Health & Personal Care
HIGH
FDA DEVICE
Philips Medical Systems Nederland recalls 5 Allura Xper FD20/20 OR Tables for BIOS battery startup
Philips Medical Systems Nederland B.V.
The BIOS
fda regulated Recalls
1,320 recalls tagged with “fda regulated”.
Health & Personal Care
HIGH
FDA DEVICE
Philips Allura Xper FD10C Recall for 2 US Units Over BIOS Battery Startup Failure (2025)
Philips Medical Systems Nederland B.V.
The BIOS
Health & Personal Care
HIGH
FDA DRUG
Viorele Desogestrel/Ethinyl Estradiol Recall 2025 for Impurities
Viorele
Failed Impurities/Degradation
Health & Personal Care
HIGH
FDA DRUG
Major Pharmaceuticals Sulfamethoxazole and Trimethoprim 800 mg/160 mg 100-Tablets Recall 2025
Presence of a Foreign Substance: A specific lot of auxiliary polyester coil, used in product packaging by manufacturer (Amneal Pharmaceuticals LLC) was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
Sulfamethoxazole and Trimethoprim
Presence of
Health & Personal Care
HIGH
FDA DRUG
High-Risk Antibiotic Recall: Sulfamethoxazole and Trimethoprim 800/160 mg Double Strength Packets Re
Presence of a Foreign Substance: A specific lot of auxiliary polyester coil, used in product packaging by manufacturer (Amneal Pharmaceuticals LLC) was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
SULFAMETHOXAZOLE AND TRIMETHOPRIM
Presence of
Health & Personal Care
HIGH
FDA DEVICE
LeMaitre Vascular Artegraft Collagen Vascular Grafts Recall 2025: 28 U.S. Units Affected
The bovine carotid arteries used to produce the impacted grafts from affected lots were sourced using raw material from a supplier that had not been reviewed and approved by the appropriate regulatory authority.
LeMaitre Vascular
The bovine
Health & Personal Care
HIGH
FDA DRUG
AvKARE Norgestimate and Ethinyl Estradiol Tablets Recall for Uniformity Issue (2025)
AvKARE
Failed Content
Health & Personal Care
HIGH
FDA DEVICE
Canon Medical System SPOT Fluoro Digital Radiography System Recall Affects 8 Units in US (2025)
Canon Medical System
It has
Food & Beverages
HIGH
FDA FOOD
ICF Factory Recalls 12 Pints Vanilla G. Nutt Ice Cream Over undeclared Almond (2025)
ICF Factory
May contained
Health & Personal Care
HIGH
FDA DEVICE
BigTree Sales Recalls BT-GERMWAND-LRG-WHT UV-C Wand for Unsafe Radiation Risk (2025)
BigTree Sales
The subject
Health & Personal Care
HIGH
FDA DRUG
Fagron Compounding Services Bevacizumab Syringe Recall Affects 109,320 Units Nationwide
Lack of Assurance of Sterility
Fagron Compounding Services
Lack of
Health & Personal Care
HIGH
FDA DEVICE
Baxter Healthcare Recalls 8,368 CLEARLINK CONTINU-FLO IV Sets for Leakage Risk (2025)
Baxter Healthcare
IV sets
Health & Personal Care
HIGH
FDA DEVICE
Northeast Scientific NES Reprocessed 0.9mm Turbo Elite Laser Atherectomy Catheter Recall 2025
Potential for breaches in the sterile barrier packaging, compromising sterility assurance.
Northeast Scientific
Potential for
Health & Personal Care
HIGH
FDA DEVICE
Fresenius Medical Care Optiflux Dialyzers Recalled for Press-On Cap Issue (172,494,732 units, 2025)
To provide further information to the user to ensure proper use of the medical device. the caps had been changed from a threaded version to a press-on version whereby the user must press the caps firmly onto the dialyzer to securely affix the cap.
Fresenius Medical Care Holdings
To provide
Health & Personal Care
HIGH
FDA DEVICE
Baxter Healthcare Recalls 15,552 CLEARLINK IV Extension Sets for Leakage Risk (2025)
Baxter Healthcare recalled 15,552 CLEARLINK SYSTEM EXTENSION SETS nationwide in the United States. The IV extension sets may leak. Healthcare providers and patients should stop using the device immediately and follow Baxter recall instructions.
Baxter Healthcare
IV sets
Health & Personal Care
HIGH
FDA DEVICE
Baxter Healthcare CLEARLINK CONTIN-FLO IV Infusion Sets Recalled for Leaks (106,176 Units)
Baxter Healthcare
IV sets
Health & Personal Care
HIGH
FDA DEVICE
Baxter Healthcare's CLEARLINK CONTINU-FLO IV Set Recall for Leakage Risk (2025)
Baxter Healthcare Corp. recalled 12,720 CLEARLINK SYSTEM CONTINU-FLO IV sets distributed nationwide to healthcare facilities. The devices may leak during use. Hospitals and clinicians should stop using immediately and follow Baxter's recall instructions.
Baxter Healthcare
IV sets
Health & Personal Care
HIGH
FDA DEVICE
Baxter Healthcare CLEARLINK CONTINU-FLO IV Set Recalled for Leaks in 2025 (958,351 Units)
Baxter Healthcare
IV sets
Health & Personal Care
HIGH
FDA DEVICE
Northeast Scientific Laser Atherectomy Catheter Recalled for Sterile Barrier Breach Risk (2025)
Potential for breaches in the sterile barrier packaging, compromising sterility assurance.
Northeast Scientific
Potential for
Health & Personal Care
HIGH
FDA DEVICE
Baxter Healthcare Recalled 69,936 CLEARLINK IV Extension Sets for Leak Risk (2025)
Baxter Healthcare recalled 69,936 CLEARLINK System Non_DEHP Extension Sets sold nationwide to hospitals and clinics. The IV extension sets may leak. Healthcare providers should stop using the device and follow Baxter's recall instructions.
Baxter Healthcare
IV sets