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.
An enzyme reagent included in the kit is not maintaining stability through claimed product expiration, resulting in the potential for false negative results when tested with patient…
The sutures inside the packaging are not the same size or type as indicated on the label.
There is a potential for silicone shedding during cleaning and sterilization.
The pin that holds the spring mechanism is not properly mounted. The pin could potentially disassemble.
The stage 1 and 2 reamer instruments used to prepare fixation for the cup in the acetabulum had a -1mm interference fit with acetabulum bone. The expected interference fit is -2mm.
Potentially lead to anchor breakage during insertion,
The internal labeling included with these implants may include incorrect part numbers and could result in these incorrect labels being added to patient records.
There is a potential for silicone shedding during cleaning and sterilization.
Visions PV .035 Intravascular Ultrasound (IVUS) Catheters (catalog number 88901 adnd81234) due to the potential inability to pass the guidewire through the y-port of the catheter.
Visions PV .035 Intravascular Ultrasound (IVUS) Catheters (catalog number 88901 adnd81234) due to the potential inability to pass the guidewire through the y-port of the catheter.
The lidstock states the incorrect priming volume and flow rates.
If the head mount knob is not properly tightened and the operator directly uses the injector head to move the unit, it may become disengaged, causing the injector head to become loose or…
The internal labeling included with these implants may include incorrect part numbers and could result in these incorrect labels being added to patient records.
Enteral Safe Feeding Tubes labeled as 6.5 FR X 24" contained 5 FR X 24" Enteral Safe Feeding Tubes.
The product may be packaged with a 5FR X 24 length Feeding tube instead of a 6.5 FR X 24 Feeding tube as labeled.
After an upgrade of the software of the Overhead Tube Crane, there were isolated cases in which the Overhead Tube Crane movement does not stop when the movement button is released. Instead…
Supplier had changed its resin sub-suppliers three (3) times without notifying BSC. These changes resulted in slight variations in resin material compositions which were not reflected in…
A component of the device was recalled by a supplier. In rare cases of inadequate maintenance or very high clinical workload, the first steel wire rope of the lifting column, which is…
During automatic tabletop movement, pressing and holding the Stop Table button may lead to an unexpected restart of the table movement.
One lot of product labeled 2.7mm x18mm Lock Screw Square Drive (Lot 029970) contains 20mm locking screws and one lot of product labeled 2.7mm x 20mm Lock Screw Square Drive (Lot 029980)…
There is a risk of detachment of the Compact Gantry Rolling Floor.
Supplier had changed its resin sub-suppliers three (3) times without notifying BSC. These changes resulted in slight variations in resin material compositions which were not reflected in…
Supplier had changed its resin sub-suppliers three (3) times without notifying BSC. These changes resulted in slight variations in resin material compositions which were not reflected in…
Hemorrhoidal Circular Stapler may have been assembled without a washer, this may potentially cause bleeding or soft tissue injury during use as the device may not fully cut when fired
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.
