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.

501–525 of 21557

  • ModerateFDA (Devices)·Z-2115-2026·2026-05-13

    Medline Tracheostomy Convenience Kits Sterilization Calibration Recall

    Medline Industries is recalling certain tracheostomy convenience kits and related products due to calibration issues with sterilization equipment that may affect the sterility assurance level of the devices.

    Product
    Medline Convenience Kits: 1) KIT STC TRACHEOSTOMY, Model Number:DYKMBNDL55; 2) KIT STC TRACHEOSTOMY, Model Number:DYKMBNDL55A; 3) TRACH TOTE, Model Number:DYNJ85691
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2117-2026·2026-05-13

    Medline Convenience Kits recalled due to sterilization calibration issues

    Medline Industries is recalling two models of gastrointestinal convenience kits (BAPTIST FLOYD ENDO GI KIT and GI LAB OTHER ENDO KIT) due to calibration issues in sterilization equipment that may have impacted the sterility assurance level of the products.

    Product
    Medline Convenience Kits: 1) BAPTIST FLOYD ENDO GI KIT, Model Number: DYKE1455B; 2) GI LAB OTHER ENDO KIT, Model Number: DYKE1721
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2073-2026·2026-05-13

    DEX Ophthalmic Tissue Forceps 23ga Maculorhexis Forceps Recalled

    Katalyst Surgical, LLC is recalling DEX Ophthalmic Tissue Forceps, Model DVF4019-23, due to a field safety corrective action for instructions for use in DEX Forceps and Scissors. The device is distributed worldwide.

    Product
    DEX Ophthalmic Tissue Forceps, 23ga DEX Maculorhexis Forceps, Model/Catalog Number: DVF4019-23
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateNHTSA·26V300000·2026-05-12

    Nova Bus speaker hole doors are missing the glazing DOT mark

    Nova Bus is recalling certain LFS transit buses because the driver's speaker hole door may lack the prime glazing manufacturer DOT code mark, breaching FMVSS 205.

    Product
    NOVA BUS — NOVA BUS LFS, LFS ARTIC
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·H-0683-2026·2026-05-06

    KLG Kesar Mukhwas contains undeclared colorings and unapproved Acid Red 14

    KLG Kesar Mukhwas is being recalled because it contains undeclared food colorings Yellow 6, Blue 1 and Yellow 5, along with unapproved Acid Red 14. 347 pouches are affected.

    Product
    KLG, Kesar Mukhwas, perishable, 24 months, flexible plastic, 200 gm, 818812022208, Ganesha Enterprises LLC, 5200 Sigstrom Drive, Carson City, Nevada 89706 USA.
    Category
    Food
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1961-2026·2026-05-06

    Philips Ingenia Ambition X MRI Systems Stiffness Value Error Recall

    Philips Ingenia Ambition X MRI systems with MR Elastography may produce incorrect stiffness values due to image reconstruction parameter errors, affecting diagnostic accuracy.

    Product
    Philips Ingenia Ambition X with MR Elastography (MRE). 1. Model Number (REF): 781356. 2. Model Number (REF): 782109. 3. Model Number (REF): 782138. 4. Model Number (REF): 782160.
    Category
    Medical Device
    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 (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 (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 (Food)·H-0677-2026·2026-05-06

    52USA passion fruit popping boba contains unapproved color additives

    52USA brand Popping Boba in passion fruit flavour is being recalled because it contains unapproved colors: tartrazine, sunset yellow and allura red. 5,196 units are affected.

    Product
    52USA brand POPPING BOBA; PASSION FRUIT FLAVOR; Net wt: 7 lb (3.2kg); Ingredients Drinking water, fructose syrup, food additives (hydroxypropyl distarch phosphate (E1442), calcium lactate (E327), DL-malic acid (E296), sodium alginate (E401), citric acid (E330), carrageenan (EE407
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1944-2026·2026-05-06

    Vacuum Bag SU Large non-sterile specimen container recall

    Milestone S.R.L. is recalling Vacuum Bag SU Large non-sterile specimen containers (Model 68409SS) due to the possibility of reagent leakage from the container. The recall affects approximately 61,600 units distributed worldwide.

    Product
    VACUUM BAG SU LARGE, Non-sterile specimen container, Model/Catalog Number: 68409SS
    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 (Food)·H-0685-2026·2026-05-06

    Calypso Tropic Tango Lemonade contains undeclared Yellow No. 5

    Calypso Tropic Tango Lemonade is being recalled because it contains undeclared Yellow No. 5. The action covers 299,779 cases distributed nationwide and to four other markets.

    Product
    Calypso Tropic Tango Lemonade. 16 FL oz (1PT) (473 ML). UPC 0 79581-18709 7. Keep Refrigerated After Opening. King Juice Company, Inc., Milwaukee, Wisconsin 53221.
    Category
    Food
    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-1982-2026·2026-05-06

    BD GasPak EZ CO2 Pouch System gas generating sachets underperforming

    Becton Dickinson is recalling certain lots of BD GasPak EZ CO2 and BD GasPak EZ Campy Gas Generating Pouch Systems because gas generating sachets may produce carbon dioxide levels below specification.

    Product
    BD GasPak EZ CO2 Pouch System. Catalog Number: 260684. for microbiologic use
    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
  • ModerateFDA (Devices)·Z-1988-2026·2026-05-06

    DePuy Synthes ATTUNE Revision Hinge Femoral Component Sterility Recall

    DePuy Synthes is recalling 3 units of ATTUNE REVISION HINGE FEMORAL LT SZ 8 CEM due to external sterile packaging adhered to internal packaging, potentially compromising sterility.

    Product
    Depuy Synthes, ATTUNE REVISION HINGE FEMORAL LT SZ 8 CEM. Part Number: 150450108.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1962-2026·2026-05-06

    Philips Ingenia Elition S MRI stiffness value error correction

    Philips Ingenia Elition S MRI systems with MR Elastography may display incorrect voxel size settings in the default scan protocol when certain image reconstruction parameters are used, potentially leading to stiffness value errors.

    Product
    Philips Ingenia Elition S with MR Elastography (MRE). 1. Model Number (REF): 781357. 2. Model Number (REF): 782106. 3. Model Number (REF): 782137.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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 (Devices)·Z-2029-2026·2026-05-06

    Medline Neuro Sponges Cervical Pack Kits Recalled for Endotoxin

    Medline Industries is recalling medical procedure kits containing Medline Neuro Sponges (Cervical Pack) due to higher-than-expected endotoxin levels that may be out-of-specification.

    Product
    Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: CERVICAL PACK, Medline Kit Number/SKU DYNJ37902F
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1958-2026·2026-05-06

    Philips Ingenia 3.0T MRI System with Elastography Software Recall

    Philips Ingenia 3.0T MRI systems with MR Elastography software may display incorrect stiffness values and voxel size settings when specific image reconstruction parameters are used, potentially affecting diagnostic accuracy.

    Product
    Philips Ingenia 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781342. 2. Model Number (REF): 781377. 3. Model Number (REF): 782103. 510(k) Numbers: K163116, K173079, K183063, K193215, K213516, K213583, K223458, K251397, K251808
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1969-2026·2026-05-06

    Philips MR 7700 MRE Upgrade MRI Equipment Stiffness Value Error Risk

    Philips is recalling 15 units of its MR 7700 with MR Elastography upgrade due to potential stiffness value errors in MRI scans when specific image reconstruction parameters are used with the Resoundant algorithm.

    Product
    Philips Upgrade to MR 7700 with MR Elastography (MRE). 1. Model Number (REF): 782130.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1965-2026·2026-05-06

    Philips SmartPath to dStream MR Elastography System Reconstruction Error

    Philips is recalling certain SmartPath to dStream 1.5T MR Elastography systems due to potential stiffness value errors when specific image reconstruction parameters are used, which may cause incorrect voxel size settings in the default MRE scan protocol.

    Product
    Philips SmartPath to dStream for 1.5T with MR Elastography (MRE). 1. Model Number (REF): 781260. 2. Model Number (REF): 782112.
    Category
    Medical Device
    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