Severity 2 of 5
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Severity 2 (Moderate) recalls cover minor labeling errors, low-risk contamination, and voluntary precautionary recalls. The agency's own classification is typically FDA Class III, or the issue is something like incomplete instructions or a small UPC mismatch where the product itself is safe but doesn't meet documentation requirements. Use the same brand-name product safely; follow the manufacturer's instructions for return or exchange if you want a refund.
The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.
Atrium Medical Corporation is recalling 11 iCast Covered Stents (Model 42616) due to an error in the Unique Device Identifier (UDI) printed on the distribution label. No illnesses or injuries have been reported.
ALCAS USA CORP. is recalling gelato ice cream packaged in compostable tubs due to possible fragmentation of the container material. Affected products were distributed in the USA, Cayman Islands, and Canada.
Inspire Medical Systems is recalling 457 Model 4063 Stimulation Leads because the serial number on the shelf box does not match the serial number of the device inside, creating identification and traceability issues.
Windstone Medical is recalling 894 Aligned Medical Tonsil ENT Packs containing Cardinal Health Salem Sump PVC tubes due to improper use concerns with a component under a separate recall action.
Howmedica Osteonics Corp. is recalling 897 MAKO Integrated Cutting System (MICS) Handpieces worldwide due to a manufacturing characterization process error that resulted in incorrect constant values being assigned to affected units.
Windstone Medical Packaging is recalling Aligned Medical T and A Pack REF AMS11482 because it contains a component subject to a separate recall action for improper use.
McNeilus is recalling 2010-2024 Rear Loader vehicles because the license plate light is installed in the wrong location, potentially failing to fully illuminate the plate.
Ryaltris nasal spray is being recalled because the dip tube is clogged, preventing the spray from functioning. The recall affects 45,504 bottles distributed nationwide.
The DVOT SARS-CoV-2 Antigen Test Kit (Model FCY-AGT-01) manufactured by Feng Chun Yuan Medical Equipment has been recalled from the U.S. market because it was not authorized for sale in the United States.
The DVOT SARS-CoV-2 & Influenza A+B Antigen Combo Test Kit (Model FAT01) has not obtained FDA authorization for sale in the United States. All lots distributed in the U.S. are subject to recall.
Glenmark Pharmaceuticals is recalling Ciclopirox Gel 0.77% tubes nationwide due to broken seals. The recall affects 11,568 tubes; no illnesses or injuries have been reported.
EnviroServe Chemicals Inc. is recalling EnviroClean Hand Sanitizer Gel due to manufacturing deviations. The voluntary recall affects 120 bottles distributed to one North Carolina distributor.
Karl Storz is recalling the Hopkins Telescope 6 endoscope because its Instructions for Use contain reprocessing procedures that have not been FDA-reviewed or approved. The recall affects 1,982 units distributed nationwide.
GE Healthcare Centricity PACS versions V2-V7 may fail to store medical images when reaching maximum unique image identifiers, potentially resulting in incomplete imaging studies. No injuries have been reported.
SHEET SPF 30 Mineral sunscreen is being recalled for microbial contamination. The product was distributed nationwide.
CooperSurgical is recalling 468 units of Silver-Plated Copper Sims Uterine Sounds because they were laser-marked with the incorrect part number during manufacturing.
Cook Biotech is recalling 93 Biodesign Fistula Plugs because the products expire prior to the expiration date printed on the labeling.
Cook Biotech, Inc. is recalling 102 units of Biodesign Fistula Plug C-FPS-0.7 because the products expire prior to the date printed on the labeling.
Cook Biotech is recalling Biodesign Inguinal Hernia Graft units because products expire before their labeled expiration date, potentially affecting surgical outcomes.
CooperSurgical, Inc. is recalling the Stainless Steel Sims Uterine Sound (Part Number 64-601) because some units were laser-marked with incorrect part numbers during manufacturing. No injuries have been reported.
Philips Ingenia 3.0T CX MRI machines may have loose screws in the RF carrier assembly that could protrude and interfere with the tabletop mechanism, potentially delaying patient scans.
Stryker Spine recalled the electronic Instructions for Use revision 5 for the AVS Anchor-C Cervical Cage System because specific indications language for the US and Canada was inadvertently removed.
Karl Storz Endoscope nephroscopes (REF: 27840KA) are being recalled because their instructions for use contain reprocessing methods that have not been reviewed or approved by the FDA for safety and efficacy.
Liberty Hardware is recalling about 174,500 Multi-Grip Tub Safety Bars because plastic grip pads can become dislodged on tapered tubs, making the bars unstable and creating a fall hazard. One minor fall injury has been reported.
Safeguard US Operating LLC is recalling 567 units of HAWK warming kits due to incorrect expiration date labeling. The kits were distributed nationwide in 16 states.