September 4, 2024Medical DevicesFDA
Smiths Medical ASD Inc. recalls PORTEX Bivona Tracheostomy Silicone Tube, labeled as: 2.5MM UNCUFFED NEONATAL FLEXTEND PLUS TRACHEOSTOMY TUBE W/NEO S
Hazard: 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.
September 4, 2024Medical DevicesFDA
Smiths Medical ASD Inc. recalls PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOSTOMY TUBE 2.5FLEXTEND PLUS , Product Code/L
Hazard: 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.
September 4, 2024Medical DevicesFDA
Smiths Medical ASD Inc. recalls PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACH TUBE , Product Code/List Number/Item Code 60N
Hazard: 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.
September 4, 2024Medical DevicesFDA
Smiths Medical ASD Inc. recalls PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item C
Hazard: 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.
September 4, 2024Medical DevicesFDA
Smiths Medical ASD Inc. recalls PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) AIRE-CUF TRACHY TUBE 6.0MM MID-RANGE , Product Code/List Num
Hazard: 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.
September 4, 2024Medical DevicesFDA
Smiths Medical ASD Inc. recalls PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS TRACHEOSTOMY TUBE 7.0MM TIGHT TO SHAFT CUFF, Product Cod
Hazard: 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.
August 28, 2024Medical DevicesFDA
Covidien recalls Covideien McGRATH MAC Video Laryngoscope, REF: 301-000-000, Non-Sterile, RxOnly
Hazard: IFU update to address device's battery handling information.
August 28, 2024Medical DevicesFDA
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Philips Allura Xper systems (R8.1 with Poly-G Stand) Interventional Fluoroscopic X-Ray System, Model Numbers 722010, 722
Hazard: A half-threaded bolt was included in the LTE kits instead of the correct full-threaded bolt.
August 28, 2024Medical DevicesFDA
NeuroLogica Corporation recalls GM60A. Digital Diagnostic Mobile X-Ray System.
Hazard: Potential for the anti-fall system of the device arm to fail.
August 28, 2024Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls Medline medical procedure kits labeled as follows: a) ARTHROSCOPY, REF DYNJ909699; b) BACK CDS, REF CDS984000C; c
Hazard: A slight dimensional variation which has the potential for increased difficulty fitting into outer canister.
August 28, 2024Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls Medline medical procedure kits labeled as follows: a) C-SECTION CDS, REF CDS983998C
Hazard: A slight dimensional variation which has the potential for increased difficulty fitting into outer canister.
August 28, 2024Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls Medline medical procedure kits labeled as follows: a) GYN CDS, REF DYNJ905499B; b) GYN LAP, REF DYNJ909936; c) GY
Hazard: A slight dimensional variation which has the potential for increased difficulty fitting into outer canister.
August 28, 2024Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls Medline medical procedure kits labeled as follows: a) BASIC NEURO, REF DYNJ909171A; b) NEURO, REF DYNJ905510D; c)
Hazard: A slight dimensional variation which has the potential for increased difficulty fitting into outer canister.
August 28, 2024Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls Medline medical procedure kits labeled as follows: a) TURNOVER KIT, REF DYKC1289F
Hazard: A slight dimensional variation which has the potential for increased difficulty fitting into outer canister.
August 28, 2024Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls Medline medical procedure kits labeled as follows: a) KIT CANISTER SUCT W 12FT, REF DYKM2169
Hazard: A slight dimensional variation which has the potential for increased difficulty fitting into outer canister.
August 28, 2024Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls Medline medical procedure kits labeled as follows: a) AAA CDS, REF CDS984011C; b) CAN KIT, REF DYKM1184; c) DENTA
Hazard: A slight dimensional variation which has the potential for increased difficulty fitting into outer canister.
August 28, 2024Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls Medline medical procedure kits labeled as follows: a) MAJOR BREAST, REF DYNJ905004C; b) MINOR BREAST, REF DYNJ90500
Hazard: A slight dimensional variation which has the potential for increased difficulty fitting into outer canister.
August 28, 2024Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls Medline medical procedure kits labeled as follows: a) ENDO KIT, REF DYKE1410A
Hazard: A slight dimensional variation which has the potential for increased difficulty fitting into outer canister.
August 28, 2024Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls Medline medical procedure kits labeled as follows: a) ENDO KIT, REF DYK1012268E1
Hazard: A slight dimensional variation which has the potential for increased difficulty fitting into outer canister.
August 28, 2024Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls Medline medical procedure kits labeled as follows: a) CYSTO, REF DYNJ905000D; b) ENDO KIT, REF DYKE1462A; c) ENDO
Hazard: A slight dimensional variation which has the potential for increased difficulty fitting into outer canister.
August 28, 2024Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls Medline medical procedure kits labeled as follows: a) BASIC NASAL, REF DYNJ909932; b) BRONCH KIT, REF DYKE1007B;
Hazard: A slight dimensional variation which has the potential for increased difficulty fitting into outer canister.
August 28, 2024Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls Medline medical procedure kits labeled as follows: DENTAL, REF DYNJ909211A
Hazard: A slight dimensional variation which has the potential for increased difficulty fitting into outer canister.
August 28, 2024Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls Medline medical procedure kits labeled as follows: a) HEART ANESTHESIA SET UP, REF DYNJ902752C, b) KIT ENDO, REF DY
Hazard: A slight dimensional variation which has the potential for increased difficulty fitting into outer canister.
August 28, 2024Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls Medline medical procedure kits labeled as follows: a) ANESTHESIA CIRCUIT ADULT, REF DYNJAAF6666B; b) ANESTHESIA CIR
Hazard: A slight dimensional variation which has the potential for increased difficulty fitting into outer canister.
August 28, 2024Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls 1,5L MED-SOFT SINGLE LINER WITH SOLIDIFIER, REF OR1920PG
Hazard: A slight dimensional variation which has the potential for increased difficulty fitting into outer canister.
August 28, 2024Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls 1,5L MED-SOFT LINER W/ 6MMX3M TUB. & ADULT VC, REF OR53929
Hazard: A slight dimensional variation which has the potential for increased difficulty fitting into outer canister.
August 28, 2024Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls 1,5L MED-SOFT LINER W/ 6MMX1,8M TUB. & ADULT VC, REF OR53926
Hazard: A slight dimensional variation which has the potential for increased difficulty fitting into outer canister.
August 28, 2024Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls 1500ML SOFT LINER, 1/4X6 TBG NS, REF OR926K
Hazard: A slight dimensional variation which has the potential for increased difficulty fitting into outer canister.
August 28, 2024Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls LINER, SOFT, SUCTION CANISTER, 1500CC, REF OR929K
Hazard: A slight dimensional variation which has the potential for increased difficulty fitting into outer canister.
August 28, 2024Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls LINER, SOFT, SUCTION CANISTER, 1500CC, REF DYNDSCL1500
Hazard: A slight dimensional variation which has the potential for increased difficulty fitting into outer canister.