FDA (Device enforcement)

11,102 recalls · page 28 of 112

• Catalog No. 8888160341; Umbilical Vessel Catheter 5 French single lumen2025-05-02
• Catalog No. 8888160556; Umbilical Vessel Catheter 5 French dual lumen2025-05-02
• Catalog No. 8888160648; Umbilical Vessel Catheter 5 French triple lumen2025-05-02
• Brand Name: Canturio¿ Smart Extension Product Name: CSE Implant Model/Catalog Number: 43-5570-030-14 Product Description: Tibial stem extension for use with Zimmer Persona¿ Personalized Knee System; 14mm diameter x 30mm height. Implantable device with integrated electronics for passive kinematic dat2025-05-02
• Adult Manual Resuscitator with Medium Adult Mask, Bag REservoir, Filter, Manometer and 7 ft Oxygen Tubing, REF CPRM1116F2025-05-01
• GM Helix Acqua Implant, Article Number: 140.9842025-05-01
• GM Helix Acqua Implant, Article Number: 140.9852025-05-01
• BX2 Needle Guide, Part Number 644-094, tool for performing needle-guided (or catheter) procedures with the use of diagnostic ultrasound transducers2025-05-01
• Cardiohelp System HKH 8820 Wall Holder. Mounting bracket designed to hold the CARDIOHELP-i system for interhospital transport by vehicle.2025-04-30
• Sample probe sucks a sample dispensed into a tube or cup and discharges the appropriate amount into a cuvette. Lot 178713114 - 1794336702025-04-30
• Sample probe sucks a sample dispensed into a tube or cup and discharges the appropriate amount into a cuvette. Lot 178713114 - 1794336702025-04-30
• Azure S DR MRI SureScan, Product number W3DR012025-04-29
• 5008X HDF Hemodialysis Blood Tubing Set, 24 units per case, with the following models: a. 5008X Standard HDF Bloodline, Model Number: 03-5100-7. b. 5008X Standard HDF Bloodline w/CLIC, Model Number: 03-5100-7C. c. 5008X Standard HDF Bloodline w/ Twister, Model Number: 03-5150-2.2025-04-29
• Brand Name: Alcon Laboratories, Inc. Product Name: Constellation Vision System Vitrectomy Procedure Pak Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List' Software Version: N/A Product Description: Surgical procedure pack to interface with Alcon Constellation Surgical console. C2025-04-28
• Brand Name: Alcon Laboratories, Inc. Product Name: Constellation Vision System Combined Procedure Pak Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List' Software Version: N/A Product Description: Surgical procedure pack to interface with Alcon Constellation Surgical console. Com2025-04-28
• Brand Name: Alcon Laboratories, Inc. Product Name: Custom Pak Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List' Software Version: N/A Product Description: Alcon Custom Paks are customer-designed sterile surgical procedure packs / convenience kits intended for use by trained oph2025-04-28
• Brand Name: Tecfen Medical Product Name: 15 degree Stab Knife Model/Catalog Number: QKN1501 Software Version: No software Product Description: This is an ophthalmic knife (manual) that is to be sterile (gamma radiation) and packaged individually in Tyvek 1059B. Stab knives are used to make precise a2025-04-25
• Brand Name: Tecfen Medical Product Name: 2.2mm Slit Knife, Angled Model/Catalog Number: QKN2261 Software Version: No software Product Description: This is an ophthalmic knife (manual) that is to be sterile (gamma radiation) and packaged individually in Tyvek 1059B. Slit knives are used to create pre2025-04-25
• Brand Name: Tecfen Medical Product Name: 2.4mm Slit Knife, Angled Model/Catalog Number: QKN2461 Software Version: No software Product Description: This is an ophthalmic knife (manual) that is to be sterile (gamma radiation) and packaged individually in Tyvek 1059B. Slit knives are used to create pre2025-04-25
• Brand Name: Tecfen Medical Product Name: 2.8mm Slit Knife, Angled Model/Catalog Number: QKN2808 Software Version: No software Product Description: This is an ophthalmic knife (manual) that is to be sterile (gamma radiation) and packaged individually in Tyvek 1059B. Slit knives are used to create pre2025-04-25
• Brand Name: Tecfen Medical Product Name: 20G (1.2mm) MVR Sideport Knife Straight Model/Catalog Number: QKN2312 Software Version: No software Product Description: This is an ophthalmic knife (manual( that is to be sterile and packaged individually in Tyvek 1059B. MVR sideport knives are used to creat2025-04-25
• Brand Name: Tecfen Medical Product Name: 2.0mm Crescent Knife Angled Bevel Up Model/Catalog Number: QKN1010 Software Version: No software Product Description: This is an ophthalmic knife (manual) that is to be sterile and packaged individually in Tyhvek 1059B. The crescent knife is used to create sm2025-04-25
• Brand Name: Tecfen Medical Product Name: 3.2mm Slit Knife, Angled Model/Catalog Number: QKN3261 Software Version: No software Product Description: This is an ophthalmic knife (manual) that is to be sterile and packaged individually in Tyvek 1059B. Slit knives are used to create precise incisions for2025-04-25
• AcoSound. Model Number: LW12-BTE-M2025-04-25
• ABBOTT RAPID DX N AMERICA LLC MULTI ANALYTE LVL1&2250UL CHOLS CONTROL2025-04-24
• ABBOTT RAPID DX N AMERICA LLC, TEST CHOLESTEC LDXLIPID PROFILE (10/BX 50BX/CS) CASSETTES.2025-04-24
• ABBOTT RAPID DX N AMERICA LLC CHOLESTECH LDX LIPID PROFILE+GLUCOSE (10/BX 50BX/CS) TEST.2025-04-24
• HEMOCUE INC F/GLUCOSE 201 ANALYZER (25/VL 4VL/BX) MICROCUVETTE.2025-04-24
• BD MICROBIOLOGY FLUID THIOGLYCOLLATE MED TUBE 1004321196 (100/CT) MEDIA.2025-04-24
• BD MICROBIOLOGY MAC CONKEY II AGAR (100/CT) 21270 MEDIA.2025-04-24
• ABBOTT RAPID DX N AMERICA LLC HBA1C HEMOGLOBIN AFINION GLYCTD (15TST/BX) TEST KIT.2025-04-24
• ORTHO CLINICAL DIAGNOSTICS INC VITROS CALCIUM (L-SEQUESTER) (300/PK) REAGENT.2025-04-24
• ORTHO CLINICAL DIAGNOSTICS INC VITROS PHOSPHORUS (60/CR 5CR/PK) ORCLNL REAGENT.2025-04-24
• ORTHO CLINICAL DIAGNOSTICS INC VANCOMYCIN (300/BX)ORCLNL REAGENT.2025-04-24
• ORTHO CLINICAL DIAGNOSTICS INC FS(3PK/BX)ORCLNL DILUENT PACK 3.2025-04-24
• ORTHO CLINICAL DIAGNOSTICS INC TOTAL BILI-ALKP XT (L-SEQUESTER) (300/PK) REAGENT.2025-04-24
• ORTHO CLINICAL DIAGNOSTICS INC ANTI-B BIOCLONE 10ML3X10ML.2025-04-24
• ORTHO CLINICAL DIAGNOSTICS INC VITROS BUN (60/CR 5CR/PK) ORCLNL REAGENT.2025-04-24
• HEMOCUE INC HEMOTROL LOW 2X1ML LEVEL 1 HEMCUE CONTROL.2025-04-24
• HEMOCUE INC HEMOTROL HIGH 2X1ML LEVEL 3 HEMCUE CONTROL.2025-04-24
• ABBOTT DIAGNOSTICS ARC CARBON DIOXIDE6X5ML B CALIBRATOR.2025-04-24
• ABBOTT DIAGNOSTICS PROBE CONDITIONING F/ARCHITECT ANLYZ ABBDIA SOLUTION.2025-04-24
• ABBOTT DIAGNOSTICS ARCH AUSAB ANTI-HBS (100/EA) REAGENT.2025-04-24
• ABBOTT DIAGNOSTICS ARC ANTI-TPO ASSAY 100TST B REAGENT.2025-04-24
• ABBOTT DIAGNOSTICS ARC T-UPTAKE ASSAY (100TST/BX) ABBDIA REAGENT.2025-04-24
• ABBOTT DIAGNOSTICS ARCHITECT HIV COMBO 1X4ML CALIBRATOR.2025-04-24
• ABBOTT POINT OF CARE TEST CREA I-STAT (25/BX) ABBTPT CARTRIDGE.2025-04-24
• ABBOTT DIAGNOSTICS ARCHITECT HBSAG ASSAY(100TST/BX) BDS REAGENT.2025-04-24
• ABBOTT DIAGNOSTICS ARCHITECT VITAMIND 6LEVEL CALIBRATOR.2025-04-24
• ABBOTT DIAGNOSTICS ARCHITECT TOTAL T36X4ML CALIBRATOR.2025-04-24
• ABBOTT DIAGNOSTICS ARCHITECT FREE T4ABBDIA CALIBRATOR.2025-04-24
• ABBOTT DIAGNOSTICS ARCHITECT PROGESTERONE (100TESTS) REAGENT.2025-04-24
• ABBOTT DIAGNOSTICS ALINITY I FREE PSA US(200TEST/EA) REAGENT.2025-04-24
• ABBOTT DIAGNOSTICS ALINITY I ANTI-CCPS REAGENT.2025-04-24
• SEKISUI DIAGNOSTICS LLC SERUM HCG OSOMGENZME CONTROL SET.2025-04-24
• HEMOCUE INC GLUC AQUEOUS 1HI/LO HEMCUE CONTROL KIT.2025-04-24
• iBOT PMD with software version 01.05.24. Personal Mobility Device.2025-04-24
• Apo B Reagent, REF: OSR61432025-04-23
• Palindrome Precision Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter.2025-04-23
• Palindrome Precision HSI Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter.2025-04-23
• Palindrome Precision SI Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter.2025-04-23
• Palindrome Precision H Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter.2025-04-23
• MIRA SURGICAL SYSTEM, Table mounted miniaturized electromechanical surgical system, Catalog Number MIRA-CAP-110, Software Version 4.0.32025-04-23
• DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, running software version 1.202025-04-23
• DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, running software versions 1.202025-04-23
• Endopath Echelon Vascular White Reload for Advanced Placement Tip (35mm, 4 row); Product code VASECR352025-04-22
• Medline Kits containing Codman Disposable Perforator 14 mm: 1. CRANI ADD A PACK, SKU DYNJ30926O 2. CRANIOTOMY, SKU CDS983611N 3. CRANIOTOMY CDS, SKU CDS983467J 4. CRANIOTOMY PACK, SKU DYNJ85807A, DYNJ85927 5. MAJOR CRANIOTOMY PACK, SKU DYNJ82007A2025-04-22
• Medline Kits containing Codman Disposable Perforator 14 mm: CRANIOTOMY, SKU DYNJ35349C2025-04-22
• Medline Kits containing Codman Disposable Perforator 14 mm: 1. CRANI ACCESSORY PACK SKU DYNJ59270 2. CRANI PACK-LF SKU DYNJ44805M 3. CRANIOTOMY SKU CDS982719V CDS982719W DYNJ904168F DYNJ908404B DYNJ908723A DYNJ908723C 4. CRANIOTOMY #IMF 56646-LF SKU DYNJVB91001A 5. CRANIOTOMY CDS SKU CDS981888X CDS92025-04-22
• Brand Name: Catalyst+ Product Name: C4D software used in conjunction with Catalyst (SP001-0025), Catalyst HD (SP001-0026), Catalyst PT (SP001-0027), Catalyst X4 (SP002-0035), Catalyst+ (SP003-0001), Catalyst+ HD (SP003-0002), Catalyst+ PT (SP003-0008), Catalyst+ X4, (SPOO3-0009) Product Description:2025-04-22
• 3M Ranger Irrigation Fluid Warming Set, REF 247502025-04-22
• BIB Balloon in Balloon Dilatation Catheter. Model Number: 4202025-04-21
• LOWER EXTREMITY, Model: NCEX20I; LOWER EXTREMITY, Model: NCEX20J; TOTAL KNEE PACK, Model: NCTK31K; TOTAL KNEE PACK, Model: NCTK31L All convenience kits contain Specialist Blend Cast Padding, Item: QTX30-322NS2025-04-21
• Precision Sampling Set, REF: C20206 for use with the CoSense End-Tidal Carbon Monoxide Monitor2025-04-21
• WB XL Anatomic Healing Abutment XC. Endosseous Dental Implant Abutments.2025-04-17
• Bard Minnesota Four Lumen Esophagogastric Tamponade Tube, REF:0092220 18 Fr. (6mm, 7/32"), 41" Length (104cm) with 8" (20.3cm) Balloon X-Ray Opaque Rubber2025-04-17
• Bard Blakemore Esophageal-Nasogastric Tube (Adult) REF: 00921002025-04-17
• Bard¿ Blakemore Esophageal-Nasogastric Tube (Child) REF: 00921102025-04-17
• Bard¿ Blakemore Esophageal-Nasogastric Tube (Intermediate)REF: 00923002025-04-17
• Bard¿ Single Intragastric Linton Balloon Tube, REF: 00927402025-04-17
• Tornado Embolization Microcoil, intended for embolization of selective vessel supply to arteriovenous malformations and other vascular lesions, RPN MWCE-18S-3/2-TORNADO (GPN G08261), RPN MWCE-18S-3/2-TORNADO-081800 (GPN G13102), RPN MWCE-18S-4/2-TORNADO (GPN G08357)2025-04-17
• Tempus Pro Patient Monitor, REFs: 00-1004-R (Tempus Pro non-printer, IBP, without headset dock), 00-1007-R and 00-1007 (Tempus Pro non-printer, IBP, with headset dock), 00-1024-R (Tempus Pro printer), 00-1026-R (Tempus Pro printer, IBP), 00-1007 [(Tempus Pro, BT Dock (IB Only)], 00-1004 00-1004 [Tem2025-04-16
• Philips Tempus Pro Patient Monitor, REF: 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R, 00-1004, 00-10072025-04-15
• Atellica IM Homocysteine Calibrator (2 Pack). Siemens Material Number: 109954982025-04-15
• ADVIA Centaur HCY Calibrator (2 Pack). Siemens Material Number: 10310376.2025-04-15
• Plus Initial Drill, Article Number: 103.170;2025-04-14
• VITROS Chemistry Products CRP Slides. One sales unit contains 5 cartridges, of 18 slides per cartridge, for a total of 90 slides.2025-04-14
• Microtek Patient Drape ECOLAB AP6MMN Patient Drape, 6mm Adapter Plug Kit REF AP6MMN UDI code: (01)10748426139986 AP8MMN Patient Drape, 8mm Adapter Plug Kit REF AP8MMN UDI code: (01)10748426139429 These adapters function as accessories for a device or drape, serving to connect a drape's drain hose to2025-04-13
• CODMAN Disposable Perforator, 14mm. Cranial perforator.2025-04-11
• CODMAN Craniotomy Kit, Disposable Perforator Cranio-blade Wire Pass Drill, 14mm. Cranial perforator kit.2025-04-11
• iGo¿2 DC Car Adapter to be used with iGo¿2 Portable Oxygen Concentrator Systems. Power cord allows the user to operate the device in a vehicle.2025-04-11
• MedicaLyte Liquid Bicarbonate Concentrate. Model Numbers: BC+201 (45X), BC+100 36.83X. Plastic bottle packaged in corrugated shipper cases (4 bottles per shipper case).2025-04-11
• TufTex Over-the-Wire Embolectomy Catheter. All Catalog numbers: 1651-34, 1651-38, 1651-44, 1651-48, 1651-58, 1651-64, 1651-68, 1651-78, 1651-84, 1651-88, E1651-34, E1651-38, E1651-44, E1651-48, E1651-64, E1651-68, E1651-78, E1651-84, E1651-88, 1651-44J, 1651-48J, 1651-84J, 1651-88J.2025-04-11
• Pruitt Occlusion Catheter. Catalog Numbers: 2103-36, 2103-46, 2103-56, E2103-36, E2103-46, E2103-562025-04-11
• Pruitt Irrigation Occlusion Catheter. Catalog Numbers: 2102-09, E2102-09.2025-04-11
• CADD Solis HSPCA Pump ***Updated 5/27/26*** Scope updated to apply specifically to customers using the wireless system. Affected products associated with the change in scope: PUMP KIT, CADD SOLIS HPCA, MDL 2110, V4.3, ENGLISH, 1/EA 21-2111-0403-51 PUMP KIT, CADD SOLIS HPCA, MDL 2110, V4.3, TRIAL, LO2025-04-10
• CADD-Solis HPCA Ambulatory Infusion Pump; Model/Number: 21-2111-0402-09-KYO 21-2111-0402-09-KYO CADD SOLIS PIB PUMP FOR CLINICAL EVALUATION/DEMO PUMP 21-2111-0300-09_LOAN CADD SOLIS PIB PUMP FOR CLINICAL EVALUATION/DEMO PUMP FOR CMSA 21-2111-0300-09_CMSA CADD Solis PIB PUMP FOR CLINICAL EVALUATION/D2025-04-10
• CADD-Solis VIP Ambulatory Infusion Pump; Model/Number: 21-2120-0100-02 21-2120-0100-03 21-2120-0100-06 21-2120-0100-232 21-2120-0100-233 21-2120-0100-50 21-2120-0100-51 21-2120-0100-95 21-2120-0102-02 21-2120-0102-03 21-2120-0102-06 21-2120-0102-07 21-2120-0102-08 21-2120-0102-12 21-2120-0102-13 21-2025-04-10
• CADD-Solis Infusion Pump Models: 1) PUMP KIT, CADD-SOLIS, MDL 2110, V4.2, CE ENGLISH 1/EA, Model Number: 21-2111-0402-51; 2) PUMP KIT, CADD-SOLIS, MDL 2110, V4.2, YELLOW, CE ENGLISH 1/EA, Model Number: 21-2112-0402-51; 3) PUMP KIT, CADD-SOLIS, YELLOW, MODEL 2110 1/EA, Model Number: 21-2112-0100-51; 2025-04-10
• CADD Solis VIP Ambulatory Infusion Pump Models: 1) PUMP KIT, CADD-SOLIS VIP, MDL 2120, NA ENGLISH, MANUAL MODE, 1/EA, Model Number: 21-2127-0105-01; 2) PUMP KIT, CADD-SOLIS VIP, MDL 2120, NA ENGLISH, PHARMGUARD ENABLED, 1/EA, Model Number: 21-2120-0105-01; 3) PUMP KIT, CADD-SOLIS VIP, MDL 2120, NA E2025-04-10