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.
27,110 detailed records are currently available in this category.
The products exhibit an unpleasant odor due to microbial contamination with Yarrowia lipolytica.
The affected products were inadvertently packaged with the inner packaging pouch being sealed together with the outer pouch.
Some integrated sterile INSPIRE family products contain an incorrect expiration date printed in the Unique Device Identification (UDI) bar code and readable code just beneath the barcode.…
An issue with one of the electric components (a resistor) could result in the device not delivering a shock when needed.
Baxter Healthcare will be installing new firmware on all Prismaflex control units to address the potential for a small number of these units to exhibit a failure mode with the pump module…
The products exhibit an unpleasant odor due to microbial contamination with Yarrowia lipolytica.
Possibility that the Biograph Horizon systems performing CT retrospective cardiac gating or PET cardiac gating examinations may experience a waveform sampling issue caused by a firmware…
Some integrated sterile INSPIRE family products contain an incorrect expiration date printed in the Unique Device Identification (UDI) bar code and readable code just beneath the barcode.…
The vial cap was mislabeled with the incorrect part number of 855708 but the product description on the cap was correct. The main vial label was correctly labeled.
Baxter Healthcare will be installing new firmware on all Prismaflex control units to address the potential for a small number of these units to exhibit a failure mode with the pump module…
The cap on the vial might be labeled with the incorrect part number but the main vial label is correct.
Three lots of Anthology HO Porous size 7 stems were manufactured with an undersized taper length. The device taper length was incorrectly manufactured as 0.393mm opposed to 0.442 mm.
An issue with one of the electric components (a resistor) could result in the device not delivering a shock when needed.
Possible leak at distal open end of the strain relief, which causes medical staff to continue adding inflation fluid to maintain balloon pressure for adequate occlusion of the ascending…
The products exhibit an unpleasant odor due to microbial contamination with Yarrowia lipolytica.
The Strip Provider Modules (SPM) on some of the instruments had not been inspected during manufacture for correct seal placement and integrity.
The affected products were inadvertently packaged with the inner packaging pouch being sealed together with the outer pouch.
Specific lots of EXACTAMIX Inlets listed below due to incorrectly performed over-labeling. The inlets were over-labeled with a blank label, or with a label containing an extended expiration…
A single lot of GENESIS II FEMORAL FIVE DEGREE VALGUS BUSHING due to a laser mark labeling error. The left valgus bushing was incorrectly laser marked as right and vice versa.
Specific lots of EXACTAMIX Inlets listed below due to incorrectly performed over-labeling. The inlets were over-labeled with a blank label, or with a label containing an extended expiration…
Getinge has received complaints concerning the X TEN Surgical Lights whose spring arms have broken, causing light heads to separate from the assembly. The issue relates to cracking of the…
Specific lots of EXACTAMIX Inlets listed below due to incorrectly performed over-labeling. The inlets were over-labeled with a blank label, or with a label containing an extended expiration…
The affected products were inadvertently packaged with the inner packaging pouch being sealed together with the outer pouch.
Firm is notifying customers that the Deep-Cleaning Service is now available in the United States. Stockert Heater-Cooler System 3T devices are suspected of microbial contamination and may…
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.
