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Other Medical Devices

🏥 Medical Devices • 15,203 recalls

Airvo 2 Humidifier, REF: PT101US, and myAirvo 2 Humidifier, REF: PT100US

Fisher & Paykel Healthcare

Class I - Dangerous

Humidifier devices, used to deliver high flow respiratory therapy to patients, manufactured before 14 August 2017, have a speaker configuration that may result in distorted, intermittent or inaudible alarm sound levels. In the absence of an audible alarm, if there is an interruption to therapy, a patient may experience oxygen desaturation.

Apr 2, 2024 Other Medical Devices Nationwide View Details →

Medtronic Arterial Cannulae packaged as: a) DLPÂż Curved Metal Tip Arterial Cannula 20 Fr., Model Number 80020; b) DLPÂż Curved Metal Tip Arterial Cannula 20 Fr., Model Number 80220; c) DLPÂż Curved Metal Tip Arterial Cannula 20 Fr., Model Number 82020; d) DLPÂż Curved Metal Tip Arterial Cannula 20 Fr., Model Number 87120; e) DLPÂż Curved Metal Tip Arterial Cannula 22 Fr. , Model Number 80222; f) DLPÂż Curved Metal Tip Arterial Cannula 22 Fr. , Model Number 87122; g) DLPÂż Curved Tip Arterial Cannula 20 Fr., Model Number 87220; h) DLPÂż Curved Tip Arterial Cannula 22 Fr., Model Number 87222; i) DLP" One-Piece Arterial Cannulae, Pediatric 6 Fr, Model Number 77006; j) DLP" One-Piece Pediatric Arterial Cannula 6 Fr, Model Number 77206; k) DLP" One-Piece Pediatric Arterial Cannula 8 Fr, Model Number 77008; l) DLP" One-Piece Pediatric Arterial Cannula 10 Fr, Model Number 77010; m) DLP" One-Piece Pediatric Arterial Cannula 10 Fr, Model Number 77110; n) DLP" One-Piece Pediatric Arterial Cannula 12 Fr, Model Number 77112; o) EOPA" Elongated One Piece Arterial Cannula 20 Fr., Model Number 77420; p) EOPA" Elongated One Piece Arterial Cannula 22 Fr., Model Number 77422; q) EOPA" Elongated One Piece Arterial Cannula 22 Fr., Model Number 77522; r) EOPA" Elongated One Piece Arterial Cannula 22 Fr., Model Number 77622; s) EOPA" Elongated One Piece Arterial Cannula 24 Fr., Model Number 77524; t) Select Series" Angled Tip Arterial Cannula 24Fr., Model Number 72424; u) Select Series" Straight Tip Arterial Cannula 20 Fr., Model Number 72120; v) Select Series" Straight Tip Arterial Cannula 24 Fr., Model Number 72224

Medtronic Perfusion Systems

Class I - Dangerous

Potential for unsealed sterile packing.

Mar 19, 2024 Other Medical Devices View Details →

Medtronic Venous Cannulae: a) DLPÂż 20 Fr. Malleable Single Stage Venous Cannula, Model Number 68120, b) DLPÂż 24 Fr. Malleable Single Stage Venous Cannula, Model Number 68124, c) DLPÂż 28 Fr. Malleable Single Stage Venous Cannula, Model Number 68128, d) DLPÂż 30 Fr. Malleable Single Stage Venous Cannula, Model Number 68130, e) DLPÂż 34 Fr. Malleable Single Stage Venous Cannula, Model Number 68134, f) DLPÂż 12 Fr. Single Stage Venous Cannula, Model Number 67312, g) DLPÂż 16 Fr. Single Stage Venous Cannula, Model Number 67316, h) DLPÂż 16 Fr. Single Stage Venous Cannula, Model Number 67516, i) DLPÂż 18 Fr. Single Stage Venous Cannula, Model Number 66118, j) DLPÂż 18 Fr. Single Stage Venous Cannula, Model Number 67318, k) DLPÂż 20 Fr. Single Stage Venous Cannula, Model Number 67320, l) DLPÂż 20 Fr. Single Stage Venous Cannula, Model Number 69320, m) DLPÂż 20 Fr. Single Stage Venous Cannula, Model Number 67520, n) DLPÂż 22 Fr. Single Stage Venous Cannula, Model Number 66122, o) DLPÂż 22 Fr. Single Stage Venous Cannula, Model Number 67522, p) DLPÂż 24 Fr. Single Stage Venous Cannula, Model Number 67524, q) DLPÂż 26 Fr. Single Stage Venous Cannula, Model Number 67526, r) DLPÂż 28 Fr. Single Stage Venous Cannula, Model Number 66128, s) DLPÂż 28 Fr. Single Stage Venous Cannula, Model Number 39628, t) DLPÂż 28 Fr. Single Stage Venous Cannula, Model Number 67528, u) DLPÂż 30 Fr. Single Stage Venous Cannula, Model Number 66130, v) DLPÂż 31 Fr. Single Stage Venous Cannula, Model Number 69331, w) DLPÂż 32 Fr. Single Stage Venous Cannula, Model Number 66132, x) DLPÂż 34 Fr. Single Stage Venous Cannula, Model Number 67534, y) DLPÂż 36 Fr. Single Stage Venous Cannula, Model Number 66236, z) MC2Âż 28/36 Fr. Two Stage Venous Cannula, Model Number 91228, aa) MC2Âż 29/37 Fr. Two Stage Venous Cannula, Model Number 91229C, bb) MC2Âż 32/40 Fr. Two Stage Venous Cannula, Model Number 91263, cc) MC2Âż 32/40 Fr. Two Stage Venous Cannula, Model Number 91240C, dd) MC2Âż 32/40 Fr. Two Stage Venous Cannula, Model Number 91263C, ee) MC2Âż 34/46 Fr. Two Stage Venous Cannula, Model Number 91246, ff) MC2Âż 34/46 Fr. Two Stage Venous Cannula, Model Number 91246C, gg) MC2Âż 36/46 Fr. Two Stage Venous Cannula, Model Number 91236C, hh) MC2Âż 36/51 Fr. Two Stage Venous Cannula, Model Number 91251, ii) MC2Âż 36/51 Fr. Two Stage Venous Cannula, Model Number 91251C, jj) VC2" 34/38 Fr. Venous Cannula, Model Number 93438, kk) VC2" 34/48 Fr. Venous Cannula, Model Number 93448C

Medtronic Perfusion Systems

Class I - Dangerous

Potential for unsealed sterile packing.

Mar 19, 2024 Other Medical Devices View Details →

BioZorb Marker-BioZorb 3D Bioabsorbable Marker-Intended Use radiographic marking of sites in soft tissue. 1) F0405 BioZorb Marker 4cm x 5cm 2) F0404 BioZorb Marker 4cm x 4cm 3) F0331 BioZorb Marker 1cm x 3cm x 3cm 4) F0231 BioZorb Marker 1cm x 3cm x 2cm 5) F0221 BioZorb Marker 1cm x 3cm x 2cm 6) F0304 BioZorb Marker 3cm x 4cm 7) F0303 BioZorb Marker 3cm x 3cm 8) F0203 BioZorb Marker 2cm x 3cm 9) F0202 BioZorb Marker 2cm x 2cm

Hologic

Class I - Dangerous

Safety Information: Complaints describe complications/adverse events that include pain, infection, rash, device migration, device erosion, seroma, discomfort, or other complications from feeling the device in the breast, and the need for additional medical treatment to remove the device

Mar 13, 2024 Other Medical Devices Nationwide View Details →

Intelli-C: Right side suspended Tabletop, REF: 03400000; Left side suspended Tabletop, REF: 03400010, used with the Intelli-C X-ray system

NRT X-RAY A/S

Class I - Dangerous

X-ray system C-arm may experience uncontrolled motion if 1) AC motor controller firmware has a faulty setting, 2) the Motor/gear assembly is worn, 3) CAT movement is driven at maximum speed and angulated more than 75 deg. from vertical, and 4) the emergency stop or touch guard is activated during the breaking sequence, which could lead to the C-arm hitting the patient or operator.

Apr 17, 2024 Other Medical Devices Nationwide View Details →

GE Healthcare Allia IGS 7 OR, Interventional fluoroscopic x-ray systems

GE Medical Systems, SCS

Class I - Dangerous

GE HealthCare has become aware of the potential that adhesive material might not have been applied to some bolts of certain Innova IGS, Discovery IGS, Interact IGS, Allia IGS and Allia Pulse IGS products. This could result in a potential fall of the Detector/Elevator or X-ray tube of the frontal Gantry assembly.

Mar 18, 2024 Other Medical Devices Nationwide View Details →

GE Healthcare Interact Discovery RT, Interventional fluoroscopic x-ray systems

GE Medical Systems, SCS

Class I - Dangerous

GE HealthCare has become aware of the potential that adhesive material might not have been applied to some bolts of certain Innova IGS, Discovery IGS, Interact IGS, Allia IGS and Allia Pulse IGS products. This could result in a potential fall of the Detector/Elevator or X-ray tube of the frontal Gantry assembly.

Mar 18, 2024 Other Medical Devices Nationwide View Details →
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