Medical device recalls
38684 federal recalls on file. Federal recalls for medical devices — surgical equipment, monitors, diagnostic tools, implants, home health devices. Sourced from the FDA.
- 2024-04-24FDA-DevicePhilips North America LlcClass IIGYROSCAN T5-NT, Magnetic Resonance System.
Patient support table floor plate may be incorrectly installed.
- 2024-04-24FDA-DevicePhilips North America LlcClass IIGYROSCAN T5, Magnetic Resonance System.
Patient support table floor plate may be incorrectly installed.
- 2024-04-24FDA-DevicePhilips North America LlcClass IIGYROSCAN T10-NT, Magnetic Resonance System.
Patient support table floor plate may be incorrectly installed.
- 2024-04-24FDA-DevicePhilips North America LlcClass IIGYROSCAN ACS-NT, Magnetic Resonance System.
Patient support table floor plate may be incorrectly installed.
- 2024-04-24FDA-DevicePhilips North America LlcClass IIEvolution Upgrade 3.0T, Magnetic Resonance System.
Patient support table floor plate may be incorrectly installed.
- 2024-04-24FDA-DevicePhilips North America LlcClass IIEnterprise 1.5T, Magnetic Resonance System.
Patient support table floor plate may be incorrectly installed.
- 2024-04-24FDA-DevicePhilips North America LlcClass IIAchieva XR, Magnetic Resonance System.
Patient support table floor plate may be incorrectly installed.
- 2024-04-24FDA-DevicePhilips North America LlcClass IIAchieva 3.0TX for PET, Magnetic Resonance System.
Patient support table floor plate may be incorrectly installed.
- 2024-04-24FDA-DevicePhilips North America LlcClass IIAchieva 3.0T for PET, Magnetic Resonance System.
Patient support table floor plate may be incorrectly installed.
- 2024-04-24FDA-DevicePhilips North America LlcClass IIAchieva 3.0T, Magnetic Resonance System.
Patient support table floor plate may be incorrectly installed.
- 2024-04-24FDA-DevicePhilips North America LlcClass IIAchieva 1.5T Initial, Magnetic Resonance System.
Patient support table floor plate may be incorrectly installed.
- 2024-04-24FDA-DevicePhilips North America LlcClass IIAchieva 1.5T Conversion, Magnetic Resonance System.
Patient support table floor plate may be incorrectly installed.
- 2024-04-24FDA-DevicePhilips North America LlcClass IIAchieva 1.5T, Magnetic Resonance System.
Patient support table floor plate may be incorrectly installed.
- 2024-04-24FDA-DeviceSiemens Healthcare Diagnostics, Inc.Class IIAtellica CH Iron3 - IVD use in the quantitative measurement of iron in human serum and plasma (lithium heparin and sodium heparin) using the Atellica¿ CI Analyzer and Atellica¿ CH Analyzer Siemens Material Number (SMN): 11537211
Potential for falsely elevated Chol_2, LDLC, and Trig_2 results on the Atellica CH and Atellica CI analyzers when the previous result in the cuvette was Iron3. Results in a positive bias ranging from 2-16% -impacts calibrator, quality control (QC), and patient results.
- 2024-04-24FDA-DeviceArtivion, IncClass IICryoValve SG Cryopreserved Pulmonary Human Heart Valve
The blood cultures performed as part of the organ donation process were positive for Staphylococcus aureus.
- 2024-04-24FDA-DeviceUnomedical A/SClass IINeria Soft Infusion Set, Product Code 507302, intravascular administration set
Specific lots of Neria Soft Infusion Sets, which have been shipped into the US Market, have been shipped with the incorrect Instruction for Use (IFU) within the final pack. The IFU included is the IFU registered for the Rest of World (ROW) countries. The difference between the US IFU and the ROW IFU is the addition of an intended use section in the ROW IFU.
- 2024-04-24FDA-DeviceSmiths Medical ASD Inc.Class IISmiths Medical Medfusion Guide Barrel Clamp, Item number G6000716
Medfusion Model 4000, 3500, and 3010 pumps manufactured or serviced with Barrel Clamp Guide (Part Number G6000716), Lot Numbers P0407365, P0486670, and P0561740 may contain a molding defect that could potentially lead to slippage of the spring within the barrel clamp assembly. If this occurs, it could result in the inability of the pump to recognize a syringe or the pump may misidentify the size of the syringe loaded.
- 2024-04-24FDA-DeviceSmiths Medical ASD Inc.Class IISmiths Medical Model 3010 Syringe pumps: a. Protege Model 3010, b. Medfusion Model 3010A, c. Protege UK Model 3010E
Medfusion Model 4000, 3500, and 3010 pumps manufactured or serviced with Barrel Clamp Guide (Part Number G6000716), Lot Numbers P0407365, P0486670, and P0561740 may contain a molding defect that could potentially lead to slippage of the spring within the barrel clamp assembly. If this occurs, it could result in the inability of the pump to recognize a syringe or the pump may misidentify the size of the syringe loaded.
- 2024-04-24FDA-DeviceSmiths Medical ASD Inc.Class IISmiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,
Medfusion Model 4000, 3500, and 3010 pumps manufactured or serviced with Barrel Clamp Guide (Part Number G6000716), Lot Numbers P0407365, P0486670, and P0561740 may contain a molding defect that could potentially lead to slippage of the spring within the barrel clamp assembly. If this occurs, it could result in the inability of the pump to recognize a syringe or the pump may misidentify the size of the syringe loaded.
- 2024-04-24FDA-DeviceSmiths Medical ASD Inc.Class IISmiths Medical Medfusion Model 3500 Syringe pumps, Item Numbers: a) 3500 b) 3500-0600-00 c) 3500-0600-01 d) 3500-0600-249 e) 3500-0600-50 f) 3500-0600-51 g) 3500-0600-82 h) 3500-306 i) 3500-402 j) 3500-414 k) 3500-415 l) 3500-500 m) 3500E n) 3500VX-306 o) 3500VX-500
Medfusion Model 4000, 3500, and 3010 pumps manufactured or serviced with Barrel Clamp Guide (Part Number G6000716), Lot Numbers P0407365, P0486670, and P0561740 may contain a molding defect that could potentially lead to slippage of the spring within the barrel clamp assembly. If this occurs, it could result in the inability of the pump to recognize a syringe or the pump may misidentify the size of the syringe loaded.
- 2024-04-24FDA-DeviceMasimo CorporationClass IIMasimo Rad-G, Pulse Oximeter (W/Patient Cable), REF:9895 Rx Only,
Their is a potential that Oximeter may automatically power off and on resulting in loss of monitoring.
- 2024-04-24FDA-DeviceMasimo CorporationClass IIMasimo Rad-G, Pulse Oximeter (W/Patient Cable), REF:9849, Rx Only,
Their is a potential that Oximeter may automatically power off and on resulting in loss of monitoring.
- 2024-04-24FDA-DeviceMasimo CorporationClass IIMasimo Rad-G, Pulse Oximeter (W/Sensor), REF:9847, Rx Only,
Their is a potential that Oximeter may automatically power off and on resulting in loss of monitoring.
- 2024-04-24FDA-DeviceMasimo CorporationClass IIMasimo Rad-G, Pulse Oximeter with temperature (W/Sensor), REF:9210, Rx Only,
Their is a potential that Oximeter may automatically power off and on resulting in loss of monitoring.
- 2024-04-24FDA-DeviceSonarMed IncClass IAW-M0001 SONARMED MONITOR. Used in conjunction with SonarMed Acoustic Sensors for airway monitoring.
Software anomaly resulted in failure to detect a partial obstruction in 2.5 mm sensors and up to 3mm distal to the sensor.
- 2024-04-24FDA-DeviceSURGICAL SPECIALTIESClass IIPOLYSIN (Polyglycolic Acid) suture, HSM9 5-0 BR PGA Part Number G503N
Complaints have been received with allegations of Incorrect Needle Curvature.
- 2024-04-24FDA-DeviceEthicon, Inc.Class IISTRATAFIX Spiral MONOCRYL Plus Bidirectional Knotless Tissue Control Device: STRATAFIX SPIRAL MONOCRYL PLUS BI UD 12+12IN(30+30CM) USP3-0(M2) D/A PS PRM- Indicated for use in soft tissue approximation where the use of absorbable sutures is appropriate. Product Code: SXMP2B412
Degraded and unusable upon removal from the foil pouch due to exposed environmental conditions during transit and storage, compromising sterility
- 2024-04-24FDA-DeviceCook IncorporatedClass IIDilator - Coons Taper - Used for dilating puncture sites or catheter tracts for percutaneous placement of devices for vascular and non-vascular applications such as in the venous, arterial, biliary and renal systems. REFERENCE PART NUMBER (RPN)/ORDER NUMBER (GPN): 1) JCD10.0-38-20- COONS G03928 2) JCD12.0-38-20- COONS G03929 3) JCD14.0-38-20- COONS G03932 4) JCD16.0-38-20- COONS G03947 5) JCD18.0-38-20- COONS G04051 6) JCD20.0-38-20- COONS G04264 7) JCD22.0-38-20- COONS G04443 8) JC
Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility
- 2024-04-24FDA-DeviceCook IncorporatedClass IIDilator With AQ Hydrophilic Coating - Intended to be used for dilating puncture sites or catheter tracts for percutaneous placement of devices for vascular and non-vascular applications such as in the venous, arterial, biliary and renal systems. REFERENCE PART NUMBER (RPN)/ORDER NUMBER (GPN): 1) JCD10.0-38-20-HC G10207 2) JCD14.0-38-20-HC G10293 3) JCD16.0-38-20-HC G10206 4) JCD6.0-38-20-HC G10285 5) JCD8.0-38-20-HC G10289
Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility
- 2024-04-24FDA-DeviceCook IncorporatedClass IIDilator - Intended to be used for dilating puncture sites or catheter tracts for percutaneous placement of devices for vascular and non-vascular applications such as in the venous, arterial, biliary and renal systems. 1) JCD10.0-38-20 2) JCD20.0-38-20 3) JCD22.0-38-20 4) JCD6.0-38-15 5) JCD8.0-38-15 6) JCD8.0-38-20
Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility
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