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 11, 2018 | ellex I.Science iTRACK 250A, Canaloplasty Microcatheter Kit, for single use, ... | Sterility failure found in one of the units in the lot. | Class II | Ellex iScience, Inc. |
| Jan 5, 2018 | Hemodynamic monitoring system (HMS), comprised of a Patient Interface Module ... | When continuous cardiac output monitoring with a pulmonary artery catheter is placed in the Pau... | Class II | ICU Medical, Inc. |
| Jan 4, 2018 | Diagnostic Ultrasound System, Aplio I-series. Labeled as i700, i800, i900 ... | The power supply unit may be damaged and may fail to start up when the power plug is inserted int... | Class II | Toshiba American Medical Systems Inc |
| Dec 29, 2017 | INFX-8000V Fluoroscopic X-Ray Systems; INFINIX CF-I/BP PLUS CARDIAC SYSTEM | During an examination a device error occurred and the ceiling drive operation was disabled. It wa... | Class II | Toshiba American Medical Systems Inc |
| Dec 29, 2017 | INFX-8000H Fluoroscopic X-Ray Systems | During an examination a device error occurred and the ceiling drive operation was disabled. It wa... | Class II | Toshiba American Medical Systems Inc |
| Dec 29, 2017 | INFX-8000F Fluoroscopic X-Ray Systems | During an examination a device error occurred and the ceiling drive operation was disabled. It wa... | Class II | Toshiba American Medical Systems Inc |
| Dec 29, 2017 | INFX-8000C Fluoroscopic X-Ray Systems | During an examination a device error occurred and the ceiling drive operation was disabled. It wa... | Class II | Toshiba American Medical Systems Inc |
| Dec 27, 2017 | Elements Obturation Unit (EOU) used with respective Buchanan Heat Pluggers ... | Buchanan Heat Pluggers will possibly overheat while used with the Elements Obturation Unit (EOU). | Class II | Ormco/Sybronendo |
| Dec 21, 2017 | Dropper Plus Point-of-Care Urinalysis Dipstick Control kit The Quantimetri... | The kits contained an incorrect lot of Dropper Plus Level 1 vials | Class III | Quantimetrix Corporation |
| Dec 21, 2017 | 3910-090-800 ASSY, PKG, 8.0MM X 90MM DRI-LOK THREADED CANNULA, 5 units per bo... | Inadvertent shipment of expired units. | Class II | Stryker Corporation |
| Dec 20, 2017 | Model #: CG8900, Medtronic Clip Gun Scalp Clip Kit (Qty 1); Model #: CG8901, ... | Medtronic is initiating a voluntary recall because the products identified above did not adequate... | Class II | Medtronic Neurosurgery |
| Dec 20, 2017 | AUTO REF/KERATOMETER ARK-1s | There is possibly a difference between the measured dioptric value of the subjective measurement ... | Class II | Nidek Inc. |
| Dec 15, 2017 | Alere iScreen Dx Urine Drug Screen Card | The kit box label incorrectly identifies Phencyclidine (PCP), where it should list Tricyclic Anti... | Class III | Ameditech Inc |
| Dec 15, 2017 | Sofia 2 Analyzer Catalog Number 20299 Sofia 2 is a bench top analyzer in... | The calibration for the affected batch of analyzers was incorrectly set during the manufacturing ... | Class II | Quidel Corporation |
| Dec 14, 2017 | Vado Bi-Directional Steerable Sheath 8.8F, REF SS8FMB74, packaged in a lidded... | Torn sheath liner material was detected at the proximal end of the device during internal product... | Class II | Kalila Medical |
| Dec 14, 2017 | Vado Steerable Sheath 8.8F, REF SS8FMU67, packaged in a lidded tray that is w... | Torn sheath liner material was detected at the proximal end of the device during internal product... | Class II | Kalila Medical |
| Dec 6, 2017 | Health Harmony Mobile application software Product Usage: Care Innovatio... | It was discovered that in certain situations, including partial sessions and when taking adhoc me... | Class II | Intel-GE Care Innovations LLC |
| Dec 4, 2017 | iChem VELOCITY Urine Chemistry Strips, REF 800-7212 Product Usage: The iC... | A subset of Lot 7212154 A of the iChem VELOCITY Urine Chemistry strips has an incorrect pad pla... | Class II | Beckman Coulter Inc. |
| Nov 29, 2017 | Tapered Screw-Vent MTX, Dental Implant, sterile. Model TSV4B10. | Two lots of the Tapered Screw-Vent Implants, with different outer thread diameters, were inadvert... | Class II | Zimmer Dental Inc |
| Nov 29, 2017 | Rapid for the TLiIQ(R) System, HOLOGIC(R), Catalog number: 01200Q | Rapid fFN cassettes were manufactured with material (A137 ascites) from a new supplier (SDIX). Th... | Class II | Hologic, Inc. |
| Nov 29, 2017 | Tapered Screw-Vent MTX, Dental Implant, sterile. Model TSVTB10. | Two lots of the Tapered Screw-Vent Implants, with different outer thread diameters, were inadvert... | Class II | Zimmer Dental Inc |
| Nov 29, 2017 | Rapid for the TLiIQ(R) System, HOLOGIC(R), Catalog number: 01200 | Rapid fFN cassettes were manufactured with material (A137 ascites) from a new supplier (SDIX). Th... | Class II | Hologic, Inc. |
| Nov 28, 2017 | lmmunalysis EDDP Urine Control Set 1 The EDDP Urine Controls (High 125 ng/... | The High (125 ng/ml) Control does not meet specification - it has been confirmed to produce value... | Class III | Alere San Diego Inc. DBA Immunalysis Corporation |
| Nov 28, 2017 | Trevo XP ProVue System kit containing 1) Trevo XP ProVue Retriever, 4x20mm an... | Stryker Neurovascular has become aware that at least 1 (one) Trevo XP Provue System was manufactu... | Class II | Stryker Neurovascular |
| Nov 21, 2017 | 15 ML REAGENT CUP, B1037307, SAP 1221037307 for use with ABX PENTRA 400 / PEN... | The ABX PENTRA Reagent Containers do not always sit properly into the reagent rack. In low reage... | Class II | Horiba Instruments, Inc dba Horiba Medical |
| Nov 21, 2017 | 10 ML REAGENT CUP, B1034626, SAP 1221034626 for use with ABX PENTRA 400 / PEN... | The ABX PENTRA Reagent Containers do not always sit properly into the reagent rack. In low reage... | Class II | Horiba Instruments, Inc dba Horiba Medical |
| Nov 20, 2017 | Tapered Screw-Vent MTX Model TSVTB11 | Some implant vial caps in the recalled implant lot may inadvertently crack as the result of a man... | Class II | Zimmer Dental Inc |
| Nov 17, 2017 | EDAN Telemetry Transmitter, Model iT20 - Product Usage: The iT20 telemetry tr... | Firm became aware that it distributed 7 units in the U.S. that included a function that had not b... | Class II | Edan Diagnostics |
| Nov 17, 2017 | StrykeFlow 2 System, labeled sterile. Includes the following: a. STRYKER ... | Routine bioburden testing of certain lots were found to have levels higher than internal acceptab... | Class II | Stryker Corporation |
| Nov 17, 2017 | Alaris Syringe Pump, Model 8110. The firm name on the label is CareFusion. ... | The syringe plunger grippers may fail to automatically close around the syringe plunger press whe... | Class II | CareFusion 303, Inc. |
| Nov 17, 2017 | ACL DISPOSABLE PACK BONE-TENDON-BONE, Model 0234020280, labeled sterile. | Routine bioburden testing of certain lots were found to have levels higher than internal acceptab... | Class II | Stryker Corporation |
| Nov 17, 2017 | STRYKER CASSETTE PUMP, AHTO Tube Set, labeled sterile. Includes the followin... | Routine bioburden testing of certain lots were found to have levels higher than internal acceptab... | Class II | Stryker Corporation |
| Nov 17, 2017 | Alaris PCA Pump, Model 8120. The firm name on the label is CareFusion. Th... | The syringe plunger grippers may fail to automatically close around the syringe plunger press whe... | Class II | CareFusion 303, Inc. |
| Nov 17, 2017 | STRYKER WEDGE INTERFERENCE SCREW SYSTEM, ACL Interface Screw, 9MM X 25MM, Mod... | Routine bioburden testing of certain lots were found to have levels higher than internal acceptab... | Class II | Stryker Corporation |
| Nov 15, 2017 | Spectra System/Legacy Guided Surgery Handle Kit (Part Number: G-HK) Spect... | The Spectra System/Legacy Guided Surgery Handle Kit had guided handle inserts that were out of Im... | Class II | Implant Direct Sybron Manufacturing, LLC |
| Nov 14, 2017 | Triage Drugs of Abuse Plus TCA 25 Test Kit, Model Numbers 92000, 92590, 92591... | The recalled lots have demonstrated unexpected false positive THC results. | Class II | Alere San Diego, Inc. |
| Nov 10, 2017 | iQ200 Series Urine Microscopy Analyzer with Barcode Reader Model NFT-2100, Ca... | iQ200 Series Urine Microscopy Analyzer may intermittently fail to read urine sample dilution barc... | Class II | Beckman Coulter Inc. |
| Nov 6, 2017 | Access 2 Immunoassay System, Remanufactured, Catalog Number 386220. In vit... | Potential for minor skin burn if the tool contacts the reagent storage interface board (B79917) w... | Class III | Beckman Coulter Inc. |
| Nov 6, 2017 | UniCel DxC 600i SYNCHRON Access Clinical Systems; A25656, A25638. In vitro... | Potential for minor skin burn if the tool contacts the reagent storage interface board (B79917) w... | Class III | Beckman Coulter Inc. |
| Nov 6, 2017 | Alaris Extension Sets with microbore tubing Model 20022 and 30914 Is used... | Reports of incorrect priming volume due to manufacturing with incorrect tubing. | Class II | CareFusion 303, Inc. |
| Nov 6, 2017 | Access 2 Immunoassay System, Catalog Number 81600N. In vitro diagnostic de... | Potential for minor skin burn if the tool contacts the reagent storage interface board (B79917) w... | Class III | Beckman Coulter Inc. |
| Nov 3, 2017 | UniCel DxH Slidemaker Stainer, Part Number 75222, for use with automated hema... | The shield for the Single-Tube Station on the DxH instrument may interfere with sample aspiration... | Class II | Beckman Coulter Inc. |
| Nov 3, 2017 | Volcano Imaging System s5i REF 807400001; CORE Mobile Imaging System (120V) R... | On certain Impacted Systems, an unexpected Microsoft Windows Security dialog may appear during us... | Class II | Volcano Corporation |
| Nov 3, 2017 | Stroke Fast Pack(TM), Trevo(TM) XP, TREVO(TM) XP PROVUE RETRIEVER, 6 mm, 25 m... | Stryker Neurovascular has become aware that some 3-Pack Stroke Fast Packs and Trevo Procedure Pac... | Class II | Stryker Neurovascular |
| Nov 3, 2017 | UniCel DxH600, Part Number B23858, automated hematology analyzer (Note: ... | The shield for the Single-Tube Station on the DxH instrument may interfere with sample aspiration... | Class II | Beckman Coulter Inc. |
| Nov 3, 2017 | Trevo(TM) XP ProVue Procedure Pack, TREVO(TM) XP PROVUE RETRIEVER, 6 mm, 25 m... | Stryker Neurovascular has become aware that some 3-Pack Stroke Fast Packs and Trevo Procedure Pac... | Class II | Stryker Neurovascular |
| Nov 3, 2017 | UniCel DxH800, Part Numbers: 629029 and B24802, automated hematology analyzer | The shield for the Single-Tube Station on the DxH instrument may interfere with sample aspiration... | Class II | Beckman Coulter Inc. |
| Nov 3, 2017 | Stroke Fast Pack(TM), Trevo(TM) XP, TREVO(TM) XP PROVUE RETRIEVER, 4 mm, 20 m... | Stryker Neurovascular has become aware that some 3-Pack Stroke Fast Packs and Trevo Procedure Pac... | Class II | Stryker Neurovascular |
| Oct 29, 2017 | OptiLITE, Products for Laser Surgery, Model # CGH1080F, 800 micron single-use... | It has been determined that a lot of fiber lasers were programmed incorrectly. As a result, the f... | Class III | Xintec Corp |
| Oct 24, 2017 | ABL800 analyzer with FLEXQ module. Device intended for in vitro testing of... | Due to misinterpretation of the barcode by the scanner, when the registration receipt barcode is ... | Class II | Radiometer America 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.