Container, Specimen, Sterile
FDA adverse event reports and recall history for container, specimen, sterile (product code FMH), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 517
- Deaths
- 0
- Injuries
- 17
- Malfunctions
- 494
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2026-05-07Open, ClassifiedProcess control
Medline Convenience Kits: 1) DRAPE PACK-CHOICE, Model Number: DYNJ63118A
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
- 2026-04-30Open, ClassifiedUnder Investigation by firm
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: GENERAL KIT, Medline Kit Number/SKU DYNJ905664I
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.
- 2026-02-17Open, ClassifiedUnder Investigation by firm
Medline Convenience Kits: 1) DRAPE PACK-CHOICE, Model Number: DYNJ63118A
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
- 2025-05-15Open, ClassifiedProcess control
KliniTray. KlinioTray. Tissue resection margin examination board/small. Model Number: 2001105-F The medical device KliniTrayTM is a system for the precise monitoring, recording and visualization of alignment during surgical procedures. It ensures the exact orientation and positioning of tissue to be removed in the patient's body, enabling improved surgical precision and patient safety.
Potential for microbial contamination.
- 2025-05-15Open, ClassifiedProcess control
KliniTray Platte Faxitron ,groB "R" sterile. Tissue resection margin examination board/large Model Number: 2001155-F The medical device KliniTrayTM is a system for the precise monitoring, recording and visualization of alignment during surgical procedures. It ensures the exact orientation and positioning of tissue to be removed in the patient's body, enabling improved surgical precision and patient safety.
Potential for microbial contamination.
- 2024-09-06Open, ClassifiedUnder Investigation by firm
Medline Convenience kits labeled as: 1) KIT, MIDSTREAM, W/BZK/FUNNL,3O, Pack Number DYND30212; 2) PROCESSING KIT 3 PTE0000204 , Pack Number DYNJ65728A ; 3) 30ML KIT, Pack Number DYNJ82155A ; 4) DISSECTION, Pack Number DYNJ85191; 5) FLAP HARVEST PACK , Pack Number DYNJ58575C ; 6) KIT, MIDSTREAM, W/BZK/FUNNL,3O, Pack Number DYND30212H ; 7) FLAP HARVEST PACK, Pack Number DYNJ58575C
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
- 2024-03-29Open, ClassifiedProcess control
Centurion Manual surgical kits labeled as: a) 15ML SAMPLING TUBE WITH CAP, Product Code 15MLVLCP; b) STERILE 9X12 RECLOSABLE BAG, Product Code MG912ST
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.
- 2023-12-08Open, ClassifiedProcess control
Para-Pak Clean Vial-For the collection, transportation, preservation, and examination of stool specimens containing intestinal parasites Catalog Number: 900312
Plastic vials contain a manufacturing defect may cause an increased risk of leakage and presents a risk of incidental exposure to biological hazards associated with direct contact with the patient specimen.
- 2023-12-08Open, ClassifiedProcess control
Cardinal Health Clean Stool Transportation System-For the collection, transportation, preservation, and examination of stool specimens containing intestinal parasites Catalog Number: CHB900312
Due to a manufacturing defect, certain Para-Pak vials may be at risk for leakage.
- 2023-08-03Open, ClassifiedNonconforming Material/Component
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. DBD-FLAP HARVEST PACK, Model Number: DYNJ58575C
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
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