These choking rescue protocols include abdominal thrusts (also called the “Heimlich” maneuver) for children and adults but not anti-choking devices.

Elekta Instrument AB Recalls Disposable Biopsy Needle Kit for Leksell Stereotactic System for Possibly Containing Microscopic Stainless Steel Debris on the Inside of the Biopsy Needle

Elekta recalls Disposable Biopsy Needles (911933) from batch 837838839 due to potential microscopic stainless steel debris inside.

Draeger, Inc. Recalls Perseus A500 Anesthesia System for Risk of Sudden Unexpected Shutdown When Used on Battery Power

The Perseus A500 that provides anesthesia and/or ventilation during surgical or diagnostic procedures may unexpectedly shutdown while using battery power.

Fresenius Medical Care Recalls Stay-Safe Catheter Extension Sets and Stay-Safe/Luer Lock Adapter for Risk of Patient Exposure to Higher Than Allowable Levels of Toxic Compound NDL-PCBA

Fresenius Stay-Safe Catheter Extension Sets and Stay-Safe/Luer Lock Adapter may expose patients who weigh less than 40 kg to higher than allowable levels of NDL-PCBA.

UPDATE: Evaluating Plastic Syringes Made in China for Potential Device Failures: FDA Safety Communication

Update: Potential Risk of Exposure to Toxic Compounds When Using Hemodialysis and Peritoneal Dialysis Systems – Letter to Health Care Providers

The FDA expanded its evaluation of the potential risk of exposure to toxic compounds when using hemodialysis and peritoneal dialysis systems

InfuTronix, LLC Recalls Nimbus and Nimbus II Infusion Pump Systems for Multiple Device Failures That May Cause Severe Injury and Death

Nimbus and Nimbus II infusion pumps may experience one or more issues that can cause severe patient injury and death.

Outset Medical, Inc. Recalls Certain Tablo Hemodialysis Systems for Risk of Patient Exposure to Higher Than Allowable Levels of Toxic Compound NDL-PCBAs

The Tablo Hemodialysis System may expose patients to higher than allowable levels of NDL-PCBAs.

DeRoyal Industries, Inc. Recalls Tracecarts Containing 16FR Urine Meter Foley Under Recall by Nurse Assist

DeRoyal is recalling Surgical Tracecarts with Nurse Assist 16FR Silver Urine Meter Foley due to sterility concerns. Other items in the tracecart are unaffected.

STOP CLOPEZ CORP Issues Voluntary Worldwide Recall of Schwinnng Capsules Due to the Presence of Undeclared Nortadalafil

Hollywood, FL, US, STOP CLOPEZ CORP is voluntarily recalling one lot of Schwinnng capsules to the consumer level. FDA analysis has found the Schwinnng products to contain Nortadalafil. Nortadalafil is an active drug ingredient known for the treatment of male erectile dysfunction. The presence of Nor

Dr. Reddy’s Issues Voluntary Nationwide Recall of Sapropterin Dihydrochloride Powder for Oral Solution 100 mg Due to Sub-Potency

Dr. Reddy's Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY, along with its subsidiaries together referred to as "Dr. Reddy's"), today announced that it is voluntarily recalling six (6) lots of Sapropterin Dihydrochloride Powder for Oral Solution 100 mg to the consumer leve

Risks with Exactech Equinoxe Shoulder System with Defective Packaging - FDA Safety Communication

Equinoxe Shoulder Systems were packaged in defective bags. Potential risks including premature implant wear or failure, which may lead to additional surgery.

BCMA-Directed or CD19-Directed Autologous Chimeric Antigen Receptor (CAR) T cell Immunotherapies: FDA Safety Communication - FDA Investigating Serious Risk of T-cell Malignancy

The FDA has received reports of T-cell malignancies, including chimeric antigen receptor CAR-positive lymphoma, in patients who received treatment with BCMA- or CD19-directed autologous CAR T cell immunotherapies.

Boston Scientific Recalls Obsidio Conformable Embolic for Increased Bowel Ischemia Risk When Used for Lower GI Bleeding

Obsidio Embolic may cause bowel ischemia if used with the aliquot technique to address lower GI bleeding.

Fresenius Kabi USA, LLC Recalls Ivenix Infusion Pump LVP Software for Anomalies That Have the Potential to Cause Serious Patient Harm or Death

Fresenius Kabi is recalling Ivenix Infusion System (IIS), LVP, due to several software issues that could cause serious harm or death to patients.

Recall of Certain Saline and Sterile Water Medical Products Associated with Nurse Assist: FDA Safety Communication

Nurse Assist, LLC announced a recall because the products may not be sterile. Patients are at risk of infection.

Abbott/Thoratec Corp. Recalls HeartMate II and HeartMate 3 Left Ventricular Assist System (LVAS) due to Long-term Buildup Causing an Obstruction

HeartMate II and HeartMate 3 devices are being recalled because a buildup of biological material is obstructing the device, making it more difficult for the heart to pump blood.

2024 Safety Communications

Listing of Medical Device 2024 Safety Communications

Medline Industries, LP Issues a Nationwide Recall of Convenience Kits Containing Nurse Assist 0.9% Sodium Chloride Irrigation USP and Sterile Water for Irrigation USP

Northfield, Ill., Apr. 5, 2024 – In direct response to the Nurse Assist, LLC voluntary product recall initiated on November 6, 2023, for saline and sterile water medical products, Medline Industries, LP initiated a nationwide recall on November 15, 2023, for its Medline and Centurion branded conveni

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2024 Medical Device Recalls

FDA Encourages the Public to Follow Established Choking Rescue Protocols: FDA Safety Communication