Monitor U.S. medical device recall enforcement reports from the FDA. Review product descriptions, recall reasons, classifications, dates, recalling firms and distribution information where the FDA provides them.
27,577 detailed records are currently available in this category.
Due to misinterpretation of the barcode by the scanner, when the registration receipt barcode is scanned by the analyzer , a result from a different patient will be printed or displayed on…
An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introducer Sheath was detected in a small quantity of the affected lot population, 0.01% (1 in 10,…
Navilyst Medical, Inc. (NMI) the manufacturer of the Xcela PICC with PASV, BioFlo PICC with PASV and the BioFlo PICC, conducted this recall to the end user level based on information…
An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introducer Sheath was detected in a small quantity of the affected lot population, 0.01% (1 in 10,…
The infant artwork on the product instructs incorrect pad placement. Also, the artwork is missing the Type BF Patient connection and High Voltage Warning symbols.
An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introducer Sheath was detected in a small quantity of the affected lot population, 0.01% (1 in 10,…
Navilyst Medical, Inc. (NMI) the manufacturer of the Xcela PICC with PASV, BioFlo PICC with PASV and the BioFlo PICC, conducted this recall to the end user level based on information…
The shield for the Single-Tube Station on the DxH instrument may interfere with sample aspiration in the open vial position.
Navilyst Medical, Inc. (NMI) the manufacturer of the Xcela PICC with PASV, BioFlo PICC with PASV and the BioFlo PICC, conducted this recall to the end user level based on information…
A small number of batches may crack or break if exposed to certain chemicals, like certain cleaning agents.
Custom surgical kits contain Aplicare Povidone Iodine Prep Pads which were subsequently recalled by Medline Industries for incorrect expiration date.
A defect in the wire-reinforced tubing may result in a partial of total occlusion when the cuff is over-inflated.
Listeria monocytogenes contamination of non-sterile plated media
Certain iOS and Android App versions contain a program error (bug) in the Bolus Advisor feature. After pairing a meter with the app for the first time, a customer may encounter the rare…
Generator may inadvertently deliver RF energy if the foot pedal is placed in close proximity and oriented toward the Stereotaxis magnets.
Possible inner labeling and packaged device not matching the outer label on the box.
The firm received reports of two breakages of the pin tips which occurred during two identical surgery procedures. The breakage occurred at the very distal end of the conical part of the…
Potential unexpected movement of robot arm
Distribution of unapproved devices with incorrect air compression level setup
Device does not produce a visual or audible impedance respiration APN alarm when an impedance respiration apnea event occurs.
Contraindication language updated in the Instructions For Use (IFU) to indicate that Pentaray Catheters should not be used in patients with prosthetic valves.
For the Fukuda Denshi patient monitor model DS-8100, in less than 0.003% (17) of the 6227 devices sold worldwide, a Short-term Battery Error message has appeared and has been traced back to…
Issue 1: The MedNet Meds 6.1 and 6.21 programs, under certain conditions, can change the piggyback medication entry set settings for existing defined medication entries. This includes (a)…
Possible inner labeling and packaged device not matching the outer label on the box.
Medical device recall records can change as the FDA receives additional information. Check the official record identifier and current FDA information before making health or product-use decisions.
Recall Lookup USA keeps the last complete source record available when an official data service is temporarily unavailable. When a source provides only a few fields, we show only those known facts rather than padding the page with generic text.
This database is designed for discovery and reference. It can help you locate a relevant recall record, identify the recalling firm or NHTSA campaign, compare dates and classifications, and follow the official source. It is not a substitute for a VIN-specific NHTSA check, a manufacturer notice, medical advice or instructions issued by the recalling company.
