Class I - Dangerous
Blister package had an unsealed edge compromising sterility.
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Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
37,779 Total Recalls
DeRoyal ORGAN RECOVERY PACK PGYBK, a) REF 89-9004.09 and b) 89-9004.10
DeRoyal Industries
Class I - Dangerous
DeRoyal is recalling certain lots of surgical procedure pack products that contain a Medtronic Non-Absorbable Suture. The recall is due to Medtronic determining a manufacturing error in the packaging of the non-absorbable sutures that may cause a gap or wrinkle in the breather seal resulting in a sterile barrier breach.
RadiaLux Lighted Retractor (Pink), REF: 50-101-1
Medtronic Navigation
Class I - Dangerous
Defect in sterile pouch seal, incomplete seal, of lighted Retractors, increases the risk of contamination, which can lead to post-operative infection.
VENTANA PD-L1 (SP142) VENTANA PD-L1 (SP142) Assay (Class III, US IVD) 07709374001 VENTANA PD-L1 (SP142) Assay (CE IVD Predictive) 08008540001 VENTANA PD-L1 (SP142) IHC Assay (CE IVD Analytical) 07011571001
Ventana Medical Systems
Class I - Dangerous
Internal comparison studies revealed unacceptable, light staining. Light staining affects the borderline of positive versus negative test results. It can cause a reduction in both staining intensity and the percent positivity, which could potentially lead to a false-negative PD-L1 result.
BD Pyxis MedBank System - Product Label/labeling pending
CareFusion 303
Class I - Dangerous
Due to customer complaints related to the MedBank software which may indicate that a different medication is loaded in a cubie (drawer) pocket than what is physically loaded and listed on the pocket label. As a result of this issue, a patient could receive the wrong medication or wrong dose of medication that could lead to patient harm.
7.5 cm Large Craniotome Attachment Use with XMax¿, microMax, and eMax¿ Systems. Ref: CRANI-L Intended for cutting and shaping bone including the spine and cranium
The Anspach Effort
Class I - Dangerous
Ball bearings in the CRANI-A (ANSPACH Power Tools Adult Craniotome Attachment) came out of the attachment, possibly during removal of the attachment, intra-operatively. Failure to follow the recommended inspection intervals provided in the IFU may result in serious patient injury
Philips Trilogy 200 Ventilator, Model Numbers 1040005, U1040005, 1040005B, U1040005B, CA1032800B, CA1032800, KO1032800, 1032800, R1032804TP, R1032804B, R1032804TPV, 1032804B
Philips Respironics
Class I - Dangerous
The replacement silicone sound abatement foam installed into some Trilogy 100 and Trilogy 200 devices may separate from the plastic backing to which it is attached. If this were to happen, the foam could potentially block air inlet, which could result in a reduction in delivered therapy volume or pressure and could cause the device to alarm.
Class I - Dangerous
Ball bearings in the CRANI-A (ANSPACH Power Tools Adult Craniotome Attachment) came out of the attachment, possibly during removal of the attachment, intra-operatively. Failure to follow the recommended inspection intervals provided in the IFU may result in serious patient injury
Class I - Dangerous
Ball bearings in the CRANI-A (ANSPACH Power Tools Adult Craniotome Attachment) came out of the attachment, possibly during removal of the attachment, intra-operatively. Failure to follow the recommended inspection intervals provided in the IFU may result in serious patient injury
Class I - Dangerous
Ball bearings in the CRANI-A (ANSPACH Power Tools Adult Craniotome Attachment) came out of the attachment, possibly during removal of the attachment, intra-operatively. Failure to follow the recommended inspection intervals provided in the IFU may result in serious patient injury
Class I - Dangerous
All lots of BIOSTOP G Bioresorbable Cement Restrictor are being removed as a precautionary measure because tested endotoxin levels were higher than recommended by the current FDA regulatory guidance. In general, endotoxins have a potential to initiate inflammatory responses, ranging from a mild fever to potentially impact or damage to vital organs.
Potential of the blade puncturing the outer foil layer causing a breach in the sterile packaging.
Adult Craniotome Ref: CRANI-A-G1 Intended for cutting and shaping bone including the spine and cranium
The Anspach Effort
Class I - Dangerous
Ball bearings in the CRANI-A (ANSPACH Power Tools Adult Craniotome Attachment) came out of the attachment, possibly during removal of the attachment, intra-operatively. Failure to follow the recommended inspection intervals provided in the IFU may result in serious patient injury
Black specks may be present on the packaged needles
Class I - Dangerous
Potential for Functional Sensitivity to not meet Instructions For Use (IFU) claims with the kit lots; control level one may result outside of published ranges; when control results are in range, users may observe increased imprecision with low level patient samples
Philips Fetal Spiral Electrode-intended for patients requiring fetal heart rate monitoring during labor. PN: 989803137631
Philips North America
Class I - Dangerous
Fetal Spiral Electrode (FSE) spiral tip of the FSE breaking off during use and requiring surgical intervention to remove the broken tip from the neonate patient. Philips has decided to discontinue the distribution of this product.
Philips Garbin Ventilator, Model Number 1058180B
Philips Respironics
Class I - Dangerous
The replacement silicone sound abatement foam installed into some Trilogy 100 and Trilogy 200 devices may separate from the plastic backing to which it is attached. If this were to happen, the foam could potentially block air inlet, which could result in a reduction in delivered therapy volume or pressure and could cause the device to alarm.
Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems for pain therapy, Model Number CT900A
Medtronic Neuromodulation
Class I - Dangerous
Software anomalies, CP App messages: "Too Many Device Found", "Unexpected Device Error Code 1502", and "System Update Needed, Service Code 303"
HCT 500mL BAGS, 2 Port, Sterile, Triple Packaged, 10 EVA BAGS/Pack, 7 Packs PER CASE. Distributed by Health Care Technology.
Stradis Healthcare
Class I - Dangerous
Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.
HCT CENTRAL LINE Insertion Tray, I2 per case. Distributed by Health Care Technology
Stradis Healthcare
Class I - Dangerous
Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.