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 |
|---|---|---|---|---|
| Jan 14, 2020 | Medtronic Simulus 850 Semi Rigid Ring/Band Accessory Kit Used to size a p... | Demonstration Simulus Reusable Sizer Accessory Kits were being incorrectly sourced to customers. ... | Class II | Medtronic CoreValve LLC |
| Jan 14, 2020 | Ormco Damon Q2 Orthodontic Metal Bracket, Part No. 491-9834, L3R Hi Tq Hook, ... | The bracket torque was mislabeled on the packaging. | Class II | Ormco/Sybronendo |
| Jan 7, 2020 | Spy-Phi Drape only (HH2020) Pack of 20 HH2000 (Sold internationally only). Dr... | Sterile drapes packaged in an unsealed pouch. | Class II | Stryker Corporation |
| Jan 7, 2020 | Spy-Phi Drape (HH2000) sold as a Spy-Phi Pack (HH9006). Only sold in the US. ... | Sterile drapes packaged in an unsealed pouch. | Class II | Stryker Corporation |
| Jan 2, 2020 | Central Venous Catheters are indicated for the assessment of hemodynamic stat... | Inability for the guidewire to pass through the needles included with the catheter kits. | Class II | ICU Medical, Inc. |
| Jan 2, 2020 | Central Venous Catheters are indicated for the assessment of hemodynamic stat... | Inability for the guidewire to pass through the needles included with the catheter kits. | Class II | ICU Medical, Inc. |
| Jan 2, 2020 | Central Venous Catheters are indicated for the assessment of hemodynamic stat... | Inability for the guidewire to pass through the needles included with the catheter kits. | Class II | ICU Medical, Inc. |
| Jan 2, 2020 | Central Venous Catheters are indicated for the assessment of hemodynamic stat... | Inability for the guidewire to pass through the needles included with the catheter kits. | Class II | ICU Medical, Inc. |
| Jan 2, 2020 | Central Venous Catheters are indicated for the assessment of hemodynamic stat... | Inability for the guidewire to pass through the needles included with the catheter kits. | Class II | ICU Medical, Inc. |
| Jan 2, 2020 | Central Venous Catheters are indicated for the assessment of hemodynamic stat... | Inability for the guidewire to pass through the needles included with the catheter kits. | Class II | ICU Medical, Inc. |
| Jan 2, 2020 | Central Venous Catheters are indicated for the assessment of hemodynamic stat... | Inability for the guidewire to pass through the needles included with the catheter kits. | Class II | ICU Medical, Inc. |
| Dec 19, 2019 | STAINLESS STEEL REPROCESSING TRAY, 2D CAMERA HEAD, IS4000, Model No. 400499-... | Small but detectable holes in the sterilization wrap used with the firm's 8 mm endoscope steriliz... | Class II | Intuitive Surgical, Inc. |
| Dec 19, 2019 | STAINLESS STEEL REPROCESSING TRAY, 8MM ENDOSCOPE, IS4000, Model No. 400498-02... | Small but detectable holes in the sterilization wrap used with the firm's 8 mm endoscope steriliz... | Class II | Intuitive Surgical, Inc. |
| Dec 13, 2019 | Beckman Coulter MicroScan PROMPT Inoculation System-D, Catalog Number B1026-1... | Due to customer reports it has been determined that the inoculation system contains the incorrec... | Class II | Beckman Coulter Inc. |
| Dec 11, 2019 | Piccolo Xpress chemistry analyzer, Model No. 1100-1001, Software version 2.1.... | Incorrect reference ranges of analytes. | Class II | Abaxis Inc |
| Dec 6, 2019 | Karl Storz SE & Co. KG, C-MAC Video Laryngoscope MIL # 1, for the following R... | The firm has become aware that there is a potential that the glass cover at the distal end of the... | Class II | Karl Storz Endoscopy |
| Dec 3, 2019 | Healon GV PRO 0.85 mL, Model (U.S.): 10-2400-14, Model (O.U.S.): 10-2705-14, ... | Ophthalmic viscosurgical device may be difficult to remove from the eye, leading to increased pos... | Class II | Johnson & Johnson Surgical Vision Inc |
| Dec 2, 2019 | HeartMate 3 Mobile Power Unit, REF 107754, UDI or GTIN: 00813024010883, and 1... | Excessive static electricity can potentially cause unrecoverable power loss and damage to the mob... | Class II | Thoratec Corp. |
| Nov 27, 2019 | QuickDraw Venous Cannula, REF: QD22, UDI: 00690103182699; and REF: QD25, UDI:... | If the venous cannula is used in an unintended manner (longer than 6 hours; particularly during e... | Class II | Edwards Lifesciences, LLC |
| Nov 24, 2019 | Terumo AZUR Peripheral Coil System, Detachable 35, Framing Coil, REF numbers ... | The devices may be missing the implant coil. | Class II | Microvention, Inc. |
| Nov 24, 2019 | Terumo AZUR CX Peripheral Coil System, Detachable 18, CX Coil, REF numbers 45... | The devices may be missing the implant coil. | Class II | Microvention, Inc. |
| Nov 24, 2019 | Terumo AZUR Peripheral Coil System, Detachable 35, Helical HydroCoil Emboliza... | The devices may be missing the implant coil. | Class II | Microvention, Inc. |
| Nov 24, 2019 | Terumo AZUR Peripheral Coil System, Detachable 18, Helical HydroCoil Emboliza... | The devices may be missing the implant coil. | Class II | Microvention, Inc. |
| Nov 24, 2019 | Terumo AZUR Peripheral Coil System, Detachable 18, Framing Coil, REF numbers ... | The devices may be missing the implant coil. | Class II | Microvention, Inc. |
| Nov 24, 2019 | Terumo AZUR CX Peripheral Coil System, Detachable 35, CX Coil, REF numbers 45... | The devices may be missing the implant coil. | Class II | Microvention, Inc. |
| Nov 22, 2019 | MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Emboliza... | The devices may be missing the implant coil. | Class II | Microvention, Inc. |
| Nov 22, 2019 | MicroVention Terumo Microplex 18, Platinum Coil System, Endovascular Emboliza... | The devices may be missing the implant coil. | Class II | Microvention, Inc. |
| Nov 22, 2019 | MicroVention Terumo HydroSoft 10, HydroCoil Embolic System, Endovascular Embo... | The devices may be missing the implant coil. | Class II | Microvention, Inc. |
| Nov 22, 2019 | MicroVention Terumo Microplex 18, Platinum Embolization Coil, Cosmos 18, Ster... | The devices may be missing the implant coil. | Class II | Microvention, Inc. |
| Nov 22, 2019 | MicroVention Terumo HydroFrame 10, HydroCoil Embolic System, Endovascular Emb... | The devices may be missing the implant coil. | Class II | Microvention, Inc. |
| Nov 22, 2019 | MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Emboliza... | The devices may be missing the implant coil. | Class II | Microvention, Inc. |
| Nov 22, 2019 | MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Emboliza... | The devices may be missing the implant coil. | Class II | Microvention, Inc. |
| Nov 22, 2019 | MicroVention Terumo Microplex, Platinum Coil System, Endovascular Embolizatio... | The devices may be missing the implant coil. | Class II | Microvention, Inc. |
| Nov 22, 2019 | LOCATOR OVERDENTURE IMPLANT SYSTEM STERILE R Rx Only QTY 1 . | The abutment provided with the Implant System may be out of specification, which could lead to a ... | Class II | Zest Anchors LLC |
| Nov 22, 2019 | MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Emboliza... | The devices may be missing the implant coil. | Class II | Microvention, Inc. |
| Nov 22, 2019 | MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Emboliza... | The devices may be missing the implant coil. | Class II | Microvention, Inc. |
| Nov 22, 2019 | MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Emboliza... | The devices may be missing the implant coil. | Class II | Microvention, Inc. |
| Nov 22, 2019 | MicroVention Terumo HydroFrame 18, HydroCoil Embolic System, Endovascular Emb... | The devices may be missing the implant coil. | Class II | Microvention, Inc. |
| Nov 22, 2019 | MicroVention Terumo Microplex 18, Platinum Coil System, Endovascular Emboliza... | The devices may be missing the implant coil. | Class II | Microvention, Inc. |
| Nov 22, 2019 | MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Emboliza... | The devices may be missing the implant coil. | Class II | Microvention, Inc. |
| Nov 22, 2019 | MicroVention Terumo Microplex 18, Platinum Coil System, Endovascular Emboliza... | The devices may be missing the implant coil. | Class II | Microvention, Inc. |
| Nov 22, 2019 | MicroVention Terumo HydroSoft 10, HydroCoil Embolic System, Endovascular Embo... | The devices may be missing the implant coil. | Class II | Microvention, Inc. |
| Nov 21, 2019 | Medtronic MiniMed 670G System with SmartGuard, Ref #s/Model Number(s) - MMT-... | There have been reported incidents of a loose reservoir that can no longer be locked into the pum... | Class I | Medtronic Inc. |
| Nov 21, 2019 | Medtronic MiniMed 620G Insulin Infusion Pump, Ref #s/Model(s) - MMT-1510, MM... | There have been reported incidents of a loose reservoir that can no longer be locked into the pum... | Class I | Medtronic Inc. |
| Nov 21, 2019 | Medtronic MiniMed 640G Insulin Infusion Pump, Ref#s/Model(s) - MMT-1511, MMT... | There have been reported incidents of a loose reservoir that can no longer be locked into the pum... | Class I | Medtronic Inc. |
| Nov 21, 2019 | Medtronic MiniMed 630G System with SmartGuard, Ref/Model # MMT-1515, MMT-1715... | There have been reported incidents of a loose reservoir that can no longer be locked into the pum... | Class I | Medtronic Inc. |
| Nov 19, 2019 | Brand Name: Dexcom G6 CGM App for iOS Software Number: SW11677 Software Ver... | It was reported that the user's low alarm feature on the iOS application were not properly alert... | Class II | Dexcom Inc |
| Nov 18, 2019 | ViewRay System: Model No. 10000 and 20000 for radiation treatment. PN11440 ... | Registering dose and structures in the treatment delivery workflow could result in an alignment d... | Class II | Viewray, Inc. |
| Nov 14, 2019 | HardyCHROM MRSA,REF; G307, LOT: 447694, A selective and differential chromoge... | False Positive results due to the MSSA (methicillin-susceptible) strain Staphylococcus aureus (AT... | Class II | Hardy Diagnostics |
| Nov 14, 2019 | FreeStyle Precision H Blood Glucose and Ketone Monitoring System, UDI: 000938... | Instructions sent in a letter or in instructions for use for disinfecting blood glucose and/or ke... | Class II | Abbott Diabetes Care, 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.