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.
The rotational locking mechanisms on the ORT 200/300 tables fail to operate such that it cannot change states between locked and unlocked.
Non-coring needle provided with the Cook Vital-Port Vascular Assess System (Vital-Port) may cut or dislodge a core or sliver of material from the Vital-Port septum when the non-coring…
Patient results determined using this calibrator lot might deviate up to 20%. Controls might not indicate false values.
Zimmer Biomet is conducting a medical device recall for the Persona Partial Knee Spacer Blocks in sizes 8mm, 9mm, 10mm, 12mm, and 14mm. Complaints received indicated that flexion has the…
The firm made multiple changes to the product requiring the submission of a new 510(k) premarket notification.
Certain lots of peripheral catheter systems may be missing the safety latch, intended to minimize the risk of sharps injuries.
Complaints have been received concerning questionable results on analyzers due to customers utilizing 13 sample tubes without tube adapters.
A complaint was received for Item 42-5320-067-02, lot 63236047. It was report that there was no set screw or taper plug included in the box. Complaint investigation confirmed that the…
Certain lots of the Phoenix Tibia Nail 3.5mm Inserter instruments are being recalled due to reports of fracturing and remaining in the device implant.
The device power supply was not manufactured according to specification which can result in the loss of the protective grounding of the instrument.
Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates.
Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates.
A locking plastic abutment sleeve, used by dental technicians in dental laboratories to aid in the creation of the final restorative crown, was packed as a non-locking plastic abutment…
Two lots of the Tapered Screw-Vent Implants, with different outer thread diameters, were inadvertently commingled during the manufacturing process and may be mislabeled.
It was discovered during a surgery that the design of the radius at the base of the pegs of the Anatomic Glenoid Trial (Part Numbers: 804-07-380, 804-07-420, 804-07-460, 804-07-500, and…
Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates.
There is a risk of circuit board breakage within the main housing of the AC Adapter unit. Smoke may be emitted from the AC Adapter as a direct result.
Zimmer Biomet is conducting a medical device recall for the ACE Trochanteric Nail (ATN) system after a Device Performance Review (DPR) failed clinical analysis for survivorship pursuant to…
Johnson & Johnson Consumer Inc. is initiating a voluntary, Class II recall at the retail level in the U.S. of select COACH Self-Adhering Sports Wraps, BAND-AID Brand First Aid Products…
There is a risk of circuit board breakage within the main housing of the AC Adapter unit. Smoke may be emitted from the AC Adapter as a direct result.
Complaints have been received concerning questionable results on analyzers due to customers utilizing 13 mm sample tubes without tube adapters.
Complaints have been received concerning questionable results on analyzers due to customers utilizing sample 13 mm tubes without tube adapters.
The device power supply was not manufactured according to specification which can result in the loss of the protective grounding of the instrument.
The firm received complaints of error messages that occurred during routine impedance checks on Proclaim DRG IPGs, model 3664. Some complaints were also associated with transient over…
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.
