The Recall Desk

Severity 2 of 5

Moderate recalls

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

What “moderate” means here

Severity 2 (Moderate) recalls cover minor labeling errors, low-risk contamination, and voluntary precautionary recalls. The agency's own classification is typically FDA Class III, or the issue is something like incomplete instructions or a small UPC mismatch where the product itself is safe but doesn't meet documentation requirements. Use the same brand-name product safely; follow the manufacturer's instructions for return or exchange if you want a refund.

The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.

3201–3225 of 21589

  • ModerateFDA (Devices)·Z-0248-2024·2023-11-15

    Disposable Bipolar Forceps Shelf Life Labeling Error Stryker

    Stryker recalls disposable Spetzler-Malis bipolar forceps due to incorrect shelf life labeling. The label states 54 months but the actual shelf life is 36 months.

    Product
    Disposable Spetzler-Malis Bipolar forceps, 20CM IM DISP BAYONET 0.5MM TIP, Catalog Number 6770-200-005
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0092-2024·2023-11-15

    Ranolazine Extended-Release Tablets Recalled for Failed Dissolution Specifications

    Glenmark Pharmaceuticals is recalling 16,944 bottles of Ranolazine 500mg tablets nationwide due to failed dissolution specifications. Tablets may not dissolve properly, potentially affecting drug efficacy.

    Product
    RANOLAZINE — RANOLAZINE (RANOLAZINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0242-2024·2023-11-15

    Disposable Surgical Forceps Recalled for Incorrect Expiration Date Labeling

    Stryker Corporation is recalling 2,321 units of Disposable Spetzler-Malis Bipolar forceps due to an error in the product label's expiration date. The label indicates a 54-month shelf life when the actual shelf life is 36 months.

    Product
    Disposable Spetzler-Malis Bipolar forceps, 23CM SM DISP BAYONET 0.5MM TIP, Catalog Number 6760-230-005
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0270-2024·2023-11-15

    Oral B Mouth Sore Rinse Recall Due to Improper Storage Conditions

    Family Dollar is recalling approximately 329,044 units of Oral B Mouth Sore Rinse 237ML because the product was stored outside of labeled temperature requirements. No illnesses or injuries have been reported.

    Product
    ORAL B MOUTH SORE RINSE 237ML, SKU 999087
    Category
    Medical Device
    Distribution
    23 states
  • ModerateFDA (Devices)·Z-0263-2024·2023-11-15

    Fixodent Denture Cream Recalled Due to Improper Storage Conditions

    Family Dollar is recalling 329,044 units of Fixodent denture cream products due to improper storage outside labeled temperature requirements. No illnesses or injuries have been reported.

    Product
    FIXODENT ORG CREAM 2.4OZ, SKU 906018 FIXODENT ADH CREAM WITH SCOPE 2OZ, SKU 906402 FIXODENT ORG CREAM TRAVEL .75OZ, SKU 901239
    Category
    Medical Device
    Distribution
    23 states
  • ModerateFDA (Drugs)·D-0091-2024·2023-11-15

    Antifungal Powder Recalled Due to Low Active Ingredient Content

    Medline Industries is recalling REMEDY Antifungal powder nationwide because it contains insufficient miconazole nitrate (the active ingredient). The product was shipped before assay testing was complete.

    Product
    REMEDY ANTIFUNGAL — REMEDY ANTIFUNGAL (MICONAZOLE NITRATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0094-2024·2023-11-15

    Oxycodone Tablets Recalled for Lower Potency Than Labeled

    OXAYDO oxycodone 7.5 mg tablets distributed nationwide are being recalled because they contain lower potency than labeled. The affected lot is 22W02 with expiration 01/31/2025.

    Product
    OXAYDO — OXAYDO (OXYCODONE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0250-2024·2023-11-15

    Disposable Bipolar Forceps Recalled for Incorrect Expiration Date Labeling

    Stryker Corporation is recalling 2,321 units of Disposable Spetzler-Malis Bipolar forceps due to incorrect expiration date labeling. The product label indicates a 54-month shelf life, but the actual shelf life is 36 months.

    Product
    Disposable Spetzler-Malis Bipolar forceps, 23CM IM DISP BAYONET 0.5MM TIP, Catalog Number 6770-230-005
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0268-2024·2023-11-15

    ARC Teeth Whitening Pen Recalled Due to Improper Storage

    Family Dollar recalls 329,044 units of ARC Teeth Whitening Pen sold between June and October 2023 across 22 states due to improper storage outside temperature requirements.

    Product
    ARC TEETH WHITENING PEN 0.06 FL OZ, SKU 997950
    Category
    Medical Device
    Distribution
    23 states
  • ModerateFDA (Drugs)·D-0087-2024·2023-11-15

    Buprenorphine HCl Injection Recalled for Crystallization Defect

    Buprenorphine HCl injection is being recalled nationwide due to white crystalline agglomeration found in stored product samples during routine inspection.

    Product
    BUPRENORPHINE HYDROCHLORIDE — BUPRENORPHINE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0097-2024·2023-11-15

    Zydus oxybutynin extended-release tablets recalled nationwide for failed stability testing

    Zydus Pharmaceuticals is recalling specific lots of oxybutynin chloride extended-release 10 mg tablets nationwide due to out-of-specification dissolution test results at the 6-month stability timepoint. The affected tablets may not release medication properly.

    Product
    OXYBUTYNIN — OXYBUTYNIN (OXYBUTYNIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0245-2024·2023-11-15

    Disposable surgical forceps recalled for incorrect expiration date labeling

    Stryker recalls disposable Spetzler-Malis Bipolar forceps due to expiration date labeling error. Labels show 54-month shelf life but actual shelf life is 36 months.

    Product
    Disposable Spetzler-Malis Bipolar forceps, 18CM IM DISP BAYONET 0.5MM TIP, Catalog Number 6770-180-005
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0285-2024·2023-11-15

    Dental Prophylaxis Cups Recalled Due to Wrong Product in Packaging

    One lot of Contra Gray Soft Turbo Plus dental prophylaxis cups may contain Contra Petite Web LF Soft Purple Cup dental angles instead. The recalled product was distributed in Indiana, Tennessee, and Missouri.

    Product
    CONTRA GRAY (soft) TURBO PLUS CUPS, REF 153112. Dental Prophylaxis Angles
    Category
    Medical Device
    Distribution
    3 states
  • ModerateCPSC·24713·2023-11-09

    E-Z-GO and Tracker Electric Vehicles Recalled for Unintended Movement Crash Hazard

    Textron Specialized Vehicles is recalling about 1,660 E-Z-GO ELiTE Express and Tracker OX EV vehicles because internal motor wiring damage can cause the vehicle to move unintentionally, creating a crash hazard. One incident of unexpected movement has been reported but no injuries.

    Product
    Electric Powered E-Z-GO ELiTE Express L6 and EliTE Express S6 PTV and Tracker OX EV vehicles
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0217-2024·2023-11-08

    DBS Lead Device Recall: Use By Date Label Discrepancy

    Medtronic is recalling a small number of LEAD 3387S-40 deep brain stimulation devices due to discrepancies in the Use By Date printed on the outer package versus the individual product label.

    Product
    LEAD 3387S-40 STIMLOC DBS, Model Number 3387S-40. Electrical implantable device.
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-0209-2024·2023-11-08

    Abbott NT2000iX radiofrequency generator serviced with out-of-tolerance tool

    Abbott is recalling 34 NT2000iX radiofrequency generators that were serviced using an out-of-tolerance calibration tool, which may have provided inaccurate measurement results for capacitance failures.

    Product
    Abbott NT2000iX Radiofrequency (RF) generator, REF RFG-NT-2000, lesioning generator
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0080-2024·2023-11-08

    Opium Tincture recalled for subpotent morphine content nationwide

    Edenbridge Pharmaceuticals recalled opium tincture nationwide because the morphine concentration fell below labeled potency. The voluntary recall affected 4,548 bottles.

    Product
    OPIUM TINCTURE DEODORIZED — OPIUM TINCTURE DEODORIZED (MORPHINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0204-2024·2023-11-08

    Coapt ControlSeal Electrode Recalled Due to Burn and Blistering Risk

    Coapt LLC is recalling 109 ControlSeal Electrodes due to risk of minor burns or blistering if exposed to direct sunlight or warm temperatures exceeding 12 hours, or if the battery is damaged.

    Product
    Coapt ControlSeal Electrode, cutaneous EMG Electrode
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0082-2024·2023-11-08

    Iodine Solution Recalled for Manufacturing Compliance Deviations

    Safecor Health recalls Strong Iodine Solution nationwide due to Current Good Manufacturing Practice (CGMP) deviations. The prescription product was distributed in multiple lots across the U.S.

    Product
    STRONG IODINE SOLUTION — STRONG IODINE SOLUTION (STRONG IODINE SOLUTION)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0085-2024·2023-11-08

    Bisoprolol Fumarate and Hydrochlorothiazide Tablets Recalled for Failed Quality Specifications

    Glenmark Pharmaceuticals is recalling Bisoprolol Fumarate and Hydrochlorothiazide Tablets due to failed impurities and degradation specifications. The recall affects 480 bottles distributed nationwide.

    Product
    BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE — BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE (BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0205-2024·2023-11-08

    Pediatric Tracheostomy Tube Recalled Due to Incorrect Box Expiration Date Label

    Smiths Medical recalls a pediatric tracheostomy tube because the outer box shows an incorrect expiration date (3/17/2021) while the actual product has the correct date (3/17/2026). The discrepancy could cause confusion about product validity.

    Product
    Smiths Medical Portex Bivona Pediatric Tracheostomy Tube, Cuffless, Model 60P045, Sterile.
    Category
    Medical Device
    Distribution
    18 states
  • ModerateFDA (Devices)·Z-0197-2024·2023-11-08

    Quest Medical Recalls Q2 Multiport Intravenous Extension Sets

    Quest Medical is recalling 17,700 Q2 Multiport Extension Sets distributed in the US and Canada. The nature of the defect is not detailed in available source documentation.

    Product
    Q2 Multiport Extension set, REF: 9520, Rx Only Sterile, single use non-pyrogenic intravenous fluid administration sets with a multiport IV manifold and integrated back-check valves, pre-attached needleless injection sites, drip chamber and roller clamps.
    Category
    Medical Device
    Distribution
    19 states
  • ModerateFDA (Devices)·Z-0210-2024·2023-11-08

    Endoscopic Vessel Harvesting System Recalled for Incorrect Outer Box Packaging

    Vasoview 6 Pro endoscopic vessel harvesting systems were packaged in incorrect outer boxes displaying artwork for a different device (Vasoview Hemopro 2). The inner labels and product documentation are correct.

    Product
    Vasoview 6 Pro (VV6) - Endoscopic Vessel Harvesting System, Model VH-2400 printed on outer label, inner label and IFU, outer box artwork for Vasoview Hemopro 2 (HP2).
    Category
    Medical Device
    Distribution
    13 states
  • ModerateFDA (Devices)·Z-0212-2024·2023-11-08

    Hillrom Progressa+ Hospital Beds Recalled for Static Electricity Risk

    Hillrom Progressa+ hospital beds (499 units) are being recalled due to potential static electricity buildup that could cause mild shock to operators during transport. The affected units were distributed nationwide.

    Product
    HILLROM PROGRESSA+ BED, Product Codes: P7501A000016, P7501A000019, P7501A000031, P7501A000032, P7501A000033, P7501A000052, P7501A000053, P7501A000054, P7501A000055, P7501A001851, P7501A001972, P7501A001973, and P7501A001974
    Category
    Medical Device
    Distribution
    Distributed nationwide