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  1. FDA Recalls
  2. ›Device Recalls

FDA Device Recalls

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

Classification
AllClass IClass IIClass III
Status
AllOngoingCompletedTerminated
Date
All timePast 30 daysPast 12 months

Showing 821–840 of 1,000 recalls

Class IOngoing

Medline procedure kits labeled as: 1) WMC HYBRID OR PACK PART 1 , Pack Number CMPJ08068F ; 2) VASCULAR PACK , Pack Number CMPJ11455B ; 3) SALEM CATH LAB-LF , Pack Number DYNJ26938J ; 4) EH PEDIATRIC CATH , Pack Number DYNJ49920L ; 5) ARTERIOGRAM PACK, Pack Number DYNJ53018; 6) CATH PACK , Pack Number DYNJ57729C ; 7) PEDS CATH PACK, Pack Number DYNJ66856; 8) PEDS CATH PACK, Pack Number DYNJ66856A ; 9) STEWARD ROCKLEDGE CATH RRS, Pack Number DYNJ81061A ; 10) CATH LAB PACK , Pack Number DYNJ84617; 11) UA/UV CATHETERIZATION TRAY, Pack Number UVT1190A

MEDLINE INDUSTRIES, LP - Northfield

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

April 8, 2024 · DeviceView details →
Class IOngoing

Medline procedure kits labeled as: 1) CONTINUOUS BLOCK, Pack Number DYNJRA0960C; 2) COMBINED SPINAL AND EPIDURAL, Pack Number DYNJRA1268C; 3) WAL- UNIVERSAL BLOCK TRAY, Pack Number DYNJRA1638C; 4) BASIC DIAGNOSTIC TRAY, Pack Number DYNJRA1928; 5) PREOP NERVE BLOCK TRAY, Pack Number DYNJRA2040; 6) UNIVERSAL BLOCK TRAY, Pack Number DYNJRA2097; 7) PAIN TRAY, Pack Number DYNJRA2230; 8) CONTINUOUS EPIDURAL, Pack Number PAIN1766A; 9) CONTINUOUS/CSE TRAY, Pack Number PAIN1856; 10) CONTINUOUS/CSE TRAY, Pack Number PAIN1856A; 11) 20G SINGLE DOSE EPIDURAL, Pack Number PAIN2047; 12) 20G SINGLE DOSE EPIDURAL/CHLOR, Pack Number PAIN2048

MEDLINE INDUSTRIES, LP - Northfield

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

April 8, 2024 · DeviceView details →
Class IOngoing

OmniLab Advanced + Ventilator Product Numbers 1111122 1111123 1111124 1111125 1111126 1111127 1111138 1111141 1111142 KR1111127 R1111122 R1111123 R1111124 U1111122 U1111124

Philips Respironics, Inc.

Device may experience an interruption or loss of therapy in case of a Ventilator Inoperative alarm. This may lead to hypoventilation, mild to severe hypoxemia, hypercarbia, respiratory failure/insufficiency, or potentially death.

April 1, 2024 · DeviceView details →
Class IOngoing

BiPAP V30 Auto Ventilator, Part Number 1111178

Philips Respironics, Inc.

Potential for devices to experience interruption/loss of therapy during a Ventilator Inoperative alarm. This may lead to hypoventilation, mild to severe hypoxemia, hypercarbia, respiratory failure/insufficiency, or potentially death in the most vulnerable patients.

March 26, 2024 · DeviceView details →
Class IOngoing

BiPAP A40 Ventilators: BiPAP A40, Part Numbers 1111169 (US and OUS) and (OUS ONLY)1111170 1111171 1111173 1111174 1111175 1111177 1116156 1111170S BR1111169 CN1111169 IT1111169 R1111169 R1111177 R1116156 ; BiPAP A40 Pro, Part Numbers (OUS Only): ARX3100S19 AUX3100S19 BLX3100S19 BRX3100S18 CAX3100S12 CAX3100T12 DEX3100S13 EEX3100S19 ESX3100S19 FRX3100S14 GBX3100H19 GBX3100S19 IAX3100S19 INX3100H19 INX3100S19 ITX3100S21 SPX3100S19 ; BiPAP A40 EFL, Part Numbers (OUS Only): AUX3000S19 DEX2900S13 DEX3000S13 EEX3000S19 ESX3000S19 FRX3000S14 GBX3000S19 INX3000H19 ITX3000S21

Philips Respironics, Inc.

Potential for devices to experience interruption/loss of therapy during a Ventilator Inoperative alarm. This may lead to hypoventilation, mild to severe hypoxemia, hypercarbia, respiratory failure/insufficiency, or potentially death in the most vulnerable patients.

March 26, 2024 · DeviceView details →
Class IOngoing

BiPAP A30 Ventilator, Part Number 1111143 (US and OUS) OUS Only: Part Numbers 1111144 1111145 1111147 1111148 1111149 1111150 1111154 1111181 1116155 1111144L 1111144M 1111144V BR1111143 CN1111143 R1111143 R1111150 R1111181

Philips Respironics, Inc.

Potential for devices to experience interruption/loss of therapy during a Ventilator Inoperative alarm. This may lead to hypoventilation, mild to severe hypoxemia, hypercarbia, respiratory failure/insufficiency, or potentially death in the most vulnerable patients.

March 26, 2024 · DeviceView details →
Class IOngoing

Stealth S8 Clinical Software Application, REF: 9735762, CE0344, Rx Only. Used in the StealthStation System as an aid for locating anatomical structures in either open or percutaneous neurosurgical procedures.

Medtronic Navigation, Inc.

Due to a software issue, there is the potential for a missing digit, letter, or decimal in either the "distance to target" or "tip stop point" display during navigation.

March 26, 2024 · DeviceView details →
Class IOngoing

AW-M0001 SONARMED MONITOR. Used in conjunction with SonarMed Acoustic Sensors for airway monitoring.

SonarMed Inc

Software anomaly resulted in failure to detect a partial obstruction in 2.5 mm sensors and up to 3mm distal to the sensor.

March 25, 2024 · DeviceView details →
Class IOngoing

Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK (5PKX3), REF H749085263002; cardiac catheter

Boston Scientific Corporation

An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.

March 21, 2024 · DeviceView details →
Class IOngoing

Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR6 (5PK), REF H74908526042; cardiac catheter

Boston Scientific Corporation

An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.

March 21, 2024 · DeviceView details →
Class IOngoing

Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AR1 (5PK), REF H74908526842; cardiac catheter

Boston Scientific Corporation

An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.

March 21, 2024 · DeviceView details →
Class IOngoing

Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR4 (5PK), REF H74908526022; cardiac catheter

Boston Scientific Corporation

An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.

March 21, 2024 · DeviceView details →
Class IOngoing

Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO IM (5PK), REF H749085262012; cardiac catheter

Boston Scientific Corporation

An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.

March 21, 2024 · DeviceView details →
Class IOngoing

AW-S035 NEO SONARMED SENSOR 3.5MM. Used in conjunction with SonarMed Monitor for airway monitoring.

SonarMed Inc

The failure to detect the partial obstruction in a 2.5mm sensor.

March 21, 2024 · DeviceView details →
Class IOngoing

Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL5 125CM (5PK), REF H749085262352; cardiac catheter

Boston Scientific Corporation

An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.

March 21, 2024 · DeviceView details →
Class IOngoing

AW-S025 NEO SONARMED SENSOR 2.5MM. Used in conjunction with SonarMed Monitor for airway monitoring.

SonarMed Inc

The failure to detect the partial obstruction in a 2.5mm sensor.

March 21, 2024 · DeviceView details →
Class IOngoing

Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL4 (5PK), REF H74908526222; cardiac catheter

Boston Scientific Corporation

An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.

March 21, 2024 · DeviceView details →
Class IOngoing

Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK 145 (5PKX3), REF H749085265022; cardiac catheter

Boston Scientific Corporation

An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.

March 21, 2024 · DeviceView details →
Class IOngoing

Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO WRP (5PK), REF H74908526512; cardiac catheter

Boston Scientific Corporation

An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.

March 21, 2024 · DeviceView details →
Class IOngoing

Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR5 (SGL), REF H74908526031; cardiac catheter

Boston Scientific Corporation

An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.

March 21, 2024 · DeviceView details →
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