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352 reported ongoing
354 records in this archive. Latest source date Aug 6, 2026.
FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
There is a potential for a rare interaction between the EMBLEM S-ICD and LATITUDE communicator, which may cause S-ICD sensing disablement for a 24-hour interval.
Class IIReported ongoing
Distribution: Worldwide
There is a potential for a rare interaction between the EMBLEM S-ICD and LATITUDE communicator, which may cause S-ICD sensing disablement for a 24-hour interval.
Class IIReported ongoing
Distribution: Worldwide
Manufactured with the incorrect component may result in lower power output and degradation or dimming of the aiming beam, leading to reduced efficiency of fiber performance. Continued use may cause overheating of the fiber connector, which could result in a...
Class IIReported ongoing
Distribution: Worldwide distribution - US Nationwide and the country of Canada.
Manufactured with the incorrect component may result in lower power output and degradation or dimming of the aiming beam, leading to reduced efficiency of fiber performance. Continued use may cause overheating of the fiber connector, which could result in a...
Class IIReported ongoing
Distribution: Worldwide distribution - US Nationwide and the country of Canada.
Manufactured with the incorrect component may result in lower power output and degradation or dimming of the aiming beam, leading to reduced efficiency of fiber performance. Continued use may cause overheating of the fiber connector, which could result in a...
Class IIReported ongoing
Distribution: Worldwide distribution - US Nationwide and the country of Canada.
Manufactured with the incorrect component may result in lower power output and degradation or dimming of the aiming beam, leading to reduced efficiency of fiber performance. Continued use may cause overheating of the fiber connector, which could result in a...
Class IIReported ongoing
Distribution: Worldwide distribution - US Nationwide and the country of Canada.
Manufactured with the incorrect component may result in lower power output and degradation or dimming of the aiming beam, leading to reduced efficiency of fiber performance. Continued use may cause overheating of the fiber connector, which could result in a...
Class IIReported ongoing
Distribution: Worldwide distribution - US Nationwide and the country of Canada.
Manufactured with the incorrect component may result in lower power output and degradation or dimming of the aiming beam, leading to reduced efficiency of fiber performance. Continued use may cause overheating of the fiber connector, which could result in a...
Class IIReported ongoing
Distribution: Worldwide distribution - US Nationwide and the country of Canada.
Manufactured with the incorrect component may result in lower power output and degradation or dimming of the aiming beam, leading to reduced efficiency of fiber performance. Continued use may cause overheating of the fiber connector, which could result in a...
Class IIReported ongoing
Distribution: Worldwide distribution - US Nationwide and the country of Canada.
The firm received complaints of the Insertion Tool component being occluded, resulting in the inability to pass a guidewire through the tool.
Class IIReported ongoing
Distribution: Worldwide
The firm received complaints of the Insertion Tool component being occluded, resulting in the inability to pass a guidewire through the tool.
Class IIReported ongoing
Distribution: Worldwide
Under specific circumstances, the U.S. product registration system did not send up enablement requests to U.S. LATITUDE Customer Support during an 8-month interval in 2022. For these patients, the HeartLogic Index and any associated Yellow Alerts are curren...
Class IIReported ongoing
Distribution: US Nationwide distribution to the healthcare facilities and healthcare providers are located in CA, CO, DE, FL, GA, ID, IL, IN, IA, KY, ME, MD, MA, NV, NH, NJ, NY, NC, OH, PA, R...
Cease use of the Habib EndoHPB Bipolar RF Catheter with the ERBE VIO3 Generator immediately due to the potential for delivery of excessive energy leading to thermal injury or tissue damage. An inaccurate setting is currently provided in the HABIB EndoHPB Ca...
Class IIReported ongoing
Distribution: Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Austria, Belgium, Bulgaria, Canada, Costa Rica, Czech Republic, Egypt, Finland, France, Germany...
Consoles were shipped without an instruction for use (IFU) or with the incorrect IFU.
Class IIReported ongoing
Distribution: Distribution was made to CA, IL, KY, OH, OK, RI, TX. There was no government/military distribution. Foreign distribution was made to Chile and Hong Kong.
***Update12/13/22***:Product removal due to higher incidence of adverse events of foreign body reactions*** Potential outcomes associated with foreign body reaction to remnant ORlSE Gel post procedure. Foreign body reaction which presented as mass formation...
Class IIReported ongoing
Distribution: Worldwide Distribution: US (Nationwide) and (Foreign) countries of: Algeria Argentina Argentina Australia Austria Bahrain Belgium Brazil Canada Chile Colombia Costa Rica Cyprus ...
***Update12/13/22***:Product removal due to higher incidence of adverse events of foreign body reactions*** Potential outcomes associated with foreign body reaction to remnant ORlSE Gel post procedure. Foreign body reaction which presented as mass formation...
Class IIReported ongoing
Distribution: Worldwide Distribution: US (Nationwide) and (Foreign) countries of: Algeria Argentina Argentina Australia Austria Bahrain Belgium Brazil Canada Chile Colombia Costa Rica Cyprus ...
***Update12/13/22***:Product removal due to higher incidence of adverse events of foreign body reactions*** Potential outcomes associated with foreign body reaction to remnant ORlSE Gel post procedure. Foreign body reaction which presented as mass formation...
Class IIReported ongoing
Distribution: Worldwide Distribution: US (Nationwide) and (Foreign) countries of: Algeria Argentina Argentina Australia Austria Bahrain Belgium Brazil Canada Chile Colombia Costa Rica Cyprus ...
There is an incorrect manufacturing date/timestamp within the software which causes an inaccurate display of battery capacity.
Class IIReported ongoing
Distribution: Worldwide distribution - US Nationwide distribution in the countries of AL, AR, CA, CO, DE, GA, IL, IA, MA, MI, MN, NV, NJ, NY, OH, PA, TN, TX, and VA. The countries of Canada, ...
There is an incorrect manufacturing date/timestamp within the software which causes an inaccurate display of battery capacity.
Class IIReported ongoing
Distribution: Worldwide distribution - US Nationwide distribution in the countries of AL, AR, CA, CO, DE, GA, IL, IA, MA, MI, MN, NV, NJ, NY, OH, PA, TN, TX, and VA. The countries of Canada, ...
The impacted products were distributed with an MPXF tip curve shape instead of the 40XF tip curve shape for the Guider/40XF/8FR/90CM guide catheter.
Class IIReported ongoing
Distribution: International distribution in the countries of Greece, France, Germany, Italy, Brazil and South Korea. UPDATE: The devices were also distributed to Russia. There was no U.S. dis...
These examples come from this result page and are not a ranking of every recall reason.
This archive contains 354 records, including 352 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product.
Compare the product, firm and lot, date, model or serial identifiers with the notice. Use the label-check guide if you need help locating an identifier.
A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall.
This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. Check source coverage and the agency's current notices.
Use monthly archives or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page.