Latest recalls — page 75
Older notices, newest first.
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Class II · 4 months ago
GE Medical Systems SCS GE Healthcare AW Server 3.2 ext.6.5 recall: GE HealthCare has become aware of a context synchronization issue in AW
GE HealthCare has become aware of a context synchronization issue in AW Server 3.2 ext. 6.5. When a user selects a patient or exam in the AW Server…
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Class II · 4 months ago
Medline Industries, LP Convenience kits containing select SKUs of 10mL Polycarbonate recall: Firm identified unapproved design changes to the products outside
Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.
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Class II · 4 months ago
Surgify Halo, 5.4 mm, Long, Model/ recall: Potential for burr breakage, occurring during bi-portal endoscopic spinal
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
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Class II · 4 months ago
Medline Industries, LP Convenience kits containing select SKUs of 10mL Polycarbonate recall: Firm identified unapproved design changes to the products outside
Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.
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Class I · 4 months ago
Medline Convenience Kits: 1) Drawer 6A Adult Central Line recall: The Medline Convenience Kits contain Arrow Kits and Sets that include
The Medline Convenience Kits contain Arrow Kits and Sets that include Lidocaine Hydrochloride Injection, USP and Bupivacaine Hydrochloride in…
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Class II · 4 months ago
Medline Industries, LP Convenience kits containing select SKUs of 10mL Polycarbonate recall: Firm identified unapproved design changes to the products outside
Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.
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Class II · 4 months ago
Medline Industries, LP Convenience kits containing select SKUs of 10mL Polycarbonate recall: Firm identified unapproved design changes to the products outside
Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.
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Class II · 4 months ago
Medline Industries, LP Convenience kits containing select SKUs of 10mL Polycarbonate recall: Firm identified unapproved design changes to the products outside
Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.
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Class II · 4 months ago
Surgify Halo, 4.0 mm, Extendable, Model/ recall: Potential for burr breakage, occurring during bi-portal endoscopic spinal
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
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Class II · 4 months ago
Pfm Medical Inc. Multi-Snare Set: 5 mm x 125 cm, REF: 147305 recall: A snare catheter including luer lock, indicated for removal or manipulation
A snare catheter including luer lock, indicated for removal or manipulation of a foreign body in the vascular system, failed to meet the…
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Class I · 4 months ago
Medline Convenience Kits: 1) DYNJ905503F recall: The Medline Convenience Kits contain Arrow Kits and Sets that include
The Medline Convenience Kits contain Arrow Kits and Sets that include Lidocaine Hydrochloride Injection, USP and Bupivacaine Hydrochloride in…
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Class II · 4 months ago
Medline Industries, LP Convenience kits containing select SKUs of 10mL Polycarbonate recall: Firm identified unapproved design changes to the products outside
Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.
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Class II · 4 months ago
Surgify Halo, 3.0 mm, Long, Model/ recall: Potential for burr breakage, occurring during bi-portal endoscopic spinal
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
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Class I · 4 months ago
Abiomed 14 Fr x 13 cm Low Profile Introducer Kit for Impella CP recall: Potential for thrombus formation during prolonged use of the introducer
Potential for thrombus formation during prolonged use of the introducer.
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Class II · 4 months ago
Zimmer, Inc. Brand Name: Persona Revision Product Name: Persona Revision¿ Trabecular recall: Firm received a complaint with no clinical impact in which a posterior
Firm received a complaint with no clinical impact in which a posterior augment was found within the distal augment package.
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Class II · 4 months ago
IPG Medical Corporation Thuvera Laser Console. Software Version 2.2. Portable Thulium recall: Software anomaly that causes a false display of error code 5018
Software anomaly that causes a false display of error code 5018.
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Class II · 4 months ago
Boston Scientific Corporation Intera Oncology Intera 3000 Hepatic Artery Infusion Pump recall: There is the potential for leakage along the drug pathway from the pump
There is the potential for leakage along the drug pathway from the pump through the end of the catheter.
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Class II · 4 months ago
Medline Industries, LP Convenience kits containing select SKUs of 10mL Polycarbonate recall: Firm identified unapproved design changes to the products outside
Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.
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Class II · 4 months ago
Surgify Halo, 5.4 mm, Short, Model/ recall: Potential for burr breakage, occurring during bi-portal endoscopic spinal
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
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Class II · 4 months ago
Medtronic Perfusion Systems Octopus 4 Tissue Stabilizer, Model 29400 recall: During the manufacturing process, Medtronic personnel identified an assembly
During the manufacturing process, Medtronic personnel identified an assembly issue where the tubing was incorrectly positioned. The short tube was…
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Class II · 4 months ago
Intuitive Surgical, Inc. Da Vinci ASSY, PSS, SP1098 recall: Operative components of surgical systems potentially distributed with E-brake
Operative components of surgical systems potentially distributed with E-brake retainer pin, so in event of a structural column failure, the E-brake…
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Class II · 4 months ago
Stryker Neurovascular Inzone Detachment System, REF: M00345100950 recall: Embolization coil detachment system devices may experience premature battery
Embolization coil detachment system devices may experience premature battery drain causing devices to: 1) Not power on; 2) Power on with faint…
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Class II · 4 months ago
Surgify Halo, 5.4 mm, Extendable, Model/ recall: Potential for burr breakage, occurring during bi-portal endoscopic spinal
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
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Class I · 4 months ago
Abiomed 14 Fr x 25 cm Low Profile Introducer Kit for Impella CP recall: Potential for thrombus formation during prolonged use of the introducer
Potential for thrombus formation during prolonged use of the introducer.