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.

201–225 of 21557

  • ModerateFDA (Drugs)·D-0698-2026·2026-07-08

    Fungal Fusion antifungal kit recalled for discontinued stability testing

    Blaine Labs Inc is recalling Fungal Fusion ERADICATION Solution kits nationwide because the manufacturer discontinued required stability testing for products still on the market within their expiration dates.

    Product
    Fungal Fusion ERADICATION Solution, Antifungal & Antimicrobial Kit. Contains, 1x2 oz bottle Fungal Fusion Antifungal (Miconazole Nitrate) Cream, 1x2oz bottle Fungal Fusion Antifungal Solution (25% Undecylenic Acid) and 1x1oz bottle of Fungal Fusion Eradication Antimicrobial Show
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2645-2026·2026-07-08

    Medela ENFit ExSet Enteral Extension Set Connector Compatibility Issue

    Medela ENFit ExSet Strl 60 enteral extension sets may contain incorrect connectors that do not attach or misconnect to ENFit connections, potentially delaying delivery of nutritional fluids or medication.

    Product
    Brand Name: Medela Product Name: ENFit ExSet Strl 60 2.0ml PV 1ct EN Model/Catalog Number: ENF060182LD / 101033086 Software Version: N/A Product Description: Enteral Extension Set, Length 60 Orange-Striped Minibore Tubing, (Approx. Priming Vol. 2.00 mL), ENFit¿ Componen
    Category
    Medical Device
    Distribution
    18 states
  • ModerateFDA (Drugs)·D-0614-2026·2026-07-01

    Sensipar Cinacalcet Tablets Recalled Due to CGMP Deviations

    Amgen, Inc. is recalling Sensipar (cinacalcet) 60 mg tablets nationwide due to Current Good Manufacturing Practice (CGMP) deviations. The recall affects 30-count bottles with Lot #1157055 and expiration date 1/31/2028.

    Product
    SENSIPAR — SENSIPAR (CINACALCET HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2527-2026·2026-07-01

    Zimmer Shoulder System Reamer Guide recalled for plastic breakage

    Zimmer is recalling the Off-Axis Comprehensive Shoulder System Small Reamer Guide due to plastic guides catching and breaking during reaming procedures.

    Product
    Off-Axis Comprehensive Shoulder System Small, Augment, Off-Axis, Reamer Guide, Model/Catalog Number: 110040240
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2576-2026·2026-07-01

    Octopus Evolution AS Tissue Stabilizer Model TS2500 Tubing Assembly Issue Recall

    Medtronic is recalling 288 units of the Octopus Evolution AS Tissue Stabilizer Model TS2500 due to incorrect tubing positioning during manufacturing, where short and long tubes were attached to wrong locations.

    Product
    Octopus Evolution AS Tissue Stabilizer, Model TS2500
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0613-2026·2026-07-01

    Sensipar (Cinacalcet Hydrochloride) Tablets Recalled for CGMP Deviations

    Amgen, Inc. is voluntarily recalling 9,565 bottles of Sensipar (cinacalcet) 30mg tablets nationwide due to CGMP manufacturing deviations. The recalled lot was distributed to patients taking the medication for secondary hyperparathyroidism.

    Product
    SENSIPAR — SENSIPAR (CINACALCET HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0612-2026·2026-07-01

    Corlanor ivabradine tablets recalled for presence of foreign substance

    Amgen Inc. is recalling Corlanor (ivabradine) 5 mg tablets nationwide due to the presence of a foreign substance. The recall affects approximately 934,577 bottles distributed in the United States.

    Product
    CORLANOR — CORLANOR (IVABRADINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2522-2026·2026-07-01

    Philips Avalon Fetal Monitor FM20 Speaker Connector Assembly Recall

    Philips is recalling certain Avalon Fetal Monitor FM20 units worldwide due to incorrect speaker connector assembly that can cause device cables to be pulled out, leading to loss of speaker output.

    Product
    Philips Avalon Fetal Monitor, FM20, Part number M2702A, Part M2703A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0615-2026·2026-07-01

    Corlanor Ivabradine Tablets Recalled for Foreign Substance Contamination

    Amgen is recalling specific lots of Corlanor (ivabradine) 7.5mg tablets nationwide due to the presence of a foreign substance. Patients should consult their healthcare provider before stopping this medication.

    Product
    CORLANOR — CORLANOR (IVABRADINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2581-2026·2026-07-01

    Medline Polycarbonate Syringes Recalled for Unapproved Design Changes

    Medline Industries is recalling convenience kits containing 10mL polycarbonate colored syringes due to unapproved design changes made outside of FDA-cleared specifications. Affected kits were distributed nationwide.

    Product
    Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. ANGIOGRAM PACK-LF DYNJ21574J JUDKINS PACK DYNJ51126
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0609-2026·2026-07-01

    METHYLERGONOVINE MALEATE Tablets 0.2 mg Drug Recall

    The Harvard Drug Group LLC is recalling METHYLERGONOVINE MALEATE Tablets 0.2 mg because the drug may be subpotent (contain less active ingredient than intended). The recall affects approximately 790 cartons distributed nationwide.

    Product
    METHYLERGONOVINE MALEATE — METHYLERGONOVINE MALEATE (METHYLERGONOVINE MALEATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2588-2026·2026-07-01

    Medline 10mL Polycarbonate Colored Syringes Convenience Kits Recalled

    Medline Industries is recalling convenience kits containing 10mL polycarbonate colored syringes due to unapproved design changes made outside of FDA clearance requirements.

    Product
    Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. MAJOR BASIN SET DYNJ85723
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0617-2026·2026-07-01

    Duloxetine 30 mg capsules recalled for impurity above FDA limits

    Direct Rx is recalling Duloxetine D/R 30 mg capsules (also sold as Cymbalta) distributed nationwide because the drug contains N-nitroso-duloxetine impurity above FDA-recommended interim limits.

    Product
    DULOXETINE D/R, a) 30 mg (NDC 61919-482-30), 30 Caps; b) 30 mg (NDC 61919-482-60), 60 Caps; CYMBALTA, Packaged and Distributed by Direct Rx.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2596-2026·2026-07-01

    Medline 10mL Polycarbonate Syringes Recalled for Unapproved Design Changes

    Medline Industries is recalling convenience kits containing 10mL polycarbonate colored syringes due to unapproved design changes made outside of FDA clearance. The affected kits were distributed nationwide.

    Product
    Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. FTMC C-SECTION TRAY-LF DYNJ54603B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2575-2026·2026-07-01

    Octopus Evolution Tissue Stabilizer Model TS2000 tubing assembly error

    Medtronic Perfusion Systems is recalling the Octopus Evolution Tissue Stabilizer, Model TS2000, due to an assembly error where tubing was incorrectly positioned during manufacturing.

    Product
    Octopus Evolution Tissue Stabilizer, Model TS2000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2526-2026·2026-07-01

    Multi-Snare Set catheter fails biocompatibility requirements

    PFM Medical Inc. is recalling Multi-Snare Set catheters (5 mm and 10 mm sizes) because they failed biocompatibility testing for in-vitro cytotoxicity and could cause localized inflammation and tissue irritation if they contact a patient's blood vessels.

    Product
    Multi-Snare Set: 5 mm x 125 cm, REF: 147305; 10 mm x 125 cm, REF: 147310
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2577-2026·2026-07-01

    Octopus 4 Tissue Stabilizer incorrectly assembled tubing positions

    Medtronic is recalling 590 units of the Octopus 4 Tissue Stabilizer, Model 29400 due to an assembly error where tubing was attached to the wrong positions during manufacturing.

    Product
    Octopus 4 Tissue Stabilizer, Model 29400
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0611-2026·2026-07-01

    Fenofibrate Capsules 200 mg Recalled for CGMP Manufacturing Deviations

    Ajanta Pharma USA Inc. is recalling Fenofibrate Capsules, USP 200 mg due to Current Good Manufacturing Practice (CGMP) deviations identified during production. The recall affects 3,648 bottles distributed nationwide.

    Product
    FENOFIBRATE — FENOFIBRATE (FENOFIBRATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2579-2026·2026-07-01

    Philips Telemetry Monitor 5500 Device Reset Risk Recall

    Philips Telemetry Monitor 5500 (Model 867232) may unexpectedly reset to default "NEW_DEVICE" state, causing loss of device configuration and disconnection from the PIC iX central monitoring system.

    Product
    Philips Telemetry Monitor 5500 1.4 GHz. Model Number: 867232. Includes the following system descriptions: TELE Monitor 5500, 1.4 Ghz, ECG only, ex; Telemetry Monitor 5500 1.4 GHz FAST EX.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2594-2026·2026-07-01

    Medline Polycarbonate Syringes in Convenience Kits Recalled for Unapproved Design Changes

    Medline Industries is recalling convenience kits containing 10mL polycarbonate colored syringes because the manufacturer made unapproved design changes not cleared by the FDA.

    Product
    Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. CENTRAL LINE TRAY DYNJ41089 FISTULAGRAM PACK DYNJ62827A FISTULOGRAM PACK DYNJ47899A INVASIVE LINE INSERTION DYNJ44123B NON VASCULAR PACK DYNJ68037A VASCULAR ACCES
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2595-2026·2026-07-01

    Medline 10mL Polycarbonate Colored Syringes in Convenience Kits Recalled

    Medline Industries is recalling convenience kits containing 10mL polycarbonate colored syringes because the products contain unapproved design changes that were not cleared by the FDA.

    Product
    Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. PICC LINEPACK (PCLUI)642-LF DYNJ47717A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·H-1110-2026·2026-07-01

    El David Gelee Bonbons Recalled for Undeclared Color Additives

    El David Gelee Bonbons with fruits (400g boxes) are recalled due to undeclared FD&C Yellow 5 and FD&C Red 40 color additives. Consumers who have purchased this product should not consume it.

    Product
    El David Gelee, Bonbons with fruits Soft & Juicy, 400g. Packaged in decorated paperboard box and covered entirely in transparent, flexible plastic wrap. (20 bonbon pieces per 400g box). UPC 5304000050757
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-0627-2026·2026-07-01

    Povi-One Povidone-Iodine 10% Topical Drug Recall for Sub Potency

    Elevate Oral Care is recalling Povi-One 10% Povidone-Iodine Oral Antiseptic nationwide due to sub potency. The affected lots have expiration dates ranging from June 2026 to October 2026.

    Product
    POVI-ONE — POVI-ONE (POVIDONE-IODINE 10% TOPICAL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2584-2026·2026-07-01

    Medline 10mL Polycarbonate Colored Syringes Convenience Kits Recalled

    Medline Industries is recalling convenience kits containing 10mL polycarbonate colored syringes because the products underwent unapproved design changes outside of FDA clearance.

    Product
    Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. DR G'S BREAST PACK DYNJ51124B LIPO SUPPLEMENT PACK-LF DYNJ0341174D PLASTIC PACK DYNJ66746 DYNJ85702
    Category
    Medical Device
    Distribution
    Distributed nationwide