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.
Medline is recalling 456 C-section procedure kits containing plastic syringes affected by an FDA safety alert. The syringes may leak or break, posing a risk to patient health during surgical procedures.
Immuno-Mycologics' Candida ID Antigen may have reduced sensitivity, causing false negative diagnostic results. Lot F4171005 has been distributed worldwide including CA and OK.
Microstream Advance neonatal-infant CO2 sampling lines may be difficult to disconnect from endotracheal tubes, potentially delaying critical procedures. This could cause unintended extubation and respiratory complications in infants.
American Contract Systems Inc is recalling 170 Diagnostic Neuro IR Tray kits due to inability to confirm sterilization assurance requirements were met. The units may lose functionality and cause treatment delays.
Growland Inc. is recalling Dried Longan Pulp products due to elevated sulfite levels. The affected product was distributed across seven states.
Optima Foods is recalling Domna's Bakery 24 PC Baklava Tray distributed in New York because it contains undeclared milk. Consumers with milk allergies should not consume this product.
Medline Industries is recalling Proxima Drape sterile surgical drapes due to potential packaging breach that could compromise sterility. The recall affects 16 units distributed nationwide.
American Contract Systems cannot confirm Major Vascular Pack surgical kits were properly sterilized. Sterilization assurance failure could result in loss of functionality and delayed patient treatment.
American Contract Systems Inc is recalling 90 AV Fistula kits because sterilization assurance requirements cannot be confirmed. Possible loss of functionality could delay or prolong patient treatment.
American Contract Systems Inc is recalling 237 laparoscopy surgical packs because sterilization assurance could not be confirmed. The packs may experience loss of functionality and require treatment delays.
American Contract Systems Inc recalls 690 laceration tray kits due to inability to confirm sterilization requirements were met. The trays may lack functionality and delay patient treatment.
American Contract Systems Inc recalls 41 URO Robotic Pack surgical kits distributed in Ohio because sterilization assurance requirements could not be confirmed. Non-sterile equipment may lead to delayed treatment.
American Contract Systems is recalling 725 Labor & Delivery Packs because the manufacturer cannot confirm sterilization requirements were met. Devices may lack functionality and could delay or prolong patient treatment.
American Contract Systems Inc is recalling 630 laparoscopy pack kits due to unconfirmed sterilization assurance. This could cause loss of functionality and treatment delays.
American Contract Systems Inc is recalling 534 kits of General Laparoscopic Pack-LF surgical instruments because sterilization assurance could not be confirmed. This could result in loss of functionality and treatment delays.
American Contract Systems Inc is recalling 1,200 DR DIULUS Injection Pack kits because the manufacturer cannot confirm sterilization assurance requirements were met. This may result in loss of functionality and treatment delays.
Brainlab's Origin Data Management software versions 3.1.0 through 3.2.1 may automatically merge patient records from unrelated individuals without user notification, creating a risk of incorrect patient data being used in clinical care.
Medline is recalling 1,482 units of Proxima sterile surgical drapes due to potential breaches in pouch packaging that could compromise sterility. No illnesses have been reported.
American Contract Systems Inc is recalling 90 Open Heart Adult Side A surgical kits due to inability to confirm sterilization requirements were met. Unsterilized devices could lose functionality and delay patient treatment.
Microstream CO2 sampling lines may be difficult to disconnect from endotracheal tubes, potentially delaying treatment or causing unintended tube removal.
American Contract Systems Inc is recalling 106 SPINE LUMBAR PACK kits (Models UTSL72AA, UTSL72AB) because the manufacturer cannot confirm sterilization assurance requirements were met, potentially causing functionality loss and treatment delays.
Microstream Neonatal-Infant Intubated CO2 Filter Lines may become difficult or impossible to disconnect from endotracheal tubes during clinical procedures, potentially delaying treatment and causing unintended extubation.
B. Braun Medical is recalling Introcan Safety 3 IV catheters because the valve housing may detach, causing fluid leakage. Approximately 28,200 units are affected.
Amgen recalls 258,750 vials of Neupogen (filgrastim) injection due to stability concerns. Stability data shows products may be out of specification at expiration; patients should consult healthcare providers about affected lots.
Microstream intubated CO2 sampling lines may be difficult or impossible to disconnect from endotracheal tubes. This could delay necessary procedures and cause unintended extubation, potentially leading to respiratory failure.