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.

8751–8775 of 29123

  • SevereFDA (Devices)·Z-0773-2021·2021-01-13

    Boston Scientific Recalls AXIOS Stent Delivery System Due to Fitting Detachment

    Boston Scientific is recalling 13 units of the AXIOS Stent and Electrocautery - Enhanced Delivery System because a fitting may detach, risking peritonitis.

    Product
    AXIOS Stent and Electrocautery - Enhanced Delivery System 10mm x10mm UPN: M00553640 - Product Usage: The stent is intended for implantation up to 60 days and should be removed upon confirmation of pseudocyst or walled-off necrosis resolution.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0188-2021·2021-01-13

    SCA Pharmaceuticals Recalls Ephedrine Sulfate Syringes Due to Sterility Concerns

    SCA Pharmaceuticals is recalling 1,879 syringes of ePHEDrine Sulfate injection due to a lack of assurance of sterility and potential defective syringe caps.

    Product
    ePHEDrine Sulfate, 50 mg/5mL in 0.9% Sodium Chloride Injection, 5 mL Single Dose Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004060509
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0196-2021·2021-01-13

    SCA Pharmaceuticals Recalls Hydromorphone Syringes Due to Sterility Concerns

    SCA Pharmaceuticals is recalling 1,056 hydromorphone syringes because a defective cap may compromise sterility. The product was distributed to hospitals nationwide.

    Product
    HYDROmorphone HCl 30 mg/30 mL in 0.9% Sodium Chloride Injection (1 mg/mL) a) 30 mL Plungerless Single Dose Syringe (barcode 70004030316) and b) 30 mL Single Dose Syringe (barcode 70004030321), Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0209-2021·2021-01-13

    SCA Pharmaceuticals Recalls Morphine Sulfate Syringes Due to Sterility Concerns

    SCA Pharmaceuticals is recalling 116 Morphine Sulfate syringes due to a lack of assurance of sterility and potential defective caps.

    Product
    Morphine Sulfate 30 mg/30 mL in 0.9% Sodium Chloride (1mg/ml), CII, Rx Only, 30 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004010016
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0195-2021·2021-01-13

    SCA Pharmaceuticals Recalls Hydromorphone Injection Syringes Due to Sterility Concerns

    SCA Pharmaceuticals is recalling 3,092 syringes of Hydromorphone HCl injection due to a lack of assurance of sterility and potential defective syringe caps.

    Product
    HYDROmorphone HCl 6 mg/30mL in 0.9% Sodium Chloride Injection (0.2 mg/mL), Rx Only, a) 30 mL Plungerless Single Dose Syringe (barcode 70004030016) and b) 30 mL Single Dose Syringe (barcode 70004030018), SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0197-2021·2021-01-13

    SCA Pharmaceuticals Recalls Ketamine Injection Syringes Due to Sterility Concerns

    SCA Pharmaceuticals is recalling 11,075 syringes of Ketamine 100 mg/10mL injection due to a lack of assurance of sterility and potential defective syringe caps.

    Product
    Ketamine 100 mg/10mL in 0.9% Sodium Chloride Injection (10 mg/mL), CII, Rx Only, 10 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004043012
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V007000·2021-01-13

    Freightliner Cascadia Trucks Recalled for Steer Tire Tread Separation and Blow-Out Risk

    Daimler Trucks North America is recalling 2020-2022 Freightliner Cascadia sleeper trucks with certain Bridgestone steer tires. The tires may experience tread separation or blow-outs, risking loss of vehicle control and crashes.

    Product
    FREIGHTLINER — FREIGHTLINER CASCADIA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0207-2021·2021-01-13

    SCA Pharmaceuticals Recalls Sodium Citrate Syringes Due to Sterility Concerns

    SCA Pharmaceuticals is recalling 5,990 syringes of Sodium Citrate 4% Anticoagulation Solution due to a lack of assurance of sterility and potential defective caps.

    Product
    Sodium Citrate 4% 3 mL Anticoagulation Solution (40mg/mL), Rx only, 3 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004090025
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0192-2021·2021-01-13

    SCA Pharmaceuticals Recalls Fentanyl and Bupivacaine Syringes Due to Sterility Concerns

    SCA Pharmaceuticals is recalling 996 fentanyl and bupivacaine syringes due to a lack of assurance of sterility and potential defective caps.

    Product
    fentaNYL 100 mcg/50mL Bupivacaine HCl 0.125% in 0.9% Sodium Chloride 50 mL, 50 mL Single Dose Syringe, Rx Only, SCA Pharmaceuticals,755 Rainbow Rd., Windsor, CT, 06095, barcode 70004023122
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0200-2021·2021-01-13

    American Blue Ribbon Recalls French Silk Pies Due to Undeclared Pecans

    American Blue Ribbon Holdings LLC is recalling 9-inch French Silk Base pies because they contain undeclared pecans, a major food allergen.

    Product
    9" French Silk Base, Item 7545, Count per case 6 Ea., Case Weight 12 lb. 3 oz. UPC 50796220075458. Keep Frozen.
    Category
    Food
    Distribution
    11 states
  • SevereNHTSA·21V003000·2021-01-08

    Braun Recalls Crestline Ambulances Due to Defective Seat Belt Fasteners

    Braun Ambulances is recalling specific Crestline CCL150 ambulances because defective seat belt fasteners may fail, increasing injury risk in a crash.

    Product
    CRESTLINE COACH — CRESTLINE COACH CCL150 TYPE III, CCL150 TYPE I
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V001000·2021-01-07

    Volvo Recalls 2021 Models for SRS Control Unit Attachment Defect

    Volvo is recalling 2021 V60, V90, XC60, and XC90 models because the SRS control unit may detach during a crash, reducing occupant protection.

    Product
    VOLVO — VOLVO XC90, XC60, V60, V60CC
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0177-2021·2021-01-06

    Imprimis Recalls Dexamethasone-Moxifloxacin Injection Due to Sterility Concerns

    Imprimis NJOF, LLC is recalling 6,520 vials of Dexamethasone-Moxifloxacin PF Injection because 13 vials were found with faulty crimps, raising concerns about sterility.

    Product
    Dexamethasone - Moxifloxacin PF Injection (1/5) mg/mL, Imprimis Rx Volume: 1mL/vial, Imprimis NJOF, LLC. 1705 Route 46 West, Unit 6B Ledgewood, NJ - 07852 (844)446-6979
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0766-2021·2021-01-06

    BD Phoenix PMIC-110 Recalled for False SXT Resistance Results

    Becton Dickinson & Co. is recalling BD Phoenix PMIC-110 IVDs due to false resistant SXT results with S. aureus, which could impact antibiotic treatment.

    Product
    BD Phoenix PMIC-110: IVD is intended for the in vitro rapid identification (ID) of gram-positive bacteria from pure culture belonging to the genera Staphylococcus, Enterococcus, and other gram-positive cocci and gram-positive bacilli Catalog Number: 449036:
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0761-2021·2021-01-06

    BD Phoenix PMIC-107 Recalled for False SXT Resistance Results

    Becton Dickinson is recalling BD Phoenix PMIC-107 IVDs because false resistant results for S. aureus could lead to reduced treatment effectiveness.

    Product
    BD Phoenix PMIC-107: IVD is intended for the in vitro rapid identification (ID) of gram-positive bacteria from pure culture belonging to the genera Staphylococcus, Enterococcus, and other gram-positive cocci and gram-positive bacilli Catalog Number: 448417
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereCPSC·21064·2021-01-06

    Massimo Percussion Massage Guns Recalled Due to Fire Hazard

    Massimo Motor Sports is recalling percussion massage guns sold at Costco because the lithium-ion battery can overheat and cause fires.

    Product
    Massage Guns
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0190-2021·2021-01-06

    Landert Multigrain Bread Recalled for Unapproved Pesticide in Sesame Seeds

    Landert LLC is recalling Multigrain Solene Figotte breads due to unapproved ethylene oxide pesticide in sesame seeds.

    Product
    Multigrain Solene Figotte, prebaked frozen breads with seeds, Item 29497, Net Weight 8.8 Lbs (4 Kg), Lot: 1234567, UPC code (01)03604380294973(10)1234567(15)191121(91)0309000001,
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Devices)·Z-0747-2021·2021-01-06

    FDA Recalls Covidien TA Auto Suture Vascular Staplers Due to Damaged Components

    The FDA is recalling specific lots of Covidien TA Auto Suture Vascular Staplers because a damaged internal component may prevent adequate hemostasis or cause tissue damage.

    Product
    Covidien TA Auto Suture Vascular Stapler with DST Series Technology 30mm-V 3. Intended for abdominal, gynecological, pediatric and thoracic surgical procedures for resection or transection of tissue. Item Number: TA30V3S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0182-2021·2021-01-06

    Cipla Recalls Esomeprazole Magnesium Suspension Due to Theophylline Contamination

    Cipla is recalling Esomeprazole Magnesium for Delayed-Release Oral Suspension 20mg due to cross-contamination with theophylline in the excipient Crospovidone.

    Product
    ESOMEPRAZOLE MAGNESIUM — ESOMEPRAZOLE MAGNESIUM (ESOMEPRAZOLE MAGNESIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0748-2021·2021-01-06

    FDA Recalls Covidien TA Auto Suture Vascular Loading Units

    FDA is recalling specific lots of Covidien TA Auto Suture Vascular Loading Units due to a damaged internal component that may prevent adequate hemostasis.

    Product
    Covidien TA Auto Suture Vascular Loading Unit with DST Series Technology 30 mm- V3. Intended for abdominal, gynecological, pediatric and thoracic surgical procedures for resection or transection of tissue. Item Number: TA30V3L
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0181-2021·2021-01-06

    Cipla Recalls Esomeprazole Magnesium Packets Due to Cross-Contamination

    Cipla is recalling 284,610 packets of Esomeprazole Magnesium delayed-release oral suspension because the excipient Crospovidone is contaminated with theophylline.

    Product
    ESOMEPRAZOLE MAGNESIUM — ESOMEPRAZOLE MAGNESIUM (ESOMEPRAZOLE MAGNESIUM)
    Category
    Drug
    Distribution
    Distributed nationwide