Medical Device Recalls

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7,979 medical device recalls from federal enforcement feeds.

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Showing 6,601–6,650 of 7,979

Medical Device Recall · April 5, 2024
Jiangsu Shenli Medical Production Co., Ltd.
Brand Name: MEDLINE Product Name: SYR 3ML L/L Model/Catalog Number: 83084 Product Description: NON-Sterile syringes without needles for single use Component: No
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
Class II
Medical Device Recall · April 5, 2024
Wishbone Medical, Inc.
WishFIX Growth Control Plating System, Model Number: TEFCS28-080US. Orthopedic device.
The products in this lot are incorrectly packed with a Stainless-Steel implant instead of a Titanium implant as the packaging and part number indicated.
Class II
Medical Device Recall · April 5, 2024
Jiangsu Shenli Medical Production Co., Ltd.
Brand Name: Wolf Medical Product Name: 20 mL (cc) Luer Lock STERILE LATEX FREE NON PYROGENIC Model/Catalog Number: SYR20L Product Description: NON-Sterile syringes without needles for single use C
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
Class II
Medical Device Recall · April 5, 2024
Jiangsu Shenli Medical Production Co., Ltd.
Brand Name: MEDLINE Product Name: SYR 5ML L/S Model/Catalog Number: 83085 Product Description: NON-Sterile syringes without needles for single use Component: No
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
Class II
Medical Device Recall · April 5, 2024
Jiangsu Shenli Medical Production Co., Ltd.
Brand Name: MEDLINE Product Name: SYR 5ML L/L GREEN Model/Catalog Number: 91826 Product Description: NON-Sterile syringes without needles for single use Component: No
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
Class II
Medical Device Recall · April 5, 2024
Jiangsu Shenli Medical Production Co., Ltd.
Brand Name: GMAX Product Name: SYR 60ML/LL syringe Model/Catalog Number: TS2260L-M Product Description: NON-Sterile syringes without needles for single use Component: No
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
Class II
Medical Device Recall · April 5, 2024
Jiangsu Shenli Medical Production Co., Ltd.
Brand Name: Wolf Medical Product Name: 3 mL (cc) Luer Lock STERILE LATEX FREE NON PYROGENIC Model/Catalog Number: SYR03L Product Description: NON-Sterile syringes without needles for single use Co
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
Class II
Medical Device Recall · April 5, 2024
IVOCLAR VIVADENT AG
IPS e.max ZirCAD CER/in. Prime BL1 C17/3- A zirconium oxide block for the fabrication of fixed, full-contour restorations in anterior and posterior teeth. Article Number: 758434
Defective blocks may show cracks after sintering If cracks are unnoticed, restorations may fracture in the patient's mouth and require restoration
Class II
Medical Device Recall · April 5, 2024
Jiangsu Shenli Medical Production Co., Ltd.
Brand Name: GMAX Product Name: SYR 12ML/LS syringe Model/Catalog Number: TS2212S-M Product Description: NON-Sterile syringes without needles for single use Component: No
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
Class II
Medical Device Recall · April 5, 2024
Jiangsu Shenli Medical Production Co., Ltd.
Brand Name: Wolf Medical Product Name: 60 mL (cc) Luer Lock STERILE LATEX FREE NON PYROGENIC Model/Catalog Number: SYR60L Product Description: NON-Sterile syringes without needles for single use C
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
Class II
Medical Device Recall · April 5, 2024
Jiangsu Shenli Medical Production Co., Ltd.
Brand Name: GMAX Product Name: SYR 20ML/LS syringe Model/Catalog Number: TS2220S-M Product Description: NON-Sterile syringes without needles for single use Component: No
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
Class II
Medical Device Recall · April 5, 2024
Jiangsu Shenli Medical Production Co., Ltd.
Brand Name: MEDLINE Product Name: SYR 5ML L/L RED NITRO Model/Catalog Number: 91866 Product Description: NON-Sterile syringes without needles for single use Component: No
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
Class II
Medical Device Recall · April 5, 2024
IVOCLAR VIVADENT AG
IPS e.max ZirCAD CER/in. Prime A2 C17/5 -A zirconium oxide block for the fabrication of fixed, full-contour restorations in anterior and posterior teeth. Article Number: 758438
Defective blocks may show cracks after sintering If cracks are unnoticed, restorations may fracture in the patient's mouth and require restoration
Class II
Medical Device Recall · April 5, 2024
Jiangsu Shenli Medical Production Co., Ltd.
Brand Name: MEDLINE Product Name: SYR 3ML L/L PURPLE Model/Catalog Number: 91840 Product Description: NON-Sterile syringes without needles for single use Component: No
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
Class II
Medical Device Recall · April 5, 2024
Jiangsu Shenli Medical Production Co., Ltd.
Brand Name: MEDLINE Product Name: SYR 10ML/L BLUE CONTRAST Model/Catalog Number: 91848 Product Description: NON-Sterile syringes without needles for single use Component: No
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
Class II
Medical Device Recall · April 5, 2024
Jiangsu Shenli Medical Production Co., Ltd.
Brand Name: MEDLINE Product Name: SYR 30ML/LS Model/Catalog Number: 83077 Product Description: NON-Sterile syringes without needles for single use Component: No
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
Class II
Medical Device Recall · April 5, 2024
Jiangsu Shenli Medical Production Co., Ltd.
Brand Name: MEDLINE Product Name: SYR 5ML L/L BLUE HEPARIN Model/Catalog Number: 91867 Product Description: NON-Sterile syringes without needles for single use Component: No
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
Class II
Medical Device Recall · April 4, 2024
Stryker Leibinger GmbH & Co. KG
8000-021-002, Scopis¿ ENT Software with TGS¿ with Sofware Version: NOVA 3.6.0 RC16. Scopis is a next-generation solution for navigating functional endoscopic sinus surgery (FESS) offering surgeons hig
Unreleased software was installed on customer systems resulting in the visual feedback on the screen to show the points to be off from the physical reference point of the pointer or suction.
Class II
Medical Device Recall · April 4, 2024
Macherey Nagel Gmbh & Co. Kg
Reagent Test Strips for Blood, Urobilinogen, Bilirubin, Protein, Nitrite, Ketones, Ascorbic Acid, Glucose, pH, Specific Gravity and Leucocytes in Urine by the Dip and Read Technique.
The reason for the recall is one of the test pads, for the parameter leukocytes, was missing on some of the test strips. The issue was identified by a consumer by way of a Henry Schein Inc. (HSI) customer complaint. This problem can potentially result in the possibility that the parameter leucocytes (a non-specific marker for urinary track infections and an indicator for inflammatory renal processes) is interpreted instrumentally as a false negative. The following HSI item number and lot number were affected: Urispec¿ 11-Way, #102-2285, LOT 65402.
Class II
Medical Device Recall · April 4, 2024
Philips Medical Systems Nederland B.V.
Philips IntelliSpace Cardiovascular software, Model 830089.
Study data is not able to be archived, copied, or exported with the cardiovascular software version.
Class II
Medical Device Recall · April 3, 2024
Olympus Corporation of the Americas
InstaClear Lens Sheath. The InstaClear lens cleaner system and versatile sheath cleans and clears the lens of a rigid endoscope almost instantly during surgery without have to remove it from the nasal
Potential for distal end of the sheath to break off during a procedure.
Class II
Medical Device Recall · April 3, 2024
Stryker Neurovascular
The Distal Access Catheter is a single-lumen, braided shaft, variable stiffness catheter with radiopaque marker on the distal end and a luer hub on the proximal end. The catheter shaft has a hydrophil
Stryker Neurovascular is recalling their DAC- Distal Access Catheter -038 136cm, a Distal Access Catheter by removal. The reason for the recall is: the DAC Lot #0000486382 was released with out-of-specification endotoxin results.
Class II
Medical Device Recall · April 2, 2024
Andover Healthcare Inc.
Sterile CoFlex NL: Latex Free Flexible Cohesive Bandage, Tan, 4INx5YD (5400S)
A packaging seal gap could impact the sterility of the product.
Class II
Medical Device Recall · April 2, 2024
Agilent Technologies
Brand Name: Dako CoverStainer, Dako CoverStainer CPO Product Name: CoverStainer, CoverStainer CPO Model/Catalog Number: CS10030, CS10040, CS10026, CS10026E Software Version: N/A Product Descriptio
There is the potential for the front plexiglass door of the automated slide processing system to break causing potential injury.
Class II
Medical Device Recall · April 2, 2024
Fisher & Paykel Healthcare, Ltd.
Airvo 2 Humidifier, REF: PT101US, and myAirvo 2 Humidifier, REF: PT100US
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.
Class II
Medical Device Recall · April 1, 2024
Cook Medical Incorporated
EchoTip¿ Ultra Endoscopic Ultrasound Access Needle, ECHO-19, G31520
Devices may contain elevated levels of bacterial endotoxin.
Class II
Medical Device Recall · April 1, 2024
Cook Medical Incorporated
EchoTip¿ Ultra HD Endoscopic Ultrasound Access Needle, ECHO-HD-19-A, G52012
Devices may contain elevated levels of bacterial endotoxin.
Class II
Medical Device Recall · April 1, 2024
Karl Storz Endoscopy
LASER Application Instrument, 23 cm, REF: 8694; LEUNIG-GREVERS LASER Application, REF: 461000
Laser surgical instruments have no specific evidence of a validated reprocessing method, therefore these instruments lack sterility assurance, so once the instruments have gone through reprocessing after use and then are used again, there is an increased risk of the patient being exposed to infection.
Class II
Medical Device Recall · April 1, 2024
Philips Respironics, Inc.
OmniLab Advanced + Ventilator Product Numbers 1111122 1111123 1111124 1111125 1111126 1111127 1111138 1111141 1111142 KR1111127 R1111122 R1111123 R1111124 U1111122 U1111124
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.
Class I
Medical Device Recall · March 29, 2024
Stryker Leibinger GmbH & Co. KG
Stryker 1,5/1,7MM DYNAMIC MESH- STD-MEDIUM-Intended for the reconstruction, stabilization and rigid fixation of the bony areas of the cranial skeleton. Catalog Number: 56-90614
Mislabeled: Product labeled 56-90614 (90x90 Gold Mesh), was actually 56-90314 (90x90 Blue Mesh), may cause a delay in procedure
Class II
Medical Device Recall · March 29, 2024
Philips North America Llc
The Oncology Essentials Package of the Spectral CT imaging system.
Potential for third party oncology marking laser to be reflected off the gantry cover surface, which can potentially lead to misdiagnosis and subsequent incorrect treatment.
Class II
Medical Device Recall · March 29, 2024
CORENTEC CO., LTD
LOSPA Patella Component Model/Catalog Number: 01.10.9XX Software Version: N/A Product Description: Patella
Due to unsupported 10 year expiration date.
Class II
Medical Device Recall · March 29, 2024
CORENTEC CO., LTD
LOSPA Tibial Insert Model/Catalog Number: See below Software Version: N/A Product Description: Tibial Insert
Due to unsupported 10 year expiration date.
Class II
Medical Device Recall · March 28, 2024
RAYSEARCH LABORATORIES AB
RayStation 14.0.0.3338. Radiation Therapy Treatment Planning System.
Potential for reported SSD to be too high.
Class II
Medical Device Recall · March 28, 2024
RAYSEARCH LABORATORIES AB
RayStation 12.0.0.932, 12.1.0.1221, 12.0.3.68, 12.0.4.12 &12.3.0.119. Radiation Therapy Treatment Planning System.
Potential for reported SSD to be too high.
Class II
Medical Device Recall · March 28, 2024
RAYSEARCH LABORATORIES AB
RayStation 10.1.0.613 and 10.1.1.54. Radiation Therapy Treatment Planning System.
Potential for reported SSD to be too high.
Class II
Medical Device Recall · March 28, 2024
Horiba Instruments Incorporated
HORIBA custom configured fluorescence instrument, modular Fluorolog-QM
HORIBA custom configured fluorescence instrument has a laser safety defect. This custom configuration of the modular Instrument removed the primary light source and the excitation monochromator. A plastic cap was installed to plug the optical port, where a more durable beam stop should have been used. The defect may allow the class 4 laser beam to burn (or transmit) through the plastic cap to exit the protective enclosure.
Class II
Medical Device Recall · March 28, 2024
RAYSEARCH LABORATORIES AB
RayStation 9.1.0.933 and 9.2.0.483. Radiation Therapy Treatment Planning System.
Potential for reported SSD to be too high.
Class II
Medical Device Recall · March 28, 2024
Medtronic Neuromodulation
Intellis AdaptiveStim Product Number 97715, Spinal Cord Stimulator
inability to reprogram one device
Class II
Medical Device Recall · March 28, 2024
RAYSEARCH LABORATORIES AB
RayStation 8.1.0.47, 8.1.1.8 and 8.1.2.5. Radiation Therapy Treatment Planning System.
Potential for reported SSD to be too high.
Class II
Medical Device Recall · March 28, 2024
RAYSEARCH LABORATORIES AB
RayStation 15.0.0.430. Radiation Therapy Treatment Planning System.
Potential for reported SSD to be too high.
Class II
Medical Device Recall · March 28, 2024
RAYSEARCH LABORATORIES AB
RayStation 11.0.0.951, 11.0.1.29, 11.0.3.116 & 11.0.4.15. Radiation Therapy Treatment Planning System.
Potential for reported SSD to be too high.
Class II
Medical Device Recall · March 28, 2024
RAYSEARCH LABORATORIES AB
RayStation 13.0.0.1547, 13.1.0.144 & 13.1.1.89. Radiation Therapy Treatment Planning System.
Potential for reported SSD to be too high.
Class II
Medical Device Recall · March 28, 2024
RAYSEARCH LABORATORIES AB
RayStation 9.0.0.113 and 9.0.1.142. Radiation Therapy Treatment Planning System.
Potential for reported SSD to be too high.
Class II
Medical Device Recall · March 28, 2024
Zimmer, Inc.
NexGen CR-Flex Femoral Component, Size E and Size E Minus (E-). Component of the NexGen CR-Flex Porous Femur System.
Out of specification violation of devices that results in a gap existing within the fixture that presses the fiber metal pad to the substrate, causing the pad to not fully bond to the substrate.
Class II
Medical Device Recall · March 28, 2024
RAYSEARCH LABORATORIES AB
RayStation 8.0.0.61, 8.0.1.10. Radiation Therapy Treatment Planning System.
Potential for reported SSD to be too high.
Class II
Medical Device Recall · March 28, 2024
RAYSEARCH LABORATORIES AB
RayStation 7.0.0.19. Radiation Therapy Treatment Planning System.
Potential for reported SSD to be too high.
Class II
Medical Device Recall · March 28, 2024
RAYSEARCH LABORATORIES AB
RayStation 10.0.0.1154, 10.0.1.52 & 10.0.2.10. Radiation Therapy Treatment Planning System.
Potential for reported SSD to be too high.
Class II
Medical Device Recall · March 27, 2024
Cardinal Health 200, LLC
Jackson-Pratt 3-Spring Reservoir Kit with PVC Round Drain, 400mL, 7Fr., REF SU130-401D
Cardinal 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
Cardinal Health 200, LLC
Jackson-Pratt 3-Spring Reservoir with Silicone Adapters, 400mL, REF SU130-475
Cardinal 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