Medical devices recalls
Implants, monitors, test kits and hospital equipment corrected or removed from the market.
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Class II · 3 months ago
Instrumentation Laboratory Brand Name: GEM Premier 5000 Product Name: GEM Premier recall: Potential for Bar Code Reader (BCR) wands, used with the GEM Premier 5000
Potential for Bar Code Reader (BCR) wands, used with the GEM Premier 5000 and GEM Premier 7000 systems, to assign patient results to an incorrect…
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Class II · 3 months ago
Windstone Medical Packaging, Inc. AMS Aligned Medical Solutions medical convenience recall: Windstone Medical Packaging recalled specific items and lots of AMS
Windstone Medical Packaging recalled specific items and lots of AMS convenience kits containing Elevaris Lidocaine HCl injection USP. Elevaris…
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Class II · 3 months ago
Windstone Medical Packaging, Inc. AMS Aligned Medical Solutions medical convenience recall: Windstone Medical Packaging recalled specific items and lots of AMS
Windstone Medical Packaging recalled specific items and lots of AMS convenience kits containing Elevaris Lidocaine HCl injection USP. Elevaris…
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Class II · 3 months ago
Olympus 4K UHD LCD Monitor recall: Potential for the HDMI and DisplayPort (DP) connectors can become faulty
Potential for the HDMI and DisplayPort (DP) connectors can become faulty resulting in image loss or image abnormalities.
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Class I · 3 months ago
Medline convenience kits labeled as: 1) Total Joint KIT recall: Medline Industries, LP is issuing a recall for specific Medline kits
Medline Industries, LP is issuing a recall for specific Medline kits containing B. Braun convenience kits that include Bupivacaine Hydrochloride in…
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Class II · 3 months ago
Boston Scientific Corporation Faradrive Steerable Sheath - US recall: Boston Scientific's complaint investigations have identified that a subset
Boston Scientific's complaint investigations have identified that a subset of air ingress complaints are associated with hemostatic valve damage…
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Class II · 3 months ago
Boston Scientific Corporation Faradrive Steerable Sheath Clear IDE recall: Boston Scientific's complaint investigations have identified that a subset
Boston Scientific's complaint investigations have identified that a subset of air ingress complaints are associated with hemostatic valve damage…
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Class II · 3 months ago
Medline medical convenience kits labeled as: Neuro Pack recall: Medline Industries, LP is issuing a recall for specific Medline convenience
Medline Industries, LP is issuing a recall for specific Medline convenience kits containing BD PurPrep 26 mL which may be contaminated with low…
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Class II · 3 months ago
Prismatik Dentalcraft, Inc. Brand Name: Silent Nite Product Name: Silent Nite Sleep recall: Due to device not having FDA Clearance
Due to device not having FDA Clearance
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Class II · 3 months ago
PIE Medical Imaging B.V. 3mensio Workstation software recall: User measurement value reported by diagnostic bioimaging software intended
User measurement value reported by diagnostic bioimaging software intended to measure/visualize cardiovascular structures may be larger (0.8% to…
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Class II · 3 months ago
SeaSpine Polyaxial Head REF Number: 41-3010 recall: Due to manufacturing error, polyaxial head may popoff from the screw
Due to manufacturing error, polyaxial head may popoff from the screw intraoperatively following insertion.
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Class II · 3 months ago
Boston Scientific Corporation Faradrive Steerable Sheath Clear OUS recall: Boston Scientific's complaint investigations have identified that a subset
Boston Scientific's complaint investigations have identified that a subset of air ingress complaints are associated with hemostatic valve damage…
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Class II · 3 months ago
Emano Flow with software version v2.0.0 GS1 GTIN code: 199874903484 recall: Problem description/Reason for recall: During the period March 22, 2026
Problem description/Reason for recall: During the period March 22, 2026, to May 29, 2026, recorded urination audio was captured at 48,000 Hz while…
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Class II · 3 months ago
Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters 5cc recall: Affected kits contain recalled Bard Silastic Foley Catheters. Catheters
Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to increased amount of raw material present…
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Class II · 3 months ago
Boston Scientific TheraSphere 360 Y-90 Management Platform recall: Software anomaly occurs when a user adds one or more vials to the cart
Software anomaly occurs when a user adds one or more vials to the cart and subsequently returns to the Activity Calculator to modify one or more…
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Class II · 3 months ago
Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters 5cc recall: Affected kits contain recalled Bard Silastic Foley Catheters. Catheters
Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to increased amount of raw material present…
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Class II · 3 months ago
Olympus High Flow Insufflation Unit - UHI-4 recall: Potential for unexpected instances where the front panel display turns off
Potential for unexpected instances where the front panel display turns off unexpectedly, and air delivery (insufflation) ceases.
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Class I · 3 months ago
Medline medical procedure convenience kit labeled as: HIP CDS-LF recall: The procedure kits contain ICU Medical, Inc. pain management kits containing
The procedure kits contain ICU Medical, Inc. pain management kits containing Bupivacaine Hydrochloride in Dextrose Injection, USP, which were…
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Class II · 3 months ago
Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters 5cc recall: Affected kits contain recalled Bard Silastic Foley Catheters. Catheters
Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to increased amount of raw material present…
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Class II · 3 months ago
Micro Therapeutics, Inc. Pipeline Flex Embolization Device with Shield Technology recall: Incorrect labeling - embolization devices labeled as 3.0 mm x 20 mm implants
Incorrect labeling - embolization devices labeled as 3.0 mm x 20 mm implants contain 12 mm implants, and devices labeled as 3.0 mm x 12 mm implants…
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Class II · 3 months ago
Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters 5cc recall: Affected kits contain recalled Bard Silastic Foley Catheters. Catheters
Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to increased amount of raw material present…
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Class II · 3 months ago
Medline medical convenience kits labeled as: 1) KIT Pediatric Open recall: Medline Industries, LP is issuing a recall for specific Medline convenience
Medline Industries, LP is issuing a recall for specific Medline convenience kits containing BD PurPrep 26 mL which may be contaminated with low…
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Class II · 3 months ago
Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters 5cc recall: Affected kits contain recalled Bard Silastic Foley Catheters. Catheters
Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to increased amount of raw material present…
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Class I · 3 months ago
Medline convenience kits labeled as: 1) C-Section recall: Medline Industries, LP is issuing a recall for specific Medline kits
Medline Industries, LP is issuing a recall for specific Medline kits containing B. Braun convenience kits that include Bupivacaine Hydrochloride in…