Severity 3 of 5
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Severity 3 (High) recalls have a known hazard but no confirmed illness, injury, or property damage in the source text. The risk is theoretical-but-real: a pathogen pre-emptively pulled from shelves before anyone got sick, an allergen mislabeling on an uncommon allergen, a precautionary correction on a device that hasn't yet malfunctioned in the field. Most allergen recalls land here, as do most preventive food recalls based on routine sampling. You should still stop using the product, but you don't need to panic.
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.
A Steris medical headrest may fail to lock during patient procedures, potentially causing injury or procedural delays. Affected units were manufactured between August and October 2023.
BD BBL Sensi Disc Cefotaxime susceptibility testing discs may produce inaccurate results for H. influenzae, potentially leading to delayed diagnosis and inappropriate antibiotic selection. The FDA has recalled 2,363,168 units distributed domestically and internationally.
BALT's Optima Coil neurovascular embolization devices may have corroded solder flux residue on the delivery pusher that could break off and cause foreign emboli in patient blood vessels.
GE Medical Systems is recalling 180 Senographe Pristina mammography X-ray systems because the audible signal indicating the end of X-ray exposure intermittently fails to sound, violating FDA safety requirements.
The Flow-e Anesthesia System model 6887900 is recalled due to a cybersecurity vulnerability that could allow remote access, denial of service, or code execution, potentially affecting anesthesia delivery safety.
Saputo Stella cheese distributed in OH, NY, and PA from November 26, 2023 through January 5, 2024 has been recalled due to improper temperature storage. The temperature failure could lead to spoilage and pathogenic growth.
BD BBL Sensi Disc Aztreonam test discs are recalled due to possible accuracy and quality control failures in antibiotic susceptibility testing. Failures could result in delayed diagnoses and inappropriate antibiotic selection.
Philips is recalling Ingenia 1.5T patient transportation trolleys with magnetic wheels that could be attracted to MRI magnetic fields. These wheels pose a potential hazard in MRI-equipped facilities when the trolley operates near the magnetic field.
Greco Sidari is recalling Ambriole Moliterno 7# wheel cheese due to improper temperature storage during distribution. The temperature conditions could allow spoilage and potentially support pathogen growth.
Greco Sidari is recalling Resers potato salad due to improper holding temperature during distribution, risking spoilage and pathogen growth. Affected: 1375 cases in Ohio, New York, and Pennsylvania from November 26 to January 5, 2024.
GRANDE SOPRAFFINA ricotta cheese was not held at appropriate temperatures, potentially supporting pathogen growth. Affected lots distributed to OH, NY, and PA from November 26, 2023 to January 5, 2024.
The FDA is recalling Lansoprazole Delayed-Release Capsules USP 15 mg due to manufacturing defects including inadequate sealing, capsule damage, and missing product codes. Affected lot 411987 was distributed nationwide.
Some ExcelsiusGPS Cannulas have an internal gap that prevents proper sterilization, increasing infection risk. Globus Medical is recalling 570 units distributed worldwide.
Greco Sidari is recalling 1,375 cases of Galbani Smoked Provalone distributed in Ohio, New York, and Pennsylvania due to improper storage temperatures that could have allowed pathogenic growth.
Greco Sidari fresh mozzarella cheese sold in Ohio, New York, and Pennsylvania was not held at appropriate temperatures, which could affect spoilage and potentially support pathogen growth. Consumers should discard affected products or return them to the retailer.
Greco Sidari is recalling 1,375 cases of Bel Gioioso Provolone Sharp cheese distributed in Ohio, New York, and Pennsylvania. The recall is due to improper storage temperature that could support pathogen growth.
BD BBL Sensi Disc Moxifloxacin test discs are recalled due to possible failures in antibiotic susceptibility testing accuracy. Test failures could lead to delayed diagnosis or inappropriate antibiotic selection.
Becton Dickinson recalled 2.3 million lab testing discs used for antibiotic susceptibility testing due to potential quality control failures. These failures could lead to delayed diagnosis or inappropriate antibiotic selection.
BD BBL Sensi Disc Ceftriaxone susceptibility test discs may have accuracy and quality control failures. These defects could lead to delayed diagnosis or incorrect antibiotic selection for H. influenzae infections.
Becton Dickinson is recalling BD BBL Sensi Disc Ofloxacin testing discs due to potential accuracy failures. These failures could lead to delayed diagnosis or inappropriate antibiotic selection.
Greco Sidari is recalling Norpaco Sweetie Pepper Goat Cheese (1,375 cases, 1/5# units) distributed in Ohio, New York, and Pennsylvania. The cheese was not held at appropriate temperatures, which could support pathogen growth.
Greco Sidari is recalling Joey's Roast Beef Sliced Premium because it was not held at appropriate temperatures, potentially allowing pathogenic growth. The product was distributed in Ohio, New York, and Pennsylvania from November 2023 to January 2024.
BALT USA is recalling Prestige Coil Systems due to corrosion of the delivery pusher. Solder flux residue can cause the discolored hypotube to break off and enter patient blood vessels as foreign emboli.
Globus Medical is recalling Cranial Drill 6.00mm units due to potential packaging breaches that may render the sterile product non-sterile, and discoloration near the drill tip.
BioFire Diagnostics is recalling FilmArray Pneumonia Panel Plus diagnostic test kits due to a potential for false positive results. These inaccurate results could lead to incorrect pneumonia diagnoses.