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.

101–125 of 4361

  • ModerateFDA (Drugs)·D-0501-2026·2026-05-06

    Similasan iVIZIA Sterile Lubricant Eye Drops Recall Due to Sterility Assurance

    Thea Pharma, Inc. is recalling Similasan iVIZIA Sterile Lubricant Eye Drops due to the lack of assurance of sterility caused by manufacturing deviations found by the FDA.

    Product
    Similasan, iVIZIA, Sterile Lubricant Eye Drops (Povidone 0.5%), 0.33 Fl oz (10 mL), Made in France, Distributed by: Thea Pharma Inc., Waltham, MA 02451, NDC 59262-700-11
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0507-2026·2026-05-06

    Ketamine Hydrochloride Injectable Solution Recalled for cGMP Deviations

    Wells Pharma of Houston LLC is recalling 4,975 syringes of Ketamine Hydrochloride Injectable Solution (50 mg/mL) distributed nationwide due to current Good Manufacturing Practice (cGMP) deviations.

    Product
    Ketamine Hydrochloride Injectable Solution, 50mg/ml, (50 mg per mL) Volume: 1 mL, 5265 Kitty Drive, Houston, TX 77054, NDC 73702-302-31.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0526-2026·2026-05-06

    Alendronate Sodium Oral Solution Recalled for Out-of-Specification Assay Results

    Hikma Pharmaceuticals USA Inc. is recalling Alendronate Sodium Oral Solution 70 mg/75 mL due to out-of-specification assay results found in a limited number of bottles. The affected lot (AC2040A) was distributed nationwide.

    Product
    ALENDRONATE SODIUM — ALENDRONATE SODIUM (ALENDRONATE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0505-2026·2026-05-06

    Fentanyl Citrate Injectable Solution Recalled for cGMP Deviations

    Wells Pharma of Houston LLC has recalled fentanyl citrate injectable solution (1250 mcg/25mL) distributed nationwide due to cGMP deviations. The recall involves 50 syringes from Lot 011226204250063, expiring 05/14/2026.

    Product
    fentaNYL Citrate Injectable Solution, Narcotic, CII, 1250 mcg/25mL (50 mcg per mL), 25 mL, wells pharma of Houston, NDC 73702-204-25.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1966-2026·2026-05-06

    Philips SmartPath dStream 3.0T MRI Scanner Software Parameter Error Recall

    Philips is recalling one unit of the SmartPath to dStream 3.0T MRI scanner with MR Elastography due to potential stiffness value calculation errors when specific image reconstruction parameters are used.

    Product
    Philips SmartPath to dStream for 3.0T with MR Elastography (MRE). 1. Model Number (REF): 782145.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1956-2026·2026-05-06

    Philips Ingenia 1.5T MRI System Stiffness Value Calculation Error Recall

    Philips Ingenia 1.5T MRI systems with MR Elastography may display incorrect stiffness values and voxel size settings due to image reconstruction parameter combinations. The error affects 54 units distributed worldwide.

    Product
    Philips Ingenia 1.5T with MR Elastography (MRE). 1. Model Number (REF): 781315. 2. Model Number (REF): 781341. 3. Model Number (REF): 781396. 4. Model Number (REF): 782115. 510(k) Numbers: K163116, K173079, K183063, K193215, K213583, K223458, K251397, K251808
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1953-2026·2026-05-06

    Philips Achieva 3.0T MR Elastography system stiffness value error recall

    Philips is recalling the Achieva 3.0T with MR Elastography system due to potential stiffness value errors in image reconstruction when specific parameters are used, which may cause incorrect voxel size display in the default scan protocol.

    Product
    Philips Achieva 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781278.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2008-2026·2026-05-06

    Medline Neuro Sponges recalled for out-of-specification endotoxin levels

    Medline Industries is recalling Medline Neuro Sponges in multiple sizes worldwide after internal review found higher-than-expected endotoxin levels in representative product samples.

    Product
    Medline Neuro Sponges, various dimensions, labeled as: 1. Neuro Sponges, Eponges neuro, Neuroesponjas, size 0.25" X 0.25", XR, 10/PK, Medline SKU NEUROSPNG02; 2. Neuro Sponges, Eponges neuro, Neuroesponjas, size 0.5" X 0.5", XR, 10/PK, Medline SKU NEUROSPNG05; 3. Neu
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0502-2026·2026-05-06

    Injectable Phenylephrine Hydrochloride Solution Recall Due to cGMP Deviations

    Wells Pharma of Houston LLC is recalling Phenylephrine Hydrochloride Injectable Solution, 40 mg, 250 mL IV bags nationwide due to cGMP deviations. The recall affects 13,070 IV bags with multiple lot numbers and expiration dates through July 2026.

    Product
    Phenylephrine Hydrochloride Injectable Solution, 40mg, 250*mL Bag, wells pharma of Houston, NDC 73702-122-03
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1980-2026·2026-05-06

    Dimension Creatinine Flex Reagent Cartridge Recalled for Imprecision Results

    Siemens Healthcare Diagnostics is recalling certain lots of Dimension Creatinine Flex reagent cartridges due to potential imprecision in creatinine test results that could be erroneously increased or decreased.

    Product
    Dimension Creatinine Flex reagent cartridge. Material Number: 10872079.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1946-2026·2026-05-06

    Disposable Mixing Bowls with Spatula recalled for compromised sterile barrier

    Zimmer, Inc. is recalling Disposable Mixing Bowls with Spatula (Model 00-5049-011-00) due to package seal defects that may compromise the sterile barrier. Ten complaints have been received identifying incomplete seals, wrinkles, or peeling seals.

    Product
    Brand Name: Disposable Mixing Bowls with Spatula Product Name: Mixing Bowl and Spatula Model/Catalog Number: 00-5049-011-00 Software Version: N/A Product Description: Mixing Bowl and Spatula Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2002-2026·2026-05-06

    Philips Bridge Prep Kit catheter may experience resistance during advancement

    Merit Medical Systems is recalling the Philips Bridge Prep Kit (Lot K12-09098B) because the catheter may experience resistance when being advanced over the guidewire.

    Product
    Philips Bridge Prep Kit REF: K12-09098B Sterile EO, Rx ONLY
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1957-2026·2026-05-06

    Philips Ingenia 1.5T CX MRI Machine MRE Stiffness Measurement Error

    Philips is recalling the Ingenia 1.5T CX MRI machine with MR Elastography because certain image reconstruction parameters may cause stiffness value measurement errors in the default scan protocol.

    Product
    Philips Ingenia 1.5T CX with MR Elastography (MRE). 1. Model Number (REF): 781262.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1950-2026·2026-05-06

    HiResolution Bionic Ear Battery Pak Fails Safety Door Compliance

    Advanced Bionics is recalling HiResolution Bionic Ear System M Zn-Air Battery Paks because the non-tamperproof battery door does not require a tool to open, violating safety standards. The issue affects 45,173 units distributed worldwide.

    Product
    Brand Name: HiResolution" Bionic Ear System Product Name: M Zn-Air Battery Pak Model/Catalog Number: CI-5501-110; CI-5501-120; CI-5501-130; CI-5501-140; CI-5501-150; CI-5501-190; CI-5501-240; CI-5501-250; CI-5501-260; CI-5501-270; CI-5501-280 Software Version: Not Applicable
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1959-2026·2026-05-06

    Philips Ingenia 3.0T CX MRI System MR Elastography Software Issue

    Philips is recalling Ingenia 3.0T CX MRI systems with MR Elastography due to potential stiffness value errors caused by specific image reconstruction parameters and Resoundant algorithm settings, resulting in incorrect voxel size displays in the default MRE scan protocol.

    Product
    Philips Ingenia 3.0T CX with MR Elastography (MRE). 1. Model Number (REF): 781271. 2. Model Number (REF): 782105. 510(k) Numbers: K173079, K183063, K193215, K213583, K223458, K251397, K251808.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1986-2026·2026-05-06

    Depuy Synthes ATTUNE Revision Hinge Femoral Component Sterility Compromise

    Depuy Synthes is recalling ATTUNE Revision Hinge Femoral components because external sterile packaging was found adhered to internal sterile packaging, potentially compromising sterility.

    Product
    Depuy Synthes, ATTUNE REVISION HINGE FEMORAL LT SZ 5 CEM. Part Number: 150450105.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0504-2026·2026-05-06

    Fentanyl Citrate Injectable Solution Recalled for cGMP Deviations

    Wells Pharma of Houston is voluntarily recalling 2,940 IV bags of fentanyl citrate injectable solution due to cGMP (current good manufacturing practice) deviations. The product was distributed nationwide.

    Product
    fentaNYL Citrate injectable Solution in 0.9% Sodium Chloride, Narcotic, (2500 mcg/ 250 mL) (10 mcg per mL), 250 mL bag, wells pharma of Houston, NDC 73702-202-03.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1967-2026·2026-05-06

    Philips SmartPath to dStream MR Elastography Software Parameter Error

    Philips is recalling specific units of SmartPath to dStream for XR and 3.0T with MR Elastography due to potential stiffness value errors when certain image reconstruction parameters are used with Resoundant's algorithm, which may cause voxel size settings in the default MRE scan protocol to display incorrectly.

    Product
    Philips SmartPath to dStream for XR and 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781270. 2. Model Number (REF): 782113.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1952-2026·2026-05-06

    Philips Achieva 1.5T MRI System MRE Protocol Parameter Error Recall

    Philips Achieva 1.5T MRI systems with MR Elastography may display incorrect stiffness values and voxel size settings when certain image reconstruction parameters are used together, potentially affecting diagnostic accuracy.

    Product
    Philips Achieva 1.5T Initial system with MR Elastography (MRE). 1. Model Number (REF): 781178.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0500-2026·2026-05-06

    iVIZIA Dry Eye Lubricant Drops Recalled for Sterility Assurance

    Thea Pharma, Inc. is recalling iVIZIA Dry Eye (Povidone 0.5%) lubricant eye drops nationwide due to the FDA's discovery of manufacturing process deviations that affect the product's sterility assurance.

    Product
    IVIZIA DRY EYE — IVIZIA DRY EYE (POVIDONE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0506-2026·2026-05-06

    Fentanyl Citrate Injectable Solution Recall Due to cGMP Deviations

    Wells Pharma of Houston is recalling fentanyl citrate injectable solution (1000 mcg/50 mL) due to current good manufacturing practice (cGMP) deviations. The recall affects 150 syringes distributed nationwide.

    Product
    fentaNYL Citrate Injectable Solution in 0.9% Sodium Chloride, 1000 mcg/50mL (20 mcg per mL), well pharma of Houston, NDC 73702-203-65.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0503-2026·2026-05-06

    Fentanyl Citrate Injectable Solution Recalled for cGMP Deviations

    Wells Pharma is recalling fentanyl citrate injectable solution (1000 mcg/100 mL, 10 mcg per mL) distributed nationwide due to current good manufacturing practice (cGMP) deviations. The recall affects 4,030 IV bags with various lot numbers and expiration dates between April and June 2026.

    Product
    fentaNYL Citrate Injectable Solution, NARCOTIC, Cii, 1000 mcg/100 mL (10 mcg per mL), 100 mL bag, Wells Pharma in Houston, NDC 73702-202-02.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1993-2026·2026-05-06

    DePuy Synthes ATTUNE Revision Hinge Femoral implant sterility concern

    DePuy Synthes is recalling 3 units of ATTUNE Revision Hinge Femoral RT SZ 8 CEM implants due to external sterile packaging adhered to internal sterile packaging, potentially compromising sterility.

    Product
    Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 8 CEM. Part Number: 150450208.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1955-2026·2026-05-06

    Philips Evolution 3.0T MR Elastography upgrade stiffness calculation error

    Philips Evolution upgrade 3.0T with MR Elastography systems may produce incorrect stiffness values when specific image reconstruction parameters are used, causing voxel size settings to display smaller than intended.

    Product
    Philips Evolution upgrade 3.0T with MR Elastography (MRE). 1. Model Number (REF): 782143. 2. Model Number (REF): 782162.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2037-2026·2026-05-06

    Medline medical procedure kits recalled for endotoxin contamination

    Medline is recalling medical procedure kits containing Neuro Sponges due to higher-than-expected endotoxin levels. The affected in-market product may be out-of-specification for endotoxin.

    Product
    Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. CATARACT PACK, Medline Kit Number/SKU DYNJ48725A; 2. OCULAR PACK, Medline Kit Number/SKU DYNJ64138B; 3. OCULOPLASTY PACK, Medline Kit Number/SKU DYNJ64572A; 4. OCULOPLASTY PACK, Medli
    Category
    Medical Device
    Distribution
    0 states