Hazard

Air In Line recalls

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

What the numbers show

Total: 17
Critical: 0
Severe: 1
Most recent: 2020-12-30

Of the 17 air in line recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1 (6%) 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 air in line 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.

1–17 of 17

SevereFDA (Devices)·Z-0707-2021·2020-12-30
ICU Medical Recalls ChemoLock Administration Sets Due to Molding Defect
ICU Medical is recalling specific ChemoLock administration sets because a molding defect may cause leaks. This could lead to fluid path contamination or exposure to hazardous medications.
Product
31" (78 cm) Appx 3.4 ml, Admin Set w/20 Drop Integrated ChemoLock Drip Chamber, Spiros, Bag Hanger, REF: 011-CL3011; 40" (102 cm) Appx 4.9 ml, Admin Set w/ChemoLock, 20 Drop In-Line Drip Chamber, Spiros, Bag Hanger, REF: 011-CL3020; ChemoLock Port w/Spiros, Red Cap, REF: CL-35; 3
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0701-2021·2020-12-30
ICU Medical Recalls Spiros and Clave IV Administration Sets
ICU Medical is recalling specific Spiros and Clave IV administration sets due to a molding defect that may cause leaks in spinning male luer components.
Product
5 IN (13 cm) Appx 1.5 ml, Bag Spike Adapter, Spiros, REF: 20123-01; 75" (191 cm) Appx 9.1 ml, 20 Drop Admin Set w/ Integrated Clave Drip Chamber, Clave, Spiros, REF: CH3035; 40" (102 cm) Appx 4.5 ml, 20 Drop Admin Set w/Integrated Clave Drip Chamber, Spiros, Hanger, REF: CH3135;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0710-2021·2020-12-30
ICU Medical Recalls Appx 1.7 ml Bag Spike Due to Molding Defect
ICU Medical is recalling 900 units of Appx 1.7 ml Bag Spike w/Integrated Clave due to a molding defect that may cause leaks in male luers.
Product
Appx 1.7 ml Bag Spike w/Integrated Clave, 2 Drop-In Spiros, REF: CH3260
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0704-2021·2020-12-30
ICU Medical Recalls Spinning Spiros Syringes and Administration Sets
ICU Medical is recalling specific syringes and administration sets with spinning Spiros components due to a molding defect that may cause fluid leaks.
Product
3mL Syringe w/Spinning Spiros, Red Cap, REF: CH2003; 5mL Syringe w/Spinning Spiros, Red Cap, REF: CH2005; 10mL Syringe w/Spinning Spiros, Red Cap, REF: CH2010; 20mL Syringe w/Spinning Spiros, Red Cap, REF: CH2020; 30mL Syringe w/Spinning Spiros, Red Cap, REF: CH2030; 60mL Syringe
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0709-2021·2020-12-30
ICU Medical Recalls Spinning Spiros Closed Male Luer Components
ICU Medical is recalling specific Spinning Spiros components due to a molding defect that may cause leaks, risking fluid path contamination or exposure to hazardous medications.
Product
Spinning Spiros Closed Male Luer, Red Cap, REF: IB-CH2000SC; 5" (13 cm) Appx 1.5 ml, Add-On Set w/Spiros, REF: IB-CH3034; 5" (13 cm) Appx 1.5 ml, Bag Spike Adapter w/Spiros, Vented Cap, REF: IB-CH3034C
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0702-2021·2020-12-30
ICU Medical Recalls Spiros Male Luer Connectors Due to Molding Defect
ICU Medical is recalling Spiros male luer connectors and administration sets due to a molding defect that may cause leaks, potentially leading to fluid path contamination or exposure to hazardous medications.
Product
30" (76 cm) Appx 3.2 ml, 20 Drop Admin Set w/Integrated Clave Drip Chamber, Spiros, Bag Hanger, REF: 20124-01; Spinning Spiros Closed Male Luer, Red Cap, REF: 20130-01; Spinning Spiros, Closed Male Luer, REF: CH2000S; Spinning Spiros Closed Male Luer, 10 units, REF: CH2000S-10; S
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0711-2021·2020-12-30
ICU Medical Recalls Spiros Blood Sets Due to Molding Defect
ICU Medical is recalling Spiros blood sets because a molding defect may cause leaks, risking fluid contamination or air-in-line.
Product
26 IN(66 cm) APPX 3.4ml, 10 DROP BLOOD SET, 170 MICRON FILTER, Spiros, REF: Z2795
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0699-2021·2020-12-30
ICU Medical Spiros Administration Sets Recalled for Molding Defect
ICU Medical is recalling Spiros administration sets due to a molding defect that may cause leaks, potentially leading to fluid path contamination or exposure to hazardous medications.
Product
42 IN (107 cm) Appx 5.0 ml, 20 Drop Admin Set, Spiros, REF: 20131-01; 31" (79 cm) Admin Set w/20 Drop Integrated Clave Drip Chamber, Spiros, Bag Hanger Drop-in Red Cap, 4 Units, REF: CH3330-C; 60 IN (152 cm) Appx 1.1 ml, Smallbore Set, MicroClave Clear, Spiros, REF: CH3353; 8" (2
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0700-2021·2020-12-30
ICU Medical Recalls Spinning Spiros and ChemoAccess Infusion Components
ICU Medical is recalling specific infusion components due to a molding defect that may cause leaks, risking fluid contamination or exposure to hazardous medications.
Product
Spinning Spiros, Closed Male Luer, REF: 060-CH2000S; SURPLUG ChemoAccess Closed Male Luer, REF: 066-CH2000S; SURPLUG ChemoAccess 5" (13cm) Bag Spike Adaptor with Closed Male Luer, REF: 066-CH3034; 35" (89 cm) Appx 3.9 ml, 10 Drop Admin Set w/Integrated Clave Drip Chamber, Clave,
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0706-2021·2020-12-30
ICU Medical Recalls Spiros Male Luer Devices Due to Molding Defect
ICU Medical is recalling Spiros closed male luer devices due to a molding defect that may cause leaks. The defect could lead to infusion delays, fluid contamination, or exposure to hazardous medications.
Product
Spiros CLOSED MALE LUER w/RED CAP, 25 UNITS, REF: 011-CH2000SC-25; 76 cm (30") Appx 3.2 ml, 20 Drop Admin Set w/Integrated ChemoClave Drip Chamber, Spiros w/Purple Cap, Bag Hanger, REF: 011-CH3185; 46 cm (18") Appx 7.4 ml, Trifuse Add-On Set w/2 Spiros w/Purple Caps, Bag Spike, 3
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1664-2018·2018-05-16
Baxter Sigma Spectrum Infusion Pump Recall Due to Testing Documentation Errors
Baxter is recalling 444 Sigma Spectrum Infusion Pumps because technicians omitted specific safety tests. The missing tests for air and occlusion detection could lead to serious health consequences.
Product
Baxter Sigma Spectrum Infusion Pump with master Drug Library (Version 6) 35700BAXL Product Usage: The Baxter Sigma Spectrum Infusion Pump with master Drug Library is intended to be used for the controlled administration of fluids. These fluids may includes pharmaceutical drug
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1667-2018·2018-05-16
Baxter Sigma Spectrum Infusion Pump Recalled for Incomplete Testing Documentation
Baxter Healthcare is recalling 444 Sigma Spectrum Infusion Pumps because final release testing was improperly documented, omitting critical safety checks.
Product
Baxter Sigma Spectrum Infusion Pump with Master Drug Library (Version 6) 35700BAXRE Product Usage: The Baxter Sigma Spectrum Infusion Pump with master Drug Library is intended to be used for the controlled administration of fluids. These fluids may includes pharmaceutical dru
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1665-2018·2018-05-16
Baxter Sigma Spectrum Infusion Pump Recalled for Documentation Errors
Baxter Healthcare is recalling 444 Sigma Spectrum Infusion Pumps because technicians incorrectly documented that all final release tests were completed, when several were actually omitted.
Product
Baxter Sigma Spectrum Infusion Pump with Master Drug Library (Version 6) 35700BAXR Product Usage: The Baxter Sigma Spectrum Infusion Pump with master Drug Library is intended to be used for the controlled administration of fluids. These fluids may includes pharmaceutical drug
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1663-2018·2018-05-16
Baxter Sigma Spectrum Infusion Pump Recalled for Documentation Errors
Baxter Healthcare is recalling 444 Sigma Spectrum Infusion Pumps because technicians omitted required safety tests, potentially compromising air and occlusion detection.
Product
Baxter Sigma Spectrum Infusion Pump with master Drug Library (Version 6) 35700BAX Product Usage: The Baxter Sigma Spectrum Infusion Pump with master Drug Library is intended to be used for the controlled administration of fluids. These fluids may includes pharmaceutical drugs
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0242-2016·2015-11-18
WalkMed Infusion Pumps Recalled for Air Detection Failure
WalkMed Infusion is recalling Triton Infusion Pumps because they may fail to detect air in the line when infusing Venofer.
Product
Triton Infusion Pump (model 300000) and Triton fp Infusion Pump (model 400000) (proprietary name: AFF (Mark I) Volumetric Infusion Pump). Used to pump fluids into a patient in a controlled manner.
Category
Medical Device
Distribution
22 states
HighFDA (Devices)·Z-1751-2013·2013-07-24
Hospira Recalls Symbiq IV Pump Sets Due to Air-in-Line Alarm Risk
Hospira is recalling Symbiq IV pump sets because a defective ball valve may fail to seal, causing air-in-line alarms during fluid administration.
Product
LifeShield; Sterile; Rx only; List No. 19666-28; SYMBIQ PUMP SET, CONVERTIBLE PIN, PIGGYBACK, 2 CLAVES PORTS AND OPTION LOK, NON-DEHP; NOMINAL LENGTH: 97 IN (249 CM); PRIMING VOLUME: 14 ML; For the administration of I.V. fluids; Made in Costa Rica; Hospira, Inc., Lake Forest, IL
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0764-2013·2013-02-06
MOOG Infinity Enteralite Feeding Pumps Recall for Manual Addendum
MOOG Medical Devices Group is recalling 92,488 Infinity Enteralite Ambulatory Feeding Pumps to add an operator's manual addendum regarding the Infinite Dose mode and air-in-line detection limitations.
Product
Infinity Enteralite Ambulatory Feeding Pumps, List number: INFKIT2 - Addendum to Operator's Manual Product usage: provide a means for the volumetric delivery of fluids used in Enteral applications.
Category
Medical Device
Distribution
Distributed nationwide