Complete FDA and NHTSA recall records dated in April 2018.
These records include useful source details for the selected month.
The device power supply was not manufactured according to specification which can result in the loss of the protective grounding of the instrument.
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.
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…
Complaints have been received concerning questionable results on analyzers due to customers utilizing 13 sample tubes without tube adapters.
Certain lots of peripheral catheter systems may be missing the safety latch, intended to minimize the risk of sharps injuries.
The firm made multiple changes to the product requiring the submission of a new 510(k) premarket notification.
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…
Patient results determined using this calibrator lot might deviate up to 20%. Controls might not indicate false values.
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…
The rotational locking mechanisms on the ORT 200/300 tables fail to operate such that it cannot change states between locked and unlocked.
The calibration for the affected batch of analyzers was incorrectly set during the manufacturing process which may lead to a failure when calibration is first performed. There may also be e…
Certain lots of in vitro fertilization (IVF) products were distributed without completed finished device quality testing with potential adverse events that may include nonviable gametes…
This Correction is being initiated based on a customer complaint received on November 16, 2017 which indicated a complication with a cataract procedure. An investigation completed by the…
Wire sets of certain devices were assembled with adhesive on the contact wires, which may impede conductivity and could cause failure
Stryker Instruments and Stryker Leibinger GmbH & Co. KG are voluntarily recalling certain serial numbers Thoracic Pedicle Feelers that are used in conjunction with the Stryker Navigation…
Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates.
Non-Conforming devices were shipped from the service center without proper evaluation and therefore may be nonconforming.
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…
Two lots of the Tapered Screw-Vent Implants, with different outer thread diameters, were inadvertently commingled during the manufacturing process and may be mislabeled.
There is the potential for the Rotating IV Pole to fall. A fall could result in an injury to a bystander holding the patient or to the operator.
When the archiving configuration is changed, data received/created after the upgrade may be flagged as "Not to be archived". This is caused by the automatic function for cleaning up…
Wire sets of certain devices were assembled with adhesive on the contact wires, which may impede conductivity and could cause failure
Certain lots of in vitro fertilization (IVF) products were distributed without completed finished device quality testing with potential adverse events that may include nonviable gametes…
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.
Use this page to compare the recalls reported during the month, then open an individual record for the exact reason, classification, company, remedy or distribution information available from the official source. Monthly counts are descriptive, not a safety rating.
