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 |
|---|---|---|---|---|
| Sep 19, 2019 | Pacific Medical GE Corometrics Nautilus Ultrasound Transducer w/wing 5700LAX,... | Fetal transducers distributed in advance of receiving 510(k) and international clearances. | Class II | Pacific Medical Group Inc. |
| Sep 12, 2019 | Stryker, REF: 0250070460, 5.0 mm x 32 cm, Strykeprobe, Outer Sheath Replaceme... | Potential diff. in the length of the sheath tube and the sheath/probe. A diff. in length could le... | Class II | Stryker Corporation |
| Sep 12, 2019 | Stryker, REF: 0250070450, 5.0 mm x 45 cm, Strykeprobe, Outer Sheath Replaceme... | Potential diff. in the length of the sheath tube and the sheath/probe. A diff. in length could le... | Class II | Stryker Corporation |
| Sep 12, 2019 | CODAN SWAN-LOCK Swabable Needlefree Connector, Catalog #BC1000N, REF 16.7220,... | Individual packages of connectors may have incomplete or bad seals which would compromise sterility. | Class II | Codan US Corporation |
| Sep 11, 2019 | Respironics V680 Ventilator, Service # 850011, (OUS Only) | Ventilator touchscreen may become frozen and fail to respond to touch commands. If a patient requ... | Class II | Respironics California, LLC |
| Sep 11, 2019 | Ultrasound Transducer (M2736A), that may have been serviced with the followin... | Fetal/maternal monitor/monitoring systems serviced or remanufactured using non-OEM equivalent com... | Class II | Pacific Medical Group Inc. |
| Sep 11, 2019 | Button-Style Tocotransducer (Nautilus), 8-foot Cord 2264HAX, that may have be... | Fetal/maternal monitor/monitoring systems serviced or remanufactured using non-OEM equivalent com... | Class II | Pacific Medical Group Inc. |
| Sep 11, 2019 | Toco+ transducer with ECG/IUP capability (wired), that may have been serviced... | Fetal/maternal monitor/monitoring systems serviced or remanufactured using non-OEM equivalent com... | Class II | Pacific Medical Group Inc. |
| Sep 11, 2019 | Respironics RP-UI Assy, V60 Ventilators User Interface RP-Kits, REF/P/N: 45... | Ventilator touchscreen may become frozen and fail to respond to touch commands. If a patient requ... | Class II | Respironics California, LLC |
| Sep 11, 2019 | External Toco Transducer (M1355A), that may have been serviced with the follo... | Fetal/maternal monitor/monitoring systems serviced or remanufactured using non-OEM equivalent com... | Class II | Pacific Medical Group Inc. |
| Sep 11, 2019 | Respironics RP-Touch Screen, V60/V680 Ventilator Serviced with Touchscreen RP... | Ventilator touchscreen may become frozen and fail to respond to touch commands. If a patient requ... | Class II | Respironics California, LLC |
| Sep 11, 2019 | Loop-Style Ultrasound Transducer (Nautilus), 8-foot Cord 5700LAX, that may ha... | Fetal/maternal monitor/monitoring systems serviced or remanufactured using non-OEM equivalent com... | Class II | Pacific Medical Group Inc. |
| Sep 11, 2019 | Toco M2734A, that may have been serviced with the following: Pacific Medical ... | Fetal/maternal monitor/monitoring systems serviced or remanufactured using non-OEM equivalent com... | Class II | Pacific Medical Group Inc. |
| Sep 11, 2019 | Respironics V60 Ventilator, Service # 850008, REF: 1053613, 1053614, 1053617,... | Ventilator touchscreen may become frozen and fail to respond to touch commands. If a patient requ... | Class II | Respironics California, LLC |
| Sep 11, 2019 | Button-Style Ultrasound Transducer (Nautilus), 8-foot Cord 5700HAX, that may ... | Fetal/maternal monitor/monitoring systems serviced or remanufactured using non-OEM equivalent com... | Class II | Pacific Medical Group Inc. |
| Sep 11, 2019 | Toco MP Transducer (M2734B), that may have been serviced with the following: ... | Fetal/maternal monitor/monitoring systems serviced or remanufactured using non-OEM equivalent com... | Class II | Pacific Medical Group Inc. |
| Sep 11, 2019 | Microsurgical Operating Room Tables;7300B (18-350-70); | Unintended tilting of the Tabletop MST 7300BX and incorrect operation due to infrared operating s... | Class II | Mizuho America, Inc. |
| Sep 11, 2019 | Loop-Style Tocotransducer (Nautilus) 2264LAX, that may have been serviced wit... | Fetal/maternal monitor/monitoring systems serviced or remanufactured using non-OEM equivalent com... | Class II | Pacific Medical Group Inc. |
| Sep 11, 2019 | Microsurgical Operating Room Tables;7300BX (18-351-70). | Unintended tilting of the Tabletop MST 7300BX and incorrect operation due to infrared operating s... | Class II | Mizuho America, Inc. |
| Sep 11, 2019 | Ultrasound Transducer (M1356A), that may have been serviced with the followin... | Fetal/maternal monitor/monitoring systems serviced or remanufactured using non-OEM equivalent com... | Class II | Pacific Medical Group Inc. |
| Sep 4, 2019 | Opiate 300 Ng Reagent (OP 1 X 250) for use in conjunction with UniCel DxC 600... | Cross-reactivity testing may not meet the claims indicated in the Opiate 300 ng (OP)Instructions ... | Class II | Beckman Coulter Inc. |
| Sep 4, 2019 | MicroScan WalkAway-96 plus Instrument | Instruments were manufactured with a shortened 30mL reagent draw straw which may result in reagen... | Class II | Beckman Coulter Inc. |
| Sep 4, 2019 | MicroScan WalkAway-96 plus Reconditioned Instrument | Instruments were manufactured with a shortened 30mL reagent draw straw which may result in reagen... | Class II | Beckman Coulter Inc. |
| Sep 4, 2019 | Synchron Systems Opiate 2000 ng Reagent (OP2 1 x 250); catalogue no. 475006 f... | Cross-reactivity testing may not meet the claims indicated in the Opiate 2000 ng (OP2) Instructio... | Class II | Beckman Coulter Inc. |
| Sep 4, 2019 | MicroScan WalkAway-40 plus Reconditioned Instrument | Instruments were manufactured with a shortened 30mL reagent draw straw which may result in reagen... | Class II | Beckman Coulter Inc. |
| Sep 4, 2019 | MicroScan WalkAway-40 plus Instrument | Instruments were manufactured with a shortened 30mL reagent draw straw which may result in reagen... | Class II | Beckman Coulter Inc. |
| Aug 28, 2019 | NobelParallel Conical Connection NP, 3.75x10mm (Endosseous Dental Implant); R... | The top label of article no. 37965, lot 12129104 (immediate packaging of endosseous dental implan... | Class II | Nobel Biocare Usa Llc |
| Aug 27, 2019 | Karl Storz, Model # 11161C2, Flexible Neuroscope | During a complaint investigation it was determined that an error was observed within the instruc... | Class II | Karl Storz Endoscopy |
| Aug 27, 2019 | Karl Storz RHINO-LARYNGO-BRONCHO FIBERSCOPE, Model # 11005BC1 | During a complaint investigation it was determined that an error was observed within the instruc... | Class II | Karl Storz Endoscopy |
| Aug 27, 2019 | Karl Storz NEURO-FIBERSCOPE, Model # 11282BN1, Flexible Pediatric Neuroscope | During a complaint investigation it was determined that an error was observed within the instruc... | Class II | Karl Storz Endoscopy |
| Aug 23, 2019 | Pharos Excimer Laser, Model: EX-308 - Product Usage: The Pharos EX-308 Excime... | At doses of less than 100 mJ, in custom and auto repeat modes, a software error in the excimer la... | Class II | Ra Medical Systems, Inc. |
| Aug 19, 2019 | BD FACSLyric Flow Cytometer, 3-Laser 8 Color Instrument, REF: 654587, when us... | Flow cytometers, when used with specific tubes may experience excessive electronic abort counts (... | Class II | Becton, Dickinson and Company, BD Biosciences |
| Aug 19, 2019 | BD FACSLyric Flow Cytometer, 2-Laser 6 Color Instrument, REF: 651165, when us... | Flow cytometers, when used with specific tubes may experience excessive electronic abort counts (... | Class II | Becton, Dickinson and Company, BD Biosciences |
| Aug 19, 2019 | BD FACSLyric Flow Cytometer,3-Laser 10 Color Instrument, REF: 659180 and 6591... | Flow cytometers, when used with specific tubes may experience excessive electronic abort counts (... | Class II | Becton, Dickinson and Company, BD Biosciences |
| Aug 19, 2019 | BD FACSLyric Flow Cytometer, 2-Laser 6 Color Instrument, REF: 662876, when us... | Flow cytometers, when used with specific tubes may experience excessive electronic abort counts (... | Class II | Becton, Dickinson and Company, BD Biosciences |
| Aug 19, 2019 | BD FACSLyric Flow Cytometer, 3-Laser 10 Color Instrument, REF: 662878, and 66... | Flow cytometers, when used with specific tubes may experience excessive electronic abort counts (... | Class II | Becton, Dickinson and Company, BD Biosciences |
| Aug 19, 2019 | BD FACSLyric Flow Cytometer, 2-Laser 4 Color Instrument, REF: 651164, when us... | Flow cytometers, when used with specific tubes may experience excessive electronic abort counts (... | Class II | Becton, Dickinson and Company, BD Biosciences |
| Aug 19, 2019 | da Vinci SP Camera; PN 430060-33; Model Number: 430060-33. For endoscopic su... | Some cameras were found to have residual soil adhered to the tip of the camera after reprocessing... | Class II | Intuitive Surgical, Inc. |
| Aug 19, 2019 | BD FACSLyric Flow Cytometer, 3-Laser 8 Color Instrument, REF: 662877, when us... | Flow cytometers, when used with specific tubes may experience excessive electronic abort counts (... | Class II | Becton, Dickinson and Company, BD Biosciences |
| Aug 19, 2019 | BD FACSLyric Flow Cytometer, 2-Laser 4 Color Instrument, REF: 662875, when us... | Flow cytometers, when used with specific tubes may experience excessive electronic abort counts (... | Class II | Becton, Dickinson and Company, BD Biosciences |
| Aug 19, 2019 | BD FACSLyric Flow Cytometer, 3-Laser 12 Color Instrument, REF: 663029, when u... | Flow cytometers, when used with specific tubes may experience excessive electronic abort counts (... | Class II | Becton, Dickinson and Company, BD Biosciences |
| Aug 19, 2019 | RespVent Closed Suction System T-Piece Tracheostomy Adult, Diameter: 4.6mm (1... | It has been determined that some units of catheters were not tightly connected to the thumb port.... | Class II | RESPIRATORY THERAPEUTICS GROUP LLC |
| Aug 15, 2019 | Direct Bilirubin Reagents (DBIL 2 x 200 ) and (DBIL 2 x 300), Ref:439715 (200... | It has been determined that N-acetyl p benzoquinone imine (NAPQI), a metabolite of acetaminophen ... | Class II | Beckman Coulter Inc |
| Aug 15, 2019 | Bioseal Trachea Extender 1/pl 50pk/Cs, REF TRAX01/50, LOT XXXX, STERILE EO, S... | The reported stress crack in the port of the swivel elbow where the flip cap is inserted could re... | Class II | Bioseal Corporation |
| Aug 15, 2019 | Total Bilirubin Reagent (TBIL 2 x 300 ) and (TBIL 2 x 400), Ref:442745 (300 t... | It has been determined that N-acetyl p benzoquinone imine (NAPQI), a metabolite of acetaminophen ... | Class II | Beckman Coulter Inc |
| Aug 15, 2019 | Uric Acid Reagent (URIC 2 X 300), REF: 442785, For In Vitro Diagnostic Use, R... | It has been determined that N-acetyl p benzoquinone imine (NAPQI), a metabolite of acetaminophen ... | Class II | Beckman Coulter Inc |
| Aug 15, 2019 | Enzymatic Creatinine Reagent (CR-E 2 X 200), REF A60298, For in Vitro Diagnos... | It has been determined that N-acetyl p benzoquinone imine (NAPQI), a metabolite of acetaminophen ... | Class II | Beckman Coulter Inc |
| Aug 15, 2019 | Triglycerides Reagent (TG 2 x 300), REF: 445850, For In Vitro Diagnostic Use,... | It has been determined that N-acetyl p benzoquinone imine (NAPQI), a metabolite of acetaminophen ... | Class II | Beckman Coulter Inc |
| Aug 12, 2019 | Varian Multileaf Collimator [MLC]; Millenium Multileaf Collimator [52, 80, 12... | After a recent upgrade to the collimator software version 8.5, the firm became aware that the mul... | Class II | Varian Medical Systems, Inc. |
| Aug 9, 2019 | Snappy Abutment 5.5 CC RP 3 mm; pre-manufactured prosthetic components direct... | Packages of abutments may contain an incorrect screw. While the screw will tighten, it cannot be ... | 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.