May 14, 2025Medical DevicesFDA
Smiths Medical ASD, Inc. recalls CADD-Solis HPCA Ambulatory Infusion Pump; Model/Number: 21-2111-0402-09-KYO 21-2111-0402-09-KYO CADD SOLIS PIB PUMP FO
Hazard: Affected pumps may trigger an erroneous (false) Upstream Occlusion Alarm under certain conditions, which will interrupt an active infusion. Interruption or delay of therapy can lead to serious patient injury or death.
May 14, 2025Medical DevicesFDA
Smiths Medical ASD, Inc. recalls CADD Solis HSPCA Pump ***Updated 5/27/26*** Scope updated to apply specifically to customers using the wireless system.
Hazard: Pumps may experience Wireless Connection Modules intermittent connection alarms, which will interrupt an active infusion. Interruption or delay of therapy can lead to serious patient injury or death.
May 7, 2025Medical DevicesFDA
Olympus Corporation of the Americas recalls Brand Name: Powered Laser Surgical Instrument Product Name: SOLTIVE Pro SuperPulsed Laser System Model/Catalog Numbers
Hazard: Preset treatment parameters are not consistently being used in accordance with the IFU.
May 7, 2025Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls Medline procedure kits, labeled as: HAND, REF DYNJ902002J
Hazard: It was identified that the Medline Sterile Water and Medline Sterile 0.9% Normal Saline bottles were leaking at the interface of the peel-foil and bottle opening.
May 7, 2025Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls Medline procedure kits, labeled as: OL OCULAR, REF DYNJ906183K
Hazard: It was identified that the Medline Sterile Water and Medline Sterile 0.9% Normal Saline bottles were leaking at the interface of the peel-foil and bottle opening.
May 7, 2025Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls Medline procedure kits, labeled as: REDDY JOINT BATH, REF MMJB001A
Hazard: It was identified that the Medline Sterile Water and Medline Sterile 0.9% Normal Saline bottles were leaking at the interface of the peel-foil and bottle opening.
May 7, 2025Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls Medline procedure kits, labeled as: 1) WOUND CARE TRAY, REF DYNDA1412A; 2) LACERATION TRAY, REF DYNDL1263A.
Hazard: It was identified that the Medline Sterile Water and Medline Sterile 0.9% Normal Saline bottles were leaking at the interface of the peel-foil and bottle opening.
May 7, 2025Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls Medline procedure kits, labeled as: PLASTICS SUTURE TRAY, REF SUT13535
Hazard: It was identified that the Medline Sterile Water and Medline Sterile 0.9% Normal Saline bottles were leaking at the interface of the peel-foil and bottle opening.
May 7, 2025Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls Medline procedure kits, labeled as: 1) STERILE PREP KIT, REF DYNDA1359A; 2) STRL EK SINGLE PACK, REF DYNDA1360B;
Hazard: It was identified that the Medline Sterile Water and Medline Sterile 0.9% Normal Saline bottles were leaking at the interface of the peel-foil and bottle opening.
May 7, 2025Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls Medline procedure kits, labeled as: NON STERILE I&D KIT, REF DYKM1438
Hazard: It was identified that the Medline Sterile Water and Medline Sterile 0.9% Normal Saline bottles were leaking at the interface of the peel-foil and bottle opening.
May 7, 2025Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls Medline procedure kits, labeled as: T AND A PACK -LF, REF DYNJ85792
Hazard: It was identified that the Medline Sterile Water and Medline Sterile 0.9% Normal Saline bottles were leaking at the interface of the peel-foil and bottle opening.
May 7, 2025Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls Medline Sterile 0.9% Normal Saline, USP, 100mL, REF RDI30296
Hazard: It was identified that the Medline Sterile Water and Medline Sterile 0.9% Normal Saline bottles were leaking at the interface of the peel-foil and bottle opening.
May 7, 2025Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls Medline Sterile Water, USP, 100mL, REF RDI30295
Hazard: It was identified that the Medline Sterile Water and Medline Sterile 0.9% Normal Saline bottles were leaking at the interface of the peel-foil and bottle opening.
May 7, 2025Medical DevicesFDA
Medtronic Neuromodulation recalls Enhanced Verify Evaluation Handset (CFN HH90130FA)
Hazard: Evaluation handsets may not be able to communicate with the neurostimulator due to handsets having a faster processing speed than prior handsets. An inability to connect may cause the therapy to stop being delivered and a system error will be displayed. Patient may experience return of underlying disease symptoms (e.g. overactive bladder, urinary retention, or fecal incontinence) based on their response to stimulation during the evaluation period.
May 7, 2025Medical DevicesFDA
IBA Dosimetry GmbH recalls myQA iON; Article Number: MQ10-000;
Hazard: Wrong analysis results can occur if the user creates two structures with the same name, except for one differing by a special character.
May 7, 2025Medical DevicesFDA
Waldemar Link GmbH & Co. KG (Mfg Site) recalls Tibial Augment; Item Numbers: (1) 880-331/11 (Sz. 1-2 - cemented x-sm), (2) 880-331/12 (Sz. 1-2 - cemented sm), (3) 880-
Hazard: The device was delivered with a preassembled Femoral Augment screw that was missing its thread.
May 7, 2025Medical DevicesFDA
Waldemar Link GmbH & Co. KG (Mfg Site) recalls L-Shaped Femoral Augment; Item Numbers: (1) 880-320/12 (Sz. 0 - cemented sm), (2) 880-320/22 (Sz. 0 - cemented lg), (3)
Hazard: The device was delivered with a preassembled Femoral Augment screw that was missing its thread.
May 7, 2025Medical DevicesFDA
Waldemar Link GmbH & Co. KG (Mfg Site) recalls Posterior Femoral Augment; Item Numbers: (1) 880-310/11 (Sz. 0 - cemented sm), (2) 880-310/21 (Sz. 0 - cemented lg), (3)
Hazard: The device was delivered with a preassembled Femoral Augment screw that was missing its thread.
May 7, 2025Medical DevicesFDA
Waldemar Link GmbH & Co. KG (Mfg Site) recalls Distal Femoral Augment; Item Numbers: (1) 880-300/11 (Sz. 0 - cemented sm), (2) 880-300/21 (Sz. 0 - cemented lg), (3) 88
Hazard: The device was delivered with a preassembled Femoral Augment screw that was missing its thread.
May 7, 2025Medical DevicesFDA
Spectrum Medical Ltd. recalls Brand Name: Quantum Informatics - VISION / LIVE VUE Product Name: Monitor, Physiological, Patient (Without Arrhythmia D
Hazard: Medical device software marketed without FDA clearance .
May 7, 2025Medical DevicesFDA
Spectrum Medical Ltd. recalls Brand Name: Quantum Informatics - VIPER Product Name: Monitor, Physiological, Patient (Without Arrhythmia Detection or
Hazard: Medical device software marketed without FDA clearance .
May 7, 2025Medical DevicesFDA
Defibtech, LLC recalls Automated External Defibrillators, Model DDU-2200, IItem numbers: DCF-E2210-D3/1¿(German/English dual language), DCF-E22
Hazard: It was noticed there was no Italian translation included for the AED. Article 16 of the Swiss Medical Devices Ordinance (MedDO) states that product information (labelling and instructions for use) should be provided in all three official languages of Switzerland (German, French, and Italian).
May 7, 2025Medical DevicesFDA
Defibtech, LLC recalls Automated External Defibrillators, Model DDU-2450. Item number: DCF-E2460DE (German language)
Hazard: It was noticed there was no Italian translation included for the AED. Article 16 of the Swiss Medical Devices Ordinance (MedDO) states that product information (labelling and instructions for use) should be provided in all three official languages of Switzerland (German, French, and Italian).
May 7, 2025Medical DevicesFDA
Defibtech, LLC recalls Automated External Defibrillators, Model DDU-2300. Item numbers: DCF-E2310D3/1¿(German/English dual language), DCF-E2310
Hazard: It was noticed there was no Italian translation included for the AED. Article 16 of the Swiss Medical Devices Ordinance (MedDO) states that product information (labelling and instructions for use) should be provided in all three official languages of Switzerland (German, French, and Italian).
May 7, 2025Medical DevicesFDA
Defibtech, LLC recalls Automated External Defibrillators, Model DDU-2200, IItem numbers: DCF-E2210-D3/1¿(German/English dual language), DCF-E22
Hazard: It was noticed there was no Italian translation included for the AED. Article 16 of the Swiss Medical Devices Ordinance (MedDO) states that product information (labelling and instructions for use) should be provided in all three official languages of Switzerland (German, French, and Italian).
May 7, 2025Medical DevicesFDA
Defibtech, LLC recalls Semi-Automated External Defibrillators; Models: DDU-100 and DDU-100E. Item numbers: DCF-E110SG-DE/1 (German language), D
Hazard: It was noticed there was no Italian translation included for the AED. Article 16 of the Swiss Medical Devices Ordinance (MedDO) states that product information (labelling and instructions for use) should be provided in all three official languages of Switzerland (German, French, and Italian).
May 7, 2025Medical DevicesFDA
Boston Scientific Corporation recalls IceSeed 1.5 CX NEEDLE OUS, Cryoablation Needle, REF H7493967534170. The needles are intended to convert high-pressure g
Hazard: Boston Scientific has identified that IceSeedTM CX needles manufactured between April 2024 and February 2025 have been programmed with DEMO settings instead of Commercial settings (see Affected Product Listing). Upon initial connection of an IceSeed CX needle to the Cryoablation System, the user will be prompted to perform the Needle Integrity and Functionality Test (NIT) per standard protocols. The affected needles perform as intended unless they are disconnected and reconnected to any channel after testing. In this case, the Cryoablation System will prompt re-execution of the NIT.
May 7, 2025Medical DevicesFDA
Boston Scientific Corporation recalls IceSeed 1.5 CX NEEDLE US, Cryoablation Needle, REF H7493967433170. The needles are intended to convert high-pressure ga
Hazard: Boston Scientific has identified that IceSeedTM CX needles manufactured between April 2024 and February 2025 have been programmed with DEMO settings instead of Commercial settings (see Affected Product Listing). Upon initial connection of an IceSeed CX needle to the Cryoablation System, the user will be prompted to perform the Needle Integrity and Functionality Test (NIT) per standard protocols. The affected needles perform as intended unless they are disconnected and reconnected to any channel after testing. In this case, the Cryoablation System will prompt re-execution of the NIT.
May 7, 2025Medical DevicesFDA
Boston Scientific Corporation recalls IceSeed 1.5 CX S NEEDLE OUS, Cryoablation Needle, REF H7493967334100. The needles are intended to convert high-pressure
Hazard: Boston Scientific has identified that IceSeedTM CX needles manufactured between April 2024 and February 2025 have been programmed with DEMO settings instead of Commercial settings (see Affected Product Listing). Upon initial connection of an IceSeed CX needle to the Cryoablation System, the user will be prompted to perform the Needle Integrity and Functionality Test (NIT) per standard protocols. The affected needles perform as intended unless they are disconnected and reconnected to any channel after testing. In this case, the Cryoablation System will prompt re-execution of the NIT.
May 7, 2025Medical DevicesFDA
Boston Scientific Corporation recalls IceSeed 1.5 CX S NEEDLE US, Cryoablation Needle, REF H7493967233100. The needles are intended to convert high-pressure
Hazard: Boston Scientific has identified that IceSeedTM CX needles manufactured between April 2024 and February 2025 have been programmed with DEMO settings instead of Commercial settings (see Affected Product Listing). Upon initial connection of an IceSeed CX needle to the Cryoablation System, the user will be prompted to perform the Needle Integrity and Functionality Test (NIT) per standard protocols. The affected needles perform as intended unless they are disconnected and reconnected to any channel after testing. In this case, the Cryoablation System will prompt re-execution of the NIT.