Home › Device types › FMH
Container, Specimen, Sterile
FDA product code FMH · Class 1 · Pathology
784
Registered devices
539
Adverse events
21
Recalls
23
510(k) clearances
Devices with this code
Para-Pak Zn-PVA / 10% Formalin / Clean — MERIDIAN BIOSCIENCE, INC.Avaline Medical NJ LLC — Avaline Medical NJ Limited Liability CompanyDover — Cardinal Health, Inc.Leakbuster — Starplex Scientific Corp.BD Vacutainer® Urinalysis Conical Urine Tube — BECTON, DICKINSON AND COMPANYSpecimen Collection Bottle — Well Lead Medical Co.,LtdPara-Pak Direct Detect — MERIDIAN BIOSCIENCE, INC.Avaline Medical NJ LLC — Avaline Medical NJ Limited Liability CompanyBioseal Inc. — BIOSEALMedline Industries, Inc. — MEDLINE INDUSTRIES, INC.Bioseal Inc. — BIOSEALDeRoyal — DEROYAL INDUSTRIES, INC.Kendall — Cardinal Health 200, LLCLeakbuster — Starplex Scientific Corp.Medline Industries, Inc. — MEDLINE INDUSTRIES, INC.Nalgene™ System 100™ Cryogenic Tube, 1 mL externally-threaded — Nalge Nunc International CorporationClikSeal™ — HARDY DIAGNOSTICSCorning® — Corning IncorporatedCARDINAL HEALTH — Cardinal Health 200, LLCCorning® — Corning IncorporatedCARDINAL HEALTH — Cardinal Health 200, LLCCenturion — CENTURION MEDICAL PRODUCTS CORPORATIONO-Wrap™ Bag — ORIGEN BIOMEDICAL, INC.Medline Industries, Inc. — MEDLINE INDUSTRIES, INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-03-19 | Medline Industries, LP | During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market |
| 2026-01-07 | Medline Industries, LP | Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated ster |
| 2026-01-07 | Medline Industries, LP | Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated ster |
| 2025-04-04 | Klinika Mdical Gmb | Potential for microbial contamination. |
| 2025-04-04 | Klinika Mdical Gmb | Potential for microbial contamination. |
| 2024-04-08 | MEDLINE INDUSTRIES, LP - Northfield | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have bee |
| 2024-02-23 | MEDLINE INDUSTRIES, LP - Northfield | Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users. |
| 2023-10-19 | Meridian Bioscience Inc | Due to a manufacturing defect, certain Para-Pak vials may be at risk for leakage. |
| 2023-10-19 | Meridian Bioscience Inc | Plastic vials contain a manufacturing defect may cause an increased risk of leakage and presents a risk of incidental exposure to biological hazards associated |
| 2023-05-15 | MEDLINE INDUSTRIES, LP - Northfield | Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications. |
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