The Recall Desk

Severity 4 of 5

Severe recalls

The hazard poses a serious risk of illness, injury, or structural failure. 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.

11851–11875 of 29163

  • SevereFDA (Devices)·Z-1841-2019·2019-06-26

    Ethicon Recalls Polyester Sutures Due to Potential High Endotoxin Levels

    Ethicon, Inc. is recalling specific lots of ETHIBOND EXCEL polyester sutures because raw materials may contain high endotoxin levels.

    Product
    ETHIBOND EXCEL¿ Polyester Suture-ETHIBOND Green 75cm USP1 Single Armed CT-1 Product Code: X425H Product Usage: ETHIBOND EXCEL Suture is intended for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1827-2019·2019-06-26

    FDA Recalls 3.1 Million Covidien EGIA 45 Articulating Xtra Thick Sulu Devices

    The FDA is recalling 3,113,280 units of the EGIA 45 Articulating Xtra Thick Sulu device due to a missing pin component that may cause incomplete staple formation and serious medical complications.

    Product
    EGIA 45 ARTICULATING XTRA THICK SULU, Item Code EGIA45AXT
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1452-2019·2019-06-26

    Zydus Recalls Pramipexole Dihydrochloride Tablets Due to Cross-Contamination Risk

    Zydus Pharmaceuticals USA Inc. is recalling Pramipexole Dihydrochloride Tablets 1.5 mg due to cross-contamination caused by cleaning failures.

    Product
    Pramipexole Dihydrochloride Tablets 1.5 mg 90-count bottle, Rx only Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ NDC 68382-200-16
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1748-2019·2019-06-26

    GE Healthcare Discovery IQ PET/CT Systems Recalled for X-Ray Exposure Defect

    GE Healthcare is recalling 1,113 Discovery IQ PET/CT systems because the table may stop moving while X-ray exposure continues.

    Product
    Discovery IQ Product Usage: The systems are intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1758-2019·2019-06-26

    Cook Inc. Recalls Advance Enforcer 35 Focal Force PTA Balloon Catheters

    Cook Inc. is recalling 73 Advance Enforcer 35 Focal Force PTA Balloon Catheters because they may burst below the rated pressure, posing risks of vessel injury and balloon fragmentation.

    Product
    Advance Enforcer 35 Focal Force PTA Balloon Catheter 6mm x 4cm, 5FR/135cm, Catalog Number ASB5-35-135-6-4, REF Number G35257 Product Usage: The Advance Enforcer 35 Focal-Force PTA Balloon Catheter is intended for percutaneous transluminal angioplasty (PTA) of lesions in…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1756-2019·2019-06-26

    Cook Inc. Recalls Advance Enforcer 35 Focal Force PTA Balloon Catheters

    Cook Inc. is recalling 34 Advance Enforcer 35 Focal Force PTA Balloon Catheters because they may burst below the rated pressure, posing risks of vessel injury and balloon fragmentation.

    Product
    Advance Enforcer 35 Focal Force PTA Balloon Catheter 6mm x 4cm, 5FR/50cm, Catalog Number ASB5-35-50-6-4, REF Number G35248 Product Usage: The Advance Enforcer 35 Focal-Force PTA Balloon Catheter is intended for percutaneous transluminal angioplasty (PTA) of lesions in…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1830-2019·2019-06-26

    Covidien EGIA 60 Curved Tip Surgical Stapler Recall for Missing Pins

    FDA is recalling 3,113,280 units of the EGIA 60 Curved Tip Art Med Thick Sulu surgical stapler because missing pin components may cause incomplete staple formation and serious medical complications.

    Product
    EGIA 60 CURVED TIP ART MED THICK SULU, EGIA60CTAMT
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1747-2019·2019-06-26

    GE Healthcare Recalls Optima PET/CT Systems Due to X-Ray Exposure Hazard

    GE Healthcare is recalling 1,113 Optima PET/CT 560 and 560FX systems because the table may stop moving while X-ray exposure continues.

    Product
    Optima PET/CT 560, 560FX Product Usage: The systems are intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1410-2019·2019-06-26

    Preferred Pharmaceuticals Recalls Robafen DM Due to Potential Bacterial Contamination

    Preferred Pharmaceuticals is recalling specific lots of Robafen DM cough syrup due to potential contamination with Burkholderia cepacia and Ralstonia pickettii.

    Product
    Robafen DM, Generic for Robitussin DM, In each teaspoonful (5mL): Dextromethorphan HBr, USP 10mg,/Guaifenesin, USP 100mg, 118mL (4oz) bottle, Manufactured for Preferred Pharmaceuticals, Inc., Anaheim, CA 92807 by Major Pharmaceuticals, Livonia, MI 48152, NDC 68788-0841-01
    Category
    Drug
    Distribution
    2 states
  • SevereNHTSA·19V489000·2019-06-25

    Mercedes-Benz Metris Recalled for Potential Loss of Power Steering

    Daimler Vans USA is recalling 2018-2019 Mercedes-Benz Metris vehicles because a steering sensor defect may cause the electric power steering assist to deactivate, increasing crash risk.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ METRIS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·071-2019·2019-06-24

    San Giuseppe Salami Recalls Frozen Andouille Sausage Due to Metal Contamination

    San Giuseppe Salami Co. by Giacomo is recalling approximately 832 pounds of frozen andouille sausage due to possible metal contamination. No illnesses have been reported.

    Product
    San Guiseppe Salami Co. by Giacomo — San Giuseppe Salami Co. by Giacomo Recalls Ready-To-Eat, Frozen Andouille Sausage Products due to Possible Foreign Matter Contamination
    Category
    Food
    Distribution
    1 state
  • SevereNHTSA·19V488000·2019-06-24

    Mazda Recalls 2010-2011 RX-8 Vehicles for Air Bag Inflator Defect

    Mazda is recalling 2010-2011 RX-8 vehicles because the passenger air bag inflator may explode during deployment, potentially causing serious injury or death.

    Product
    MAZDA — MAZDA RX-8
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V485000·2019-06-21

    Oshkosh Recalls 2019 McNeilus Front Loader Trucks Due to Fire Risk

    Oshkosh is recalling 2019 McNeilus Meridian, Atlantic, and Contender front loader trucks because battery cables may rub against the fuse box bracket, increasing the risk of fire.

    Product
    MCNEILUS — MCNEILUS MERIDIAN FRONT LOADER, ATLANTIC FRONT LOADER, CONTENDER FRONT LOADER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V484000·2019-06-21

    Oshkosh Recalls 2018 McNeilus Concrete Mixers for Tank Rupture Risk

    Oshkosh is recalling 2018 McNeilus Bridgemaster V Concrete Mixers because an incorrect filler neck part may cause the tank to overpressurize and rupture.

    Product
    MCNEILUS — MCNEILUS BRIDGEMASTER V MIXER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V483000·2019-06-21

    Altec Aerial Devices Recalled for Air Brake System Defects

    Altec is recalling 2003-2019 aerial devices due to potential air brake pressure loss. Owners should contact dealers for free inspection and repair.

    Product
    ALTEC — ALTEC AERIAL DEVICE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V486000·2019-06-21

    Oshkosh Recalls 2018-2019 S-Series Mixers Due to Steering Hose Error

    Oshkosh is recalling 2018-2019 S-Series Mixer vehicles because hydraulic hoses may be installed incorrectly, causing loss of steering assist and increasing crash risk.

    Product
    OSHKOSH — OSHKOSH S-SERIES
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·19E043000·2019-06-20

    TRW Air Bag Electronic Control Units Recalled for Malfunction Risk

    TRW is recalling air bag electronic control units that may malfunction, potentially disabling or unexpectedly deploying air bags and seat belt pretensioners.

    Product
    AIR BAGS: AIR BAG/RESTRAINT CONTROL MODULE recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1353-2019·2019-06-19

    Torrent Pharma Recalls Pseudoephedrine Oral Solution Due to Potential Bacterial Contamination

    Torrent Pharma Inc is recalling Pseudoephedrine Oral Solution due to potential contamination with Burkholderia cepacia and Ralstonia pickettii.

    Product
    Pseudoephedrine Oral Solution, 30 mg in each teaspoonful, Nasal Decongestant, One Pint (473 mL) bottle, NDC: 0536-1850-85, Distributed by Rugby Laboratories, Livonia MI 48152.
    Category
    Drug
    Distribution
    0 states
  • SevereNHTSA·19V471000·2019-06-19

    Blue Bird Recalls 2018-2019 Electric School Buses for Software Defect

    Blue Bird is recalling 2018-2019 Vision and All American electric school buses because a software defect may cause the vehicle to lose drive and power steering.

    Product
    BLUE BIRD — BLUE BIRD VISION, ALL AMERICAN
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1383-2019·2019-06-19

    Torrent Pharma Recalls Hydrocodone Oral Solution Due to Bacterial Contamination

    Torrent Pharma Inc. is recalling specific lots of Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution due to potential contamination with Burkholderia cepacia and Ralstonia pickettii.

    Product
    Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg/1.5 mg per 5 mL, Rx Only, 16 FL. oz. (473 mL) bottle, NDC: 59741-262-16 Manufactured by Bio-Pharm Inc., Levittown, PA 19057 USA.
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-1347-2019·2019-06-19

    Torrent Pharma Recalls Allergy Liquid Antihistamine Due to Bacterial Contamination

    Torrent Pharma Inc. is recalling 118,080 bottles of Allergy Liquid Antihistamine due to potential contamination with Burkholderia cepacia and Ralstonia pickettii.

    Product
    Allergy Liquid Antihistamine, Diphenhydramine HCl USP 12.5 mg/5 mL), Alcohol free, 4 FL. oz. (118 mL) bottle, NDC: 59741-119-06, Manufactured by Bio-Pharm Inc., Levittown, PA 19057, Assured.
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-1364-2019·2019-06-19

    Torrent Pharma Recalls Guaifenesin DAC Oral Solution Due to Contamination

    Torrent Pharma Inc. is recalling specific lots of Guaifenesin DAC Oral Solution due to potential contamination with Burkholderia cepacia and Ralstonia pickettii.

    Product
    Guaifenesin DAC Oral Solution, Sugar free, (Guaifenesin, Pseudoephedrine HCl and Codeine Phosphate Oral Solution, USP), Expectorant, Nasal Decongestant, Cough Suppressant, 100 mg/30 mg/10 mg per 5 mL, One Pint (473 mL) bottle, NDC: 16571-301-16, Manufactured by Bio-Pharm Inc.…
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-1365-2019·2019-06-19

    Torrent Pharma Recalls Phenobarbital Oral Solution Due to Potential Bacterial Contamination

    Torrent Pharma is recalling Phenobarbital Oral Solution due to potential contamination with Burkholderia cepacia and Ralstonia pickettii.

    Product
    Phenobarbital Oral Solution, USP, 20 mg per 5 mL, Rx Only, One Pint (473 mL) bottle, NDC:16571-330-16, Manufactured by Bio-Pharm Inc., Levittown, PA 10957, Distributed by Rising Pharmaceuticals Inc., Saddle Brook, NJ 07663.
    Category
    Drug
    Distribution
    0 states