The Recall Desk

Severity 4 of 5

Severe recalls

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

What “severe” means here

Severity 4 (Severe) recalls have a real, documented risk of significant injury, hospitalization, or property damage even if no deaths have been reported. The agency classification is FDA Class II with hospitalization reports, USDA Class I, or a structural vehicle defect. These need attention quickly — not five-alarm urgency but not something to put off. Examples include allergen mislabeling on common allergens for products eaten by children, drug potency out of specification by a margin that could cause measurable harm, and vehicle defects affecting braking or steering.

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.

1901–1925 of 4878

  • SevereFDA (Devices)·Z-2376-2023·2023-08-23

    Mahurkar Dialysis Catheters Recalled for Center Lumen Obstruction

    Covidien is recalling 1,099 MAHURKAR dialysis catheters worldwide due to excessive silicone lubricant that can block the center lumen, potentially delaying treatment.

    Product
    MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Straight Extensions, PASS Tray REF: 8888104003HP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2367-2023·2023-08-23

    Covidien MAHURKAR Dialysis Catheter Recalled for Lumen Occlusion Risk

    Covidien is recalling dialysis catheters with excessive lubricant in the center lumen, which may cause occlusion, obstruct blood flow, and delay treatment.

    Product
    MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 13 cm, Curved Extensions, IC Tray REF:8888101001HP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2370-2023·2023-08-23

    Dialysis catheter recalled due to potential tip occlusion risk

    Covidien is recalling MAHURKAR dialysis catheters that may have excessive lubricant in the catheter tip, potentially causing obstruction. This could delay treatment or cause serious blood complications including thrombosis or embolism.

    Product
    MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Curved Extensions, IC Tray REF: 8888101004HP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1403-2023·2023-08-23

    Heinen's Cashew Butter Recalled for Undeclared Peanut and Almond

    Heinen's Fresh Ground Cashew Butter may contain undeclared peanut butter and/or almond butter. People with peanut or tree nut allergies could experience serious allergic reactions.

    Product
    Heinen's Fresh Ground Cashew Butter: packaged in plastic circle containers 1lb. Sold individually.
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Devices)·Z-2411-2023·2023-08-23

    Alcon Custom Pak Intraocular Lens Packages Recalled for Plastic Debris Risk

    Alcon Custom Pak intraocular lens packages are recalled due to reports of patient injury during surgical procedures caused by plastic debris from over-tightening with the included plastic wrench.

    Product
    Alcon Custom Pak
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2375-2023·2023-08-23

    Dialysis catheter recalled due to excessive lubricant causing obstruction

    Covidien's MAHURKAR dialysis catheter is recalled because excessive silicone lubricant can block the center lumen, preventing or reducing blood flow during dialysis. This Class I recall affects 271 units and carries risk of treatment delays, hemolysis, and blood clots.

    Product
    MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Curved Extensions, PASS Tray REF: 8888103004HP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2371-2023·2023-08-23

    Dialysis Catheters Recalled for Catheter Obstruction from Excessive Silicone Lubricant

    Covidien is recalling 1,875 MAHURKAR dialysis catheters with lot numbers 2204000239 and 2227800110 due to excessive silicone lubricant causing catheter obstruction. The obstruction may delay treatment or cause hemolysis and thrombosis.

    Product
    MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Straight Extensions, IC Tray REF: 8888102003HP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2389-2023·2023-08-23

    MAHURKAR Dialysis Catheter Recalled for Center Lumen Obstruction Risk

    Covidien LP recalled 15,209 MAHURKAR dialysis catheters due to excessive lubricant in the center lumen, which may cause catheter occlusion, reduce blood flow, or lead to hemolysis and blood clots.

    Product
    MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Curved Extensions, Kit REF: 8888345629HP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2382-2023·2023-08-23

    Mahurkar Dialysis Catheter Center Lumen Occlusion, FDA Class I Recall

    Covidien's Mahurkar dialysis catheters are recalled due to center lumen occlusion from excessive silicone lubricant, risking treatment delay and serious vascular complications.

    Product
    MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 16 cm, Curved Extensions REF: 8888345512HP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2377-2023·2023-08-23

    Acute Dialysis Catheters Recalled for Catheter Tip Occlusion

    Covidien recalls 519 MAHURKAR acute dialysis catheters (Lot 2200400292) due to excessive silicone lubricant coating the catheter tip that may cause partial or full occlusion and treatment delays.

    Product
    MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensions, PASS Tray REF: 8888104004HP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2373-2023·2023-08-23

    Dialysis Catheter Recall Due to Potential Lumen Occlusion

    Covidien LP is recalling MAHURKAR dialysis catheters due to excess silicone lubricant that can block the central lumen, potentially delaying treatment or causing serious complications.

    Product
    MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 13 cm, Curved Extensions, PASS Tray REF: 8888103001HP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2408-2023·2023-08-23

    Infinity FMS Pak surgical device recalled for plastic debris hazard

    Alcon is recalling the Infinity FMS Pak surgical device after reports of patient injuries during procedures caused by plastic debris from over-tightening the included wrench. The recall affects 51,054 units distributed worldwide.

    Product
    Infinity FMS Pak
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2374-2023·2023-08-23

    Dialysis Catheter Recall: Center Lumen Occlusion Due to Excessive Lubricant

    Covidien LP is recalling MAHURKAR 12 Fr dialysis catheters due to center lumen occlusion from excessive lubricant. The defect may cause treatment delays and serious complications including embolism and thrombosis.

    Product
    MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Curved Extensions, PASS Tray REF: 8888103002HP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2384-2023·2023-08-23

    Dialysis catheters recalled for potential center lumen obstruction

    Covidien LP is recalling MAHURKAR dialysis catheters because excessive silicone lubricant coats the center lumen, potentially blocking blood flow or creating clots and other blood vessel complications.

    Product
    MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 13 cm, Curved Extensions, Kit" REF: 8888345603
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2369-2023·2023-08-23

    Dialysis Catheter Recalled Due to Silicone Lubricant Obstruction Risk

    Covidien LP is recalling 5,373 MAHURKAR dialysis catheters because excessive silicone lubricant can occlude the catheter lumen, potentially causing treatment delays or blood clotting complications.

    Product
    MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Curved Extensions, IC Tray REF: 8888101003HP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2368-2023·2023-08-23

    Dialysis Catheter Recalled Due to Excessive Lubricant Causing Center Lumen Obstruction

    Covidien is recalling MAHURKAR dialysis catheters due to excessive silicone-based lubricant coating the center lumen tip, which may cause partial or complete obstruction, delaying treatment or causing thrombosis.

    Product
    MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 16 cm, Curved Extensions, IC Tray REF: 8888101002HP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2378-2023·2023-08-23

    Dialysis catheter recall: excessive lubricant causes center lumen obstruction

    A dialysis catheter product is being recalled due to excessive lubricant coating in the center lumen, which may cause full or partial obstruction. The blockage could delay treatment and increase risk of blood clots and hemolysis.

    Product
    MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 20 cm, Straight Extensions, Kit REF: 8888340629
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2390-2023·2023-08-23

    Dialysis Catheter Occlusion Recall Due to Excessive Lubricant Coating

    Covidien recalls 647 MAHURKAR dialysis catheters due to center lumen occlusion caused by excessive silicone lubricant. The blockage may delay treatment or increase risks of blood clots.

    Product
    MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 24 cm, Curved Extensions, Kit REF: 8888345637
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2385-2023·2023-08-23

    Acute Dialysis Catheter Recalled for Potential Lumen Obstruction and Embolism Risk

    Covidien is recalling MAHURKAR acute dialysis catheters for excessive silicone lubricant causing lumen obstruction that may delay treatment and lead to hemolysis, embolism, or thrombosis.

    Product
    MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 13 cm, Curved Extensions, Kit REF: 8888345603HP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2388-2023·2023-08-23

    Dialysis Catheter Recall Due to Center Lumen Occlusion

    Covidien is recalling MAHURKAR Triple Lumen Acute Dialysis Catheters due to excessive lubricant blocking the center lumen, which may delay dialysis and cause blood clots. The recall affects 6,949 units distributed in the US and worldwide.

    Product
    MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 20 cm, Curved Extensions, Kit" REF: 8888345629
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2380-2023·2023-08-23

    FDA Recalls Mahurkar Dialysis Catheter for Potential Tip Obstruction Risk

    Covidien's Mahurkar acute dialysis catheters may have excessive silicone lubricant causing tip obstruction. This could delay treatment or cause serious complications including blood clots and embolism.

    Product
    MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensions, Kit REF: 8888340637
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2391-2023·2023-08-23

    Dialysis Catheter Recalled for Center Lumen Occlusion Risk

    Covidien LP is recalling 3,965 MAHURKAR dialysis catheters due to excessive lubricant causing center lumen occlusion. This may obstruct blood flow or cause hemolysis and blood clots.

    Product
    MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Curved Extensions, Kit REF: 8888345637HP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2406-2023·2023-08-23

    Alcon Constellation Procedure Pak recalled due to plastic debris risk

    Alcon is recalling the Constellation Procedure Pak due to reports of patient injury from plastic debris. The debris can result from over-tightening the device with the included plastic wrench.

    Product
    Constellation Procedure Pak
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2372-2023·2023-08-23

    FDA Recalls MAHURKAR Dialysis Catheters Over Obstruction Defect Risk

    Covidien's MAHURKAR dialysis catheters are recalled due to excessive lubricant on the catheter tip causing partial or complete obstruction. This risks delaying treatment and may cause blood clots, hemolysis, or embolism.

    Product
    MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensions, IC Tray REF: 8888102004HP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2386-2023·2023-08-23

    MAHURKAR dialysis catheters recalled for center lumen occlusion risk

    Covidien LP recalls MAHURKAR dialysis catheters due to excessive silicone lubricant on the catheter tip, which can obstruct the center lumen. This may delay treatment and cause serious blood complications including embolism and thrombosis.

    Product
    MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 16 cm, Curved Extensions, Kit" REF: 8888345611
    Category
    Medical Device
    Distribution
    Distributed nationwide