial Corp. is recalling Drogueria San Juan Puerto Rico Isopropyl Alcohol 70% (32 oz.) due to subpotency. Affected lots 250206B1, 250218B2, and 250507B1 were distributed nationwide in the US.

    Product
    Drogueria San Juan Puerto Rico Isopropyl Alcohol 70%, 32 oz., 946 mL, Distributed by: Drogueria San Juan, Calle De Diego 590, Sabana Llana Rio Piedras, PR 00924, UPC 659685696567.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2717-2026·2026-07-15

    Versius Surgical System Console affected by cybersecurity vulnerability

    CMR Surgical Limited is recalling the Versius Surgeon Console (Model V-SS-1020, Software Version Pratchett 1 version 62.1) due to Secure Boot not being enabled at manufacturing, presenting a potential cybersecurity risk.

    Product
    Brand Name: Versius Surgical System US Product Name: Vesius Surgeon Console US Model/Catalog Number: V-SS-1020 Software Version: Pratchett 1 version 62.1 Product Description: The Versius Surgical System is a modular, open console, software controlled, electromechanical system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0665-2026·2026-07-15

    Gasco Isopropyl Alcohol 70% Recalled for Subpotent Drug Content

    Gasco Industrial Corp. is recalling Gasco Isopropyl Alcohol 70% (16 oz bottles, Lot 250306B3) nationwide because the product is subpotent. Consumers should stop using the affected product and contact their healthcare provider if they have health concerns.

    Product
    Gasco Isopropyl Alcohol 70%, Net Contents: 16 Oz. (474 mL). Manufactured by: Gasco Industrial Corp., PO Box 1360 Gurabo PR 00778 Made in USA UPC 7 87302 13044 3
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0668-2026·2026-07-15

    Drogueria San Juan Isopropyl Alcohol 70% Recalled for Subpotency

    Gasco Industrial Corp. is recalling Drogueria San Juan Puerto Rico Isopropyl Alcohol 70% (1 gallon) due to subpotency. The affected lots are 250221A5 and 250224A2 distributed nationwide.

    Product
    Drogueria San Juan Puerto Rico Isopropyl Alcohol 70%, 1 gallon (3.78 liter), Distributed by: Drogueria San Juan, Calle De Diego 590, Sabana LLana Rio Piedras, PR 00924
    Category
    Drug
    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-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 (Drugs)·D-0669-2026·2026-07-15

    Isopropyl Alcohol 70% recalled for subpotency nationwide

    Drogueria San Juan Puerto Rico Isopropyl Alcohol 70% is recalled nationwide because the product is subpotent. The manufacturer Gasco Industrial Corp. initiated this voluntary recall.

    Product
    Drogueria San Juan Puerto Rico Isopropyl Alcohol 70%, 16 oz, 474 mL, Distributed by: Drogueria San Juan, Calle De Diego 590, Sabana LLana Rio Piedras, PR 00924, UPC 69685696529
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2702-2026·2026-07-15

    5008X Blood Tubing Set connection errors FDA Class II recall

    Fresenius Medical Care is recalling 5008X Blood Tubing Sets due to potential online port errors that may occur when connecting the SafeLine to the substitution fluid port of the 5008X CAREsystem.

    Product
    5008X Blood Tubing Set, 24 units per case. Includes the below model numbers and descriptions. 1. 5008X HD Pre-Flush Standard Blood Tubing Set; Model Number: 03-5110-6. 2. 5008X HD Pre-Flush With Twister Blood Tubing Set; Model Number: 03-5160-1. 3. 5008X HD/HDF St
    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 (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
  • 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 (Single
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2548-2026·2026-07-08

    Hillrom VOLARA System P.CIRCUIT KIT Medical Device Recall for Oxygen Drop Risk

    Baxter Healthcare is recalling the Hillrom VOLARA System P.CIRCUIT KIT (Model REF M08085) due to reports of air and medication leakage from the nebulizer cup, which can cause oxygen level drops and reduce treatment effectiveness.

    Product
    Hillrom VOLARA System P.CIRCUIT KIT (Single Patient Use Circuit), Model/Catalog Number REF M08085; Oscillation Lung Expansion Therapy, positive pressure breathing device
    Category
    Medical Device
    Distribution
    Distributed nationwide