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ROi CPS, LLC recalls Regard Operative Lap P&S Surgical Kit due to sterility concerns. Kits contain a Cardinal Health item linked to Nurse Assist, LLC's recall.
Fresenius Kabi USA, LLC Recalls Ivenix Large Volume Pump (LVP) of the Ivenix Infusion System Due to Mechanical Interference
Fresenius Kabi is recalling the Ivenix Large Volume Pump (LVP) for mechanical issues causing the internal Fluid Valve Pins not to move correctly.
Certain Type of Medicines Approved for Type 2 Diabetes and Obesity: Drug Safety Communication - Update on FDA’s Ongoing Evaluation of Reports of Suicidal Thoughts or Actions
The FDA has been evaluating reports of suicidal thoughts or actions in patients treated with a class of medicines called glucagon-like peptide-1 receptor agonists. FDA's preliminary evaluation has not found evidence that use of these medicines causes suicidal thoughts or actions.
ResMed Ltd. Recalls Continuous Positive Airway Pressure (CPAP) Masks with Magnets due to Possible Magnetic Interference with Certain Medical Devices
ResMed Ltd. recalls AirFit & AirTouch masks due to possible magnetic interference with certain medical devices. ResMed is updating the labels for safer use.
Busse Hospital Disposables, Inc. Recalls Care Trays and Kits Containing Sterile Water Based Products Under Recall by Nurse Assist
Busse Hospital Disposables is recalling their Tracheostomy Care Trays and sets in response to Nurse Assist’s November saline recall due to sterility concerns.
2024 Letters to Health Care Providers
The FDA posts letters to health care providers about the safe use of medical devices.
Potential Exposure to Certain Chemicals with Use of GE HealthCare EVair and EVair03 Compressors with Certain Ventilators – Letter to Health Care Providers
FDA issues a letter to health care providers on potential exposure to certain chemicals with use of GE HealthCare EVair and EVair03 compressors with certain ventilators.
Megadyne Medical Products, Inc. Recalls Mega Soft Universal Patient Return Electrode Due to Reports of Patient Burns
Megadyne is updating the instructions and product labeling to reflect that the Mega Soft Universal pads should not be used in patients under 12 years old.
Leiters Health Issues Voluntary Nationwide Recall of Vancomycin IV Bags, Phenylephrine IV Bags, and Fentanyl IV Bags Due to Potential for Superpotent Drug
January 5, 2024 – Englewood, Colorado, Leiters Health is voluntarily recalling 33 lots of products listed below to the user level. The recalled batches of vancomycin IV bags, phenylephrine IV bags, and fentanyl IV bags are being recalled due to the potential for superpotency because they may contain
Insulet Corporation Recalls Omnipod 5 Android App due to a Software Error
Omnipod 5 App recalled due to a software error which occurs when users input bolus amounts below 1 unit without adding a zero before the decimal point.
2024 Medical Device Recalls
2024 Medical Device Recalls
Getinge / Atrium Medical Corporation Issues Medical Device Correction for Nurse Assist Syringes Provided with Express Drains
On December 13, 2023, Getinge / Atrium Medical Corporation notified affected customers of a nationwide recall (medical device correction) for certain Atrium Express Dry Suction Dry Seal Chest Drains in response to a voluntary medical device recall initiated by a supplier, Nurse Assist. On November
2024 Safety Communications
Listing of Medical Device 2024 Safety Communications
Do Not Use Synovo Total Hip Resurfacing System: FDA Safety Communication
This device has significantly changed since FDA authorization, and the safety and effectiveness of the modified device has not been established.
HSV-2 Tests for Genital Herpes Can Produce False Reactive Results - Letter to Clinical Laboratory Staff and Health Care Providers
Herpes simplex virus-2 serological tests can produce false reactive results especially if a person has a low risk of infection or if test results are near the test’s cut-off.
2023 Letters to Health Care Providers
The FDA posts letters to health care providers about the safe use of medical devices.
Hospira, Inc. Issues A Voluntary Nationwide Recall For 4.2% Sodium Bicarbonate Injection, 8.4% Sodium Bicarbonate Injection, and Atropine Sulfate Injection Due to the Potential Presence of Glass Particulate Matter
Hospira, Inc., a Pfizer company, is voluntarily recalling the lots listed in the table below of 4.2% Sodium Bicarbonate Injection, USP ABBOJECT® Glass Syringe, 5 mEq/10 mL; 8.4% Sodium Bicarbonate Injection, USP Lifeshield® ABBOJECT® Glass Syringe, 50 mEq/50 mL; and Atropine Sulfate Injection, USP L
Insight Pharmaceuticals Issues Voluntary Nationwide Recall of Americaine® 20% Benzocaine Topical Anesthetic Spray Due to the Presence of Benzene
Insight Pharmaceuticals, a Prestige Consumer Healthcare Inc. company (“Insight”), is voluntarily recalling one lot of Americaine® 20% Benzocaine Topical Anesthetic Spray to the consumer level. While benzene is not an ingredient in any Americaine® 20% Benzocaine Topical Anesthetic Spray products, a r
Hospira, Inc. Issues A Voluntary Nationwide Recall For One Lot of Bleomycin for Injection, USP 15 Units Single Dose ONCO-TAIN™ Glass Fliptop Vial Due To The Potential For Presence of Glass Particulate Matter
Hospira, Inc., a Pfizer company, is voluntarily recalling one lot of Bleomycin for Injection, USP 15 units Single Dose ONCO-TAIN™ Glass Fliptop Vial, lot BL12206A, to the user level. The recall was initiated due to a confirmed customer report for the presence of glass particulate within a single via
ResMed Notifies Customers About Updated Instructions and Labeling for Masks with Magnets Due to Potential Interference with Certain Medical Devices
ResMed (NYSE: RMD, ASX: RMD) is conducting a voluntary global field action to update its guides for all masks with magnets to inform users about potential magnetic interference when magnets are near certain implants and medical devices in the body. This voluntary field correction does not require a