The latest food, drug and medical device recalls reported by the U.S. Food and Drug Administration, newest first. Data updated Oct 21, 2026.
87,918 recalls · page 5 of 30
Lack of Assurance of Sterility
Reported Oct 14, 2026 · D-0003-2027
Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.
Reported Oct 14, 2026 · D-0019-2027
Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.
Reported Oct 14, 2026 · D-0018-2027
Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.
Reported Oct 14, 2026 · D-0020-2027
Lack of Assurance of Sterility
Reported Oct 14, 2026 · D-0008-2027
Lack of Assurance of Sterility
Reported Oct 14, 2026 · D-0037-2027
Diagnostic electrophysiology (EP) catheter may have a breached sterile barrier on the straight seal side of the primary pouch, which if used could lead to particulate embolization, infection, thrombus or ganuloma formation from particulate matter.
Reported Oct 14, 2026 · Z-0085-2027
Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf life specification. When used to monitor steam sterilization cycles, the potential hazard is that the biological indicator will show no growth, indicating that the steam cycle was effective, even if the steam cycle did not achieve the intended spore reduction
Reported Oct 14, 2026 · Z-0074-2027
Some MiniMed Flex insulin pumps were released with missing (i.e., devices with no result or abort test results are presumed to have failed) or failed verification test results in one or more of 9 functional tests. The unverified/failed pumps released to users potentially have one or more of the following issues: inoperable pump at setup, lack of protection for moisture exposure, slow battery charging, disconnection issues with other system components (i.e., continuous glucose monitoring sensor or MiniMed mobile app), reduced ability to detect occlusion events, compromised audio for pump alarms/alerts, and/or inaccurate insulin delivery.
Reported Oct 14, 2026 · Z-0088-2027
Software issues may affect the safety and performance of Spectral CT system(s). The issues may result in image artifacts, wrong slice thickness, or unintended system motion.
Reported Oct 14, 2026 · Z-0078-2027
The front fork stem bolt/wheel assembly may disconnect from the rollator frame tubing. If the front fork stem bolt/wheel assembly disconnects from the rollator frame tubing, the front wheels may become loose or detach from the rollator. If the front wheels become loose or detach during use, there is risk of severe adverse events. The immediate consequences could include falls resulting in head trauma, bone fractures, or other critical injuries.
Reported Oct 14, 2026 · Z-0087-2027
Personalized pelvic implants inadvertently mixed up and distributed to incorrect customers.
Reported Oct 14, 2026 · Z-0091-2027
Due to a cybersecurity issue associate with a NULL Pointer Dereferences vulnerabiity. If exploited would potentially cause disruption of the centralized monitoring of multiple beds and the visualization of alarms.
Reported Oct 14, 2026 · Z-0089-2027
Compression bandage may be degraded, which may cause unwanted foreign material to be introduced inside the wound, which may lead to wound exploration and irrigation, formation of scar tissue, and infection.
Reported Oct 14, 2026 · Z-0081-2027
Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf life specification. When used to monitor steam sterilization cycles, the potential hazard is that the biological indicator will show no growth, indicating that the steam cycle was effective, even if the steam cycle did not achieve the intended spore reduction
Reported Oct 14, 2026 · Z-0070-2027
Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf life specification. When used to monitor steam sterilization cycles, the potential hazard is that the biological indicator will show no growth, indicating that the steam cycle was effective, even if the steam cycle did not achieve the intended spore reduction
Reported Oct 14, 2026 · Z-0073-2027
Lack of 510(k) clearance.
Reported Oct 14, 2026 · Z-0080-2027
Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf life specification. When used to monitor steam sterilization cycles, the potential hazard is that the biological indicator will show no growth, indicating that the steam cycle was effective, even if the steam cycle did not achieve the intended spore reduction
Reported Oct 14, 2026 · Z-0072-2027
Product may be potentially contaminated with a lubricant used during the manufacturing process.
Reported Oct 14, 2026 · Z-0098-2027
Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf life specification. When used to monitor steam sterilization cycles, the potential hazard is that the biological indicator will show no growth, indicating that the steam cycle was effective, even if the steam cycle did not achieve the intended spore reduction
Reported Oct 14, 2026 · Z-0071-2027
Product may be potentially contaminated with a lubricant used during the manufacturing process.
Reported Oct 14, 2026 · Z-0094-2027
Personalized pelvic implants inadvertently mixed up and distributed to incorrect customers.
Reported Oct 14, 2026 · Z-0090-2027
Product may be potentially contaminated with a lubricant used during the manufacturing process.
Reported Oct 14, 2026 · Z-0096-2027
A software issue may result in unintended mismatch of patient information on manually printed images. Incorrect patient information appearing on printed images could create a documentation discrepancy or incorrect association of clinical images with a patient record.
Reported Oct 14, 2026 · Z-0118-2027
Product may be potentially contaminated with a lubricant used during the manufacturing process.
Reported Oct 14, 2026 · Z-0103-2027
Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions
Reported Oct 14, 2026 · Z-0109-2027
Product may be potentially contaminated with a lubricant used during the manufacturing process.
Reported Oct 14, 2026 · Z-0092-2027
Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf life specification. When used to monitor steam sterilization cycles, the potential hazard is that the biological indicator will show no growth, indicating that the steam cycle was effective, even if the steam cycle did not achieve the intended spore reduction
Reported Oct 14, 2026 · Z-0075-2027
The front fork stem bolt/wheel assembly may disconnect from the rollator frame tubing. If the front fork stem bolt/wheel assembly disconnects from the rollator frame tubing, the front wheels may become loose or detach from the rollator. If the front wheels become loose or detach during use, there is risk of severe adverse events. The immediate consequences could include falls resulting in head trauma, bone fractures, or other critical injuries.
Reported Oct 14, 2026 · Z-0086-2027
Product may be potentially contaminated with a lubricant used during the manufacturing process.
Reported Oct 14, 2026 · Z-0105-2027