Medical Device Recalls
RSS ↗7,979 medical device recalls from federal enforcement feeds.
Showing 6,651–6,700 of 7,979
- Class II
Medical Device Recall · March 27, 2024
Jackson-Pratt 3-Spring Reservoir Kit with PVC Round Drain, 400mL, 15Fr., REF SU130-403DCardinal Health is issuing a lot number specific voluntary removal of Jackson-Pratt 3-Spring Reservoir kits due to specific products being shipped to users before undergoing sterilization.
- Class II
Medical Device Recall · March 27, 2024
Jackson-Pratt Universal Connector PVC Tubing Anti Reflux Transparent Y, REF SU130-4601Cardinal Health is issuing a lot number specific voluntary removal of Jackson-Pratt 3-Spring Reservoir kits due to specific products being shipped to users before undergoing sterilization.
- Class II
Medical Device Recall · March 27, 2024
Newport s N-LHP-928(j) units if sold as a laser head/power supply set, and N5-LPL-944-080 and N6-LPL-944-080 if sold as a power supply alone.According to 21 CFR 1040.10(f)(4), each laser system classified as a Class IIIb or IV laser product shall incorporate a key-actuated master control. The key shall be removable and the laser shall not be operable when the key is removed. However, the key of the subject laser products can be removed from key switch and the laser remains on. This is a safety concern.
- Class II
Medical Device Recall · March 27, 2024
Jackson-Pratt 3-Spring Reservoir Kit with PVC Round Drain, 400mL, 10Fr., REF SU130-402DCardinal Health is issuing a lot number specific voluntary removal of Jackson-Pratt 3-Spring Reservoir kits due to specific products being shipped to users before undergoing sterilization.
- Class II
Medical Device Recall · March 26, 2024
Power Cords, marketed under the following models: a) CORD,METAL EARTH PIN, 2.5A,250V,2.5M,C7, 714682; b) PLFM CLASS II POWER CORD - AUSTRALIA, 716010; c) PLFM CLASS II POWER CORD - EUROPE, 716Baxter received reports of an issue related to the construction of the power cord not meeting the insulation rating per country-specific requirements and international electrical standards.
- Class II
Medical Device Recall · March 26, 2024
Hillrom Welch Allyn Spot Vision Screener VS100, marketed under the following models: a) SPOT VISION SCREENER,W/O CASE,PLUG2/EUR, VS100-2; b) SPOT VISION SCREENER,W/O CASE,PLUG4/UK, VS100-4; c)Baxter received reports of an issue related to the construction of the power cord not meeting the insulation rating per country-specific requirements and international electrical standards.
- Class II
Medical Device Recall · March 26, 2024
POLYSIN (Polyglycolic Acid) suture, HSM9 5-0 BR PGA Part Number G503NComplaints have been received with allegations of Incorrect Needle Curvature.
- Class I
Medical Device Recall · March 26, 2024
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 pDue 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.
- Class II
Medical Device Recall · March 26, 2024
Hillrom Welch Allyn Connex ProBP 3400 Digital Blood Pressure Device, marketed under the following models: a) PROBP 3400, SUREBP, BLUETOOTH, MOBILE,EU, Product Code 34BFST-2; b) PROBP 3400, SUREBPBaxter received reports of an issue related to the construction of the power cord not meeting the insulation rating per country-specific requirements and international electrical standards.
- Class I
Medical Device Recall · March 26, 2024
BiPAP V30 Auto Ventilator, Part Number 1111178Potential 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.
- Class I
Medical Device Recall · March 26, 2024
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 R11111Potential 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.
- Class I
Medical Device Recall · March 26, 2024
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 BR11111Potential 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.
- Class I
Medical Device Recall · March 25, 2024
AW-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.
- Class II
Medical Device Recall · March 25, 2024
RKN130002, RHEO KNEE 2 YR WARRANTY, MD, CE, External lower limb prosthetic componentDue to firmware issues with the prosthetic knee, there is the potential for unintended warnings and device shutdown which could result in patient falls.
- Class II
Medical Device Recall · March 25, 2024
RKNXC0005, RHEO KNEE XC 5 YR WARRANTY, MD, CE, External lower limb prosthetic componentDue to firmware issues with the prosthetic knee, there is the potential for unintended warnings and device shutdown which could result in patient falls.
- Class II
Medical Device Recall · March 25, 2024
RKNXC0003, RHEO KNEE XC 3 YR WARRANTY, MD, CE, External lower limb prosthetic componentDue to firmware issues with the prosthetic knee, there is the potential for unintended warnings and device shutdown which could result in patient falls.
- Class II
Medical Device Recall · March 25, 2024
RKN130003, RHEO KNEE 3 YR WARRANTY, MD, CE, External lower limb prosthetic componentDue to firmware issues with the prosthetic knee, there is the potential for unintended warnings and device shutdown which could result in patient falls.
- Class II
Medical Device Recall · March 23, 2024
5000 Compact Series Ultrasound Systems, Product/REF: 5500 CV/795141, 5500 P/795143, 5500 W/795144, 5500 G/795145, and Product/REF: 5300 W/795146, 5300 P/795147, 5300 G/795148, used with Deluxe and PreUltrasound system with: 1) transesophageal echocardiography transducer (TEE) connected/not selected 2) 1, 2 non-TEE connected 3) Imaging with non-TEE 4) Selected/not selected imaging transducer removed 5) Transducer connected 6) Non-TEE imaging continues, Then though TEE is unselected, it may have power, no temperature monitoring/control, and may result in temperature above limit and patient burns
- Class II
Medical Device Recall · March 22, 2024
Redux Electrolyte Creme, Product Ref. 66-04. Highly conductive electrolyte creme.Product demonstrates low viscosity.
- Class II
Medical Device Recall · March 22, 2024
MEDLINE INDUSTRIES, LP - Northfield
1500ML SOFT LINER, 1/4X6 TBG NS, REF OR926KA slight dimensional variation which has the potential for increased difficulty fitting into outer canister.
- Class II
Medical Device Recall · March 22, 2024
MEDLINE INDUSTRIES, LP - Northfield
Medline medical procedure kits labeled as follows: a) AAA CDS, REF CDS984011C; b) CAN KIT, REF DYKM1184; c) DENTAL CDS, REF CDS984010B; d) EGD KIT, REF DYK1253578F; e) EGD REG KIT, REF DYKA slight dimensional variation which has the potential for increased difficulty fitting into outer canister.
- Class II
Medical Device Recall · March 22, 2024
MEDLINE INDUSTRIES, LP - Northfield
Medline medical procedure kits labeled as follows: a) ENDO KIT, REF DYKE1410AA slight dimensional variation which has the potential for increased difficulty fitting into outer canister.
- Class II
Medical Device Recall · March 22, 2024
MEDLINE INDUSTRIES, LP - Northfield
Medline medical procedure kits labeled as follows: a) BASIC NEURO, REF DYNJ909171A; b) NEURO, REF DYNJ905510D; c) NEURO, REF DYNJ902388L; d) NEURO SAS, REF DYNJ908566A slight dimensional variation which has the potential for increased difficulty fitting into outer canister.
- Class II
Medical Device Recall · March 22, 2024
MEDLINE INDUSTRIES, LP - Northfield
Medline medical procedure kits labeled as follows: a) ARTHROSCOPY, REF DYNJ909699; b) BACK CDS, REF CDS984000C; c) EXTREMITY, REF DYNJ900847A; d) HAND-LF, REF DYNJ902619G; e) HIP PINNING CDA slight dimensional variation which has the potential for increased difficulty fitting into outer canister.
- Class II
Medical Device Recall · March 22, 2024
MEDLINE INDUSTRIES, LP - Northfield
Medline medical procedure kits labeled as follows: a) GYN CDS, REF DYNJ905499B; b) GYN LAP, REF DYNJ909936; c) GYN LAPAROSCOPY, REF DYNJ902371J; d) GYN LAPAROSCOPY, REF DYNJ905509F; e) GYNA slight dimensional variation which has the potential for increased difficulty fitting into outer canister.
- Class II
Medical Device Recall · March 22, 2024
MEDLINE INDUSTRIES, LP - Northfield
LINER, SOFT, SUCTION CANISTER, 1500CC, REF OR929KA slight dimensional variation which has the potential for increased difficulty fitting into outer canister.
- Class II
Medical Device Recall · March 22, 2024
MEDLINE INDUSTRIES, LP - Northfield
1,5L MED-SOFT LINER W/ 6MMX3M TUB. & ADULT VC, REF OR53929A slight dimensional variation which has the potential for increased difficulty fitting into outer canister.
- Class II
Medical Device Recall · March 22, 2024
MEDLINE INDUSTRIES, LP - Northfield
Medline medical procedure kits labeled as follows: a) BASIC NASAL, REF DYNJ909932; b) BRONCH KIT, REF DYKE1007B; c) ENT, REF DYNJ909935; d) NASAL SINUS-LF, REF DYNJ902624G; e) ORAL, REF DA slight dimensional variation which has the potential for increased difficulty fitting into outer canister.
- Class II
Medical Device Recall · March 22, 2024
MEDLINE INDUSTRIES, LP - Northfield
Medline medical procedure kits labeled as follows: a) TURNOVER KIT, REF DYKC1289FA slight dimensional variation which has the potential for increased difficulty fitting into outer canister.
- Class II
Medical Device Recall · March 22, 2024
MEDLINE INDUSTRIES, LP - Northfield
Medline medical procedure kits labeled as follows: a) MAJOR BREAST, REF DYNJ905004C; b) MINOR BREAST, REF DYNJ905002B; c) SUCTION MEDI VAC, REF DYKM2033A slight dimensional variation which has the potential for increased difficulty fitting into outer canister.
- Class II
Medical Device Recall · March 22, 2024
20" Lead Wires, Replacement Part Number: 1067724-2Damage to the lead wire sheath (black cable) component and causing exposure of the wires, potentially lead to no therapeutic treatment signal being delivered to the electrodes, and result in delay of treatment
- Class II
Medical Device Recall · March 22, 2024
Biomet OrthoPak Non-invasive Bone Growth Stimulator System-Indicated for the treatment of an established nonunion acquired secondary to trauma, excluding vertebrae and all flat bones. Part Number:Damage to the lead wire sheath (black cable) component and causing exposure of the wires, potentially lead to no therapeutic treatment signal being delivered to the electrodes, and result in delay of treatment
- Class II
Medical Device Recall · March 22, 2024
MEDLINE INDUSTRIES, LP - Northfield
Medline medical procedure kits labeled as follows: a) ENDO KIT, REF DYK1012268E1A slight dimensional variation which has the potential for increased difficulty fitting into outer canister.
- Class II
Medical Device Recall · March 22, 2024
MEDLINE INDUSTRIES, LP - Northfield
Medline medical procedure kits labeled as follows: a) KIT CANISTER SUCT W 12FT, REF DYKM2169A slight dimensional variation which has the potential for increased difficulty fitting into outer canister.
- Class II
Medical Device Recall · March 22, 2024
MEDLINE INDUSTRIES, LP - Northfield
Medline medical procedure kits labeled as follows: a) C-SECTION CDS, REF CDS983998CA slight dimensional variation which has the potential for increased difficulty fitting into outer canister.
- Class II
Medical Device Recall · March 22, 2024
MEDLINE INDUSTRIES, LP - Northfield
Medline medical procedure kits labeled as follows: DENTAL, REF DYNJ909211AA slight dimensional variation which has the potential for increased difficulty fitting into outer canister.
- Class II
Medical Device Recall · March 22, 2024
MEDLINE INDUSTRIES, LP - Northfield
LINER, SOFT, SUCTION CANISTER, 1500CC, REF DYNDSCL1500A slight dimensional variation which has the potential for increased difficulty fitting into outer canister.
- Class II
Medical Device Recall · March 22, 2024
MEDLINE INDUSTRIES, LP - Northfield
Medline medical procedure kits labeled as follows: a) ANESTHESIA CIRCUIT ADULT, REF DYNJAAF6666B; b) ANESTHESIA CIRCUIT PEDS-LF, REF DYNJAP9918A; c) CV ANESTHESIA - ROOM SET UP, REF DYNJ905503FA slight dimensional variation which has the potential for increased difficulty fitting into outer canister.
- Class II
Medical Device Recall · March 22, 2024
48" Lead Wires, Replacement Part Number: 1067724-4Damage to the lead wire sheath (black cable) component and causing exposure of the wires, potentially lead to no therapeutic treatment signal being delivered to the electrodes, and result in delay of treatment
- Class II
Medical Device Recall · March 22, 2024
MEDLINE INDUSTRIES, LP - Northfield
Medline medical procedure kits labeled as follows: a) HEART ANESTHESIA SET UP, REF DYNJ902752C, b) KIT ENDO, REF DYKE1872A, c) LOWER ENDO KIT, REF DYKE1921A, d) PACEMAKER, REF DYNJ901681D,A slight dimensional variation which has the potential for increased difficulty fitting into outer canister.
- Class II
Medical Device Recall · March 22, 2024
MEDLINE INDUSTRIES, LP - Northfield
1,5L MED-SOFT SINGLE LINER WITH SOLIDIFIER, REF OR1920PGA slight dimensional variation which has the potential for increased difficulty fitting into outer canister.
- Class II
Medical Device Recall · March 22, 2024
MEDLINE INDUSTRIES, LP - Northfield
Medline medical procedure kits labeled as follows: a) CYSTO, REF DYNJ905000D; b) ENDO KIT, REF DYKE1462A; c) ENDOSCOPY KIT, REF DYKE1431B; d) ENDOSCOPY KIT, REF DYKE1623B; e) GENERAL LAPAROA slight dimensional variation which has the potential for increased difficulty fitting into outer canister.
- Class II
Medical Device Recall · March 22, 2024
Biomet SpinalPak Non-invasive Spine Fusion Stimulator System- Indicated for the treatment of an established nonunion acquired secondary to trauma, excluding vertebrae and all flat bones, Part NumbeDamage to the lead wire sheath (black cable) component and causing exposure of the wires, potentially lead to no therapeutic treatment signal being delivered to the electrodes, and result in delay of treatment
- Class II
Medical Device Recall · March 22, 2024
MEDLINE INDUSTRIES, LP - Northfield
1,5L MED-SOFT LINER W/ 6MMX1,8M TUB. & ADULT VC, REF OR53926A slight dimensional variation which has the potential for increased difficulty fitting into outer canister.
- Class II
Medical Device Recall · March 22, 2024
Philips Patient Information Center (PIC) iX Uninterruptable Power Supply (UPS): 1. APC (Schneider Electric IT Corporation) 120V Uninterruptable Power Supply Model: SCL500RM1U 2. APC (Schneider EPossible failure of Uninterruptable Power Supply (UPS) devices supporting the Patient Information Center (PIC) iX system, potential for the associated PIC iX system to shut down due to the lack of power. may lead to the delay in the detection of a change in a patient condition
- Class I
Medical Device Recall · March 21, 2024
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK 155 (5PKX3), REF H749085263022; cardiac catheterAn 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.
- Class I
Medical Device Recall · March 21, 2024
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR5 (SGL), REF H74908526031; cardiac catheterAn 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.
- Class I
Medical Device Recall · March 21, 2024
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR5 125CM (5PK), REF H749085262302; cardiac catheterAn 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.
- Class I
Medical Device Recall · March 21, 2024
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL3.5 (5PK), REF H74908526212; cardiac catheterAn 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.
- Class I
Medical Device Recall · March 21, 2024
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AR2 (5PK), REF H74908526862; cardiac catheterAn 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.