Medical device recalls
38684 federal recalls on file. Federal recalls for medical devices — surgical equipment, monitors, diagnostic tools, implants, home health devices. Sourced from the FDA.
- 2024-09-04FDA-DeviceSmiths Medical ASD Inc.Class IPORTEX Bivona Tracheostomy Silicone Tube, labeled as: 2.5MM UNCUFFED NEONATAL FLEXTEND PLUS TRACHEOSTOMY TUBE W/NEO STRAIGHT STRAP, Product Code/List Number/Item Code 60NFPS25
Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of a manufacturing defect.
- 2024-09-04FDA-DeviceSmiths Medical ASD Inc.Class IPORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOSTOMY TUBE 2.5FLEXTEND PLUS , Product Code/List Number/Item Code 60NFP25; b) NEONATAL TRACHEOSTOMY TUBE 3.0FLEXTEND PLUS , Product Code/List Number/Item Code 60NFP30; c) NEONATAL TRACHEOSTOMY TUBE 3.5FLEXTEND PLUS , Product Code/List Number/Item Code 60NFP35; d) NEONATAL TRACHEOSTOMY TUBE 4.0FLEXTEND PLUS , Product Code/List Number/Item Code 60NFP40
Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of a manufacturing defect.
- 2024-09-04FDA-DeviceSmiths Medical ASD Inc.Class IPORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACH TUBE , Product Code/List Number/Item Code 60N030; b) NEONATAL TRACH TUBE , Product Code/List Number/Item Code 60N035; c) NEONATAL TRACH TUBE , Product Code/List Number/Item Code 60N040;
Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of a manufacturing defect.
- 2024-09-04FDA-DeviceSmiths Medical ASD Inc.Class IPORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60N025
Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of a manufacturing defect.
- 2024-09-04FDA-DeviceSmiths Medical ASD Inc.Class IPORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) AIRE-CUF TRACHY TUBE 6.0MM MID-RANGE , Product Code/List Number/Item Code 750160; b) AIRE-CUF TRACHY TUBE 7.0MM MID-RANGE , Product Code/List Number/Item Code 750170; c) AIRE-CUF TRACHY TUBE 8.0MM MID-RANGE , Product Code/List Number/Item Code 750180
Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of a manufacturing defect.
- 2024-09-04FDA-DeviceSmiths Medical ASD Inc.Class IPORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS TRACHEOSTOMY TUBE 7.0MM TIGHT TO SHAFT CUFF, Product Code/List Number/Item Code 670170; b) TTS TRACHEOSTOMY TUBE 8.0MM TIGHT TO SHAFT CUFF 1/EA, Product Code/List Number/Item Code 670180
Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of a manufacturing defect.
- 2024-08-28FDA-DeviceCovidienClass IICovideien McGRATH MAC Video Laryngoscope, REF: 301-000-000, Non-Sterile, RxOnly
IFU update to address device's battery handling information.
- 2024-08-28FDA-DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Class IIPhilips Allura Xper systems (R8.1 with Poly-G Stand) Interventional Fluoroscopic X-Ray System, Model Numbers 722010, 722012, 722013
A half-threaded bolt was included in the LTE kits instead of the correct full-threaded bolt.
- 2024-08-28FDA-DeviceNeuroLogica CorporationClass IIGM60A. Digital Diagnostic Mobile X-Ray System.
Potential for the anti-fall system of the device arm to fail.
- 2024-08-28FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IIMedline medical procedure kits labeled as follows: a) ARTHROSCOPY, REF DYNJ909699; b) BACK CDS, REF CDS984000C; c) EXTREMITY, REF DYNJ900847A; d) HAND-LF, REF DYNJ902619G; e) HIP PINNING CDS, REF CDS984009C; f) HIP PINNING/TFN/ANTERIOR HIP, REF DYNJ902380K; g) KNEE, REF DYNJ904771B; h) KNEE ARTHROSCOPY, REF DYNJ905519D; i) KNEE ARTHROSCOPY, REF DYNJ906273F; j) KNEE ARTHROSCOPY, REF DYNJ909747; k) KNEE ARTHROSCOPY V, REF DYNJS2029D; l) LAMINECTOMY, REF DYNJ907159A; m) L
A slight dimensional variation which has the potential for increased difficulty fitting into outer canister.
- 2024-08-28FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IIMedline medical procedure kits labeled as follows: a) C-SECTION CDS, REF CDS983998C
A slight dimensional variation which has the potential for increased difficulty fitting into outer canister.
- 2024-08-28FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IIMedline medical procedure kits labeled as follows: a) GYN CDS, REF DYNJ905499B; b) GYN LAP, REF DYNJ909936; c) GYN LAPAROSCOPY, REF DYNJ902371J; d) GYN LAPAROSCOPY, REF DYNJ905509F; e) GYN LAPAROSCOPY II, REF DYNJS2030F; f) LAP ROBOTIC, REF DYNJ902384K; g) LAPAROSCOPY-ROBOT, REF DYNJ905003C; h) ROBOTIC, REF DYNJ907156A
A slight dimensional variation which has the potential for increased difficulty fitting into outer canister.
- 2024-08-28FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IIMedline medical procedure kits labeled as follows: a) BASIC NEURO, REF DYNJ909171A; b) NEURO, REF DYNJ905510D; c) NEURO, REF DYNJ902388L; d) NEURO SAS, REF DYNJ908566
A slight dimensional variation which has the potential for increased difficulty fitting into outer canister.
- 2024-08-28FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IIMedline medical procedure kits labeled as follows: a) TURNOVER KIT, REF DYKC1289F
A slight dimensional variation which has the potential for increased difficulty fitting into outer canister.
- 2024-08-28FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IIMedline medical procedure kits labeled as follows: a) KIT CANISTER SUCT W 12FT, REF DYKM2169
A slight dimensional variation which has the potential for increased difficulty fitting into outer canister.
- 2024-08-28FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IIMedline medical procedure kits labeled as follows: a) AAA CDS, REF CDS984011C; b) CAN KIT, REF DYKM1184; c) DENTAL CDS, REF CDS984010B; d) EGD KIT, REF DYK1253578F; e) EGD REG KIT, REF DYKE1830; f) ENDO KIT, REF DYKE1516A; g) ERCP REG KIT, REF DYKM2127; h) GI PACK, REF DYKE1898; i) KIT, PEG, REG, REF DYKM2128; j) KIT,1500CC, 50CS, REF DYKM2126; k) LITHOTOMY, REF DYNJ909937; l) MAJOR BASIC, REF DYNJ909703; m) MINOR GENERAL SURGERY, REF DYNJ909940; n) SUCTION SET UP
A slight dimensional variation which has the potential for increased difficulty fitting into outer canister.
- 2024-08-28FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IIMedline medical procedure kits labeled as follows: a) MAJOR BREAST, REF DYNJ905004C; b) MINOR BREAST, REF DYNJ905002B; c) SUCTION MEDI VAC, REF DYKM2033
A slight dimensional variation which has the potential for increased difficulty fitting into outer canister.
- 2024-08-28FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IIMedline medical procedure kits labeled as follows: a) ENDO KIT, REF DYKE1410A
A slight dimensional variation which has the potential for increased difficulty fitting into outer canister.
- 2024-08-28FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IIMedline medical procedure kits labeled as follows: a) ENDO KIT, REF DYK1012268E1
A slight dimensional variation which has the potential for increased difficulty fitting into outer canister.
- 2024-08-28FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IIMedline medical procedure kits labeled as follows: a) CYSTO, REF DYNJ905000D; b) ENDO KIT, REF DYKE1462A; c) ENDOSCOPY KIT, REF DYKE1431B; d) ENDOSCOPY KIT, REF DYKE1623B; e) GENERAL LAPAROSCOPY, REF DYNJ902385I; f) GENERAL LAPAROSCOPY, REF DYNJ905508G; g) GENERAL LAPAROSCOPY V, REF DYNJS2032D; h) LAP APPY, REF DYNJ902383I; i) LAP CHOLE, REF DYNJ9062767D; j) LAP CHOLE, REF DYNJ907187A; k) MAJOR, REF DYNJ904768B; l) MAJOR, REF DYNJ905520F; m) MAJOR, REF DYNJ907154A; n
A slight dimensional variation which has the potential for increased difficulty fitting into outer canister.
- 2024-08-28FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IIMedline medical procedure kits labeled as follows: a) BASIC NASAL, REF DYNJ909932; b) BRONCH KIT, REF DYKE1007B; c) ENT, REF DYNJ909935; d) NASAL SINUS-LF, REF DYNJ902624G; e) ORAL, REF DYNJ902377I; f) PACK,BRONCHOSCOPY, REF DYNJ65475B; g) PACK,HEAD AND NECK, REF DYNJ65487B; h) PACK,SINUS, REF DYNJ906898; i) PACK,T & A, REF DYNJ906897B; j) PACK,T & A ASC, REF DYNJ906914; k) T AND A, REF DYNJ909941
A slight dimensional variation which has the potential for increased difficulty fitting into outer canister.
- 2024-08-28FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IIMedline medical procedure kits labeled as follows: DENTAL, REF DYNJ909211A
A slight dimensional variation which has the potential for increased difficulty fitting into outer canister.
- 2024-08-28FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IIMedline medical procedure kits labeled as follows: a) HEART ANESTHESIA SET UP, REF DYNJ902752C, b) KIT ENDO, REF DYKE1872A, c) LOWER ENDO KIT, REF DYKE1921A, d) PACEMAKER, REF DYNJ901681D, e) UPPER ENDO KIT, REF DYKE1922A, f) VASCULAR, REF DYNJ905515D, g) VASCUALR, REF DYNJ902387K, h) VASCULAR III, REF DYNJS2035C
A slight dimensional variation which has the potential for increased difficulty fitting into outer canister.
- 2024-08-28FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IIMedline medical procedure kits labeled as follows: a) ANESTHESIA CIRCUIT ADULT, REF DYNJAAF6666B; b) ANESTHESIA CIRCUIT PEDS-LF, REF DYNJAP9918A; c) CV ANESTHESIA - ROOM SET UP, REF DYNJ905503F
A slight dimensional variation which has the potential for increased difficulty fitting into outer canister.
- 2024-08-28FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass II1,5L MED-SOFT SINGLE LINER WITH SOLIDIFIER, REF OR1920PG
A slight dimensional variation which has the potential for increased difficulty fitting into outer canister.
- 2024-08-28FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass II1,5L MED-SOFT LINER W/ 6MMX3M TUB. & ADULT VC, REF OR53929
A slight dimensional variation which has the potential for increased difficulty fitting into outer canister.
- 2024-08-28FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass II1,5L MED-SOFT LINER W/ 6MMX1,8M TUB. & ADULT VC, REF OR53926
A slight dimensional variation which has the potential for increased difficulty fitting into outer canister.
- 2024-08-28FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass II1500ML SOFT LINER, 1/4X6 TBG NS, REF OR926K
A slight dimensional variation which has the potential for increased difficulty fitting into outer canister.
- 2024-08-28FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IILINER, SOFT, SUCTION CANISTER, 1500CC, REF OR929K
A slight dimensional variation which has the potential for increased difficulty fitting into outer canister.
- 2024-08-28FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IILINER, SOFT, SUCTION CANISTER, 1500CC, REF DYNDSCL1500
A slight dimensional variation which has the potential for increased difficulty fitting into outer canister.
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