Hazard
3,438 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.
Of the 3,438 infection risk recalls we have scored against our rubric, 25 (1%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 993 (29%) are Severe.
Which agencies issued them
Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all infection risk recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.
A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.
Boston Scientific is recalling HYDRATOME RX catheters due to sterile barrier compromise. The 112 affected units worldwide may pose infection risk if used.
Boston Scientific is recalling Hydratome RX 44-30MM/260CM devices due to a sterile barrier breach that could compromise device sterility. The recall affects 3,371 units distributed worldwide.
Boston Scientific is recalling 4,487 JAGTOME RX medical devices worldwide due to sterility compromise from a sterile barrier breach. Users face contamination risk if devices are used.
Boston Scientific is recalling 32 units of DREAMTOME endoscopic devices due to a sterile barrier breach that compromises device sterility, creating potential infection risk. No illnesses have been reported.
Boston Scientific's JAGTOME RX medical device (367 units) is being recalled worldwide due to a sterile barrier breach that compromises device sterility.
Boston Scientific is recalling RX Cholangiogram Kits because the sterile barrier has been breached, compromising the sterility of the devices. The affected kits were distributed worldwide.
Boston Scientific is recalling 98 units of the JAGTOME RX 39-30-260-025 medical device due to compromised sterile barrier that affects device sterility. Units were distributed worldwide.
Boston Scientific is recalling JAGTOME RX medical devices because the sterile barrier may be compromised, which could allow contamination. The recall affects 163 units distributed worldwide.
B. Braun Medical is recalling dispensing pins with an elevated leakage risk in the air inlet filter. The leakage may reduce medication doses, delay treatment, or contaminate the fluid path, potentially causing bloodstream infection.
Orthosoft's NavitrackER knee navigation system may lack proper sterilization. The product was distributed without passing required sterilization tests, risking infection.
Collagen Matrix is recalling 68 units of DuraMatrix-Onlay Collagen Dura Substitute Membrane due to unsealed outer packaging that may compromise product sterility and increase infection risk.
CooperSurgical, Inc is recalling 48,645 cartons of Paragard T380A intrauterine contraceptive devices nationwide due to non-sterility concerns. The voluntary recall affects Lot #517001 with expiration date 1/2024.
Smith & Nephew is recalling the Acufex Access Advanced Positioning Kit because the products were shipped to a distribution center instead of the sterilizer and were not sterilized before distribution.
DePuy Orthopaedics is recalling 3 units of ATTUNE REVISION DISTAL FEMORAL AUGMENT due to adhesive residue that could cause tissue irritation or infection if not detected before surgery.
DePuy Orthopaedics is recalling ATTUNE Revision knee implant components due to possible adhesive residue on the surface. If undetected before surgery, the residue may cause soft tissue irritation or infection.
Edge Pharma is recalling Cefuroxime sterile ophthalmic solution for injection because the company cannot assure the product meets sterility requirements. The recall affects approximately 1,720 syringes distributed nationwide.
Edge Pharma LLC is recalling Dexamethasone sodium phosphate sterile otic solution for injection syringes (NDC 05446-0848-01) due to lack of assurance of sterility. Approximately 323 syringes were distributed nationwide.
Edge Pharma is recalling phenylephrine injection (20 mg/250 mL) because the manufacturer cannot assure the product maintains sterility. The recall affects 3,930 bags distributed nationwide.
Edge Pharma is recalling Lidocaine HCl Sterile Buffered Solution for Injection (1%, 10 mL syringes) due to lack of assurance of sterility. The recall affects approximately 4,465 syringes distributed nationwide.
Edge Pharma LLC is recalling Vancomycin HCl sterile ophthalmic solution for injection due to lack of assurance of sterility. The affected product was distributed nationwide.
Edge Pharma is recalling a combination ophthalmic solution (Phenylephrine HCl/Tropicamide/Cyclopentolate HCl/Ketorolac) distributed nationwide due to lack of assurance of sterility. The product is used for topical eye application.
Edge Pharma is recalling MVASI (bevacizumab-awwb) intraocular injection syringes nationwide due to lack of assurance of sterility. The recall affects 199 syringes with code 11-2021-01@2 dated 12/15/2021.
Edge Pharma is recalling a multi-ingredient sterile ophthalmic solution nationwide due to lack of assured sterility. The product is used for topical eye application.
Edge Pharma is recalling approximately 8,140 syringes of Lidocaine HCl/Epinephrine sterile buffered injection solution due to lack of assurance of sterility. The product was distributed nationwide.
Edge Pharma is recalling Phenylephrine HCl/Lidocaine sterile ophthalmic solution for injection due to lack of assurance of sterility. The recalled product consists of 2,750 single-use syringes distributed nationwide.