FDA (Device enforcement)

11,102 recalls · page 3 of 112

• TD Navio Maxi Speech Generating Device Model/Catalog Number: 10007992026-07-08
• Fort Defiance Industries (FDI), Automated Field Steam Sterilizer REF: P21312026-07-08
• Medline medical convenience kits, labeled as: 1) SINUS PACK-LF, Medline Kit SKU DYNJ0966146F; 2) ENT PACK, Medline Kit SKU DYNJ40154D; 3) ENT PACK, Medline Kit SKU DYNJ40154F; 4) ENT SCOPE PACK, Medline Kit SKU DYNJ44480D; 5) ENT NASAL ORAL PACK MOSES, Medline Kit SKU DYNJ58928A; 6) HEAD & NECK PACK2026-07-08
• Medline medical convenience kits, labeled as: 1) CRANIOTOMY PACK, Medline Kit SKU DYNJT6545; 2) ORTHO SPINE PACK, Medline Kit SKU DYNJ88056A; 3) ENT SINUS PACK, Medline Kit SKU DYNJ89001; 4) THYROID ENT, Medline Kit SKU DYNJ908641.2026-07-08
• Medline medical convenience kits, labeled as: 1) NEURO CDS, Medline Kit SKU CDS985246J; 2) NEURO PACK, Medline Kit SKU DYNJ32770V; 3) NEURO BUNDLE-LF, Medline Kit SKU DYNJ40095D; 4) NEURO PACK-LF, Medline Kit SKU DYNJ42844D; 5) NEURO PACK, Medline Kit SKU DYNJ45121I; 6) NEURO LAMINECTOMY PACK, Medli2026-07-08
• Medline medical convenience kits, labeled as: 1) LAMINECTOMY PACK, Medline Kit SKU DYNJT6548; 2) ORTHO SPINE PACK, Medline Kit SKU DYNJ44504G; 3) NEURO SPINE PACK, Medline Kit SKU DYNJ45419F; 4) CRANIOTOMY PACK, Medline Kit SKU DYNJ46024F; 5) SPINE PACK, Medline Kit SKU DYNJ54479C; 6) CRANIOTOMY PAC2026-07-08
• Olympus 4K UHD LCD Monitor. Model Number: OEV321UH. An electrically powered visual display unit designed for displaying graphical information in color.2026-07-07
• Atellica CH Urine Albumin REF: 11537225, in vitro diagnostic2026-07-06
• Endo-Model, Replacement Set, Tibial Plateau, right/left, L, UHMWPE, CoCrMo, Rotating Hinge Item Number 15-0027/162026-07-06
• Esteem Body Soft Convex Urostomy Pouch Model/Catalog Numbers: 423703, 423704, 423705, 423707, 423708, 423709, 423710, 423712, 423713, 423714, 423715, 423716, 423717, 423718, 423721, 423722, 423723, 423725, 423726, 423727.2026-07-06
• Pi-Cardia Inc. ShortCut REF: Z-A-20.003-US2026-07-06
• OsteoBallast, 45 x 17.5 mm (SeaSpine Brand), REF: 56800095. Ballast, 45 x 17.5 mm (IsoTis Brand), REF: 02-8000-0952026-07-02
• Stryker Hoffmann II Connecting Rod Micro 3 x 30mm. Catalog Number: 50796030.2026-07-01
• Stryker Hoffmann II Connecting Rod Micro 3 x 40mm. Catalog Number: 50796040.2026-07-01
• Stryker Hoffmann II Connecting Rod Micro 3 x 50mm. Catalog Number: 50796050.2026-07-01
• Stryker Hoffmann II Connecting Rod Micro 3 x 60mm. Catalog Number: 50796060.2026-07-01
• Stryker Hoffmann II Connecting Rod Micro 3 x 90mm. Catalog Number: 50796090.2026-07-01
• Stryker Hoffmann II Connecting Rod Micro 3 x 120mm. Catalog Number: 50796120.2026-07-01
• Stryker Hoffmann II Connecting Rod Micro 3 x 150mm. Catalog Number: 50796150.2026-07-01
• Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475620 Product Description: Intramedullary Bone Saw Blade Assembly 12mm2026-07-01
• Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475625 Product Description: Intramedullary Bone Saw Blade Assembly 13mm2026-07-01
• Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475630 Product Description: Intramedullary Bone Saw Blade Assembly 14mm2026-07-01
• Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475635 Product Description: Intramedullary Bone Saw Blade Assembly 15mm2026-07-01
• Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475640 Product Description: Intramedullary Bone Saw Blade Assembly 16mm2026-07-01
• Cardiac Workstation 5000. Product Number: 860439.2026-07-01
• Cardiac Workstation 7000. Product Number: 860441.2026-07-01
• Rapid Refill Continuous Injection System, UPN M005660012026-06-30
• Radial Jaw 4 Standard Capacity Biopsy Forceps with the following descriptions and UPN: 1. Radial Jaw 4 SC 240cm Box 20; Outer Box UPN: M00513401; Inner Box UPN: M00513400. 2. Radial Jaw 4 SC 240cm Box 40; Outer Box UPN: M00513402; Inner Box UPN: M00513400. 3. Radial Jaw 4 SC w/ Needle 240cm Box 20; 2026-06-30
• Radial Jaw 4 Large Capacity Biopsy Forceps with the following descriptions and UPN: 1. Radial Jaw 4 LC 240cm Box 20; Outer Box UPN: M00513321; Inner Box UPN: M00513320. 2. Radial Jaw 4 LC 240cm Box 40; Outer Box UPN: M00513322; Inner Box UPN: M00513320. 3. Radial Jaw 4 LC w/Needle 240cm Box 20; Oute2026-06-30
• Radial Jaw 4 Jumbo Biopsy Forceps with the following descriptions and UPN: Radial Jaw 4 Jumbo 240cm Box 5; Outer Box UPN: M00513363; Inner Box UPN: M00513360.2026-06-30
• Merge PACS, medical imaging diagnostic workstation2026-06-30
• Medline Micro-Kill Bleach Germicidal Bleach Wipes,7" x 8", 150 count, 150 count, Product Number MSC351400AN2026-06-30
• Medline Micro-Kill Bleach Germicidal Bleach Wipes, 6" x 5", 150 count, Product Number MSC351410AN2026-06-30
• Medline Micro-Kill Bleach Germicidal Bleach Wipes, 12" x 12", 110 Count, Product Number MSC351450AN2026-06-30
• Medline Micro-Kill Bleach Germicidal Bleach Wipes, 12" x 12", 110 Count Bag, Product Number MSC351450BG42026-06-30
• Brand Name: Veritas Standard Reverse Total Shoulder Product Name: Veritas Standard Glenoid Baseplate Model/Catalog Number: 1500-1030; 1500-1035 Software Version: N/A - off-the-shelf hardware product Product Description: The restor3d Reverse Total Shoulder Arthroplasty System is intended for patients2026-06-30
• Fresenius Medical Care, 2008T BlueStar Hemodialysis Machine, Model Numbers: 191126, 191130.2026-06-30
• GE Healthcare MAC VU360, REF# part number 2030361-023; Electrocardiograph2026-06-29
• Neuroguard IEP 3 in 1 Carotid Stent and Post-Dilation Balloon System with Integrated Embolic Protection (Neuroguard IEP System), REF: NG-0630-140-2, NG-0640-140-2, NG-0730-140-2, NG-0740-140-2, NG-NV-6-30, NG-NV-6-40, NG-NV-7-30, NG-NV-7-402026-06-29
• Allura Xper FD. Model Numbers: 722026, 722027, 722028, 722029, 722035, 722038, 722039, 722058. Interventional fluoroscopic x-ray system.2026-06-29
• American Contract System Convenience Kit, CV B PACK, Model/Catalog Number: TNCB10AM2026-06-29
• American Contract System Convenience Kit, CV B PACK, Model/Catalog Number: TNCB10AN2026-06-29
• American Contract System Convenience Kits, CV B PACK, Model/Catalog Number: TNCB10AP2026-06-29
• American Contract System Convenience Kit, D & C PACK, Model/Catalog Number: LLPD90H2026-06-29
• Syva Emit Disopyramide Assay Enzyme Immunoassay, Lidocaine SMN 10445370 Catalog No 6N319UL2026-06-26
• Syva Emit tox Serum Tricyclic Antidepressant Calibrator/Controls SMN 10445390 Catalog No. 7C219UL2026-06-26
• REF # D23352, MicroScan LabPro V5.03 Panel Update 11 (US), Electronic installed on the following instruments: - B1018-280 MicroScan autoSCAN-4 Instrument - B1018-283 MicroScan WalkAway-40 plus Instrument - B1018-284 MicroScan WalkAway-96 plus Instrument - B1018-440 DxM-1040 MicroScan WalkAway Instru2026-06-26
• REF # D23354, MicroScan LabPro V5.03 Panel Update 11 DVD Kit (US) on the following instruments: - B1018-280 MicroScan autoSCAN-4 Instrument - B1018-283 MicroScan WalkAway-40 plus Instrument - B1018-284 MicroScan WalkAway-96 plus Instrument - B1018-440 DxM-1040 MicroScan WalkAway Instrument - B1018-42026-06-26
• Boston Scientific Enhance Transcarotid/Peripheral Access Kit REF: SR-4F21G7D-MP (Kit-075-03) Sheath with Dilator , Stiffen Dilator, Nitinol Mandrel Wire w/ Radiopaque Tip [Au}, Needle, Extension Tube with Stopcock2026-06-26
• ERBECRYO 2 Cryosurgical Unit Model/Catalog Number: 10402-0002026-06-26
• Resmed Astral 100/150 Resmed Astral 100/50 is a ventilator system that provides continuous or intermittent ventilatory support for patients weighing more than 11lb (5kg) who require mechanical ventilation.2026-06-25
• Brand Name: Quantum Rehab Product Name: Quantum 4Front 2 Model/Catalog Number: Quantum 4Front 2 Software Version: 2.0.11, new version: 2.0.13 Product Description: Wheelchair, Powered (ITI), 890.3860 Component: Controller2026-06-25
• Brand Name: Quantum Rehab Product Name: Quantum Outback Model/Catalog Number: Quantum Outback Software Version: 2.0.11, new version: 2.0.13 Product Description: Wheelchair, Powered (ITI), 890.3860 Component: Controller2026-06-25
• Brand Name: Quantum Rehab Product Name: Q6 Edge 3 Stretto Model/Catalog Number: Q6 Edge 3 Stretto Software Version: 2.0.11, new version: 2.0.13 Product Description: Wheelchair, Powered (ITI), 890.3860 Component: Controller2026-06-25
• Brand Name: Quantum Rehab Product Name: R-TRAK Model/Catalog Number: R-TRAK Software Version: 2.0.11, new version: 2.0.13 Product Description: Wheelchair, Powered (ITI), 890.3860 Component: Controller2026-06-25
• Brand Name: Quantum Rehab Product Name: Q6 Edge HD Model/Catalog Number: Q6 Edge HD Software Version: 2.0.11, new version: 2.0.13 Product Description: Wheelchair, Powered (ITI), 890.3860 Component: Controller2026-06-25
• Brand Name: Quantum rehab Product Name: Q6 Edge 2.0 Model/Catalog Number: Q6 Edge 2.0 Software Version: 2.0.11, new version: 2.0.13 Product Description: Wheelchair, Powered (ITI), 890.3860 Component: Controller2026-06-25
• Brand Name: Quantum Rehab Product Name: Quantum 1450 Model/Catalog Number: Quantum 1450 Software Version: 2.0.11, new version: 2.0.13 Product Description: Wheelchair, Powered (ITI), 890.3860 Component: Controller2026-06-25
• Brand Name: Quantum Rehab Product Name: Q6 Edge 2.0 (ilevel) Model/Catalog Number: Q6 Edge 2.0 (ilevel) Software Version: 2.0.11, new version: 2.0.13 Product Description: Wheelchair, Powered (ITI), 890.3860 Component: Controller2026-06-25
• Brand Name: Quantum Rehab Product Name: Q6 Edge 3 Model/Catalog Number: Q6 Edge 3 Software Version: 2.0.11, new version: 2.0.13 Product Description: Wheelchair, Powered (ITI), 890.3860 Component: Controller2026-06-25
• Brand Name: Quantum Rehab Product Name: Q6 Edge 4 Model/Catalog Number: Q6 Edge 4 Software Version: 2.0.11, new version: 2.0.13 Product Description: Wheelchair, Powered (ITI), 890.3860 Component: Controller2026-06-25
• Brand Name: Quantum Rehab Product Name: Quantum 4Front 2HD Model/Catalog Number: Quantum 4Front 2HD Software Version: 2.0.11, new version: 2.0.13 Product Description: Wheelchair, Powered (ITI), 890.3860 Component: Controller2026-06-25
• Brand Name: Quantum Rehab Product Name: 4Front Model/Catalog Number: 4Front Software Version: 2.0.11, new version: 2.0.13 Product Description: Wheelchair, Powered (ITI), 890.3860 Component: Controller2026-06-25
• Brand Name: Quantum Rehab Product Name: Quantum Rival Model/Catalog Number: Quantum Rival Software Version: 2.0.11, new version: 2.0.13 Product Description: Wheelchair, Powered (ITI), 890.3860 Component: Controller2026-06-25
• Products that contain the Pericare Wipes: Bardex Lubricath Foley Catheter Tray REF: 899914 899916 899918 UDI codes: 00801741024801¿ 10801741024808 00801741024818¿ 10801741024815 00801741024825¿ 10801741024822 SureStep" Foley Tray System with Bardex¿ Lubricath Temp Sensing Foley Catheter REF: A1194162026-06-25
• Products that contain the Pericare Wipes: Bard¿ Foley Tray With Lubri-Sil¿ All-Silicone Foley Catheter REF: 947314 947316 947318 UDI codes: 00801741024924¿ 10801741024921 00801741024931¿ 10801741024938 00801741024948¿ 10801741024945 Lubri-Sil¿ I.C. Complete Care¿ All-Silicone Foley Catheter Tray REF2026-06-25
• Products that contain the Pericare Wipes: *Bardex¿ I.C. Complete Care¿ Foley Catheter Tray REF: 300316A UDI codes: 00801741024344¿ 10801741024341 *Bardex¿ I.C. Complete Care¿ Foley Catheter Tray and Urine Meter REF: 303314A 303316A 303318A UDI code: 00801741024252¿ 10801741024259 00801741024269 10802026-06-25
• Products that contain the Pericare Wipes: SureStep Intermittent Catheter Tray REF: INTP16 INTS14 INTS14C INTS16 INTS16C PEDINTS06 PEDINTS08 PEDINTS10 UDI code: 00801741183300¿ 10801741183307 00801741183218¿ 10801741183215 00801741183232 10801741183239 00801741183225¿ 10801741183222 00801741183249 102026-06-25
• Products that contain the Pericare Wipes: SureStep" Foley Tray System Add-A-Foley Catheter REF: A153200 UDI code: 00801741121067¿ 10801741121064 SureStep" Foley Tray System Complete Care¿ Add-A-Foley Catheter REF: A304400A UDI code: 00801741073847¿ 10801741073844 SureStep" Foley Tray System Add-A-Fo2026-06-25
• Products that contain the Pericare Wipes: (Canada Only) SureStep" Foley Tray System Bardex¿ IC Complete Care¿ REF: A300314AC UDI-DI code: 00801741143243 SureStep" Foley Tray System Bardex¿ IC Complete Care¿ REF: A300316AC UDI-DI code: 00801741143250 SureStep" Foley Tray System Lubri-Sil¿ IC Complete2026-06-25
• Hotline Fluid Warming Set, single use device, is designed to warm blood and intravenous fluids and deliver them to the patient's intravenous access site at normothermic temperatures under gravity flow conditions, List Number L-702026-06-24
• EOPA Elongated One-Piece Arterial Cannula BLUNT 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 774222026-06-24
• EOPA Elongated One-Piece Arterial Cannula BLUNT 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 775222026-06-24
• EOPA Elongated One-Piece Arterial Cannula DIL TIP 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 776222026-06-24
• EOPA Elongated One-Piece Arterial Cannula DIL TIP 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 777222026-06-24
• EOPA 3D Arterial Cannula DIL TIP 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 782222026-06-24
• EOPA 3D Arterial Cannula 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 783222026-06-24
• Flow Anesthesia Machine Flow-i C20 6677200 Flow-i C30 6677300 Flow-i C40 6677400 Flow-i C20 6888520 Flow-i C30 6888530 Flow-i C40 6888540 Flow-c 6887700 Flow-e 68879002026-06-24
• V-Loc 90 Absorbable Wound Closure Device VLOC 90 0 VL 22 GS-21 VLOCM0336 VLOC 90 0 VL 22 GS-25 VLOCM0436 VLOCM0436 VLOCM0003 V-LOC* 90 4-0 CLR 15CM P12X12 VLOCM0003 VLOCM0013 V-LOC* 90 4-0 CLR 30CM P12X12 VLOCM0013 VLOCM0024 V-LOC* 90 3-0 CLR 45CM P12X12 VLOCM0024 VLOCM0123 V-LOC* 90 4-0 CLR 45CM P12026-06-24
• V-Loc 180 Absorbable Wound Closure Device BOX BEDSIDE STAPLING IS KING BOX06614V4 BOX BY PASS FINAL BOX07405V1 BOX BYPASS CARDON BOX01056V2 BOX BYPASS DR LAGAE BOX01482V2 BOX BYPASS KIT DEZEMBER 2025 BOX09222V1 BOX BYPASS KIT NEU BOX 003 BOX08767V1 BOX GASTRIC BYPASS JAWBYPASS2 BOX GASTRIC BYPASS SI2026-06-24
• Dermalon 88861757-31 DERMALON* 4-0 BLU 75CM C13 88861757-31 88861799-31 DERMALON* 4-0 BLU 75CM C14 88861799-312026-06-24
• Surgipro SP-623 SURGIPRO* 2-0 BLU 75CM SC2 X36 SP-6232026-06-24
• Surgipro II S8698GX SURGIPRO II BL 5/0 18 P-13 S8698GX2026-06-24
• Charger for the Therabody Theragun, G4 PRO massage device, and products which include the 4th Generation Theragun PRO charger. G4 PRO Black US - Refurb., SKU TG02428-01 G4 PRO NA, SKU G4-PRO-PKG-NA G4-PRO-PKG-US, SKU G4 PRO US G4 PRO Black US - Refurb V, SKU TG0002428-1V10 Pro Charger Single Unit, S2026-06-23
• Arrow-LOK Implant, REF: 21-253519, 21-253522, 21-253525, 21-253528, 21-253530, 21-253533, 21-253535, 21-253540, 21-253545, 21-253550, 21-353513, 21-353516, 27-253519, 27-253522, 27-253525, 27-253528, 27-253530, 27-253533, 27-253535. Implant indicated for fixation of osteotomies, arthrodeses and reco2026-06-23
• Power F2 Powered Fastening System, Product No. 0567091 Powered fastening system intended for professional use only. Designed to load, unload, and secure a compatible wheeled stretcher inside a ground-based ambulance. Item no. 05670912026-06-19
• Boston Scientific TheraSphere 360 Y-90 Management Platform, Model Number M00139509001; Radiological Image Processing System.2026-06-19
• munevo DRIVE and munevo DRIVE r-net Powered Wheelchair Hands-Free Control Application/Smart Glasses Interface/Wheelchair Head Control System2026-06-19
• P28 PHANTON INTRAMEDULLARY NAIL SYSTEM, Phantom Hindfoot TTC/TC Ball Tipped Guide Rod, SIZE: 0.30 mm, LENGTH: 800 mmm, ITem number P31-955-1800-S; provides stabilization of the hindfoot and ankle.2026-06-17
• Ventriculostomy Kit, REF: 461542026-06-17
• AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) Loop Recorder Pack 2 -RX, Part Number AMS10164; 2) NY Tray - RX, Part Number AMS10276A; 3) NYC Tray - RX, Part Number AMS10281B; 4) Vein Pack - RX, Part Number AMS11398C; 5) Radiology Tray-RX, Part Number AMS1217A; 6) Custom Pack 2026-06-17
• INFINION CX LEAD KIT, 50CM, Model: SC-2317-50, Material: M365SC2317500; INFINION CX LEAD KIT, 70CM, Model: SC-2317-70, Material: M365SC2317700. part of the Boston Scientific Spinal Cord Stimulator (SCS) Systems.2026-06-17
• Philips Allura under the following System Descriptions and corresponding model numbers: 1. Allura Xper FD10; Model Numbers: 722003, 722010, 722026. 2. Allura Xper FD10 OR Table; Model Number: 722033. 3. Allura Xper FD10/10; Model Numbers: 722005, 722011, 722027. 4. Allura Xper FD10C; Model Number: 72026-06-17
• Philips Azurion under the following System Descriptions and corresponding model numbers: 1. Azurion 3 M12; Model Numbers: 722063, 722221. 2. Azurion 3 M15; Model Numbers: 722064, 722222, 722280. 3. Azurion 5 M12; Model Number: 722227. 4. Azurion 5 M20; Model Numbers: 722228, 722281. 5. Azurion 7 B122026-06-17
• Philips Allura, Cardio Vascular-Allura Centron. Model Number: 722400. Interventional Fluoroscopic X-Ray System.2026-06-17
• Blom-Singer Classic Indwelling Voice Prosthesis, 16Fr/10 mm REF: 1610-LEF2026-06-17
• Blom-Singer Classic Indwelling Voice Prosthesis, 16Fr/10 mm REF: 1610-LF2026-06-17
• Olympus High Flow Insufflation Unit - UHI-4. Model Number: UHI-42026-06-16
• MiniMed Go App, Model: MMT-8600 (iOS), MMT-8601 (Android)2026-06-16
• 60 In Non-DEHP Minibore Extension Set RES ME2010 UDI-DI code: 10885403236235 MaxPlus Ext Set w/Needleless and Y-Site REF MPX5305-C UDI-DI code: 10885403274619 9 IN Extension Set w/Max Y REF MPX5300-C UDI-DI code: 10885403237218 Intravascular Administration Set and Extension Set used to administer fl2026-06-16