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.

8351–8375 of 26961

  • SevereFDA (Devices)·Z-0482-2025·2024-11-27

    Medical Device Recall: Counterfeit Batteries in Plum Infusion Systems

    Counterfeit CSB batteries are being used in Plum Infusion Systems. These unauthorized batteries fail to hold their charge and have not been tested for use with the pumps.

    Product
    Allegedly counterfeit batteries manufactured by CSB batteries being used with Plum Infusion Systems: Plum 360" Infusion System, Pump List Number 30010; Plum A+ & Plum A+3" Infusion Systems, Pump List Numbers: 11005, 11971, 12391, 12618, 20678, 20679, 20792, 60529, 12348, 1197
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0379-2025·2024-11-27

    Baxter MiniCap Dialysis Transfer Sets Recalled for PCB Exposure Risk

    Baxter is recalling MiniCap Extended Life PD Transfer Sets used in peritoneal dialysis due to potential exposure to polychlorinated biphenyls (PCBs). About 62,394 units distributed worldwide may be affected.

    Product
    Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4483; use in Peritoneal Dialysis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0378-2025·2024-11-27

    Baxter MiniCap Peritoneal Dialysis Transfer Set recalled for potential PCB exposure

    Baxter Healthcare is recalling 58,680 units of its MiniCap Extended Life PD Transfer Set due to potential exposure to polychlorinated biphenyls (PCBs). Users should stop using affected units and consult their healthcare provider.

    Product
    Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4482E; use in Peritoneal Dialysis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0219-2025·2024-11-27

    FDA Recalls U-BAKE Frozen Marionberry Pie for Undeclared Egg

    Grand Central Bakery is recalling U-BAKE Marionberry Pie due to undeclared egg, a major allergen not listed on the label. The recall affects 336 packages distributed in Oregon and Washington with expiration dates from February 1 to April 17, 2025.

    Product
    U-BAKE Marionberry Pie, frozen product and packaged in LDPE bag, net wt. 2lbs. 4oz. Made by Grand Central Baking Company. Label declares Wheat and Milk.
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Devices)·Z-0377-2025·2024-11-27

    Baxter Peritoneal Dialysis Transfer Set Recalled for PCB Contamination Risk

    Baxter Healthcare is recalling the MiniCap Extended Life PD Transfer Set due to potential exposure to polychlorinated biphenyls (PCBs). Approximately 410,862 units are affected.

    Product
    Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4482; use in Peritoneal Dialysis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0375-2025·2024-11-27

    Baxter peritoneal dialysis transfer set recalled for PCB exposure risk

    Baxter MiniCap Extended Life PD Transfer Sets (Part 5C4482S) are being recalled due to potential exposure to polychlorinated biphenyls (PCBs). The FDA Class I recall affects 151,020 units distributed worldwide.

    Product
    Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482S; use in Peritoneal Dialysis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0220-2025·2024-11-27

    Frozen Chicken Pot Pie Recalled for Undeclared Egg Allergen

    U-BAKE Chicken Pot Pie frozen packages are being recalled because they contain undeclared egg, a common allergen. Consumers with egg allergies should not consume this product.

    Product
    U-BAKE Chicken Pot Pie, frozen product and packaged in heat-sealable polypropylene film. Net wt. 11.5oz. Made by Grand Central Baking Company. Label declares Wheat and Milk.
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Devices)·Z-0373-2025·2024-11-27

    Peritoneal Dialysis Transfer Set Recalled for PCB Contamination Risk

    Baxter Healthcare recalls peritoneal dialysis transfer sets (Part Number 5C4482) due to potential contamination with polychlorinated biphenyls (PCBs). The recall affects 2.7 million units distributed worldwide.

    Product
    Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482; use in Peritoneal Dialysis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0467-2025·2024-11-27

    Bard Marquee Biopsy Instruments Recalled for Potential Needle Detachment

    Bard Peripheral Vascular Inc. is recalling Bard Marquee Disposable Core Biopsy Instrument Kits due to a manufacturing defect where some units lack a needle retention feature, risking detachment during use and potential tissue damage or bleeding.

    Product
    Bard Marquee Disposable Core Biopsy Instrument Kit: BARD MARQUEE KIT 12G X 10 CM, REF: MQK1210; BARD MARQUEE 12G X 10 CM, REF: MQ1210; BARD MARQUEE Kit 12G X 13 CM, REF: MQK1213; BARD MARQUEE 12G X 13 CM, REF: MQ1213
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0466-2025·2024-11-27

    Smiths Medical CADD-Solis AC adapter input plugs pose electrical shock risk

    Smiths Medical is recalling 156,400 CADD-Solis AC adapters due to damaged or broken input plugs that may expose metal contacts. The affected adapters could pose a risk of electrical shock or fire.

    Product
    smiths medical CADD-Solis Li-ion Rechargeable Battery Packs AC adapter, Model Number REF 21-0270-25, for use with the CADD-Solis infusion pumps
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0471-2025·2024-11-27

    Injection Needles Recalled for Manufacturing Debris Blocking Medication Flow

    Hobbs Medical is recalling Posi-Stop Injection Needles due to manufacturing debris inside the needle shaft that blocks medication flow. The affected lot was distributed across multiple US states and Canada.

    Product
    Posi-Stop Injection Needle, 23 Gauge, Catalog Number: 4716
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0060-2025·2024-11-27

    Docusate Sodium 250 mg softgels recalled due to defective blister packaging

    Safecor Health is recalling Docusate Sodium 250 mg softgels due to manufacturing defects where blister card-foils separated from the medication cavity, potentially compromising product integrity.

    Product
    Docusate Sodium 250 mg, 1 Softgel in blister card-foils, 100-count unit dose box, www.safecorhealth.com, NDC 48433-101-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0050-2025·2024-11-27

    Guaifenesin Dextromethorphan Syrup Recalled for Failed Quality Specifications

    Major Pharmaceuticals has recalled Guaifenesin Dextromethorphan Syrup due to failed impurity and degradation specifications. Three lot numbers were distributed nationwide.

    Product
    Guaifenesin Dextromethorphan Syrup, 100 mg/10mg per 5 mL, Major Pharmaceuticals 8401 Bearing Drive, Suite 100, Indianapolis, IN, 46268, NDC 0904-7134-70
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0146-2025·2024-11-27

    Glenview Farms Spreadable Brie Recalled for Listeria Contamination Risk

    Glenview Farms Spreadable Brie is being recalled due to potential Listeria monocytogenes contamination. 754 cases distributed across multiple states are affected.

    Product
    Glenview Farms Spreadable Brie 2, 3lb tubs per case
    Category
    Food
    Distribution
    12 states
  • HighFDA (Devices)·Z-0475-2025·2024-11-27

    Posi-Stop 25-Gauge Injection Needles Recalled for Manufacturing Debris Blockage

    Hobbs Medical is recalling Posi-Stop 25-Gauge injection needles because some units contain manufacturing debris that blocks the needle's inner diameter, preventing injection solutions from flowing properly.

    Product
    Posi-Stop Injection Needle, 25 Gauge, Catalog Number: 4722
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0477-2025·2024-11-27

    JuggerLoc/ToggleLoc 2.9mm Drill Guide Warping in Packaging

    Biomet's JuggerLoc/ToggleLoc 2.9mm Drill Guide may warp when removed from packaging, potentially extending surgical time or causing tissue damage requiring intervention.

    Product
    JuggerLoc/ToggleLoc 2.9mm Drill Guide, Model number 110027357
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0470-2025·2024-11-27

    Posi-Stop Injection Needle Recall Due to Manufacturing Debris

    Hobbs Medical is recalling Posi-Stop Injection Needles (23 Gauge, Catalog 4706) due to manufacturing debris in the inner sheath that can block the needle and prevent injection solution flow.

    Product
    Posi-Stop Injection Needle, 23 Gauge, Catalog Number: 4706
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0479-2025·2024-11-27

    CAIRE FreeStyle Comfort Portable Oxygen Concentrator Battery Charging Failure

    CAIRE FreeStyle Comfort portable oxygen concentrators may fail to recharge their batteries, potentially leaving patients without access to supplemental oxygen. Twenty-three units have been recalled.

    Product
    CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-101.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0476-2025·2024-11-27

    FDA Recalls Posi-Stop Injection Needles Due to Manufacturing Debris

    Hobbs Medical is recalling Posi-Stop Injection Needles (25 gauge) because some units contain debris in the needle shaft that blocks injection solution flow.

    Product
    Posi-Stop Injection Needle, 25 Gauge, Catalog Number: 4723
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0053-2025·2024-11-27

    Prescription Drug Recall: Ramipril Capsules from Unapproved Supplier

    Lupin Pharmaceuticals is recalling certain lots of Ramipril 5 mg capsules because the active ingredient was sourced from an unapproved vendor, raising concerns about product quality and safety.

    Product
    RAMIPRIL — RAMIPRIL (RAMIPRIL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0468-2025·2024-11-27

    Posi-Stop Injection Needles Recalled for Manufacturing Debris Blocking Flow

    Hobbs Medical is recalling Posi-Stop Injection Needles because manufacturing debris blocks the needle, preventing injection solutions from flowing properly. The 70 affected units were distributed to healthcare facilities in multiple U.S. states and Canada.

    Product
    Posi-Stop Injection Needle, 23 Gauge, Catalog Number: 4720
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0499-2025·2024-11-27

    Cook Incorporated Recalls Approach CTO Micro Wire Guide for Incorrect Expiration Dates

    Cook Incorporated is recalling Approach CTO Micro Wire Guide devices due to incorrect expiration dates printed on product labels. Contact the manufacturer for corrected expiration information.

    Product
    Approach CTO Micro Wire Guide, RPN CMW-14-190-25G, GPN G50789
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0489-2025·2024-11-27

    Medical Device Homocysteine Test Assay Recalled for Calibration Defects

    Roche's cobas HCYS homocysteine test assay is recalled due to calibration defects that can produce inaccurate results. The assay can yield false positive or negative values.

    Product
    cobas HCYS, Homocysteine Enzymatic Assay, Material Number REF 06542921190, for use on cobas c 701/702, in vitro test for total L-homocysteine
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-0478-2025·2024-11-27

    CAIRE FreeStyle Comfort Oxygen Concentrators Recalled for Battery Charging Failure

    Caire recalls 739 FreeStyle Comfort portable oxygen concentrators that may fail to recharge their batteries. The devices were distributed in the US, Puerto Rico, Israel, and Peru.

    Product
    CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-1.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0483-2025·2024-11-27

    Hip Prosthesis Mislabeled with Wrong Size; Risk of Joint Instability

    Novosource is recalling NovoHip Total Hip System units (lot CER0023) packaged in boxes labeled 32 long but containing 28 long components. If implanted, the wrong size may cause joint instability.

    Product
    NovoHip Biolox Ball Head 32mmL Ref: 1345-2803 NovoHip Total Hip System - NovoHip Total Hip System is a non-cemented hip prosthesis that consists of a 4-part total hip replacement system including femoral stem, femoral head, acetabular poly liner, and acetabular metal (or shel
    Category
    Medical Device
    Distribution
    0 states