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.

126–150 of 4361

  • ModerateFDA (Devices)·Z-1983-2026·2026-05-06

    BD GasPak EZ Campy Pouch System Recall for Below-Specification Gas Production

    Becton Dickinson & Co. is recalling certain lots of BD GasPak EZ Campy Gas Generating Pouch Systems because gas generating sachets may produce carbon dioxide levels below specification, potentially affecting microbiologic laboratory testing.

    Product
    BD GasPak EZ Campy Pouch System. Catalog Number: 260685. for microbiologic use
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0508-2026·2026-05-06

    Fentanyl Citrate Injectable Solution Recalled for cGMP Deviations

    Wells Pharma is recalling fentanyl citrate injectable solution (50 mcg/5mL, NDC 73702-202-15) nationwide due to cGMP manufacturing deviations. The recall affects 50 syringes from Lot 020226202150202 with expiration date 05/05/2026.

    Product
    fentaNYL Citrate Injectable Solution in 0.9% Sodium Chloride, 50 mcg/5mL)(10 mcg per mL), wells pharma, NDC 73702-202-15.
    Category
    Drug
    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-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-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-2004-2026·2026-05-06

    Philips Bridge Prep Kit catheter may experience resistance during advancement

    Merit Medical Systems, Inc. is recalling the Philips Bridge Prep Kit (Ref K12-09098C) because the catheter may experience resistance when being advanced over the guidewire during use.

    Product
    Philips Bridge Prep Kit REF: K12-09098C Sterile EO, Rx ONLY
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1964-2026·2026-05-06

    Philips MR 7700 MR Elastography device stiffness value error recall

    Philips is recalling certain MR 7700 devices with MR Elastography due to potential stiffness value errors when specific image reconstruction parameters are used, which may cause voxel size settings to display incorrectly.

    Product
    Philips MR 7700 with MR Elastography (MRE). 1. Model Number (REF): 782120. 2. Model Number (REF): 782153.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2003-2026·2026-05-06

    Philips Bridge Prep Kit catheter may experience resistance during advancement

    Merit Medical Systems is recalling the Philips Bridge Prep Kit (REF K12-09098C) because the catheter may experience resistance when advanced over the guidewire, potentially affecting proper device function.

    Product
    Philips Bridge Prep Kit REF: K12-09098C Sterile EO, Rx ONLY
    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 (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-1945-2026·2026-05-06

    Kiwi Omni Vacuum Delivery System devices recalled for traction force gauge breakage

    Clinical Innovations is recalling the Kiwi Omni Vacuum Delivery System (Model VAC-6000MT) due to complaints of device breakage at the traction force gauge to handle joint. The recall affects 49,175 devices distributed nationwide and internationally.

    Product
    Brand Name: Kiwi Omni Vacuum Delivery System Product Name: Kiwi Omni Vacuum Delivery System Model/Catalog Number: VAC-6000MT Product Description: The Clinical Innovations Kiwi is a disposable vacuum assisted fetal delivery system. It is a sterile, single-patient-use device desig
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1968-2026·2026-05-06

    Philips SmartPath to Ingenia Elition X MR Elastography Stiffness Value Errors

    Philips is recalling three models of SmartPath to Ingenia Elition X with MR Elastography devices due to potential stiffness value errors when specific image reconstruction parameters are combined with Resoundant's algorithm.

    Product
    Philips SmartPath to Ingenia Elition X with MR Elastography (MRE). 1. Model Number (REF): 782118. 2. Model Number (REF): 782144. 3. Model Number (REF): 782163.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-1985-2026·2026-05-06

    DePuy Synthes ATTUNE Revision Hinge Femoral Component Recall

    DePuy Synthes is recalling 3 units of ATTUNE Revision Hinge Femoral Left Size 4 Cement prosthetic components because external sterile packaging was found adhered to internal packaging, potentially compromising sterility.

    Product
    Depuy Synthes, ATTUNE REVISION HINGE FEMORAL LT SZ 4 CEM. Part Number: 150450104.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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 (Devices)·Z-2014-2026·2026-05-06

    Medline Neuro Sponges in Medical Procedure Kits Recalled for Endotoxin

    Medline Industries is recalling medical procedure kits containing Medline Neuro Sponges (ANGIO PACK-LF) due to higher-than-expected endotoxin levels that may exceed specifications.

    Product
    Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: ANGIO PACK-LF, Medline Kit Number/SKU DYNJ0774765U
    Category
    Medical Device
    Distribution
    0 states
  • 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 (Food)·H-0678-2026·2026-05-06

    52USA Brand Popping Boba Mango Flavor Recalled for Unapproved Food Colorants

    52USA brand mango-flavored popping boba is being recalled for containing unapproved food colorants. Consumers who purchased this product with lot number 20250813 should discard it.

    Product
    52USA brand POPPING BOBA; MANGO 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), potas
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Food)·H-0676-2026·2026-05-06

    52USA Popping Boba Recalled for Unapproved Food Colors

    52USA brand popping boba containing unapproved food colorants is being recalled. The product contains tartrazine, sunset yellow, and allura red, which are not approved for use in the United States.

    Product
    52USA brand POPPING BOBA; STRAWBERRY 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), carageenan (EE407), p
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1914-2026·2026-04-29

    Arrow Pressure Injectable Central Venous Catheters Recalled

    Arrow International is recalling 395 pressure injectable central venous catheters across nine U.S. states due to incorrect manufacturing of the liquid adhesive by a supplier.

    Product
    ARROW, ARROWG+ARD AND ARROWG+ARD BLUE PLUS PRESSURE INJECTABLE CENTRAL VENOUS CATHETER REF ASK-42802-PLH UDI code: (01)10801902133110(17)261231(11)251211(10)33F25L0140 REF ASK-45703-MGH UDI code: (01)10801902223675(17)261231(11)251209(10)33F25L0143 REF ASK-42854-MGH
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1937-2026·2026-04-29

    Protocol Configuration Tool software v1.3.0 for Hamilton AutoLys STAR

    Foundation Medicine is recalling Protocol Configuration Tool (PCT) software v1.3.0 for Hamilton AutoLys STAR used within FoundationOneCDx due to potential spontaneous closures of Hamilton HxRunControl software during protocol execution.

    Product
    Protocol Configuration Tool (PCT) software v1.3.0 for Hamilton AutoLys STAR used within FoundationOneCDx (F1CDx) installed on Research Triangle Park laboratory Equipment IDs 01342, 01591, 01989, 01990, 01994, 01995.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1848-2026·2026-04-29

    Medline D and C Pack Kits Recalled Due to Rescinded Regulatory Clearances

    Medline Industries is recalling D and C Pack kits (Model DYNJ41254B) nationwide because regulatory clearances for certain Control Syringes, Guidewires, and High-Pressure Tubing have been rescinded.

    Product
    Medline Kits: 1) D AND C PACK, Model Number: DYNJ41254B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1840-2026·2026-04-29

    Medline General Laparoscopy Kit regulatory clearance rescinded

    The FDA has rescinded the 510(k) regulatory clearances for certain Control Syringes, Guidewires, and High-Pressure Tubing components in Medline's General Laparoscopy Kit (Model CDS930027Y). Affected units should not be used.

    Product
    Medline Kits: 1) GENERAL LAPAROSCOPY, Model Number: CDS930027Y
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1887-2026·2026-04-29

    Medline Convenience Kits with 10mL 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 510(k) clearance. The recall affects approximately 270,311 units distributed nationwide and internationally.

    Product
    Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes EXTREMITY PACK DYNJ34846C HAND PACK DYNJ83218A, DYNJ85396 LAMINECTOMY DYNJ905156R MAJOR EXTREMITY DYNJ905159L, DYNJ905159M MAJOR EXTREMITY PACK DYNJ69926A PODIATRY PACK D
    Category
    Medical Device
    Distribution
    Distributed nationwide