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FDA Recalls
›Device Recalls

FDA Device Recalls

Recalls of medical devices, diagnostic equipment, implants, and surgical instruments.

Classification

All Class I Class II Class III

Status

All Ongoing Completed Terminated

Date

All time Past 30 days Past 12 months

Showing 881–900 of 1,000 recalls

Trilogy Evo Universal Ventilator, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients.

Philips Respironics, Inc.

Potential for sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while unit has sufficient power.

March 19, 2024 · DeviceView details →

LifeVentEVO2, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients. (sold outside US)

Philips Respironics, Inc.

Potential for sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while unit has sufficient power.

March 19, 2024 · DeviceView details →

Class IOngoing

Aeris EVO, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients. (sold outside US)

Philips Respironics, Inc.

Potential for sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while unit has sufficient power.

March 19, 2024 · DeviceView details →

Trilogy Evo O2, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients.

Philips Respironics, Inc.

Potential for sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while unit has sufficient power.

March 19, 2024 · DeviceView details →

Trilogy EV300, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients.

Philips Respironics, Inc.

Potential for sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while unit has sufficient power.

March 19, 2024 · DeviceView details →

Garbin EVO, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients. (sold outside US)

Philips Respironics, Inc.

Potential for sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while unit has sufficient power.

March 19, 2024 · DeviceView details →

Trilogy Evo, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients.

Philips Respironics, Inc.

Potential for sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while unit has sufficient power.

March 19, 2024 · DeviceView details →

Elekta Disposable Biopsy Needle Kit for Leksell Stereotactic System, REF 911933, 2.1mm Diameter / 14 Gauge, containing 6 inner boxes labeled REF 911761, Disposable Biopsy Needle Kit for Leksell Stereotactic System. Each inner box of REF 911761 contains a Tyvek bag labeled REF 912465, Disposable Biopsy Needle and Aspirator Tube.

Elekta Instrument AB

Elekta has become aware that Disposable Biopsy Needles (911933) from one batch (837838839) can contain some microscopic debris on the inside of the biopsy needle. The material in the debris is stainless steel, same material as the biopsy needle. No debris has been found on the outer parts of the biopsy needles. The sterility of the biopsy needles has not been affected. This issue has been reported from one site.

March 15, 2024 · DeviceView details →

VITEK 2 - AST Test kits (in vitro diagnostic test cards for antimicrobial susceptibility): a) AST-N334, REF 418984; b) AST-GN95, REF 421982; c) AST-GN99, REF 423102; d) AST-N390, REF 423340; e) AST-N391, REF 423341; f) AST-N392, REF 423342; g) AST-N395, REF 423491; h) AST-N401, REF 423643; i) AST-N402, REF 423644; j) AST-N404, REF 423664; k) AST-N802, REF 423706; l) AST-N405, REF 423864; m) AST-N417, REF 423880; n) AST-N408, REF 423924; o) AST-N409, REF 423925; p) AST-N420, REF 424039; q) AST-N423, REF 424042; r) AST-N422, REF 424056; s) AST-N436, REF 424440; t) AST-N809, REF 424703; u) AST-N806, REF 424709; v) AST-N807, REF 424710; w) AST-N808, REF 424711; x) AST-N810, REF 424712; y) AST-N812, REF 424721

Biomerieux Inc

Ceftriaxone (cro02n) concentration errors associated with specific recently manufactured test kits which would have the potential for for false susceptible results. The risk is present for isolates that have a result of MIC=0.5, 1, 2.

March 14, 2024 · DeviceView 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, Inc

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

March 13, 2024 · DeviceView details →

Route 92 Medical, 070 Access System, REF 1004, Rxonly , Sterile EO. Used for introduction of interventional devices into the neurovasculature.

ROUTE 92 MEDICAL INC

Their is the potential for distal tip separation at the proximal marker band of the delivery catheters

March 8, 2024 · DeviceView details →

Route 92 Medical, Tenzing 7 Delivery Catheter, REF 1005, Rx Only, Sterile EO. Used for introduction of interventional devices into the neurovasculature.

ROUTE 92 MEDICAL INC

Their is the potential for distal tip separation at the proximal marker band of the delivery catheters

March 8, 2024 · DeviceView details →

Route 92 Medical, Full Length 070 Reperfusion System, REF: 7001, Rxonly, SterileEO. Used for Introduction of interventional devices into the neurovasculature.

ROUTE 92 MEDICAL INC

Their is the potential for distal tip separation at the proximal marker band of the delivery catheters

March 8, 2024 · DeviceView details →

Route 92 Medical Full Length 070 Access System, REF 7002, Rxonly, SterileEO. Used for Introduction of interventional devices into the neurovasculature.

ROUTE 92 MEDICAL INC

Their is the potential for distal tip separation at the proximal marker band of the delivery catheters.

March 8, 2024 · DeviceView details →

Route 92 Medical 070 Reperfusion System, REF 1003, Rxonly, SterileEO. Used for introduction of interventional devices into the neurovasculature and aspiration of thrombus in ischemic stroke patients.

ROUTE 92 MEDICAL INC

Their is the potential for distal tip separation at the proximal marker band of the delivery catheters

March 8, 2024 · DeviceView details →

LVP Software of the Ivenix Infusion System (IIS), Version 5.8.0.

Fresenius Kabi USA, LLC

Software has anomalies that have the potential to cause underdose, overdose, or delay in therapy which could lead to serious patient harm or death.

March 7, 2024 · DeviceView details →

Tablo Hemodialysis System, REF: PN-0003000, PN-0006000 and PN-0007001

Outset Medical, Inc.

Hemodialysis System, pre and post dialyzer peroxide-cured silicone tubing, with less than 336 hours usage, will be replaced because tubing may contain non-dioxin-like (NDL) polychlorinated biphenyl acids (PCBAs), that have not been flushed out over time with usage. Exposure to PCBAs could cause: skin conditions, liver damage, impaired reproduction, development of certain kinds of cancer in humans.

March 6, 2024 · DeviceView details →

t:connect mobile app used in conjunction with t:slim X2 insulin pump with Control-IQ technology

Tandem Diabetes Care, Inc.

During normal use, the mobile app version 2.7 may crash and be automatically relaunched by the iOS operating system. This cycle intermittently repeats, which leads to excessive Bluetooth communication that may result in pump battery drain and may lead to the pump shutting down sooner than typically expected. Pump shutdown will cause insulin delivery to suspend, which could lead to an under-delivery of insulin and may result in hyperglycemia, including severe hyperglycemia.

March 5, 2024 · DeviceView details →

Mojo 2 Full Face AAV Non Vented Mask, All Sizes

SleepNet Corporation

Update to contraindications and warning language due to CPAP masks containing magnets.

March 1, 2024 · DeviceView details →

Thoratec HeartMate 3, LVAS Implant Kit, REF:106524US, Sterile EO, RxOnly

Thoratec Corp.

Potential for a leak path at the seal interface between the left ventricle assist system inflow cannula and the titanium apical cuff.

March 1, 2024 · DeviceView details →

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