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 |
|---|---|---|---|---|
| Apr 19, 2019 | IntelliSpace PACS 4.4, Product number 837507 - Product Usage: intended to be ... | Images may potentially become corrupt while using the system. | Class II | Philips Healthcare Informatics, Inc. |
| Apr 19, 2019 | Monarch, Aspirating Biopsy Needle, REF: MBR-000012, Rx Only, UDI: B634MBR0000120 | Reports of aspirating biopsy needle breakage | Class II | AURIS HEALTH INC |
| Apr 18, 2019 | Stryker Neurovascular, AXS Infinity LS Plus Long Sheath, Rx Only, Sterile EO,... | A design related issue can contribute to the device exhibiting brittle behavior. This behavior ma... | Class II | Stryker Neurovascular |
| Apr 11, 2019 | da Vinci Xi Surgical System, IS4000 - Product Usage: The da Vinci Xi surgical... | Failure of Universal Surgical Manipulators due to a high friction points, resulting in an increas... | Class II | Intuitive Surgical Inc |
| Apr 11, 2019 | da Vinci X Surgical System, IS4200 - Product Usage: The da Vinci Xi surgical ... | Failure of Universal Surgical Manipulators due to a high friction points, resulting in an increas... | Class II | Intuitive Surgical Inc |
| Apr 10, 2019 | Stryker Neurovascular, AXS Vecta 74 Aspiration Catheter, Ref. Catalog No. INC... | The firm has become aware of a potential problem that their Catheters may break/fracture and/or k... | Class II | Stryker Neurovascular |
| Apr 10, 2019 | Stryker Neurovascular, AXS Vecta 71 Aspiration Catheter, Ref. Catalog No. INC... | The firm has become aware of a potential problem that their Catheters may break/fracture and/or k... | Class II | Stryker Neurovascular |
| Apr 9, 2019 | Quidel Triage TOX Drug Screen Control 1 Kit Box containing 5 Control 1 vial... | Due to an error in the programming of the Control CODE CHIP module for this lot, a failing result... | Class II | QUIDEL CARDIOVASCULAR INC |
| Apr 4, 2019 | SoundWave Professional Suite Software 3.2, Ref CI-6055-014, SPN 058-023-32085... | The manufacturer received complaints that customers were attempting to install the fitting softwa... | Class III | Advanced Bionics, LLC |
| Apr 3, 2019 | Autoimmune EIA Anti-Tissue Transglutaminase (tTG) IgA Test; Material Number 4... | An elevated lot-to-lot bias was observed for Autoimmune EIA Anti-Tissue Transglutaminase (tTG) Ig... | Class II | Bio-Rad Labs |
| Apr 2, 2019 | Maestro Orthodontic Bracket REF711-206-10 QTY. 10 Rx Only (01)0019070701651... | Orthodontic Bracket is mislabeled | Class II | Ortho Organizers, Inc. |
| Apr 2, 2019 | Maestro Orthodontic Bracket REF711-298Q QTY. 20 Rx Only (01)00190707017064 (... | Orthodontic Bracket is mislabeled | Class II | Ortho Organizers, Inc. |
| Apr 1, 2019 | da Vinci SP surgical system | Intuitive has become aware that the da Vinci SP system may trigger a mechanical vibration of the ... | Class II | Intuitive Surgical, Inc. |
| Mar 30, 2019 | Thoratec HeartMate 3 LVAS Implant Kit, Sterile, REF 106524/106524US, RX only,... | Outflow Graft leaking at the pump connection during the implantation process. If the C-Ring is in... | Class II | Thoratec Corp. |
| Mar 30, 2019 | Thoratec Heartmate 3 Sealed Outflow Graft with Bend Relief, Sterile, REF 1055... | Outflow Graft leaking at the pump connection during the implantation process. If the C-Ring is in... | Class II | Thoratec Corp. |
| Mar 29, 2019 | Ally Bone Screw - Product Usage:Bone Screws are indicated for use in bone rec... | There may be dimensional manufacturing error that represents a potential safety risk to patients. | Class II | PROVIDENCE MEDICAL TECHNOLOGIES |
| Mar 28, 2019 | Edwards Lifesciences, Fogarty Dilation Atrioseptostomy Catheter, Sterile EO, ... | Difficulty with atrioseptostomy catheter balloon deflation after deployment, and reports of ballo... | Class I | Edwards Lifesciences, LLC |
| Mar 28, 2019 | Edwards Lifesciences, Miller Balloon Atrioseptostomy Catheter, Sterile EO, Rx... | Difficulty with atrioseptostomy catheter balloon deflation after deployment, and reports of ballo... | Class I | Edwards Lifesciences, LLC |
| Mar 25, 2019 | Canon Aquilion One, Model TSX-301A | Scanning may be interrupted due to an error during execution of the eXam Plan and the system is u... | Class II | Canon Medical System, USA, INC. |
| Mar 25, 2019 | Canon Aquilion Premium, Model TSX-301B | Scanning may be interrupted due to an error during execution of the eXam Plan and the system is u... | Class II | Canon Medical System, USA, INC. |
| Mar 25, 2019 | Canon Aquilion One Vision, Model TSX-301C | Scanning may be interrupted due to an error during execution of the eXam Plan and the system is u... | Class II | Canon Medical System, USA, INC. |
| Mar 25, 2019 | Canon Aquilion Precision, Model TSX-304A | Scanning may be interrupted due to an error during execution of the eXam Plan and the system is u... | Class II | Canon Medical System, USA, INC. |
| Mar 25, 2019 | Canon Aquilion Lightning, Model TSX-036A | Scanning may be interrupted due to an error during execution of the eXam Plan and the system is u... | Class II | Canon Medical System, USA, INC. |
| Mar 25, 2019 | Canon Aquilion Prime, Model TSX-303A | Scanning may be interrupted due to an error during execution of the eXam Plan and the system is u... | Class II | Canon Medical System, USA, INC. |
| Mar 25, 2019 | Canon Aquilion Prime SP, Model TSX-303B | Scanning may be interrupted due to an error during execution of the eXam Plan and the system is u... | Class II | Canon Medical System, USA, INC. |
| Mar 25, 2019 | Canon Aquilion One, Model TSX-305A/3 V8.3 with FIRST 2.1 | Scanning may be interrupted due to an error during execution of the eXam Plan and the system is u... | Class II | Canon Medical System, USA, INC. |
| Mar 21, 2019 | EV1000 Clinical Platform, Models: EV1000A, EV1000NI, EV1000CS Product Usag... | Potential for an electrical short circuit leading to possible fire hazard due to liquid ingress i... | Class I | Edwards Lifesciences, LLC |
| Mar 18, 2019 | MRIdian Linac Radiation Therapy System, Model 20000. | A discrepancy between optimization and planning forward dose calculation between adaptive optimiz... | Class II | Viewray, Inc. |
| Mar 18, 2019 | HiResolution Bionic Ear System HiRes 90K Advantage CI HiFocus MS Electrode RE... | Three materials used in the makeup of the implant were mistakenly left off the list of bio-compat... | Class III | Advanced Bionics, LLC |
| Mar 14, 2019 | Drill Tapered RP 4.3x13 mm Single-Pat - Product Usage: The Guided Drills (Twi... | Due to a problem in the packaging sealing process at the supplier of the affected devices, it can... | Class II | Nobel Biocare Usa Llc |
| Mar 14, 2019 | Implant Retrieval Instrument Tri Channel 6.0 22 mm - Product Usage: They can ... | Due to a problem in the packaging sealing process at the supplier of the affected devices, it can... | Class II | Nobel Biocare Usa Llc |
| Mar 14, 2019 | Abutment Screw Retrieval Instrument RP/WP/6.0 - Product Usage: The instrument... | Due to a problem in the packaging sealing process at the supplier of the affected devices, it can... | Class II | Nobel Biocare Usa Llc |
| Mar 14, 2019 | Implant Retrieval Kit - Product Usage: The kit itself does not have a specifi... | Due to a problem in the packaging sealing process at the supplier of the affected devices, it can... | Class II | Nobel Biocare Usa Llc |
| Mar 14, 2019 | Implant Retrieval Instrument Hex & Tri-Ch NP/RP 22mm - Product Usage: They ca... | Due to a problem in the packaging sealing process at the supplier of the affected devices, it can... | Class II | Nobel Biocare Usa Llc |
| Mar 14, 2019 | Drill Tapered RP 4.3x10 mm Single-Pat - Product Usage: The Guided Drills (Twi... | Due to a problem in the packaging sealing process at the supplier of the affected devices, it can... | Class II | Nobel Biocare Usa Llc |
| Mar 14, 2019 | Implant Retrieval Instrument CC RP & Tri Ch Hex WP 22 mm - Product Usage: Th... | Due to a problem in the packaging sealing process at the supplier of the affected devices, it can... | Class II | Nobel Biocare Usa Llc |
| Mar 14, 2019 | Implant Retrieval Instrument CC 3.0 31 mm- Product Usage: They can be used to... | Due to a problem in the packaging sealing process at the supplier of the affected devices, it can... | Class II | Nobel Biocare Usa Llc |
| Mar 14, 2019 | Implant Retrieval Instrument CC NP & Ext Hex WP 22 mm - Product Usage: They c... | Due to a problem in the packaging sealing process at the supplier of the affected devices, it can... | Class II | Nobel Biocare Usa Llc |
| Mar 14, 2019 | Dense Bone Drill NP 3.5x16 mm Single-Pat - Product Usage: Drills are intended... | Due to a problem in the packaging sealing process at the supplier of the affected devices, it can... | Class II | Nobel Biocare Usa Llc |
| Mar 14, 2019 | Drill Tapered 6.0 6x8 mm Single-Pat - Product Usage: Drills are intended to b... | Due to a problem in the packaging sealing process at the supplier of the affected devices, it can... | Class II | Nobel Biocare Usa Llc |
| Mar 14, 2019 | Drill Tapered WP 5x11.5 mm Single-Pat - Product Usage: Drills are intended to... | Due to a problem in the packaging sealing process at the supplier of the affected devices, it can... | Class II | Nobel Biocare Usa Llc |
| Mar 14, 2019 | Implant Retrieval Instrument Hex & Tri-Chi NP/RP 31mm - Product Usage: They c... | Due to a problem in the packaging sealing process at the supplier of the affected devices, it can... | Class II | Nobel Biocare Usa Llc |
| Mar 14, 2019 | Drill Tapered NP 3.5x8 mm Single-Pat - Product Usage: The Guided Drills (Twis... | Due to a problem in the packaging sealing process at the supplier of the affected devices, it can... | Class II | Nobel Biocare Usa Llc |
| Mar 14, 2019 | Dense Bone Drill 6.0 6x16 mm Single-Pat- Product Usage: The Guided Drills (Tw... | Due to a problem in the packaging sealing process at the supplier of the affected devices, it can... | Class II | Nobel Biocare Usa Llc |
| Mar 14, 2019 | Drill Tapered NP 3.5x10 mm Single-Pat - Product Usage: The Guided Drills (Twi... | Due to a problem in the packaging sealing process at the supplier of the affected devices, it can... | Class II | Nobel Biocare Usa Llc |
| Mar 14, 2019 | Abutment Screw Retrieval Kit - Product Usage: The kit itself does not have a ... | Due to a problem in the packaging sealing process at the supplier of the affected devices, it can... | Class II | Nobel Biocare Usa Llc |
| Mar 14, 2019 | Abutment Screw Retrieval Instrument 3.0/NP - Product Usage: The instruments f... | Due to a problem in the packaging sealing process at the supplier of the affected devices, it can... | Class II | Nobel Biocare Usa Llc |
| Mar 14, 2019 | Screw Tap Tapered WP Single-Pat - Product Usage: The Guided Drills (Twist (St... | Due to a problem in the packaging sealing process at the supplier of the affected devices, it can... | Class II | Nobel Biocare Usa Llc |
| Mar 14, 2019 | Drill Tapered WP 5x10 mm Single-Pat - Product Usage: Drills are intended to b... | Due to a problem in the packaging sealing process at the supplier of the affected devices, it can... | Class II | Nobel Biocare Usa Llc |
| Mar 14, 2019 | Dense Bone Drill WP 5x13 mm Single-Pat - Product Usage: Drills are intended t... | Due to a problem in the packaging sealing process at the supplier of the affected devices, it can... | Class II | Nobel Biocare Usa Llc |
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.