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.

4751–4775 of 4878

  • SevereCPSC·21168·2021-07-21

    Harbor Freight Tank Top Propane Heaters Recalled for Burn Hazard

    Harbor Freight Tools is recalling about 350,000 One Stop Gardens tank top propane heaters because wind can redirect the flame to melt the safety shutoff, preventing the heater from turning off if tipped. Three minor burn injuries have been reported.

    Product
    One Stop Gardens 15,000 and 30,000 BTU Tank Top Propane Heaters
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0657-2021·2021-07-21

    Durisan Hand Sanitizing Wipes Recalled for Microbial Contamination

    Sanit Technologies is recalling Durisan Antimicrobial Solutions Hand Sanitizing Wipes because certain lots were found to contain Burkholderia contaminans and/or yeast and mold through internal testing.

    Product
    Durisan Antimicrobial Solutions (benzalkonium chloride) Hand Sanitizing Wipes, 0.13%, 160-count canister; Sanit Technologies, LLC, 7810 25th Court East, Sarasota, Florida 34243, UPC 8 52379 00631 8.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1957-2021·2021-07-21

    Philips Respironics BiPAP ventilators recalled for foam degradation and off-gassing

    Philips Respironics BiPAP ventilators' polyurethane foam may degrade into particles that could be inhaled or ingested, or off-gas certain chemicals. About 8,047 devices worldwide are affected.

    Product
    A-Series BiPAP Hybrid A30 (not marketed in US), A-Series BiPAP V30 Auto Continuous Ventilator, Minimum Ventilatory Support, Facility Use
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0656-2021·2021-07-21

    Durisan Antimicrobial Hand Sanitizer recalled for microbial contamination

    Sanit Technologies is recalling Durisan Antimicrobial Solutions hand sanitizer due to internal testing that found contamination with Burkholderia contaminans and/or yeast and mold in certain lots.

    Product
    Durisan Antimicrobial Solutions (benzalkonium chloride) Hand Sanitizer, listed as 0.1% or 0.13%, Alcohol-Free, packaged in a) 18 mL Net Content 0.61 fl oz credit card size container, (UPC 8 52379 00614 1); b) 50 mL Net Content 1.69 oz bottle, (UPC 8 52379 00634 9 and 8 52379 0061
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1974-2021·2021-07-21

    Philips Respironics ventilators recalled for degrading foam and chemical hazards

    Philips Respironics ventilators are recalled because foam components may degrade and release particles and chemicals that patients could inhale.

    Product
    SystemOne (Q-Series), DreamStation, DreamStation Go, Dorma 400, Dorma 500, REMstar SE Auto Noncontinuous Ventilators The Philips Respironics E30 ventilator is intended to provide invasive and non-invasive ventilatory support for individuals with Respiratory Insufficiency. It
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1956-2021·2021-07-21

    Philips Respironics Continuous Ventilators Recalled for Foam Degradation Risk

    Philips Respironics is recalling approximately 255,810 continuous ventilators because polyurethane foam may degrade into particles that could be inhaled or ingested, or release chemicals.

    Product
    Trilogy 100, Trilogy 200, Garbin Plus, Aeris, LifeVent Continuous Ventilators.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2016-2021·2021-07-21

    INGENIO DR EL Pacemakers Recalled: Defective Battery May Trigger Safety Mode

    Dual chamber INGENIO DR EL pacemakers with Extended Life batteries may develop high internal impedance, causing devices to enter Safety Mode later in life. Affected patients should contact their healthcare provider about replacement.

    Product
    INGENIO DR EL (pacemakers), Model Numbers: a) J174 b) J177 c) K174 (added 7/15/2021) d) K184 (added 7/15/2021) e) K187 (added 7/15/2021)
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2017-2021·2021-07-21

    VITALIO DR EL Pacemakers Recalled Due to Battery-Related Device Resets

    Boston Scientific is recalling VITALIO DR EL pacemakers with Extended Life batteries due to a latent battery condition that may cause unexpected device resets and Safety Mode activation later in device life.

    Product
    VITALIO DR EL (pacemaker), Model Numbers: a) J274 b) J277 c) K274 (added 7/15/2021) d) K277 (added 7/15/2021) e) K284 (added 7/15/2021) f) K287 (added 7/15/2021)
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Food)·F-0774-2021·2021-07-21

    Cooked Snow Crab Sections Recalled for Salmonella and Listeria

    Cooked frozen snow crab sections from Crustaces Baie-Trinite Inc. are being recalled due to potential contamination with Salmonella and Listeria monocytogenes. The affected product was distributed to restaurant distributors in Massachusetts and Missouri.

    Product
    Cooked Snow Crab, Brine Frozen Sections, 2L and L sizes, Net Wt 13.15 kg / 29 lb
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Devices)·Z-2020-2021·2021-07-21

    Boston Scientific INLIVEN CRT-P Pacemakers Battery Impedance Recall

    Boston Scientific recalls dual chamber INGENIO family pacemakers and CRT-Ps with Extended Life batteries that may develop high internal impedance, causing Safety Mode and system resets, requiring device replacement.

    Product
    INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2015-2021·2021-07-21

    Boston Scientific ADVANTIO DR EL Pacemakers Recalled for Battery Malfunction

    Boston Scientific is recalling ADVANTIO DR EL dual chamber pacemakers and CRT-Ps due to a latent battery condition that may cause system resets and trigger Safety Mode, requiring device replacement.

    Product
    ADVANTIO DR EL (pacemaker), Model Numbers: a) J064 b) J067 c) K064 (added 7/15/2021) d) K084 (added 7/15/2021) e) K087 (added 7/15/2021)
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0654-2021·2021-07-21

    Poseidon Platinum 3500 Capsules Recalled for Undeclared Prescription Drugs

    Poseidon Platinum 3500 capsules are being recalled because they contain undeclared sildenafil and tadalafil, which are prescription drugs that were not approved for this product. The safety and efficacy of these undeclared ingredients have not been established.

    Product
    Poseidon Platinum 3500 capsule, 1-count per blister card, Distributed by: Poseidon, Made in the USA, UPC 0 95842 05876 0
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1958-2021·2021-07-21

    Philips BiPAP A-Series Ventilators Recalled for Foam Degradation Risk

    Philips Respironics recalled 72,665 BiPAP A-Series ventilators worldwide. The foam in these devices may degrade into particles that could be inhaled or ingested, and may release chemicals.

    Product
    A-Series BiPAP A 40, A-Series BiPAP A30 Continuous Ventilator, Non-life Supporting
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2018-2021·2021-07-21

    Boston Scientific INGENIO CRT-P Pacemakers Recalled for Battery Defect

    Boston Scientific is recalling INGENIO CRT-P pacemakers that may develop high internal battery impedance, causing unexpected device resets and Safety Mode activation. Affected devices require replacement.

    Product
    INVIVE CRT-P, Model Numbers: a) V172 b) V173 c) V182 d) V183 e) W172 f) W173
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1972-2021·2021-07-21

    Philips Respironics E30 ventilator foam degradation poses inhalation hazard

    Philips Respironics E30 ventilators may have polyurethane foam that degrades into particles. These particles can enter the air pathway and be inhaled or ingested by patients, or the foam may off-gas chemicals.

    Product
    Philips Respironics E30 with Humidifier, Continuous Ventilator, Minimum Ventilatory Support, Facility Use; Product Numbers DSX9999H11, INX9999H19, RINX9999H19 The Philips Respironics E30 ventilator is intended to provide invasive and non-invasive ventilatory support for indiv
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0661-2021·2021-07-14

    Topotecan Injection recalled for particulate contamination

    Teva Pharmaceuticals is recalling Topotecan Injection 4 mg/4mL single-dose vials due to the presence of particulate matter, including glass, silicone, and cotton fiber, found inside affected vials.

    Product
    Topotecan Injection 4 mg/4mL (1 mg/mL), Single-Dose vial, Teva Pharmaceuticals USA, Inc. North Whales, PA 19454, Carton NDC# 0703-4714-01, Vial NDC# 0703-4714-71
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereCPSC·21762·2021-07-08

    SOWTECH Espresso Machines Recalled Due to Glass Carafe Breaking Hazard

    LoHi Tech is recalling about 24,900 SOWTECH Espresso Machines (Model CM6811) because the glass carafe can break during use, posing a burn hazard. The firm has received 48 reports of breaking carafes, resulting in five burn injuries.

    Product
    SOWTECH Espresso Machines with Glass Carafes
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0752-2021·2021-07-07

    Smilin' Bob's Smoked Fish Dip Recalled for Listeria Contamination

    Lakeview Farms LLC is recalling Smilin' Bob's Key West Style Smoked Fish Dip in 8 oz and 15.5 oz containers due to potential Listeria monocytogenes contamination. The product was distributed to five distributors in Florida.

    Product
    Smilin' Bob's Key West Style Smoked Fish Dip Original 8 oz and 15.5 oz plastic container 12 per case
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0646-2021·2021-07-07

    ProtectoRx Ethyl Alcohol 70% Hand Sanitizer Recalled for Methanol Contamination

    ProtectoRx hand sanitizer (ethyl alcohol 70%) is being recalled nationwide because some lots were found to contain methanol and all lots were manufactured under the same conditions as the contaminated product.

    Product
    ProtectoRx (ethyl alcohol 70%), packaged in a) 2 FL OZ (59 mL), NDC 75408-002-01 and b) 16 FL OZ (473.2 mL), NDC 75408-002-02 bottles, Imported by: Dibar Labs, LLC., Sugar Land, TX 77479; Distributed by: PR Trading LLC, PO Box 19647, San Juan, PR 00910, Made in Mexico.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1952-2021·2021-07-07

    LeadCare II Blood Lead Test Kit Control Test Inaccuracy Recall

    The LeadCare II Blood Lead Test Kit may generate artificially low control test results, causing blood lead levels to be underestimated in patient samples. Kits were distributed worldwide.

    Product
    LeadCare II Blood Lead Test Kit Catalog Number 70-6762
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0644-2021·2021-07-07

    DiBAR LABS Hand Sanitizer Recalled for Methanol Contamination

    DiBAR LABS Hand Sanitizer (ethyl alcohol 70%, 8 FL OZ) is being recalled because FDA testing found three lots contain methanol contamination and have ethanol content below the label claim.

    Product
    DiBAR LABS Hand Sanitizer (ethyl alcohol 70%), 8 FL OZ. (236.5 mL), Distributed by S.E.N.D. LLC, Anthony, NM 88021, Imported by Dibar Labs, LLC, Sugar Land, TX 77479, Made in Mexico,77479, NDC 73009-0001-08 UPC 8 53090 00301 3.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0759-2021·2021-07-07

    Little Hatch's Spicy Queso Recalled for Listeria and Undeclared Soy

    Interstate Food Products is recalling Little Hatch's Spicy Queso due to Listeria monocytogenes contamination and undeclared soy lecithin. The product was distributed across multiple states.

    Product
    Little Hatch's Spicy Queso, 13.5 oz. (382.7g) clear plastic container, Mfg. by Interstate Food Products, Lakewood, CO, [email protected] Must be Refrigerated UPC 638183961469
    Category
    Food
    Distribution
    8 states
  • SevereFDA (Drugs)·D-0647-2021·2021-07-07

    Advance Hand Sanitizer Recalled for Methanol Contamination

    Dibar Labs is recalling Advance Hand Sanitizer (70% ethyl alcohol, 16 FL OZ) distributed nationwide because it was manufactured under the same conditions as lots found to contain methanol.

    Product
    ADVANCE HAND SANITIZER, (ethyl alcohol 70%), 16 FL OZ (473.2 mL), Imported by: Dibar Labs, LLC,.Sugar Land, TX 77479, Distributed by: Lifetime Health Services, Pharr, TX 78577, Made in Mexico, NDC; 79284-005-00. UPC 8 60004 06470 1
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0760-2021·2021-07-07

    Little Hatch's Roasted Chili Salsa Recalled for Listeria

    Interstate Food Products is recalling Little Hatch's Roasted Chili Salsa (Hot, 13.5 oz) because product samples tested positive for Listeria monocytogenes, a potentially harmful bacteria.

    Product
    Little Hatch's Roasted Chili Salsa - Hot, 13.5 oz. (382.7g) clear plastic container, Mfg. by Interstate Food Products, Lakewood, CO, [email protected] Must be Refrigerated UPC 705105009308
    Category
    Food
    Distribution
    8 states