Medical devices recalls
Implants, monitors, test kits and hospital equipment corrected or removed from the market.
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Class II · 4 months ago
Surgify Halo, 4.0 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 I · 4 months ago
Abiomed Impella CP Set with SmartAssist containing affected 14Fr Low 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
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
Ventec Life Systems, Inc. VOCSN+Pro package, REF: PRT-00853-000 recall: Respiratory system intended to provide continuous/intermittent ventilator
Respiratory system intended to provide continuous/intermittent ventilator support, may have a damaged back-up battery supporting backup alarm…
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Class II · 4 months ago
Zimmer, Inc. Off-Axis Comprehensive Shoulder System, Medium, Augment recall: Five complaints have been received identifying issues where the plastic
Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.
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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
Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product recall: Certain lots of Dexcom G7 sensors originally designated as scrap and intended
Certain lots of Dexcom G7 sensors originally designated as scrap and intended for destruction were stolen during the destruction process. The sensors…
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Class II · 4 months ago
Surgify Halo, 5.4 mm, Medium, 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 convenience kits: Port A Cath Dynj906818A recall: Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive
Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable…
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Class II · 4 months ago
Medline convenience kits: Loop Pack Dynj61460C Open Heart CDS840150Y recall: Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive
Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable…
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Class II · 4 months ago
Beta Bionics, Inc. iLet Bionic Pancreas, REF: BB1001 recall: The reason for the recall is: it was found in version 3.3.6 of the iLet ACE
The reason for the recall is: it was found in version 3.3.6 of the iLet ACE Pump firmware and all previous releases that a screen unlock failure…
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Class II · 4 months ago
Medline convenience kits: 20CM CVC Insertion KIT Ecvc6805B 2L 8.5FR recall: Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive
Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable…
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Class II · 4 months ago
Medline Medical Procedure Kits labeled as: Adult Tracheostomy Tube recall: During an internal review, Medline identified representative samples did
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include…
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Class II · 4 months ago
Steris Corporation ALYON Surgical Lighting System recall: The the plus and minus buttons (+/-) used to control light intensity
The the plus and minus buttons (+/-) used to control light intensity on the light heads may detach.
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Class I · 4 months ago
Arrow International, LLC Description/REF: Agba Picc G4 Stylet: 3L 6FR x 55CM recall: Lidocaine, Bupivacaine, and 0.9% sodium chloride
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have…
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Class II · 4 months ago
Accriva Diagnostics, Inc. directCHECK ACT-LR whole blood quality control recall: Assayed Whole blood control contains labeling with incorrect performance range
Assayed Whole blood control contains labeling with incorrect performance range.
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Class I · 4 months ago
Arrow International, LLC Description/REF: Hemodialysis KIT: 2-Lumen 8 FR X 11 recall: Lidocaine, Bupivacaine, and 0.9% sodium chloride
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have…
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Class I · 4 months ago
Arrow International, LLC Description/REF: PI CVC KIT: 3L 7 FR X 16 CM recall: Lidocaine, Bupivacaine, and 0.9% sodium chloride
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have…
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Class II · 4 months ago
Medline convenience kits: Basic EYE Dynj905154I Tubal Ligation CDS recall: Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive
Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable…
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Class II · 4 months ago
Medline convenience kit: KIT: Dressing Change PED Dyndc3359 recall: Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive
Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable…
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Class II · 4 months ago
ConMed AirSeal 12mm Access Port and Palm Grip Obturator with Bladeless recall: Potential for overpressure alerts
Potential for overpressure alerts.
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Class II · 4 months ago
GE Medical Systems, LLC Giraffe OmniBed Carestations and Giraffe OmniBed Carestation recall: GE HealthCare has become aware of a potential issue involving the canopy
GE HealthCare has become aware of a potential issue involving the canopy soffit beneath the control panel end of the device. Under certain…
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Class II · 4 months ago
Medline Medical Procedure Kits labeled as: KIT URO Robot Cystectomy recall: During an internal review, Medline identified representative samples did
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include…