Browse Device Recalls
4,602 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 4,602 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 4,602 FDA device recalls in CA.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jun 21, 2018 | Abbott TECNIS 1-Piece Aspheric Acrylic IOL with the TECNIS iTEC Preloaded Del... | Expired intraocular lenses were distributed. | Class II | Johnson & Johnson Surgical Vision Inc |
| Jun 21, 2018 | Ossur, J Tong, Sterile, Part/ Description: JT-115/ J TONG MED/LGE-No App... | Halo system products labeled MR conditional will undergo confirmatory safety testing to confirm M... | Class II | Ossur Americas |
| Jun 21, 2018 | Ossur Skull Pin, Sterile Ceramic Tip Pin, Part/ Description: 516CS/ Skul... | Halo system products labeled MR conditional will undergo confirmatory safety testing to confirm M... | Class II | Ossur Americas |
| Jun 21, 2018 | Ossur OB Resolve, Sterile, Part/ Description: 505300D/ OB RESOLVE STERIL... | Halo system products labeled MR conditional will undergo confirmatory safety testing to confirm M... | Class II | Ossur Americas |
| Jun 21, 2018 | Ossur CB Resolve, Sterile, Part/ Description: 505300C/ CB RESOLVE STERIL... | Halo system products labeled MR conditional will undergo confirmatory safety testing to confirm M... | Class II | Ossur Americas |
| Jun 21, 2018 | Ossur, ReSolve Halo Vest, Part/ Description: 545700K/ ReSolve Halo Vest-... | Halo system products labeled MR conditional will undergo confirmatory safety testing to confirm M... | Class II | Ossur Americas |
| Jun 21, 2018 | Ossur Skull Pin, Sterile Titanium Pin, Part/Description: 516TS/ Skull Pi... | Halo system products labeled MR conditional will undergo confirmatory safety testing to confirm M... | Class II | Ossur Americas |
| Jun 15, 2018 | TRINIAS Digital Angiographic System intended to be used for cardiac angiograp... | Due to a software issue the C-arm may unexpectedly moved when being moved to the park position an... | Class II | Shimadzu Medical Systems Usa Com |
| Jun 14, 2018 | RT-5100 Refractor, a component of the Epic-5100 System. | The lens bonding was incomplete on the refractor. | Class III | Nidek Inc. |
| Jun 11, 2018 | Edwards SAPIEN 3 Transcatheter Heart Valve (THV), Model: 9600TFX, Size: 26 mm | SAPIEN 3 THV was packaged with the incorrect valve size with respect to the label. | Class II | Edwards Lifesciences, LLC |
| Jun 8, 2018 | Synchro2, 0.014in x 200cm, SOFT PRE-SHAPED Guidewire with Hydrophilic Coatin... | The product labels (pouch and carton) for products contain an incorrect value in millimeters (0.0... | Class II | Stryker Neurovascular |
| Jun 8, 2018 | Synchro2, 0.014in x 300cm SOFT Guidewire with Hydrophilic Coating , UPN Produ... | Class II | Stryker Neurovascular | |
| Jun 8, 2018 | Synchro2, 0.014in. x 200cm STANDARD PRE-SHAPED Guidewire with Hydrophilic Coa... | The product labels (pouch and carton) for products contain an incorrect value in millimeters (0.0... | Class II | Stryker Neurovascular |
| Jun 8, 2018 | Synchro2, 0.014in x 300cm STANDARD Guidewire with Hydrophilic Coating UPN Pro... | The product labels (pouch and carton) for products contain an incorrect value in millimeters (0.0... | Class II | Stryker Neurovascular |
| Jun 8, 2018 | Synchro2, 0.014in x 300cm STANDARD PRE-SHAPED Guidewire with Hydrophilic Coat... | The product labels (pouch and carton) for products contain an incorrect value in millimeters (0.0... | Class II | Stryker Neurovascular |
| Jun 8, 2018 | Synchro2, 0.014in x 200cm STANDARD Guidewire with Hydrophilic Coating, UPN Pr... | The product labels (pouch and carton) for products contain an incorrect value in millimeters (0.0... | Class II | Stryker Neurovascular |
| Jun 8, 2018 | Synchro2, 0.014in. x 300cm, SOFT PRE-SHAPED Guidewire with Hydrophilic Coatin... | The product labels (pouch and carton) for products contain an incorrect value in millimeters (0.0... | Class II | Stryker Neurovascular |
| Jun 8, 2018 | Synchro2, 0.014 in x 200cm, SOFT Guidewire with Hydrophilic Coating, UPN Prod... | The product labels (pouch and carton) for products contain an incorrect value in millimeters (0.0... | Class II | Stryker Neurovascular |
| Jun 5, 2018 | Wingspan Stent System, Rx Only, Sterile EO, Catalog #: M003WE0250090, M003WE0... | Use-related coating damage on delivery catheter shafts of Wingspan delivery catheters were reported | Class II | Stryker Neurovascular |
| Jun 4, 2018 | EndoWrist Suction Irrigator, Single Use Instrument. Part Number: 480299-04. ... | The firm has identified the potential for a silicone particle to be generated within the Suction ... | Class II | Intuitive Surgical, Inc. |
| May 30, 2018 | Nuclear Magnetic Resonance Imaging Systems that are indicated for use as a di... | When using respiratory gating with Steady Mode ON in Spin Echo sequence scanning, the SAR (Specif... | Class II | Canon Medical System, USA, INC. |
| May 29, 2018 | Implant Direct Legacy Implant Closed-Tray Transfer-Concave Profile, 3.5mmD Pl... | Cap may be mislabeled with incorrect part number, although the correct part number is on the main... | Class II | Implant Direct Sybron Manufacturing, LLC |
| May 25, 2018 | ABL90 FLEX analyzers with software versions 3.3MR1 or below. The ABL90 FLEX A... | The ABL90 FLEX can aspirate Cal 2 solution instead of rinse solution, when the following take pla... | Class II | Radiometer America Inc |
| May 24, 2018 | Software Package, iPAW 4.2.1 User Kit for Windows XP and Windows 10, Part No.... | Sorting-Drive software version 4.2 (released in October 2015) introduced a new option for iPAW an... | Class III | Beckman Coulter Inc. |
| May 24, 2018 | Software Package, Sorting-Drive 4.2.1 User Kit for Windows XP and Windows 10... | Sorting-Drive software version 4.2 (released in October 2015) introduced a new option which inclu... | Class III | Beckman Coulter Inc. |
| May 24, 2018 | Software Package, iPAW 4.2 User Kit, Part No. B73489, Manufactured by: Beckma... | Sorting-Drive software version 4.2 (released in October 2015) introduced a new option for iPAW an... | Class III | Beckman Coulter Inc. |
| May 24, 2018 | Sorting-Drive Professional Part, Sorting-Drive Professional Kit, (Sorting Dr... | Sorting-Drive software version 4.2 (released in October 2015) introduced a new option for iPAW an... | Class III | Beckman Coulter Inc. |
| May 24, 2018 | Intelligent Peri-Analytical Workstation (HW+SW), Catalog #: A89492 (iPAW Soft... | Sorting-Drive software version 4.2 (released in October 2015) introduced a new option for iPAW an... | Class III | Beckman Coulter Inc. |
| May 24, 2018 | Sorting-Drive Product Part, Sorting-Drive Plus Kit (Sorting Drive Software v4... | Sorting-Drive software version 4.2 (released in October 2015) introduced a new option for iPAW an... | Class III | Beckman Coulter Inc. |
| May 24, 2018 | Software Package, Sorting-Drive 4.2 User Kit, Part No. B73488, Manufactured b... | Sorting-Drive software version 4.2 (released in October 2015) introduced a new option which inclu... | Class III | Beckman Coulter Inc. |
| May 18, 2018 | REPLANT 5.0mmD ABUTMENT, Part number 6050-52-60 | Due to out of specification, the clinician would not be able to fit and engage the abutment with ... | Class II | Implant Direct Sybron Manufacturing, LLC |
| May 17, 2018 | The da Vinci Xi Surgical System (IS4000) Model Name: IS4000, Endoscope Contro... | An Endoscope Controller has been improperly calibrated during manufacturing. This improper calibr... | Class II | Intuitive Surgical, Inc. |
| May 16, 2018 | BD FACS Universal Loader (Optional) to the BD FACSLyric Clinical System, Mode... | The solenoid plunger tip length is too short resulting in insufficient engagement to the Univers... | Class III | Becton, Dickinson and Company, BD Biosciences |
| May 16, 2018 | Ceterix Disposable Knot Pusher / Suture Cutter; NovoCut Suture Manager. Model... | Possible nonconforming blades may result in a higher than specified cut force required to cut the... | Class II | Ceterix Orthopedics, Inc. |
| May 16, 2018 | Contour Plus Link 2.4, Product Catalog Number: MMT-1151SK. wireless blood glu... | CONTOUR PLUS LINK 2.4 meter with an incorrect unit of measure was included into meter kits and di... | Class II | Medtronic Inc. |
| May 10, 2018 | Outer Package Label: Tapered Screw-Vent Implant System, 4.1mm X 10mm, 3.5mm, ... | Dental implants have incorrect item/lot numbers and size on the inner package labeling. Correct i... | Class II | Zimmer Dental Inc |
| May 9, 2018 | OptiMedica Catalys Precision Laser System, CE 0044 containing software cOS 5.... | Software upgrade exhibits failures when executing Daily Alignment Verification (DAV), specificall... | Class II | Johnson & Johnson Surgical Vision Inc |
| May 7, 2018 | WaveCrest Left Atrial Appendage (LAA), Occlusion System (32 mm), Catalog Numb... | When attempting to recapture the 32-mm device, the tip of the delivery sheath may fold or buckle,... | Class I | Biosense Webster, Inc. |
| May 4, 2018 | MicroScan Pos Combo Panel Type 43, Catalog number B1017-217for use in determi... | The drug dilution sequence for Moxifloxacin printed on the panel is incorrect. As a result, incor... | Class II | Beckman Coulter Inc. |
| May 3, 2018 | Medtronic Clip Gun Magazines are packaged in individually sealed pouches and ... | The packaging sterile barrier does not comply with the applicable packaging standard for terminal... | Class II | Medtronic Neurosurgery |
| May 2, 2018 | AXS Infinity LS Long Sheath:((6F/.088in)/ x 70cm GEN-10800-70, (6F/.088in)/ x... | The AXS Infinity LS Long Sheath Dilator outer diameter (OD) specification was exceeded. | Class II | Stryker Neurovascular |
| Apr 26, 2018 | ABX Pentra Micro ALBUMIN 2 CP, Serum/Plasma, REF 1300032563 The device i... | When the ABX Pentra Micro ALBUMIN 2 CP (ALBT2) Reagent 2 is sampled and dispensed immediately aft... | Class II | Horiba Instruments, Inc dba Horiba Medical |
| Apr 24, 2018 | Vulcan Fast Red Chromogen Kit 2, part of an immunohistochemistry (IHC) proced... | Chromogen failed to develop due to a stability issue caused by environmental factors with a raw m... | Class II | Biocare Medical, LLC |
| Apr 24, 2018 | Medtronic MiniMed Paradigm Veo Insulin Pump Product Catalog Number: MMT-554,... | The MiniMed Paradigm Veo insulin pump has an error that impacts the Arabic language translation.T... | Class II | Medtronic Inc. |
| Apr 23, 2018 | da Vinci Xi EndoWrist Stapler 45 Reload Blue, Model 48645B-03, 12 reloads/box. | Intuitive Surgical, Inc. (ISI) has recently become aware of an issue with the da Vinci Xi Stapler... | Class II | Intuitive Surgical, Inc. |
| Apr 23, 2018 | da Vinci Xi EndoWrist Stapler 45 Reload Green, Model 48445G-03, 12 reloads/box. | Intuitive Surgical, Inc. (ISI) has recently become aware of an issue with the da Vinci Xi Stapler... | Class II | Intuitive Surgical, Inc. |
| Apr 23, 2018 | t:slim G4 Insulin Pump with Dexcom G4 Platinum CGM Software version: 4.3.4... | The fuel gauge, the component that reads and reports the battery parameters to the pump, could pr... | Class II | Tandem Diabetes Care Inc |
| Apr 20, 2018 | Alaris Infusion Pump administration sets labeled as: -Infusion Set Alaris P... | Complaints where users were unable to prime the administration set. | Class II | CareFusion 303, Inc. |
| Apr 18, 2018 | DRAD-3000E (Radrex-i) TFP-4336W (Wireless FPD) | It was found when an operator performs a radiography using the wireless flat panel detector (FPD)... | Class II | Canon Medical System, USA, INC. |
| Apr 16, 2018 | Quadra Assura, Sterile EO, Model #/ Part #: CD3265-40/100042335, 100059846;... | The firm is releasing new firmware for high voltage implantable cardiac devices (ICD) and cardiac... | Class II | St Jude 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.