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
Medline Convenience kits containing recalled Swan-Ganz Catheters recall: Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has
Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of leaks/breakage involving failures of the (blue)…
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Class I · 4 months ago
Insulet Corporation Omnipod 5 Pods. Includes the below Model/REF Numbers: 1 recall: External soft cannula damage during manufacturing that results in insulin
External soft cannula damage during manufacturing that results in insulin leaking around the Pod instead of being delivered to the user regardless of…
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Class II · 4 months ago
Carl Zeiss Meditec AG Zeiss Intrabeam Spherical Applicator 1.5 cm REF:304534-6000-557 recall: Spherical applicators (radiation therapy accessory) failed to meet
Spherical applicators (radiation therapy accessory) failed to meet manufacturing specifications.
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Class II · 4 months ago
Medline Convenience kits containing recalled Swan-Ganz Catheters Open recall: Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has
Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of leaks/breakage involving failures of the (blue)…
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Class II · 4 months ago
Medline Convenience Kits: 1) Imaging Biopsy Tray recall: The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules
The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd…
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Class II · 4 months ago
Medline Convenience Kits: 1) STD, Intro-Flex Introducer 6F, C recall: The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules
The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd…
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Class II · 4 months ago
Bard Access Systems, Inc. 5855240 Power-Trialysis Slim-Cath Straight Short-Term recall: Due to lidocaine ampoules being manufactured under deficient manufacturing
Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled…
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Class II · 4 months ago
Masimo Corporation Radius VSM ECG pre-connected Set, REF: 4842, 4695 recall: Two devices recalled: 1) Electrocardiogram (ECG) electrode assembly ECG
Two devices recalled: 1) Electrocardiogram (ECG) electrode assembly ECG feature may incorrectly detect extreme bradycardia, tachycardia and trigger…
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Class II · 4 months ago
Medline Convenience Kits: 1) Suture Tray recall: The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules
The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd…
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Class II · 4 months ago
Teleflex LLC Brand Name: Pilling Wecksorb Product Name: Pilling Wecksorb recall: Due to out-of-specification, or potential out-of-specification
Due to out-of-specification, or potential out-of-specification, levels of endotoxins
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Class II · 4 months ago
Boston Scientific Corporation CRE Pro Wireguided 12-15mm 240cm recall: Potential sterile breach of the pouches in which devices are packaged
Potential sterile breach of the pouches in which devices are packaged.
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Class II · 4 months ago
Medline Convenience kits containing recalled Swan-Ganz Catheters recall: Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has
Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of leaks/breakage involving failures of the (blue)…
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Class II · 4 months ago
Bard Access Systems, Inc. CK000495A Poly Midline Catheter 4 Fr Single-Lumen UDI-DI recall: Due to lidocaine ampoules being manufactured under deficient manufacturing
Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled…
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Class II · 4 months ago
Raysearch Laboratories Ab RayCare 2024A SP1. Oncology Information Systems recall: Beam set delivery note issues in which there is potential data loss
Beam set delivery note issues in which there is potential data loss if the beam set delivery note is modified simultaneously and/or if a note is…
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Class II · 4 months ago
Medline Convenience kits containing recalled Swan-Ganz Catheters KIT recall: Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has
Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of leaks/breakage involving failures of the (blue)…
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Class II · 4 months ago
Remel, Inc GC Agar Base 10/PK R04030 recall: Reduced or no recovery of some strains of Neisseria gonorrhoeae
Reduced or no recovery of some strains of Neisseria gonorrhoeae.
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Class II · 4 months ago
Philips Telemetry Monitor 5500 1.4 GHz recall: Potential for device reset to default "NEW_DEVICE" state
Potential for device reset to default "NEW_DEVICE" state, which may lead to a to loss of device configuration and the equipment label, resulting in a…
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Class II · 4 months ago
Zimmer, Inc. Off-Axis Comprehensive Shoulder System, Large, 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, 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
Surgify Halo, 40 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
Zimmer, Inc. Off-Axis Comprehensive Shoulder System Small, Augment, Off-Axis 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
Acumed Hexalob Screw various sizes: REF Numbers: : 3070-27008 2.7mm x recall: Due to manufacturing error, hexalobe screws used with wrist fixation system
Due to manufacturing error, hexalobe screws used with wrist fixation system may break during use.
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Class II · 4 months ago
Zimmer, Inc. Off-Axis Alliance Glenoid, Left, 4-Peg, Augment, Reamer Guide, Model/ 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
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.