The Recall Desk

Hazard

Class I Recall recalls

35 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
35
Critical
0
Severe
35
Most recent
2026-04-08

Of the 35 class i recall recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 35 (100%) are Severe.

Which agencies issued them

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all class i recall recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.

A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.

1–25 of 35

  • SevereFDA (Devices)·Z-1649-2026·2026-04-08

    Trilogy Evo Universal obstruction alarm may take up to four breaths

    Philips Respironics is recalling the Trilogy Evo Universal ventilator because in some situations the Obstruction Alarm does not trigger within the timeframe required by the relevant standards.

    Product
    Philips Respironics Trilogy Evo Universal, Software Version 1.05.15.00. Continuous home-use ventilator device.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1646-2026·2026-04-08

    Trilogy Evo obstruction alarm may take up to four breaths

    Philips Respironics is recalling the Trilogy Evo ventilator because in some situations the Obstruction Alarm does not trigger within the timeframe required by the relevant standards.

    Product
    Philips Respironics Trilogy Evo, Software Version 1.05.15.00. Continuous home-use ventilator device.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1637-2026·2026-04-08

    Volara ventilator adapter recalled as Class I over desaturation and barotrauma

    Baxter is issuing an urgent correction for the Blue Ventilator Adapter Module used with the Volara system because home users may be unaware of possible oxygen desaturation or lung injury from overexpansion.

    Product
    Blue Ventilator Adapter Module, single-patient use circuit, Product Code M07937. Accessory to Baxter Volara Respiratory Therapy system.
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1589-2026·2026-04-08

    Impella purge cassettes recalled as Class I over purge leak risk

    Purge Cassettes sold within Impella Pump Sets and individually packaged are being recalled because of an increased risk of purge leaks with Generation 1 purge cassettes.

    Product
    Purge Cassette, sold within Impella Pump Sets and Individually Packaged. Labeled and distributed in the below configurations and corresponding product codes. 1. Purge Cassette, 5 Pack; Product Code: 0043-0003. 2. Impella RP US Pump Set; Product Code: 004334. 3. Purge C
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1647-2026·2026-04-08

    Trilogy Evo O2 obstruction alarm may take up to four breaths

    Philips Respironics is recalling the Trilogy Evo O2 ventilator because in some situations the Obstruction Alarm does not trigger within the timeframe required by the relevant standards.

    Product
    Philips Respironics Trilogy Evo O2, Software Version 1.05.15.00. Continuous home-use ventilator device.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1648-2026·2026-04-08

    Trilogy EV300 obstruction alarm may take up to four breaths

    Philips Respironics is recalling the Trilogy EV300 ventilator because in some situations the Obstruction Alarm does not trigger within the timeframe required by the relevant standards.

    Product
    Philips Respironics Trilogy EV300, Software Version 1.05.15.00. Continuous home-use ventilator device.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0478-2026·2026-04-08

    Magnesium sulfate pouch recalled as Class I for containing tranexamic acid

    One lot of Magnesium Sulfate in Water for Injection is being recalled after a foil pouch labeled as magnesium sulfate was found to contain an IV bag of tranexamic acid.

    Product
    MAGNESIUM SULFATE — MAGNESIUM SULFATE (MAGNESIUM SULFATE IN WATER FOR)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1591-2026·2026-04-08

    Impella controller purge blocked alarm may be delayed on older pumps

    Abiomed is recalling Automated Impella Controllers because the Purge System Blocked alarm display could be delayed when using first generation Impella 5.5 pumps.

    Product
    Automated Impella Controller (AIC), labeled as the following with corresponding Product Codes: 1. Impella Controller, Packaged, CA; Product Code: 0042-0000-CA. 2. Impella Controller, Packaged, EU; Product Code: 0042-0000-EU. 3. Impella Controller, Packaged, UK; Produc
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1614-2026·2026-04-01

    Trilogy Evo ventilator recalled as Class I over tidal volume

    Philips Respironics is recalling the Trilogy Evo ventilator because using non-pneumatic nebulizers may cause a discrepancy between the set tidal volume and the volume the patient receives.

    Product
    Philips Respironics Trilogy Evo, Software Version 1.05.15.00. Continuous home-use ventilator device.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1575-2026·2026-04-01

    CentrosFLO hemodialysis catheters recalled as Class I over sheath introducer defect

    Merit Medical is recalling CentrosFLO Hemodialysis Catheters because a design defect in the 16F dual-valved splittable sheath introducer may prevent it splitting as intended.

    Product
    CentrosFLO Hemodialysis Catheters, REF: CENFP15K/A, CENFP15K/B, CENFP17K/A, CENFP19K/A, CENFP23K/A, CENFP27K/A, CENFP31K/A, CENFT15K, CENFT15K/D, CENFT17K, CENFT17K/A, CENFT17K/D, CENFT19K, CENFT19K/A, CENFT19K/B, CENFT19K/D, CENFT23K, CENFT23K/A, CENFT23K/B, CENFT23K/D, CENFT27K
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1568-2026·2026-04-01

    Erbe flexible cryoprobe 20402-411 recalled as Class I over rupture

    Erbe USA is recalling the Flexible Cryoprobe REF 20402-411 because the probes may rupture or burst during activation. The FDA has classified this recall as Class I.

    Product
    Flexible Cryoprobe (OD 2.4mm, L1.15mm) REF: 20402-411. For surgical use
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1615-2026·2026-04-01

    Trilogy Evo O2 ventilator recalled as Class I over tidal volume

    Philips Respironics is recalling the Trilogy Evo O2 ventilator because using non-pneumatic nebulizers may cause a discrepancy between the set tidal volume and the volume the patient receives.

    Product
    Philips Respironics Trilogy Evo O2, Software Version 1.05.15.00. Continuous home-use ventilator device.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1567-2026·2026-04-01

    Erbe flexible cryoprobe 20402-410 recalled as Class I over rupture

    Erbe USA is recalling the Flexible Cryoprobe REF 20402-410 because the probes may rupture or burst during activation. The FDA has classified this recall as Class I.

    Product
    Flexible Cryoprobe (OD 1.7mm, L1.15mm) REF: 20402-410. For surgical use
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1588-2026·2026-04-01

    Heating pad recalled as Class I because folding causes excessive temperatures

    Navajo Manufacturing is recalling the Handy Solutions Neck & Shoulders Heating Pad because folding it during use raises power density in the folded area, causing excessive temperatures the limit device cannot sense.

    Product
    Handy Solutions Neck & Shoulders Heating Pad, Number: 25607, Manufactured by Ninbo Unico Products Co., Ltd
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1616-2026·2026-04-01

    Trilogy EV300 ventilator recalled as Class I over tidal volume

    Philips Respironics is recalling the Trilogy EV300 ventilator because using non-pneumatic nebulizers may cause a discrepancy between the set tidal volume and the volume the patient receives.

    Product
    Philips Respironics Trilogy EV300, Software Version 1.05.15.00. Continuous home-use ventilator device.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1578-2026·2026-04-01

    DuraMax hemodialysis catheter sheath introducer may not split as intended

    Merit Medical is recalling DuraMax Chronic Hemodialysis Catheters because a design defect in the 16F dual-valved splittable sheath introducer may prevent it splitting as intended.

    Product
    DuraMax Chronic Hemodialysis Catheter, REF: H787103028015/A, H787103028025/A, H787103028031/A, H787103028035/A, H787103028041/A, H787103028045/A, H787103028051/A, H787103028055/A, H787103028061/A, H787103028075/A, H787103028085/A, H787103028095/A, H787103028165/A, H787103028181/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1566-2026·2026-04-01

    Erbe flexible cryoprobe 20402-401 recalled as Class I over rupture

    Erbe USA is recalling the Flexible Cryoprobe REF 20402-401 because the probes may rupture or burst during activation. The FDA has classified this recall as Class I.

    Product
    Flexible Cryoprobe (OD 1.1mm, L1.15mm) w/ oversheath (OD2.6mm, L817mm) REF: 20402-401 STERILE EO. For surgical use
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1576-2026·2026-04-01

    ProGuide chronic dialysis catheters recalled as Class I over sheath introducer defect

    Merit Medical is recalling ProGuide Chronic Dialysis Catheters because a design defect in the 16F dual-valved splittable sheath introducer may prevent it splitting as intended.

    Product
    ProGuide Chronic Dialysis Catheters, REF: DC01455550/C, DC21452419/C, DC21452419-NE5/C, DC21452823-NE5/C, DC21454035/C, DC21455550/C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1579-2026·2026-04-01

    BioFlo DuraMax catheters recalled as Class I over sheath introducer defect

    Merit Medical is recalling BioFlo DuraMax Catheters because a design defect in the 16F dual-valved splittable sheath introducer may prevent it splitting as intended.

    Product
    BioFlo DuraMax Catheter, REF: H965103028011/A, H965103028021/A, H965103028021/EU, H965103028031/A, H965103028031/EU, H965103028041/A, H965103028041/EU, H965103028051/A, H965103028051/EU, H965103028061/A, H965103028061/EU, H965103028070/A, H965103028070/EU, H965103028080/A, H96510
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1577-2026·2026-04-01

    Merit 16F splittable sheath introducer recalled as Class I bulk product

    Merit Medical is recalling the 16F Dual Valved Splittable Sheath Introducer in bulk non-sterile form because a design defect may prevent it splitting as intended.

    Product
    16F Dual Valved Splittable Sheath Introducer (bulk, non-sterile), REF: FCL-174-00/B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1617-2026·2026-04-01

    Trilogy Evo Universal ventilator recalled as Class I over tidal volume

    Philips Respironics is recalling the Trilogy Evo Universal ventilator because using non-pneumatic nebulizers may cause a discrepancy between the set tidal volume and the volume the patient receives.

    Product
    Philips Respironics Trilogy Evo Universal, Software Version 1.05.15.00. Continuous home-use ventilator device.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0528-2026·2026-03-25

    Webcol alcohol prep pads recalled as Class I for microbial contamination

    Cardinal Health is recalling Webcol Alcohol Prep pads because of non-sterility, with microbial contamination identified as Paenibacillus phoenicis. The FDA has classified this recall as Class I.

    Product
    Webcol Alcohol Prep pad (70% isopropyl alcohol) 2 ply, 200 count boxes, Cardinal Health 200 LLC 3651 Birchwood Drive, Waukegan, IL 60085.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1547-2026·2026-03-18

    TRUE METRIX AIR manuals recalled as Class I over E-5 guidance

    Trividia Health is recalling owner's booklets and instructions for TRUE METRIX AIR blood glucose meters because the labeling did not give lay users adequate directions for the E-5 error code.

    Product
    Owner's Booklets and Instructions for Use that are used with the following blood glucose measuring devices. Description/Item: Walgreens TRUE METRIX AIR Kit/REA4001-01, Leader TRUE METRIX AIR Kit/REA4002-01, CVS TRUE METRIX AIR Kit/REA4007-01, GNP TRUE METRIX AIR Kit/REA4011-
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1546-2026·2026-03-18

    TRUE METRIX PRO manuals recalled as Class I over E-5 guidance

    Trividia Health is recalling owner's booklets and instructions for TRUE METRIX PRO blood glucose meters because the labeling did not give lay users adequate directions for the E-5 error code.

    Product
    Owner's Booklets and Instructions for Use that are used with the following blood glucose measurement devices. Description/Item: TRUE METRIX PRO Meter Only/RE4H01P-40, TRUE METRIX PRO Starter Kit/RE4H01P-43, PROCURE TRUE METRIX PRO Meter Only/RE4212P-00, Henry Schein TRUE MET
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1548-2026·2026-03-18

    TRUE METRIX GO manuals recalled as Class I over E-5 error guidance

    Trividia Health is recalling owner's booklets and instructions for TRUE METRIX GO blood glucose meters because the labeling did not give lay users adequate directions for the E-5 error code.

    Product
    Owner's Booklets and Instructions for Use that are used with the following blood glucose measuring devices. Description/Item: Walgreens TRUE METRIX GO Kit/RF4001-01BK, CVS TRUE METRIX GO Kit/RF4007-01, Meijer TRUE METRIX GO Kit/RF4019-01, Fred's Phamarcy TRUE METRIX GO Kit/R
    Category
    Medical Device
    Distribution
    Distributed nationwide