Medical device recalls

39180 federal recalls on file. Federal recalls for medical devices — surgical equipment, monitors, diagnostic tools, implants, home health devices. Sourced from the FDA.

2020-10-28FDA-DeviceSmith & Nephew, Inc.Class II
TWINFIX 5.0MM AB SUTURE ANCHOR WITH TWO- Absorbable Suture anchors Product Number: 7210710
Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch
2020-10-28FDA-DeviceSmith & Nephew, Inc.Class II
TWINFIX 5.0MM AB SUTURE ANCHOR WITH TWO Absorbable Suture anchors Product Number: 7210309
Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch
2020-10-28FDA-DeviceEncore Medical, LPClass II
EMPOWR Acetabular System *** EMPOWR Acetabular Cup, Cluster Hole, 54G *** Size 54G 54 mm Dia./Cluster Hole Alpha Code G Liner P2 Porous Coated REF 940-02-54G - Product Usage: are intended for treatment of patients who are candidates for total hip arthroplasty per the indications for use.
Due to incomplete machining a small peg remnant on the top of the dome that protrudes above the surrounding porous coating causing the cup not to seat properly.
2020-10-28FDA-DeviceSiemens Healthcare Diagnostics, Inc.Class II
Siemens Dimension Vista Akaline Phosphatase (ALPI) Flex reagent cartridge - In vitro diagnostic test for the quantitative measurement of alkaline phosphatase in human serum and plasma Catalog Number: K2115, SMN# 10642444
Low outlier resultsgenerated with Alkaline Phosphatase (ALPI) Flex reagent cartridge.The maximum difference observed with a patient sample was approximately -27% at a concentration of 129 U/L (2.15 ukat/L). The low outlier results are generated from the last five (5) tests of the well
2020-10-28FDA-DeviceMaquet Cardiovascular Us Sales, LlcClass II
Yuno II Mobile Operating Table - Product Usage: support and position the patient immediately before, during and after surgical interventions as well as for examination and treatment. Part 143302F0 (US) Part 143302B0 (OUS)
Plastic socket of the IEC 60320-1 socket pulled out of the metal cage and electronic parts exposed; where the socket was pulled out and main cable is still connected to the main socket (power source), there is a risk that a user or third person may suffer an electric shock when coming in contact with the exposed electronic components
2020-10-28FDA-DeviceMaquet Cardiovascular Us Sales, LlcClass II
Yuno Mobile Operating Table - Product Usage: Intended for support and position the patient immediately before, during and after surgical interventions as well as for examination and treatment. Part 143301F0 (US) Part 143301B0 (OUS)
Plastic socket of the IEC 60320-1 socket pulled out of the metal cage and electronic parts exposed; where the socket was pulled out and main cable is still connected to the main socket (power source), there is a risk that a user or third person may suffer an electric shock when coming in contact with the exposed electronic components
2020-10-28FDA-DeviceGE Healthcare, LLCClass II
Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance - Product Usage: The combined system maintains independent functionality of the MR and PET devices, allowing for single modality MR and / or PET imaging.
Potential electrical arc flash within the Power Gradient & RF (PGR) Cabinet.
2020-10-28FDA-DeviceGE Healthcare, LLCClass II
System, Nuclear Magnetic Resonance Imaging - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times.
Potential electrical arc flash within the Power Gradient & RF (PGR) Cabinet.
2020-10-28FDA-DeviceGE Healthcare, LLCClass II
System, Nuclear Magnetic Resonance Imaging - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times.
Potential electrical arc flash within the Power Gradient & RF (PGR) Cabinet.
2020-10-28FDA-DeviceGE Healthcare, LLCClass II
System, Nuclear Magnetic Resonance Imaging - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times.
Potential electrical arc flash within the Power Gradient & RF (PGR) Cabinet.
2020-10-28FDA-DeviceGE Healthcare, LLCClass II
System, Nuclear Magnetic Resonance Imaging - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times.
Potential electrical arc flash within the Power Gradient & RF (PGR) Cabinet.
2020-10-28FDA-DeviceInvivo CorporationClass III
MR Coils The MR Coil is intended to be used in conjunction with a Magnetic Resonance Scanner to produce diagnostic images of the anatomy of interest that can be interpreted by a trained physician.
The labels have been mistakenly printed with an IPX1 rating symbol. IPX ratings relate to protections that products have from water ingress.
2020-10-28FDA-DeviceBecton Dickinson & CompanyClass II
BD Nexiva Closed IV Catheter System Dual Port (20 GA 1.75 IN) Catalog (Ref) No. 383538 BD Nexiva closed IV catheter systems are intended to be inserted into a patient s vascular system for short term use to sample blood, monitor blood pressure, or administer fluids.
Dull/blunt needles within the IV Catheter System may lead to missed insertion attempts and delay in diagnosis or treatment until a new needle is inserted
2020-10-28FDA-DeviceQuidel CorporationClass II
Sofia SARS Antigen FIA Package Insert The Sofia SARS Antigen FIA is a lateral flow immunofluorescent sandwich assay that is used with the Sofia and Sofia 2 instrument intended for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in nasopharyngeal (NP) and nasal (NS) swab specimens directly from individuals who are suspected of COVID-19 by their healthcare provider within the first five days of the onset of symptoms.
Instructions for use in the package insert for SARS Antigen FIA test were updated to remove all references to a specific viral transport medium product as well as the use of other viral transport media. Use of the specific viral transport medium products may result in False-positive results. Directly testing from specimens (NS or NP swab) is recommended.
2020-10-28FDA-DeviceBaxter Healthcare CorporationClass I
Spectrum IQ Infusion System with Dose IQ Safety Software
Baxter is updating the device IFU for safety communication regarding cleaning practices.
2020-10-28FDA-DeviceBaxter Healthcare CorporationClass I
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8)
Baxter is updating the device IFU for safety communication regarding cleaning practices.
2020-10-28FDA-DeviceBaxter Healthcare CorporationClass I
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8)
Baxter is updating the device IFU for safety communication regarding cleaning practices.
2020-10-28FDA-DeviceBaxter Healthcare CorporationClass I
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6)
Baxter is updating the device IFU for safety communication regarding cleaning practices.
2020-10-28FDA-DeviceOlympus Corporation of the AmericasClass II
Olympus CHF-CB30S Choledoscope Intended Use: The device was designed to be used with an Olympus TV camera system, light source, TV monitor, endo-therapy accessories and other ancillary equipment for endoscopic diagnosis and treatment within the biliary tract (common bile duct, cystic duct, and hepatic duct).
The CHF-CB30S Device did not have a 510(k) clearance. Additionally, the device has been associated with breakage of the insertion section and protrusion of metal parts, as well as breakage and displacement of the rubber on the bending section during surgical procedures.
2020-10-28FDA-DeviceSmith & Nephew, Inc.Class II
Genesis (GII) - Product Usage: designed for use in patients in primary and revision surgery, where the posterior cruciate ligament and one or both of the collateral ligaments (i.e. medial collateral and/or lateral collateral ligament) are absent or incompetent.
The anterior locking detail does not meet its design specifications.
2020-10-28FDA-DeviceEncore Medical, LPClass II
AltiVate Reverse Small Socket Insert, 44mm Semi Constrained - E-Plus, Part Number: 509-03-044 - Product Usage: Per IFU, DJO Surgical shoulder devices are intended for treatment of patients who are candidates for shoulder arthroplasty per the Indication for use.
Product mislabeled. Use may result in a delay in surgery, stopping of surgery, and revision surgery.
2020-10-28FDA-DeviceEthicon, Inc.Class II
VICRYL MONOFILAMENT VIOLET 4IN (10CM) USP 10-0 (M0.2) SINGLE-ARMED CS140-6 - Product Usage: Intended for ophthalmic soft tissue approximation/ligation. Product Code: V960G
Product in the foil package for VICRYL V960 may not match the foil label and sales unit carton. The correct VICRYL suture is size 10-0, 4 inches (10 cm) in length, has monofilament construction, and a single needle. The incorrect VICRYL suture is size 6-0, 18 inches (45 cm) in length, has braided construction, and two needles
2020-10-28FDA-DeviceSiemens Healthcare Diagnostics, IncClass II
Atellica IM HER-2/neu (H2n) assay, 50 Test Kit, Catalog No. SMN 10995591, UDI Codes: (01)00630414599151(10)98034139(17)20210130 and (01)00630414599151(10)32478139(17)20210130 Atellica IM HER-2/neu (H2n) calibrator, 2 Pack, Catalog No. SMN 10995592, UDI Code (01)00630414599168(10)22695A49(17)20201211 ADVIA Centaur HER-2/neu (H2n) assay, 50 Test Kit, Catalog No. SMN 10308994, UDI codes : (01)00630414471235(10)43157138(17)20210130 (01)00630414471235(10)81653138(17)20210130 (01)0063041447
Siemens confirmed that the Upper Limit of Normal (ULN) as claimed in the Instructions for Use (IFU) was no longer achieved. This can potentially result in false positive or false negative results.
2020-10-28FDA-DeviceStryker NeurovascularClass I
Trevo XP ProVue Retriever, REF (Size): 90182 (4MM x 20MM); 90185 (4MM x 30MM); 90186 (6MM x 25MM). Procedure Pack REF: 80052, 93067, 93068, M0032PK42010001, M0033PK42022001, M0033PK43022001, M0033PK62523001, M0032PK42010002, M0032PK43010002, M0032PK62510002, M0033PK42022002, M0033PK43022002, M0033PK62523002
Increase in fracture complaints of the flexible, tapered core wire, resulting in stent retriever separation from the core wire during use. The stent retriever can be left behind in the vasculature.
2020-10-28FDA-DeviceVascular Solutions, Inc.Class I
Langston Dual Lumen Catheter.
The inner lumen of the Langston catheter may separate from the hub during pressure injection.
2020-10-28FDA-DeviceVascular Solutions, Inc.Class I
Langston Dual Lumen Catheter.
The inner lumen of the Langston catheter may separate from the hub during pressure injection.
2020-10-28FDA-DeviceVascular Solutions, Inc.Class I
Langston Dual Lumen Catheter.
The inner lumen of the Langston catheter may separate from the hub during pressure injection.
2020-10-28FDA-DeviceVascular Solutions, Inc.Class I
Langston Dual Lumen Catheter
The inner lumen of the Langston catheter may separate from the hub during pressure injection.
2020-10-28FDA-DeviceMedtronic VascularClass I
Rashkind Balloon Septostomy Catheter, 4F, Closed end, 50 cm, Pediatric, Single Lumen Product number: 007161 GTIN: 00613994760272 The Rashkind balloon septostomy catheters are designed for creating an atrial septal defect or enlarging an existing atrial septal defect as a treatment option for patients with a Cyanotic Congenital heart defect. Cyanotic congenital heart defects are rare conditions that are associated with high morbidity and mortality.
Subsequent failure of catheters in the field and failed quality testing
2020-10-28FDA-DeviceMedtronic VascularClass I
Rashkind Balloon Septostomy Catheter, 5F, Closed end, 50 cm, Pediatric, Single Lumen Product number: 007160 GTIN: 00613994760265 The Rashkind balloon septostomy catheters are designed for creating an atrial septal defect or enlarging an existing atrial septal defect as a treatment option for patients with a Cyanotic Congenital heart defect. Cyanotic congenital heart defects are rare conditions that are associated with high morbidity and mortality.
Subsequent failure of catheters in the field and failed quality testing

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