FDA (Device enforcement)

11,102 recalls · page 10 of 112

• Brand Name: DONJOY Product Name: ICEMAN W/,UNIV,LOOP,NS,RH Model/Catalog Number: 11-1422 Software Version: no Product Description: 11-1422 - ICEMAN W/,UNIV,LOOP,NS,RH The IceMan CLASSIC3¿ cold therapy unit helps reduce pain and swelling, speeding up rehabilitation. The IceMan¿ helps provide extended2026-03-19
• Brand Name: DONJOY Product Name: ICEMAN W/,UNIV,LOOP,NS,EH Model/Catalog Number: 11-1424 Software Version: No Product Description: 11-1424 - ICEMAN W/,UNIV,LOOP,NS,EH The IceMan CLASSIC3¿ cold therapy unit helps reduce pain and swelling, speeding up rehabilitation. The IceMan¿ helps provide extended2026-03-19
• Brand Name: DONJOY Product Name: ICEMAN, W/COLDPAD, NS, RH Model/Catalog Number: 11-9099 Software Version: No Product Description: 11-9099 - ICEMAN, W/COLDPAD, NS, RH The IceMan CLASSIC3¿ cold therapy unit helps reduce pain and swelling, speeding up rehabilitation. The IceMan¿ helps provide extended2026-03-19
• Diversatek Healthcare Viper¿ 3-Stage Wire Guided Balloon Dilator, 18mm-19mm-20mm, REF 1205-202026-03-18
• Dimension Creatinine Flex reagent cartridge. Material Number: 10872079.2026-03-18
• Custom Abutment Ti, for Straumann RC, incl. TAN screw; Catalog Number/Art.: 027.4620;2026-03-17
• Custom Abutment AS Ti, for Straumann RC, incl. TAN screw; Catalog Number/Art.: 010.5438;2026-03-17
• Access Total T4 Calibrator, Catalog No. 338052026-03-16
• Centurion medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as: Universal Central/Art Line Insertion Kit, Medline Kit SKU ART155A2026-03-16
• Medline medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as: 1. BLOOD CULTURE KIT, Medline Kit SKU DYNDH1520; 2. BLOOD DRAW KIT, Medline Kit SKU EBSI1317.2026-03-16
• Medline and Centurion medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as: 1. FOLEY CARE KIT, Medline Kit SKU UROT1044; 2. IV START KIT WITH EXTENSION TUBING, Medline Kit SKU IV8770; 3. IV START KIT, Medline Kit SKU DYNDV2520; 4. ARTERIAL LINE BUNDLE, Medline Kit SKU ART22026-03-16
• Centurion medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as: LATEX FREE GENERAL PURPOSE TRAY, Medline Kit SKU 756702026-03-16
• Medline or Centurion medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as: 1. NEONATAL IV START KIT (Centurion), Medline Kit SKU IV8310E; 2. IV SECUREMENT KIT (Centurion), Medline Kit SKU IVS1700; 3. IV START KIT (Centurion), Medline Kit SKU IV8675; 4. NEONATAL IV SECUREME2026-03-16
• Centurion medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as: DERMATOLOGY SHAVE KIT, Medline Kit SKU SK3952026-03-16
• Medline and Centurion medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as: 1. LVAD DRIVELINE KIT (Centurion), Medline Kit SKU DT17360 (Centurion); 2. LONG TERM/INPATIENT IV SECUREMENT SET (Centurion), Medline Kit SKU IVS1975A; 3. CVC DRESSING CHANGE TRAY (Centurion), Medl2026-03-16
• TRIGEN PROXIMAL STRAIGHT HUMERAL NAIL 8/7 X 16, REF: 717608162026-03-16
• (1)(2) LeadCare¿ II Blood Lead Test Kit, (3)LeadCare¿ II 5X Blood Lead Test Kit, (4)LeadCare¿ II 9X Blood Lead Test Kit ; Catalog Number(s): (1) 70-6762, (2) 70-6762RUO, (3) 70-8404 (Box containing 5 Test Kits), (4) 70-9000 (Box containing 9 test kits); The LeadCare II kit is provided with the follo2026-03-13
• LeadCare¿ Plus Blood Lead Test Kit; Catalog Number: 82-0004; The LeadCare¿ Plus kit is provided with the following materials: " Sensors (4 containers of 24 each; 96 tests) " Treatment Reagent Tubes (4 packages of 24 each; 96 tests) " Calibration Button (1 @) " Lead Control Level 1 (1 @ 2 mL) " Lead 2026-03-13
• LeadCare Ultra Blood Lead Test Kit; Catalog Number: 70-8098; The LeadCare Ultra kit is provided with the following materials: " Sensors (8 containers of 24 each; 192 tests) " Treatment Reagent Tubes (8 containers of 24 each; 192 tests) " Calibration Button (1 @) " Lead Control Level 1 (1 @ 2 mL) " L2026-03-13
• Halyard CARDIAC CATH PACK kit. Model Number: EAMC1000-05, WAFB208-02.2026-03-13
• Halyard CARDIAC CATH TRAY SHANDS JAX kit. Model Number: SHND401-04, SHND401-05.2026-03-13
• Halyard CATH LAB kit. Model Number: SACL75-01.2026-03-13
• Halyard HEART CATH, SELF REGIONAL kit. Model Number: SELF131-05.2026-03-13
• Halyard NEURO IR PERIPHERAL (PS 64405) kit. Model Number: UINR44-01.2026-03-13
• Halyard PERC TRAY kit. Model Numbers: SLPC34-01, SLPC34-02.2026-03-13
• Halyard SAMMC ANGIOGRAPHY kit. Model Numbers: SAMM066-15.2026-03-13
• B¿R¿A¿H¿M¿S KRYPTOR compact REACT, REF: 89986, used with B¿R¿A¿H¿M¿S PlGF Plus KRYPTOR, REF: 859075N, and run on the B¿R¿A¿H¿M¿S KRYPTOR compact PLUS analyzers. in vitro diagnostic test for Placental Growth Factor2026-03-12
• Omnipod 5 Pods. Model/Catalog number: PT-001662 ASM 5PK Pod STRL OPS G6G72026-03-12
• Stryker Sustainability Solution Color Cuff 24" (Yellow) Quick Connect Dual Port Single Bladder REF 5921-024-235 Stryker Sustainability Solution Color Cuff 18" (Red), Quick Connect Dual Port Single Bladder REF 5921-018-135 Stryker Sustainability Solution Color Cuff 18" (Red) Dual Port Single Bladder 2026-03-12
• ARTIS Pheno VE30A and VE40A, Model 108490002026-03-12
• Intuitive 8 mm SureForm 30 Gray Reloads Reference Numbers: 48230M-05 and 48230M-062026-03-11
• ARROW RADIAL ARTERY CATHETERIZATION KIT REF ASK-04220-UCL1 UDI code: (01)10801902159127(17)270331(11)251203(10)33F25J0352 REF ASK-04020-EUH2 UDI code: (01)10801902213379(17)270731(11)251218(10)33F25J0869 REF ASK-04020-FMC UDI code: (01)10801902212099(17)270731(11)251218(10)33F25J0870 REF ASK-04020-M2026-03-11
• ARROW, ARROWG+ARD AND ARROWG+ARD BLUE PLUS PRESSURE INJECTABLE CENTRAL VENOUS CATHETER REF ASK-42802-PLH UDI code: (01)10801902133110(17)261231(11)251211(10)33F25L0140 REF ASK-45703-MGH UDI code: (01)10801902223675(17)261231(11)251209(10)33F25L0143 REF ASK-42854-MGH UDI code: (01)10801902223668(17)22026-03-11
• Pressure Injectable Arrowg+ard Blue Plus¿ Four-Lumen CVC Kit REF ASK-45854-PUPM1 UDI code: (01)10801902159578(17)270531(11)251205(10)33F25M0011 The Arrowg+ard technology is intended to provide protection against catheter-related bloodstream infections (CRBSIs). It is not intended to be used as a tre2026-03-11
• Medtronic Sphere-9 Catheter, Model Number AFR-00001; catheter, percutaneous, cardiac ablation, for treatment of atrial flutter.2026-03-11
• ARTIS pheno and ARTIS Icono biplane, floor and ceiling. Model Numbers 10849000, 11327600, 11328100, 11327700.2026-03-10
• Arjo Tenor mobile passive patient lift, Model Numbers KHA1000 US and KHA1010 US2026-03-10
• nanOss 3D Advanced Bone Graft Substitute nanOss 3D Plus Advanced Bone Graft Substitute 90-300-251008: nanOss 3D Advanced Bone Graft Substitute, 25x100x8mm, 20cc 90-300-25508: nanOss 3D Advanced Bone Graft Substitute, 25x50x8mm, 10cc 90-300-251004: nanOss 3D Advanced Bone Graft Substitute, 25x100x4mm2026-03-09
• LSL Healthcare, Standard Central Line Dressing Change Kit, Model/Catalog Number: 2717J2026-03-09
• Brand Name: Kiwi Omni Vacuum Delivery System Product Name: Kiwi Omni Vacuum Delivery System Model/Catalog Number: VAC-6000MT Product Description: The Clinical Innovations Kiwi is a disposable vacuum assisted fetal delivery system. It is a sterile, single-patient-use device designed to provide assist2026-03-09
• ARTIS Icono biplane, floor and ceiling.: ARTIS icono biplane Model 11327600. ARTIS icono ceiling Model 11328100. ARTIS icono floor Model 11327700. interventional fluoroscopic x-ray system2026-03-09
• Philips Spectral CT on Rails. Model Number: 728334.2026-03-07
• CUSA Clarity C7000 Console, Software Version: 2.1.1.909. Ultrasonic surgical aspirator system.2026-03-06
• Vue Motion V12. Product Number: 1017979.2026-03-05
• Tornier HRS Max parts: 1. TORNIER HRS Max Tuberosity Body Lat Coat, Small, Cat. No. ARS1041101 2. TORNIER HRS Max Tuberosity Body No Coat, Small, Cat. No. ARS1041102 3. TORNIER HRS Max Trial, Cat. No. ARS102522026-03-05
• COOK MEDICAL Approach CTO-12 Micro Wire Guide: Reference Part Number CMW-14-190-12G, Order Number G50787; Reference Part Number CMW-14-300-12G, Order Number G507912026-03-05
• COOK MEDICAL Approach CTO-18 Micro Wire Guide, Reference Part Number CMW-14-190-18G, Order Number G50788; Reference Part Number CMW-14-300-18G, Order Number G507922026-03-05
• COOK MEDICAL Arterial Pressure Monitoring Tray, Reference Part Number APMY-2.5-15-0-2.5 , Order Number G58412; Reference Part Number APMY-4.0-21J-1-12, Order Number G584192026-03-05
• COOK MEDICAL Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set: Reference Part Number C-PTIS-100-HC-G-EU, Order Number G57685; Reference Part Number C-PTIS-100-HC-G-NA, Order Number G57682; Reference Part Number C-PTIS-100-UNL-HC-G-EU, Order Number G57687; Reference Part Number C-PTIS-1002026-03-05
• COOK MEDICAL Blue Rhino¿ G2-Multi Percutaneous Tracheostomy Introducer Tray: Reference Part Number C-PTISY-100-HC-G-NA, Order Number G57703; Reference Part Number C-PTISY-100-UNL-HC-G-NA, Order Number G57706; Reference Part Number C-PTISY-100-UNS-HC-G-NA, Order Number G57704.2026-03-05
• COOK MEDICAL Ciaglia Blue Rhino Percutaneous Tracheostomy Introducer Set: Reference Part Number C-PTIS-100-FLEX-HC, Order Number G32092; Reference Part Number C-PTIS-100-HC, Order Number G12115.2026-03-05
• COOK MEDICAL Cook¿ Spectrum¿ Central Venous Catheter Tray: Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0003, Order Number G56424; Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0018, Order Number G21053; Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0042, Order Number G34914; Reference Part Numb2026-03-05
• COOK MEDICAL Cook¿ Strange Bile Duct Stone Exploration Set: Reference Part Number C-CSRC-7.5D-40-STRANGE, Order Number G091082026-03-05
• Melker Universal Cuffed Emergency Cricothyrotomy Catheter Set: Reference Part Number C-TCCSB-500-UNI, Order Number G32193; Reference Part Number C-TCCSB-500-UNI-01, Order Number G47665.2026-03-05
• COOK MEDICAL Multipurpose Drainage Catheter: Reference Part Number ULT8.5-38-25-P-CLMS-8-RH-FS, Order Number G297752026-03-05
• COOK MEDICAL NCompass¿ Nitinol Stone Extractor: Reference Part Number C-NTSE-2.4-115-NC3, Order Number G36250; Reference Part Number C-NTSE-2.4-115-NCT4, Order Number G36251.2026-03-05
• COOK MEDICAL Spectrum¿ Central Venous Catheter Set: Reference Part Number C-UDLM-401J-ABRM-HC, Order Number G43983; Reference Part Number C-UDLM-401J-ABRM-HC-CAH, Order Number G24754; Reference Part Number C-UDLM-401J-LSC-ABRM-HC, Order Number G43986; Reference Part Number C-UDLM-401J-PED-ABRM-HC, O2026-03-05
• COOK MEDICAL Spectrum¿ Central Venous Tray: Reference Part Number C-UQLMYJ-1001J-RSC-ABRM-HC-FST-A-RD, Order Number G44800; Reference Part Number C-UTLMYJ-701J-ABRM-HC-IHI-FST-A-RD, Order Number G44809; Reference Part Number C-UTLMYJ-701J-RSC-ABRM-HC-FST-A-RD, Order Number G44806; Reference Part Num2026-03-05
• COOK MEDICAL Thal-Quick Chest Tube Tray: Reference Part Number C-TQTSY-3200, Order Number G072422026-03-05
• COOK MEDICAL Wayne Pneumothorax Set: Reference Part Number C-UTPT-1020-WAYNE-IMH, Order Number G56532; Reference Part Number C-UTPT-1400-WAYNE-112497-IMH, Order Number G56535.2026-03-05
• COOK MEDICAL Wayne Pneumothorax Tray: Reference Part Number C-UTPTY-1400-WAYNE-112497-IMH, Order Number G56537; Reference Part Number C-UTPTY-1400-WAYNE-112497-IMH, Order Number G56537; Reference Part Number C-UTPTY-1400-WAYNE-112497-IMH, Order Number G56537; Reference Part Number C-UTPTY-1400-WAYNE2026-03-05
• ALLURA Xper FD10; System Code: (1) 722003, (2)722010, (3)722026;2026-03-03
• ALLURA Xper FD10/10; System Code: (1) 722005, (2)722011, (3)722027;2026-03-03
• ALLURA Xper FD20; System Code: (1) 722006, (2)722012, (3)722028;2026-03-03
• ALLURA Xper FD20 Biplane; System Code: (1) 722008, (2)722013;2026-03-03
• ALLURA Xper FD20 OR Table; System Code: (1) 722015, (2)722023, (3)722035;2026-03-03
• ALLURA Xper FD20 Biplane OR Table; System Code: (1) 722020, (2)722025;2026-03-03
• ALLURA Xper FD10 OR Table; System Code: (1) 722022, (2)722033;2026-03-03
• Allura Xper FD20/10; System Code: 722029;2026-03-03
• Allura Xper FD20/20; System Code: 722038;2026-03-03
• Allura Xper FD20/20 OR Table; System Code: 722039;2026-03-03
• Allura Xper FD20/15; System Code: 722058;2026-03-03
• Allura Xper FD20/15 OR Table; System Code: 722059;2026-03-03
• Azurion 3 M12; System Code: (1)722063, (2)722221, (3)722229;2026-03-03
• Azurion 3 M15; System Code: (1)722064, (2)722222, (3)722230, (4)722280 (OUS Only);2026-03-03
• Azurion 7 B12; System Code: (1)722067, (2)722225, (3)722235;2026-03-03
• Azurion 7 B20; System Code: (1)722068, (2)722226, (3)722236;2026-03-03
• Azurion 7 M12; System Code: (1)722078, (2)722223, (3)722233;2026-03-03
• Azurion 7 M20; System Code: (1)722079, (2)722224, (3)722234, (4)722282 (OUS only);2026-03-03
• Azurion 5 M12; System Code: (1)722227, (2)722231;2026-03-03
• Azurion 5 M20; System Code: (1)722228, (2)722232, (3) 722281 (OUS only);2026-03-03
• Instinct Plus Endoscopic Clipping Device REF: G58010 Rx Only, Sterile EO2026-03-03
• Soft-Vu Angiographic Catheter, Pigtail, Non-Braided; SOFT-VU PT 4F X 100CM 035 NB 10SH; Catalog No.: 10707103; Product/UPN No.: H787107071035 (Box), H787107071030 (Pouch); Box Quantity: 10;2026-03-03
• Soft -Vu Angiographic Catheter, Kumpe, Non-Braided; SOFT-VU KMP 4F X 40CM 038 NB 0SH; Catalog No.: 10710013; Product/UPN No.: H787107100135 (Box), H787107100130 (Pouch); Box Quantity: 5 pouches;2026-03-03
• Soft-Vu Angiographic Catheter, Omni Flush, Non-Braided; SOFT-VU OF 4F X 65CM 038 NB 6SH; Catalog No.: 10714001; Product/UPN No.: H787107140015 (Box), H787107140010 (Pouch); Box Quantity: 10 pouches;2026-03-03
• Soft-Vu Angiographic Catheter, Pigtail, Non-Braided; SOFT-VU PT 4F X 65CM 038 NB 10SH; Catalog No.: 10714002; Product/UPN No.: H787107140025 (Box), H787107140020 (Pouch); Box Quantity: 10 pouches;2026-03-03
• Soft-Vu Angiographic Catheter, Berenstein, Non-Braided; SOFT-VU BER 4F X 65CM 038 NB 0SH; Catalog No.: 10714009; Product/UPN No.: H787107140095 (Box), H787107140090 (Pouch); Box Quantity: 5 pouches;2026-03-03
• Soft-Vu Angiographic Catheter, Cobra (2), Non-Braided; SOFT-VU CB2 4F X 65CM 038 NB 0SH; Catalog No.: 10714011; Product/UPN No.: H787107140115 (Box), H787107140110 (Pouch); Box Quantity: 5 pouches;2026-03-03
• Soft-Vu Angiographic Catheter, Kumpe, Non-Braided; SOFT-VU KMP 4F X 65CM 038 NB 0SH; Catalog No.: 10714014; Product/UPN No.: H787107140145 (Box), H787107140140 (Pouch); Box Quantity: 5 pouches;2026-03-03
• Soft-Vu Angiographic Catheter, Berenstein, Non-Braided; SOFT-VU BER 4F X 100CM 038 NB 0SH; Catalog No.: 10714016; Product/UPN No.: H787107140165 (Box), H787107140160 (Pouch); Box Quantity: 5 pouches;2026-03-03
• Soft-Vu Angiographic Catheter, Cobra (1), Non-Braided; SOFT-VU CB1 4F X 100CM 038 NB 0SH; Catalog No.: 10714017; Product/UPN No.: H787107140175 (Box), H787107140170 (Pouch); Box Quantity: 5 pouches;2026-03-03
• Soft-Vu Angiographic Catheter, Cobra (2), Non-Braided; SOFT-VU CB2 4F X 100CM 038 NB 0SH; Catalog No.: 10714018; Product/UPN No.: H787107140185 (Box), H787107140180 (Pouch); Box Quantity: 5 pouches;2026-03-03
• Soft-Vu Angiographic Catheter, Kumpe, Non-Braided; SOFT-VU KMP 4F X 100CM 038 NB 0SH; Catalog No.: 10714021; Product/UPN No.: H787107140215 (Box), H787107140210 (Pouch); Box Quantity: 5 pouches;2026-03-03
• Soft-Vu Angiographic Catheter, Sos Omni Selective (1), Non-Braided; SOFT-VU SO1 4F X 80CM 038 NB 0SH; Catalog No.: 10714024; Product/UPN No.: H787107140245 (Box), H787107140240 (Pouch); Box Quantity: 5 pouches;2026-03-03
• Soft-Vu Angiographic Catheter, Headhunter (1), Non-Braided; SOFT-VU HH1 4F X 100CM 038 NB 0SH; Catalog No.: 10714040; Product/UPN No.: H787107140405 (Box), H787107140400 (Pouch); Box Quantity: 5 pouches;2026-03-03
• Soft-Vu Angiographic Catheter, Straight Art, Non-Braided; SOFT-VU STR ART 4F X 65CM 035 NB 0SH; Catalog No.: 10731401; Product/UPN No.: H787107314015 (Box), H787107314010 (Pouch); Box Quantity: 5 pouches;2026-03-03
• Soft-Vu Angiographic Catheter, Omni Flush, Non-Braided; SOFT-VU OF 4F X 65CM 035 NB 6SH; Catalog No.: 10732301; Product/UPN No.: H787107323015 (Box), H787107323010 (Pouch); Box Quantity: 10 units;2026-03-03
• Soft-Vu Angiographic Catheter, Kumpe, Non-Braided; SOFT-VU KMP 4F X 40CM 035 NB 0SH; Catalog No.: 10734301; Product/UPN No.: H787107343015 (Box), H787107343010 (Pouch); Box Quantity: 5 pouches;2026-03-03
• AccuVu Angiographic Catheter, Omni Flush, Non-Braided, With 2 R/O Markers; ACCU-VU OF 4F X 70CM 035 NB 6SH 2 R/O 2CM; Catalog No.: 13709005; Product/UPN No.: H787137090055 (Box), H787137090050 (Pouch); Box Quantity: 5 pouches;2026-03-03
• AccuVu Angiographic Catheter, Straight Flush, Non-Braided, With 10 R/O Markers; ACCU-VU STR FL 4F X 100CM 035 NB 6SH 10 R/O 6@1CM 4@5CM; Catalog No.: 13709604; Product/UPN No.: H787137096045 (Box), H787137096040 (Pouch); Box Quantity: 5 pouches;2026-03-03