Browse Device Recalls
4,686 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 4,686 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.
Medical Device Recalls
Browse 4,686 FDA device recalls in CA.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Oct 12, 2022 | Superion¿ Indirect Decompression System (IDS) Model Numbers and Size: 101... | Due to Indirect Decompression System devices exhibiting a potential for weld breakage at the spin... | Class II | Boston Scientific Neuromodulation Corporation |
| Oct 7, 2022 | INTUITIVE Da Vinci Xi 8mm SureForm 30 Curved-Tip Stapler Da Vinci Xi|X REF 48... | Potential staple deployment failure and device fragment generation | Class II | Intuitive Surgical, Inc. |
| Oct 6, 2022 | Fogarty Biliary Balloon Probes Model Number: 410235FP 410405FP 410236FP | Due to an increase of confirmed latex deterioration complaints for arterial embolectomy catheters... | Class II | Edwards Lifesciences, LLC |
| Oct 6, 2022 | Fogarty Arterial Embolectomy Catheters Model Number: 120602FP 120403FP 12... | Due to an increase of confirmed latex deterioration complaints for arterial embolectomy catheters... | Class II | Edwards Lifesciences, LLC |
| Oct 3, 2022 | BD Trucount Tubes (Cat. No. 340334), used for determining absolute counts of ... | Due to partial label detachment on tubes. This can cause tubes to become stuck together in the po... | Class II | Becton, Dickinson and Company, BD Biosciences |
| Oct 3, 2022 | BD Trucount Tubes (Cat. No. 663028), used for determining absolute counts of ... | Due to partial label detachment on tubes. This can cause tubes to become stuck together in the po... | Class II | Becton, Dickinson and Company, BD Biosciences |
| Oct 3, 2022 | MicroScan autoSCAN-4 Instrument, Catalog Number B1018-280 | Due to MicroScan autoSCAN-4 Instruments being manufactured with an incorrect diffuser plate. | Class II | Beckman Coulter, Inc. |
| Oct 3, 2022 | BD Multitest 6-Color TBNK with optional BD Trucount Tubes (Cat. No. 662995), ... | Due to partial label detachment on tubes. This can cause tubes to become stuck together in the po... | Class II | Becton, Dickinson and Company, BD Biosciences |
| Sep 29, 2022 | Canon Aplio ultrasound system, Model: Aplio i900 TUS-AI900, Aplio i800 TUS-AI... | After completion, ultrasound system's Stress Echo may not terminate if user does not manually ter... | Class II | Canon Medical System, USA, INC. |
| Sep 28, 2022 | Zio AT Clinical Reference Manual, Part: ALB0031, and Zio AT Important Informa... | Ambulatory ECG monitoring system labeling update: 1) Clinically actionable arrhythmia notificatio... | Class II | iRhythm Technologies, Inc. |
| Sep 22, 2022 | AutoPulse Li-ion Battery used on the AutoPulse Resuscitation System Model 100... | Due to increase in Li-Ion Battery failures | Class II | ZOLL Circulation, Inc. |
| Sep 21, 2022 | WEB Detachment Controller, REF: WDC-2, WDC, MV-WDC2. Component of WEB Aneury... | Detachment controller, of an aneurysm embolization system, has an out of specification tunnel ope... | Class II | MICROVENTION INC. |
| Sep 20, 2022 | Insulin Pump/Model: MiniMed 630G/ MMT-1715, MMT-1755, MMT-1754; MiniMed 67... | Medtronic identified a cybersecurity vulnerability in the MiniMed 600 series Insulin Pump Systems... | Class II | Medtronic MiniMed |
| Sep 20, 2022 | Insulin Pump/Model: MiniMed 620G/ MMT-1750 MiniMed 640G/ MMT-1711, MMT-1712... | Medtronic identified a cybersecurity vulnerability in the MiniMed 600 series Insulin Pump Systems... | Class II | Medtronic MiniMed |
| Sep 20, 2022 | da Vinci X (IS4200) and Xi (IS4000) systems, which consists of finished devic... | Inadvertent energy delivery from surgical system instrument if 1) Force bipolar and bipolar instr... | Class II | Intuitive Surgical, Inc. |
| Sep 14, 2022 | Disc Preparation instruments contained in the following products: CI-11050-0... | Due to manufacturing instruments which included additional features and adequate consideration wa... | Class II | Alphatec Spine, Inc. |
| Sep 8, 2022 | Product/Part: MitraClip G4 CDS NT REPAIR-MR Clinical/CDS0704-NT, MitraClip G... | An increase in clip locking malfunctions, Establish Final Arm Angle and Clip Opening While Locked... | Class II | Abbott Vascular |
| Sep 8, 2022 | Product/Part: MitraClip NTR Clip Delivery System US/CDS0601-NTR, MitraClip N... | An increase in clip locking malfunctions, Establish Final Arm Angle and Clip Opening While Locked... | Class II | Abbott Vascular |
| Sep 8, 2022 | Product/Part: MitraClip XTR Clip Delivery System US/CDS0601-XTR, MitraClip G... | An increase in clip locking malfunctions, Establish Final Arm Angle and Clip Opening While Locked... | Class II | Abbott Vascular |
| Sep 7, 2022 | Optima Coil System Model Number OPTI0208CSS10, Model Number OPTI0308... | Product pouch label does not match up with carton label | Class II | BALT USA, LLC |
| Sep 7, 2022 | THERMOCOOL SMARTTOUCH SF Bi-Directional Navigation Catheter, REF: D-1348-05-S... | Manufacturing error resulted in potential contamination of Bi-Directional navigation catheter irr... | Class II | Johnson & Johnson Surgical Vision, Inc. |
| Sep 2, 2022 | Clip COVID Rapid Antigen Test Kit (25-pack), Catalog Number: MDL002 | COVID test kit shelf life was periodically extended, as real-time stability test timepoints passe... | Class II | LUMINOSTICS, INC dba CLIP HEALTH |
| Sep 1, 2022 | Veritas Advanced Infusion Packs. Used in ophthalmic procedures. | As a result of returned product complaints for Veritas Phaco packs related to broken or cracked i... | Class II | Johnson & Johnson Surgical Vision, Inc. |
| Aug 29, 2022 | OSSUR Power Knee REF PKA10003 OSSUR Power Knee REF PKA10003 OSSUR Power... | Battery may dislodge from the Power Knee | Class II | Ossur Americas |
| Aug 1, 2022 | BD MaxGuard Extension Set, REF: ME1069 | Administration set, and extension set product labels list expiration year 2027 but the labels sho... | Class II | CAREFUSION |
| Aug 1, 2022 | BD MaxGuard Extension Set with 4-way stopcock, REF: M4058 | Administration set, and extension set product labels list expiration year 2027 but the labels sho... | Class II | CAREFUSION |
| Aug 1, 2022 | BD MaxGuard Extension Set with 2 Needleless Y-Site, REF: MX9059 | Administration set, and extension set product labels list expiration year 2027 but the labels sho... | Class II | CAREFUSION |
| Aug 1, 2022 | 6.5" (17 cm) Appx 0.84 ml, Smallbore Bifuse Ext Set w/2 MicroClave Clear, 2 C... | Due to a manufacturing defect which results in a visible gap between the connector's top and bott... | Class II | ICU Medical, Inc. |
| Aug 1, 2022 | BD MaxGuard Extension Set with 0.2 Micron Filter and Needleless Y-Site, REF: ... | Administration set, and extension set product labels list expiration year 2027 but the labels sho... | Class II | CAREFUSION |
| Aug 1, 2022 | BD MaxGuard Flow Controller Extension Set with Needleless Y-Site, REF: MFS106 | Administration set, and extension set product labels list expiration year 2027 but the labels sho... | Class II | CAREFUSION |
| Aug 1, 2022 | 8.5" (22 cm) Appx 0.85 ml, Bifuse Pressure Infusion (400 psig) Ext Set w/2 Re... | Due to a manufacturing defect which results in a visible gap between the connector's top and bott... | Class II | ICU Medical, Inc. |
| Aug 1, 2022 | The product is a handheld ultraviolet-C germicidal wand and contains two, nar... | Excessive ultraviolet-C radiation | Class II | MERCHSOURCE LLC |
| Aug 1, 2022 | BD MaxGuard Flow Controller Extension Set with Needleless Y-Site, REF: MFS141 | Administration set, and extension set product labels list expiration year 2027 but the labels sho... | Class II | CAREFUSION |
| Aug 1, 2022 | BD MaxGuard Extension Set with 1.2 Micron Filter and Needleless Y-Site, REF: ... | Administration set, and extension set product labels list expiration year 2027 but the labels sho... | Class II | CAREFUSION |
| Aug 1, 2022 | MicroClave Clear Neutral Connector. A bidirectional connector used as an acce... | Due to a manufacturing defect which results in a visible gap between the connector's top and bott... | Class II | ICU Medical, Inc. |
| Aug 1, 2022 | 6" (15 cm) Appx 0.85 ml, Smallbore Trifuse Ext Set w/3 MicroClave Clear, 2 Ch... | Due to a manufacturing defect which results in a visible gap between the connector's top and bott... | Class II | ICU Medical, Inc. |
| Aug 1, 2022 | MicroClave Clear Neutral Connector; MicroClave Clear Connector; MicroCl... | Due to a manufacturing defect which results in a visible gap between the connector's top and bott... | Class II | ICU Medical, Inc. |
| Aug 1, 2022 | BD MaxGuard 15 Drop Administration Set with 4 Needleless Y-Sites, REF: MX9433 | Administration set, and extension set product labels list expiration year 2027 but the labels sho... | Class II | CAREFUSION |
| Aug 1, 2022 | BD MaxGuard Drop Administration set with 3 Needleless Y-Sites Removable 3-por... | Administration set, and extension set product labels list expiration year 2027 but the labels sho... | Class II | CAREFUSION |
| Aug 1, 2022 | 6.5 IN (17 cm) APPX 0.78 ml, EXT SET w/Clave CLEAR, Clave 4-WAY Stopcock, Spi... | Due to a manufacturing defect which results in a visible gap between the connector's top and bott... | Class II | ICU Medical, Inc. |
| Jul 26, 2022 | Optima Coil System Model OPTI0520CSF10. For endovascular embolization. | Products were released to customers prior to the approval and release of a test report authorizin... | Class II | BALT USA, LLC |
| Jul 19, 2022 | NuVasive MD Pulse III Multimodality System REF 1881500 Pulse Software vers... | Due to an incorrect security key, customers were unable to connect to remote monitoring during sp... | Class III | NuVasive Inc |
| Jul 5, 2022 | ZAP-X Radiosurgery System | Software issue identified in cases of initial patient setup with large (greater-than-or-equal-to ... | Class II | Zap Surgical Systems |
| Jul 1, 2022 | Da Vinci X/Xi Large Clip Applier, Model 470230 Da Vinci X/Xi Medium-Large Cl... | Due to the potential for unexpected motion caused by the partial disengagement of the instrument ... | Class II | Intuitive Surgical, Inc. |
| Jul 1, 2022 | Da Vinci S/Si Large Clip Applier, Model 420230 Da Vinci S/Si Medium-Large Cl... | Due to the potential for unexpected motion caused by the partial disengagement of the instrument ... | Class II | Intuitive Surgical, Inc. |
| Jun 30, 2022 | Echelon -14 Micro Catheter, REF: 105-5092-150, sterile EO, Rx Only | Outer carton packaging of microcatheters were exposed to wet substance during transport. | Class II | Micro Therapeutics, Inc. |
| Jun 30, 2022 | Echelon -14, 45 Tip Shape, REF 145-5092150, sterile EO, Rx Only | Outer carton packaging of microcatheters were exposed to wet substance during transport. | Class II | Micro Therapeutics, Inc. |
| Jun 29, 2022 | CARTO VIZIGO 8.5F Bi-Directional Guiding Sheath, REF: D138501. Used to intro... | Outside packaging for a device indicated for introducing cardiovascular catheters into the heart,... | Class II | Biosense Webster, Inc. |
| Jun 27, 2022 | Product Description/Item: ChemoLock Vial Spike, 20mm/011-CL-80S; ChemoLock B... | Ports have a potential for unintended disconnection, inability to connect to or fully engage with... | Class II | ICU Medical, Inc. |
| Jun 27, 2022 | Product Description/Item: ChemoLock Bag Spike, 10 units/CL-10-10; ChemoLock ... | Ports have a potential for unintended disconnection, inability to connect to or fully engage with... | Class II | ICU Medical, Inc. |
Frequently Asked Questions
When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.
All types, from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.
Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.