Hazard

Hypoxia recalls

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

What the numbers show

Total: 54
Critical: 16
Severe: 19
Most recent: 2026-06-24

Of the 54 hypoxia recalls we have scored against our rubric, 16 (30%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 19 (35%) are Severe.

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all hypoxia 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 54

SevereFDA (Devices)·Z-2358-2026·2026-06-24
Giraffe and Panda warmer blender knobs may deliver wrong oxygen concentration
Giraffe and Panda Warmers with Integrated Resuscitation System are being recalled because a loosening blender knob shaft can cause delivery of an unintended oxygen concentration.
Product
Giraffe Warmer with Integrated Resuscitation System (iRes), Panda Warmer with Integrated Resuscitation System (iRes) Product Identifiers: M1118179, M1112198 Impacted only if service blender M1091607-R was installed during the last Preventative Maintenance.
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-2357-2026·2026-06-24
Giraffe infant resuscitation system may deliver wrong oxygen concentration
Giraffe Stand-alone Infant Resuscitation Systems are being recalled because a loosening blender knob shaft can cause delivery of an oxygen concentration that does not match the setting.
Product
Giraffe Stand-alone Infant Resuscitation System; Powered emergency ventilator (resuscitator) Product identifiers: 2082663-001, 2082663-002, M1241424 Product impacted only if service blender M1091607-R was installed during the last Preventative Maintenance
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-2359-2026·2026-06-24
Panda freestanding warmer blender knobs may deliver wrong oxygen concentration
Panda Freestanding Warmers are being recalled because a loosening blender knob shaft can cause delivery of an oxygen concentration that does not match the setting.
Product
Panda Freestanding Warmer, Infant Radiant Warmer Product Identifiers: 2063568-001 Impacted only if service blender M1091607-R was installed during the last Preventative Maintenance.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1035-2026·2026-01-14
Oxygen masks recalled after complaints of tubing disconnecting during use
Medline is recalling 1,611,081 Hudson RCI medium concentration oxygen masks after multiple complaints of tubing disconnecting, which may lead to shortness of breath and hypoxia.
Product
Medline Hudson RCI Medium Concentration Oxygen Masks: 1041CE MASK,OXYGEN,UND CHIN,MED CO OUS ONLY; HUD1035 O2 MASK,MED CONC,SHORT,PEDI,7' TUB SC; HUD1042 O2 MASK,MED CONC,PEDI,7' TUB SC; HUD1930 O2 MASK,MED CONC,ADULT,7' TUB UC; HUDRHO41U MASK,OXYGEN,MEDIUM-CONCENTRAT
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-0451-2026·2025-11-19
Orthopedic and spine kits recalled over cracked anesthesia circuit tubing
Medline is recalling ortho spine, total joint and kyphoplasty convenience kits after complaints of anesthesia circuit leaks from cracks in the 120-inch expandable tubing. The FDA classified it Class I.
Product
Convenience kits; DYNJ901047R ORTHO SPINE FUMICH DYNJ902308K TOTAL JOINT DYNJ909111F DR SALMA'S SPINE DYNJ909117G PATTERSON TOTAL JOINT DYNJ909113F KYPHOPLASTY
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-0447-2026·2025-11-19
Surgical convenience kits recalled over cracked anesthesia circuit tubing
Medline is recalling 96,406 breast and hernia convenience kits after complaints of anesthesia circuit leaks caused by cracks in the 120-inch expandable tubing. The FDA classified it Class I.
Product
Convenience Kit, BREAST HERNIA DYNJ909125G
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-0450-2026·2025-11-19
Robotic surgery kits recalled over cracked anesthesia circuit tubing
Medline is recalling GYN Robotic and Robotic Prostate convenience kits after complaints of anesthesia circuit leaks caused by cracks in the 120-inch expandable tubing. The FDA classified it Class I.
Product
Convenience kits; DYNJ901046M GYN ROBOTIC DYNJ909120D ROBOTIC PROSTATE
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-0445-2026·2025-11-19
Airway procedure kits recalled over cracks in anesthesia circuit tubing
Medline is recalling ENT and laryngoscopy-bronchoscopy kits containing anesthesia circuits after complaints of leaks from cracks in the 120-inch expandable tubing. The FDA classified it Class I.
Product
Anesthesia Circuit Kits and other various kits that contain Anesthesia Circuits; ENT DYNJ909128I; LARYNGOSCOPY - BRONCHOSCOPY DYNJ909114D
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-0444-2026·2025-11-19
Open heart and vascular kits recalled over cracked anesthesia circuit tubing
Medline is recalling open heart supplement and vascular kits containing anesthesia circuits after complaints of leaks from cracks in the 120-inch expandable tubing. The FDA classified it Class I.
Product
Anesthesia Circuit Kits and other various kits that contain Anesthesia Circuits; OPEN HEART SUPPLEMENT DYNJ909116D; VASCULAR DYNJ909124F
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-0443-2026·2025-11-19
Breathing kits recalled over cracks in the expandable anesthesia tubing
Medline is recalling the latex-free Breathing Kit DYNJ10550 after complaints of anesthesia circuit leaks caused by cracks in the 120-inch expandable tubing. The FDA classified it Class I.
Product
Anesthesia Circuit Kits and other various kits that contain Anesthesia Circuits; BREATHING KIT-LF DYNJ10550
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-0448-2026·2025-11-19
Urology and hip pinning kits recalled over cracked anesthesia circuit tubing
Medline is recalling ortho spine, urology minor, set up and hip pinning convenience kits after complaints of anesthesia circuit leaks from cracked tubing. The FDA classified it Class I.
Product
Convenience Kits: DYNJ901048N ORTHO SPINE ST CLAIR DYNJ909123F UROLOGY MINOR DYNJ909132F SET UP DYNJ909308D HIP PINNING
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-0446-2026·2025-11-19
Laparoscopy and cysto kits recalled over cracked anesthesia circuit tubing
Medline is recalling robotic gastric sleeve, cysto and general laparoscopy kits after complaints of anesthesia circuit leaks from cracks in the 120-inch expandable tubing. The FDA classified it Class I.
Product
DYNJ909119G ROBOTIC GASTRIC LAP SLEEVE-LF DYNJ909127F CYSTO DYNJ909129D GENERAL LAPAROSCOPY-LF
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-0449-2026·2025-11-19
Expandable anesthesia circuits recalled over cracks causing leaks in tubing
Medline is recalling the 120-inch latex-free ExtendFlex anesthesia circuit after complaints of leaks caused by cracks in the expandable tubing. The FDA has classified it Class I.
Product
Anesthesia circuit kit; CIRCUIT,ANES,EXTENDFLEX,120,LF DYNJAA10230
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-0442-2026·2025-11-19
Adult anesthesia circuit kits recalled over cracked expandable tubing
Medline is recalling multiple adult 120-inch expandable anesthesia circuits after complaints of leaks caused by cracks in the tubing. The FDA has classified it Class I.
Product
Anesthesia Circuit Kits and other various kits that contain Anesthesia Circuits; Product description/Product numbers: ADULT 120 EXPANDABLE W/MASK DYNJAA10591; ANES CIRC 120IN EXP-LF DYNJAA6555G; ANES CIRCUIT ADULT 120"-LF DYNJAA10817; ANESTHESIA 120" ADLT-LF DYNJAA10
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-1814-2025·2025-06-11
Adult Manual Resuscitator with Medium Adult Mask recalled nationwide
SunMed Holdings is recalling 11,358 Adult Manual Resuscitators because the filter may be incorrectly attached to the patient port instead of the exhalation port, risking interruption or delay in patient resuscitation that could cause serious harm or death.
Product
Adult Manual Resuscitator with Medium Adult Mask, Bag REservoir, Filter, Manometer and 7 ft Oxygen Tubing, REF CPRM1116F
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1385-2025·2025-03-26
Microstream neonatal CO2 filter lines difficult to disconnect from breathing tubes
Microstream Advance neonatal-infant CO2 sampling lines may be difficult to disconnect from endotracheal tubes, potentially delaying critical procedures. This could cause unintended extubation and respiratory complications in infants.
Product
Microstream Instructions for Use and Part Number used with - Product Description, REF: Microstream Advance Intubated Infant, PT00156250 - Microstream Advance Neonatal-Infant Intubated CO2 Filter Line 2m/6.5ft Extended Duration, MVIIH; Microstream Advance Neonatal-Infan
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1378-2025·2025-03-26
Microstream CO2 sampling lines recalled for difficult adapter disconnection
Microstream CO2 sampling lines may be difficult to disconnect from endotracheal tubes, potentially delaying treatment or causing unintended tube removal.
Product
Microstream Instructions for Use and Part Number used with - Product Description, REF: Filter Line Sets Adult/Pediatric & Infant/Neonatal, 10129497 - CapnoLine Neonatal-Infant Intubated Filter Line with Microstream Technology H, Length 7 (2.0 m), 006324COV; CapnoLine
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1377-2025·2025-03-26
Microstream CO2 Sampling Lines May Be Difficult to Disconnect From Breathing Tubes
Microstream CO2 sampling lines and airway adapters may be difficult or impossible to disconnect from endotracheal tubes during clinical procedures, potentially causing treatment delays and unintended extubation with risk of serious complications.
Product
Microstream Instructions for Use and Part Number used with - Product Description, REF: FilterLine Sets & VitaLine Sets Adult/Pediatric, MQ04616 - MICROSTREAM FilterLine H Set Long Adult-Pediatric CO2 Sampling Line and Airway Adapter for Humid Environments, 007737; MICR
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1381-2025·2025-03-26
Microstream CO2 Intubated Filter Lines Difficult to Disconnect
Microstream CO2 filter lines used with intubated patients may be difficult or impossible to disconnect from the endotracheal tube, potentially delaying treatment or causing unintended extubation.
Product
Microstream Instructions for Use and Part Number used with - Product Description, REF: Microstream Adv. Adult-Pediatric Intubated, PT00134333 - Microstream Advance Adult-Pediatric Intubated CO2 Filter Line 2m/6.5ft Short-term use: Procedural/Emergency, QMVAI; Microstre
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1379-2025·2025-03-26
CO2 Sampling and Airway Adapter Devices May Be Difficult to Disconnect
Oridion Medical's CO2 sampling and airway adapter devices may be difficult to disconnect from endotracheal tubes, potentially causing treatment delays and serious respiratory complications in neonatal, infant, and pediatric patients.
Product
Microstream Instructions for Use and Part Number used with - Product Description, REF: Airway Adapter and CO2 Sampling Line, 01158 - Microstream Luer Adult-Pediatric Airway Adapter, 010989; Omnistream CO2 Sampling Line X25, 010991
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1380-2025·2025-03-26
CO2 Sampling Line Adapter May Be Difficult to Disconnect; Risk of Respiratory Failure
Microstream CO2 sampling line and airway adapter may be difficult or impossible to disconnect during procedures, potentially causing treatment delays and respiratory complications including hypoxia.
Product
Microstream Instructions for Use and Part Number used with - Product Description, REF: OmniVentLine Set, 012808 - OmniVentLine Set Adult-Pediatric CO2 Sampling Line and Airway Adapter, 012495;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1376-2025·2025-03-26
CO2 Sampling Lines May Fail to Disconnect During Neonatal Care
Microstream CO2 sampling lines and airway adapters may be difficult or impossible to disconnect from endotracheal tubes, potentially delaying treatment or causing unintended extubation. The defect affects neonatal and pediatric patients worldwide.
Product
Microstream Instructions for Use and Part Number used with - Product Description, REF: FilterLine H Set & VitaLine H Set Infant/Neonatal, 006147 - MICROSTREAM FilterLine H Set Infant/Neonatal CO2 Sampling Line and Airway Adapter for Humid Environments, 006324; MICROSTREAM
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1382-2025·2025-03-26
Microstream Neonatal-Infant CO2 Filter Line May Be Difficult to Disconnect
Microstream Neonatal-Infant Intubated CO2 Filter Lines may become difficult or impossible to disconnect from endotracheal tubes during clinical procedures, potentially delaying treatment and causing unintended extubation.
Product
Microstream Instructions for Use and Part Number used with - Product Description, REF: Microstream Adv. Infant Intubated, PT00134354 - Microstream Advance Neonatal-Infant Intubated CO2 Filter Line 2m/6.5ft Extended Duration, QMVIIH
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-1289-2025·2025-03-19
Portex Endotracheal Tubes may deliver inadequate ventilation due to smaller diameter
Portex Endotracheal Tubes from Smiths Medical ASD, Inc. may have a smaller diameter than expected, potentially causing inadequate ventilation and patient hypoxia.
Product
Portex Endotracheal Tube, Item Codes 100/105/025 100/105/030 100/105/035 100/111/020 100/111/025 100/111/030 100/111/035 100/111/035 100/126/025 100/126/030 100/126/035 100/127/025 100/127/030 100/127/035 100/141/025 100/141/030 100/141/035
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0571-2025·2024-12-04
Essenz HLM Heart-Lung Machines May Fail Due to Software Defect
The recalled Essenz HLM heart-lung machines (38 units) may experience GUI display failures and sensor deactivation. This can lead to hypoxia and hypoperfusion.
Product
Essenz HLM (Heart-Lung Machine), REF: 49-00-10, with Software
Category
Medical Device
Distribution
Distributed nationwide