FDA (Device enforcement)

11,102 recalls · page 92 of 112

• TyTek PneumoDart- Intended for introduction into the body to facilitate removal of air from the pleural cavity in patients with a tension pneumothorax Model Number: TM-3172020-10-05
• KWIK-STIK(TM), Streptococcus pneumoniae derived from ATCC(R) 49619(TM), packaged as follows: a. KWIK-STIK(TM) 2 Pack; b. KWIK-STIK(TM) 6 Pack. Each KWIK-STIK unit contains a lyophilized microorganism pellet, an ampoule of hydrating fluid, and an inoculating swab. Each device is sealed within a lamin2020-10-01
• LYFO DISK(TM), LYFO DISK(TM) Streptococcus pneumoniae derived from ATCC(R) 49619(TM). LYFO DISK microorganisms are packaged in a resealable vial that contains 6 lyophilized microorganism pellets and a desiccant to prevent adverse moisture accumulation. The LYFO DISK microorganisms are 3 passages or 2020-10-01
• QC Sets and Panels: KWIK-STIK" 2 Pack. Common Name: QC Sets and Panels GP Comprehensive QC Set. Each KWIK-STIK unit contains a lyophilized microorganism pellet, an ampoule of hydrating fluid, and an inoculating swab. Each device is sealed within a laminated pouch that contains a desiccant to prevent2020-10-01
• ADVIA Chemistry Systems-Fructosamine (FRUC)-For in vitro diagnostic use in the quantitative measurement of glycated protein (fructosamine) in human serum or plasma on the ADVIA Chemistry systems Siemens Material Number (SMN): 103619412020-09-22
• Atellica CH Systems Fructosamine (FRUC)-For in vitro diagnostic use in the quantitative measurement of glycated protein (fructosamine) in human serum or plasma on the ADVIA¿ Chemistry systems Siemens Material Number (SMN): 110976372020-09-22
• 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, M0033PK2020-09-21
• Hurricane RX Biliary Balloon Dilatation Catheter Catalog REF No. M00545890; M00545900; M00545910; M00545920; M00545930; M00545940; M00545950; M00545960 The device is a double lumen catheter with a balloon mounted at the distal tip. Dilatation balloon catheters are used to exert radial force to dilat2020-09-16
• MeritMedical Cultura Flex Swab, Sterile Flocked Collection Device, Ref C100F, Sterile, for the following unit count:1 unit - (01)00884450491102, 25 unit - (01)10884450491109, 100 unit - (01)208844504911062020-09-16
• Merit Medical Cultura Collection and Transport System, Ref CFTS100, Single Use, IVD, for the following unit counts: 1 Unit - (01)00884450492123, 50 Units - (01)10884450492120, 200 units - (01)208844504921272020-09-16
• Merit Medical Cultura Collection and Transport System, 3 mL Viral Transport Medium, Ref: VCTS100, Single Use, IVD, for the following unit counts: 1 Unit - (01)00884450499917, 50 Units - (01)10884450499914, 200 units - (01)208844504999112020-09-16
• Novaplus Monitoriing Electrode with Foam Tape and Sticky Gel - Product Usage: intended to be used by healthcare professionals for ECG monitoring. 5 electrodes per card; 1 card per pouch; 200 pouches per shipper box (1000 electrodes total).2020-09-15
• Novaplus Monitoriing Electrode with Foam Tape and Sticky Gel - Product Usage: intended to be used by healthcare professionals for ECG monitoring. 3 electrodes per card; 1 card per pouch; 200 pouches per shipper box (600 electrodes total).2020-09-15
• 3M Red Dot Monitoring Electrode with 4mm Adapter - Product Usage: intended to be used by healthcare professionals for ECG monitoring. 10 electrodes per card; 4 cards per pouch; 20 pouches per shipper box (800 electrodes total).2020-09-15
• 3M Red Dot Monitoring Electrode with Foam Tape - Product Usage: intended to be used by healthcare professionals for ECG monitoring. 50 electrodes per pouch; 20 pouches per shipper box (1000 electrodes total).2020-09-15
• 3M Red Dot Monitoring Electrode with Foam Tape - Product Usage: intended to be used by healthcare professionals for ECG monitoring. 50 electrodes per pouch; 20 pouches per shipper box (1000 electrodes total).2020-09-15
• Monitron II Waveform Analyzer, REF: S00015-1, used with ventilators.2020-09-14
• 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: V960G2020-09-09
• Neoprobe GDS Control Unit, Model Number NPCU32020-09-07
• (1) RingLoc Bi-Polar Hip System Acetabular Cup ArCom: Acetabular Bi-Polar Cup, E1 Antioxidant Infused, 28 MM, 41 MM: Item No. 110010458; Lot No. 710930; UDI No. (01) 00880304568747 (17) 230614 (10) 710930 (2) RingLoc Hip system Acetabular Bi-Polar Cup: Acetabular Cup, ArCom, 41 MM OD, 28 MM ID: Item2020-09-03
• Biomet Comprehensive Reverse Shoulder Glenosphere Mini Baseplate with Taper Adapter-Shoulder Prosthesis item: 010000589 - Product Usage: intended to serve as the foundation for the reverse shoulder prosthesis head (glenosphere).2020-09-02
• PermaFlo Flowable Composite REF-UP 948 Shade: A2 - Product Usage: is a light cured, radiopaque, methacrylate based, flowable composite. PermaFlo contains H1¿m average particle size with narrow upper limit particle distribution.2020-08-31
• Ultrasound Navigation Software 1.0 and Ultrasound Integration Software for Cranial/ENT Navigation 3.0.x and 3.1.x - Product Usage: intended to be an intra-operative image guided localization system to enable minimally invasive surgery.2020-08-31
• BELLATEK TITANIUM ABUTMENT 4.1MM Reference Number: EDAT42020-08-31
• CERTAIN BELLATEK TIN ABUTMENT 4.1MM Reference Number: IEDAN42020-08-31
• CERTAIN BELLATEK TIN ABUTMENT 5.0MM Reference Number: IEDAN52020-08-31
• CERTAIN BELLATEK TITANIUM ABUTMENT 4.1MM Reference Number: IEDAT42020-08-31
• CERTAIN BELLATEK TITANIUM ABUTMENT 5.0MM Reference Number: IEDAT52020-08-31
• CERTAIN BELLATEK TITANIUM ABUTMENT 6.0MM Reference Number: IEDAT62020-08-31
• Langston Dual Lumen Catheter2020-08-31
• Langston Dual Lumen Catheter.2020-08-31
• Langston Dual Lumen Catheter.2020-08-31
• Langston Dual Lumen Catheter.2020-08-31
• BECKMAN COULTER ACCESS Immunoassay Systems - Access Unconjugated Estriol, REF 33570.2020-08-26
• 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)202012112020-08-25
• Terumo Advanced Perfusion System 1 Ultrasonic Air Sensor 3/8x3/32, Catalog Number 5773 - Product Usage: intended for use with Terumo and Sarns brand air detection and heart-lung systems to detect gross air bubbles in the line during extracorporeal procedures.2020-08-25
• Terumo Advanced Perfusion System 1 Ultrasonic Air Sensor 1/4x1/16 UAS BLK, Catalog Number 5785 - Product Usage: intended for use with Terumo and Sarns brand air detection and heart-lung systems to detect gross air bubbles in the line during extracorporeal procedures.2020-08-25
• Terumo Advanced Perfusion System 1 Ultrasonic Air Sensor 1/4x3/32, Catalog Number 5791 - Product Usage: intended for use with Terumo and Sarns brand air detection and heart-lung systems to detect gross air bubbles in the line during extracorporeal procedures.2020-08-25
• Opticross 35 15 MHz Peripheral Imaging Catheter 8F (2.74 mm) X 105 cm Expiration Date June 8th 2021 - July 22nd 2021 Material Number (UPN) # H7493932800350 UDI # 08714729984542 Lot #25754545; 25852104; 2582106; 25856700 Product Usage: intended for ultrasound examination of peripheral vascular pathol2020-08-24
• Inquiry Steerable Diagnostic Catheter, REF: IBI-81104 - Product Usage: INDICATIONS FOR USE The Inquiry fixed curve and steerable electrophysiology catheters are used for electrogram recording and cardiac stimulation during diagnostic electrophysiology studies. The catheters are commonly placed at th2020-08-24
• Inquiry Steerable Diagnostic Catheter, REF: IBI-87002 - Product Usage: INDICATIONS FOR USE The Inquiry fixed curve and steerable electrophysiology catheters are used for electrogram recording and cardiac stimulation during diagnostic electrophysiology studies. The catheters are commonly placed at th2020-08-24
• SwiftHook sold as the following: a. Individually as SwiftHook b. Included with Vega505EE mobile lifts Product Usage: The mobile lifts are intended to assist people with functional impairments in scenarios involving physical positioning.2020-08-21
• Cirq Arm System - Model SBS 1.3.2 (Art.No. 56000-01B) and SBS 1.4 (Art.No. 56000-01C) of the CIRQ Arm System (56000 and 56000A)2020-08-20
• Discovery NM 630 Model # H3101RH2020-08-14
• Discovery NM670 Pro Model # H3100XB2020-08-14
• Stryker IsoAir 2.0 support surface-provides pressure redistribution and is intended to assist in management of the microclimate of the patient skin, Model Number: 2941-001-1002020-08-12
• Lactate Dehydrogenase L-P, (LDH) (NAO), Catalog Number LD3842 - Product Usage: device intended for the quantitative in vitro determination of Lactate Dehydrogenase (LD) activity in serum and plasma. This product is suitable for use on the RX series instruments which includes the RX daytona and RX im2020-08-11
• Lactate Dehydrognease P-L, (UV), Catalog Number LD3818 - Product Usage: device intended for the quantitative in vitro determination of Lactate Dehydrogenase (LD) activity in serum and plasma. This product is suitable for use on the RX series instruments which includes the RX daytona and RX imola.2020-08-11
• Maquet/Getinge Rotaflow System Console US (115 V / 60 Hz) - Product Usage: Instructions for Use - Centrifugal Pump System is a device that uses a method other than revolving rollers to pump the blood through an extracorporeal circuit Material Number: 7010432922020-08-07
• RSP Standard HUMERAL SOCKET INSERT, 44MM, HXe-Plus, Part No. 509-00-0442020-08-07
• RSP Standard HUMERAL SOCKET INSERT, 40 MM plus 4MM, HXe-Plus, Part No. 509-00-4402020-08-07
• Merge PACS2020-08-06
• PROFEMUR Titanium and Cobalt Chrome modular necks, Item Numbers and descriptions: Item Number Description Description 2 PHAC1202 PROFEMUR NECK NEUTRAL SHORT COBALT CHROME PHAC1204 PROFEMUR NECK NEUTRAL LONG COBALT CHROME PHAC1212 PROFEMUR NECK A/R VAR/VAL 2 SHORT COBALT CHROME PHAC1214 PROFEMUR NECK2020-07-31
• ALTERA Spacer ALTERA Spacer, 10x26, 8-12mm, 8¿2020-07-22
• ALTERA Spacer ALTERA Spacer, 10x26, 9-13mm, 8¿2020-07-22
• ALTERA Spacer ALTERA Spacer, 10x26, 10-14mm, 8¿2020-07-22
• ALTERA Spacer ALTERA Spacer, 10x26, 12-16mm, 8¿2020-07-22
• ALTERA Spacer ALTERA Spacer, 10x26, 9-13mm, 15¿2020-07-22
• ALTERA Spacer ALTERA Spacer, 10x26, 10-14mm, 15¿2020-07-22
• ALTERA Spacer ALTERA Spacer, 10x26, 12-16mm, 15¿2020-07-22
• ALTERA Spacer ALTERA Spacer, 10x31, 8-12mm, 8¿2020-07-22
• ALTERA Spacer ALTERA Spacer, 10x31, 9-13mm, 8¿2020-07-22
• ALTERA Spacer ALTERA Spacer, 10x31, 10-14mm, 8¿2020-07-22
• ALTERA Spacer ALTERA Spacer, 10x31, 12-16mm, 8¿2020-07-22
• ALTERA Spacer ALTERA Spacer, 10x31, 9-13mm, 15¿2020-07-22
• ALTERA Spacer ALTERA Spacer, 10x31, 10-14mm, 15¿2020-07-22
• ALTERA Spacer ALTERA Spacer, 10x31, 12-16mm, 15¿2020-07-22
• ALTERA Spacer ALTERA Spacer, 10x36, 8-12mm, 8¿2020-07-22
• ALTERA Spacer ALTERA Spacer, 10x36, 9-13mm, 8¿2020-07-22
• ALTERA Spacer ALTERA Spacer, 10x36, 10-14mm, 8¿2020-07-22
• ALTERA Spacer ALTERA Spacer, 10x36, 9-13mm, 15¿2020-07-22
• NobelReplace Conical Connection (CC) PMC RP 4.3x10mm, REF: 37291 - Product Usage: implants are intended to be used in the upper or lower jaw bone (osseointegration) and used for anchoring or supporting tooth replacements to restore chewing function.2020-07-20
• Restore Clinician Programmer Application Software, model number A71100, used with the Restore Neurostimulators.2020-07-17
• uEXPLORER PET/CT Diagnostic Imaging System - Product Usage: This system is intended to be operated by qualified healthcare professionals to assist in the detection, localization, diagnosis, staging, restaging, treatment planning and treatment response evaluation for diseases and disorders in, but no2020-07-16
• OmniTom Computed tomography x-ray system, Model NL5000, all NL5000 systems with software version before 05.01.01 - Product Usage: is intended to be used for x-ray computed tomography applications for anatomy that can be imaged in the 40 cm aperture, primarily head and neck.2020-07-15
• The Guardian Connect App CSS7200 iOS - Product Usage: intended for use by patients with a compatible consumer mobile device.2020-07-15
• VITROS Chemistry Products TBIL Slides- 5 PACK/300 SLDS In vitro Diagnostic quantitatively measure total bilirubin (TBIL) concentration in serum and plasma, Product code: 81599312020-07-13
• VITROS Chemistry Products BuBc Slides - in vitro diagnostic use only. VITROS Chemistry Products BuBc Slides quantitatively measure unconjugated bilirubin (Bu) and conjugated bilirubin (Bc) concentrations in serum and plasma, Product code: 8383051 (60 slide); 1612365 (18 slide)2020-07-13
• VITROS XT Chemistry Products TBIL-ALKP Slides (ALKP is not affected) In Vitro Diagnostic use only - The TBIL test within the VITROS XT Chemistry Products TBIL-ALKP Slides quantitatively measures total bilirubin (TBIL) concentration in serum and plasma, Product Code: 68442962020-07-13
• Orasure Technologies Interept Benzodiazopene Miro-Plate EIA-Benzo EIA 5plate Matrix Oral Fluid Coated Micro-Plate-IVD Immunoassay for Benzodiazepines, Product Number: 1110IB2020-07-13
• Amylase AY3805 batch 480449 Amylase Ethylidene Blocked-pNPG7 Reagent2020-07-10
• Pancreatic Amylase AY3855 batch 480483 Pancreatic Amylase Ethylidene Blocked-pNPG7 Reagent2020-07-10
• Mako Hip End Effector, Variable Angle Catalog Number: 206967 GTIN:008484860221672020-07-09
• Captivator Polypectomy Snare, Single-Use Polypectomy Snare consists of a flexible wire cable and loop which can be extended and retracted from the snare s flexible outer sheath using a three-ring handle. The inner diameter of the sheath is PolyGlide" Lubricant coated to provide minimal friction duri2020-07-06
• Captivator Polypectomy Snare, Single-Use Polypectomy Snare consists of a flexible wire cable and loop which can be extended and retracted from the snare s flexible outer sheath using a three-ring handle. The inner diameter of the sheath is PolyGlide" Lubricant coated to provide minimal friction duri2020-07-06
• Captivator Polypectomy Snare, Single-Use Polypectomy Snare consists of a flexible wire cable and loop which can be extended and retracted from the snare s flexible outer sheath using a three-ring handle. The inner diameter of the sheath is PolyGlide" Lubricant coated to provide minimal friction duri2020-07-06
• Captivator Polypectomy Snare, Single-Use Polypectomy Snare consists of a flexible wire cable and loop which can be extended and retracted from the snare s flexible outer sheath using a three-ring handle. The inner diameter of the sheath is PolyGlide" Lubricant coated to provide minimal friction duri2020-07-06
• Captivator Polypectomy Snare, Single-Use Polypectomy Snare consists of a flexible wire cable and loop which can be extended and retracted from the snare s flexible outer sheath using a three-ring handle. The inner diameter of the sheath is PolyGlide" Lubricant coated to provide minimal friction duri2020-07-06
• Captiflex Snares, Single-Use Polypectomy Snare consists of a flexible wire cable and loop which can be extended and retracted from the snares flexible outer sheath using a three-ring handle. The inner diameter of the sheath is PolyGlide" Lubricant coated to provide minimal friction during extension 2020-07-06
• Captivator Polypectomy Snare, Single-Use Polypectomy Snare consists of a flexible wire cable and loop which can be extended and retracted from the snare s flexible outer sheath using a three-ring handle. The inner diameter of the sheath is PolyGlide" Lubricant coated to provide minimal friction duri2020-07-06
• DYNEX Agility, Agility Analyzer, Model No. 670002020-07-05
• REF MC330209 6' (15 cm) Appx 0.09 ml, Smallbore Trifuse Ext Set w/3 MicroClave Clear, 0.2 Micron Filter, 1.2 Micron Filter, 3 Clamps (Blue, Yellow, White), Rotating Luer - Product Usage: The intravascular administration set is a single use, sterile, non-pyrogenic device, which provides access for th2020-07-01
• Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6)2020-06-30
• Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8)2020-06-30
• Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8)2020-06-30
• Spectrum IQ Infusion System with Dose IQ Safety Software2020-06-30
• InnoWave Sonic Irrigator, There are currently six models (PCF, Pro, Ultra, Ultra+, Unity, and ECO) - Product Usage: STERIS InnoWave Sonic Irrigators are intended to thoroughly clean (remove tissue, blood, and other contaminants from) a variety of reusable surgical instruments. The equipment provides2020-06-26
• Randox Lipase Assay: Lipase Colorimetric Reagent - Product Usage: A Lipase test system is a device intended for the quantitative in vitro determination of Lipase in human serum and plasma.2020-06-26
• Beacon EUS Access System Preloaded Access 90degree Needle sterile, single-use, endoscopic ultrasound device consisting of a sharp stylet and an 18.5-gauge, echo-enhanced, tip-shaped, nitinol cannula intended to pierce tissue and then act as an access channel to facilitate guidewire placement to loca2020-06-26
• Beacon EUS Access System Preloaded Access 135degree Needle sterile, single-use, endoscopic ultrasound device consisting of a sharp stylet and an 18.5-gauge, echo-enhanced, tip-shaped, nitinol cannula intended to pierce tissue and then act as an access channel to facilitate guidewire placement to loc2020-06-26