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.
26,628 detailed records are currently available in this category.
A potential bias was identified with certain kits compared to the internal standards.
There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.
There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.
There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.
There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.
There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.
There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.
Atellica Solution system software (SW) version 1.13 and lower, five (5) behavioral issues were identified: 1. Reagent Lock may not work as intended with Primary Reagent ReadyPacks and…
There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.
The products manufactured on 5/5/17 may be assembled incorrectly. If the incorrectly assembled products is used for patient transport, this could allow the patient to fall, resulting in…
Atellica Solution system software (SW) version 1.13 and lower, five (5) behavioral issues were identified: 1. Reagent Lock may not work as intended with Primary Reagent ReadyPacks and…
There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.
The service manual was not updated at the time of the release of software version 1.30.
If an operator attempts to manually program a Basic Infusion for a drug that is not included in the Drug Library using the Basic-Dose Mode, the operator will receive a false hard limit…
The terminals on the plug may become loose and overheat.
There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.
There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.
There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.
There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.
There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.
A potential bias was identified with certain kits compared to the internal standards.
Leaky bottles due to a defect in the bottle cap compromising the sterility of the product
The conduit length and branch length of a SG Pulmonary Hemi-Artery were switched on the product labeling. The graft labeling indicates the conduit length is 1.0cm and the branch length is…
There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.
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.
