Recalls
Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.
Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means deaths or serious injuries are reported, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.
The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.
Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.
Minimum severity
Olympus tracheal intubation fiberscopes are being recalled because the manufacturer lacks adequate data confirming the suction flow rate meets device specifications. No injuries have been reported.
Medline leg bags contain undeclared latex, creating a risk for users with latex allergies. The company is recalling 28,942 devices distributed in the US and Panama.
SagiPlan 2.2 brachytherapy treatment planning software is recalled due to a software malfunction that may round numerical values, potentially causing inaccurate treatment measurements.
The Sensica Urine Output System (SCCS1002) displays incorrect timestamps and monitoring data when connected to WiFi or internet due to a time synchronization issue. This malfunction affects the accuracy of patient monitoring records.
Ortho-Clinical Diagnostics is recalling 51 units of the VITROS 4600 Chemistry System due to software defects causing system freezes and disconnections that could delay critical test result reporting.
Medline Industries is recalling 1,800 units of Sterile Betadine (Ref DYNDA1998) because the foil sachet contents are non-sterile, despite labeling that claims sterility. The recall affects units nationwide in eight states.
Limacorporate is recalling 33 PHYSICA HPS Tibial Liner units distributed in the U.S. due to incorrect product labeling. No adverse events have been reported.
Meridian Bioscience is recalling Para-Pak Clean Vials used for stool specimen collection due to a manufacturing defect that increases leakage risk and may expose users to biological hazards.
BioReference Health is recalling the 4Kscore Test, a prostate cancer risk diagnostic test used nationwide. The recall follows mathematical modeling performed on over 3,000 specimens regarding digital rectal exam (DRE) information requirements.
Medline STERILE PVP SLN KIT (Lot 21GBJ087) is recalled because its contents are non-sterile despite labeling stating sterile product. Consumers should stop use immediately.
Incorrect bolt torque on GE Definium Tempo X-ray systems may cause the overhead tube suspension assembly to fall. No injuries have been reported, but GE recommends immediate inspection of affected systems.
Riverpoint Medical is recalling Iconix Knotless 1.4mm surgical anchors because the inserter can fail or bend when used in hard bone, potentially damaging sutures during insertion or use.
Medline Industries is recalling 8,250 units of sterile PVP solution distributed nationwide because the contents are non-sterile despite being labeled as sterile.
Spectranetics Corporation is recalling 1,239 Turbo-Elite Laser Atherectomy Catheters due to incorrect labeling where the exterior product box label does not match the internal pouch label.
APN Health LLC is recalling the Navik 3D v2 3D Mapping System to update the product instructions for use. The firm initiated this voluntary recall.
B. Braun Infusomat Administration Sets may have incorrect tubing dimensions that cause false air-in-line alarms, interrupting medication delivery. The defects may prevent critical medications from reaching patients.
The FDA is recalling CARDIOHELP Emergency Drive units due to potential blocking that impairs blood flow. Affected patients may experience ischemia and hypoxia from inappropriate low blood oxygen.
AURIS Health is recalling the Monarch Platform virtual bronchoscope due to potential software issues that may flip the displayed surgical image, which could impair visualization during minimally invasive procedures.
Integra LifeSciences is recalling a cranial access kit due to a packaging defect that can cause the sterile outer packaging to split without additional force, potentially compromising device sterility.
Wilson-Cook Medical is recalling QUANTUM TTC BILIARY BALLOON DILATORS due to nonconforming devices that may detach during use. Detachment could require endoscopic retrieval and carries a risk of bleeding.
Ortho-Clinical Diagnostics is recalling certain VITROS ECO2 diagnostic slides that may produce inaccurate carbon dioxide measurements, potentially leading to misdiagnosis of acid-base balance disorders.
Integra LifeSciences is recalling the Integra Cranial Access Kit due to a defect in the outer packaging that can split and compromise device sterility. A total of 173 units are affected.
Fresenius Medical Care is updating the Stay Safe Cap's labeling to include additional warnings and contraindications for potential side effects. No illnesses have been reported.
Atrium Oasis chest drain devices were re-sterilized by a third party using unapproved packaging and sterilization processes lacking manufacturer validation. Affected devices were distributed in Virginia.
The Cooper Surgical H/S ELLIPTOSPHERE CATH 5 Fr catheter may detach or leak due to defective bonding material used in assembly. The 73 affected units were distributed nationwide and internationally.