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 1, 2017 | da Vinci Xi Surgical System Product Usage: The da Vinci Xi Surgical Syste... | da Vinci Xi(R) Surgical System Patient Side Carts (PSC) were shipped to the field with potentiall... | Class II | Intuitive Surgical, Inc. |
| May 30, 2017 | Kit w/3 Ext Sets, 3 Drop-In MicroClave¿ Clear. Product Usage: The device is... | The connection between the Female Luer and the NanoClave¿ manifold has the potential for developi... | Class II | ICU Medical, Inc. |
| May 30, 2017 | PROXIMALE - 28 cm (11") Smallbore Ext Set w/6-Port NanoClave¿ Manifold, Check... | The connection between the Female Luer and the NanoClave¿ manifold has the potential for developi... | Class II | ICU Medical, Inc. |
| May 30, 2017 | 10" Smallbore Ext Set w/6-Port NanoClave¿ Manifold (Orange, Red, Blue, Purple... | The connection between the Female Luer and the NanoClave¿ manifold has the potential for developi... | Class II | ICU Medical, Inc. |
| May 30, 2017 | 18 cm (7") PUR Smallbore Ext Set w/6-Port NanoClave¿ Manifold, Check Valve, N... | The connection between the Female Luer and the NanoClave¿ manifold has the potential for developi... | Class II | ICU Medical, Inc. |
| May 30, 2017 | 28 cm (11") PUR Smallbore Ext Set w/6-Port NanoClave¿ Manifold, Check Valve, ... | The connection between the Female Luer and the NanoClave¿ manifold has the potential for developi... | Class II | ICU Medical, Inc. |
| May 30, 2017 | 28 cm (11") PUR Bifuse Ext Set w/6-Port NanoClave¿ Manifold, Check Valve, 2 N... | The connection between the Female Luer and the NanoClave¿ manifold has the potential for developi... | Class II | ICU Medical, Inc. |
| May 30, 2017 | 168 cm (66") Appx 2.6 ml, PVC/PUR Smallbore Ext Set w/6-Port NanoClave¿ Manif... | The connection between the Female Luer and the NanoClave¿ manifold has the potential for developi... | Class II | ICU Medical, Inc. |
| May 30, 2017 | 10" Smallbore Ext Set w/6-Port NanoClave¿ Manifold, Check Valve, Clamp, Rotat... | The connection between the Female Luer and the NanoClave¿ manifold has the potential for developi... | Class II | ICU Medical, Inc. |
| May 30, 2017 | 10" Smallbore Ext Set w/6-Port NanoClave¿ Manifold (Orange, Red, Blue, Purple... | The connection between the Female Luer and the NanoClave¿ manifold has the potential for developi... | Class II | ICU Medical, Inc. |
| May 23, 2017 | SHIMADZU Ceiling Type X-ray Tube Support CH-200/CH-200M Catalog Number: CH-20... | Cracks may occur over time on the tube holding shaft near the base of the tube mounting flange. | Class II | Shimadzu Medical Systems Usa Com |
| May 23, 2017 | SHIMADZU FDR Visionary Catalog Number: FDR Visionary Suite Stationary x-ra... | Cracks may occur over time on the tube holding shaft near the base of the tube mounting flange. | Class II | Shimadzu Medical Systems Usa Com |
| May 23, 2017 | SHIMADZU RADspeed Pro Catalog Number: RADspeed Pro; Stationary x-ray system | Cracks may occur over time on the tube holding shaft near the base of the tube mounting flange. | Class II | Shimadzu Medical Systems Usa Com |
| May 22, 2017 | Coulter PrepPlus 2, Part Number 378600, Product Usage: The COULTER PrepP... | When samples are prepared using the PrepPlus or PrepPlus 2 sample preparation systems and then ru... | Class II | Beckman Coulter Inc. |
| May 22, 2017 | Coulter PrepPlus, Part Number 286600, Product Usage: The COULTER PrepPlu... | When samples are prepared using the PrepPlus or PrepPlus 2 sample preparation systems and then ru... | Class II | Beckman Coulter Inc. |
| May 17, 2017 | PENTARAY NAV High-Density Mapping Catheter. | Contraindication language updated in the Instructions For Use (IFU) to indicate that Pentaray Cat... | Class II | Biosense Webster, Inc. |
| May 17, 2017 | PENTARAY NAV High-Density Mapping Catheter. | Contraindication language updated in the Instructions For Use (IFU) to indicate that Pentaray Cat... | Class II | Biosense Webster, Inc. |
| May 15, 2017 | Beckman Coulter Synchron AQUA CAL Level 1, Part No. 471288 Product Usage: ... | The firm identified a negative shift of 5mmol/L for sodium recovery in Synchron Control Level 3 w... | Class II | Beckman Coulter Inc |
| May 9, 2017 | Access System-Free T4 Assay, B01902E, Catalog No. 33880 | The Access immunoassays are susceptible to biotin interference. | Class II | Beckman Coulter Inc. |
| May 9, 2017 | Access Total T3, A34435H, Catalog No. 33830 | The Access immunoassays are susceptible to biotin interference. | Class II | Beckman Coulter Inc. |
| May 9, 2017 | Access Thyroglobulin, A34085G, Catalog No. 33860 | The Access immunoassays are susceptible to biotin interference. | Class II | Beckman Coulter Inc. |
| May 9, 2017 | Access System-GI Monitor (CA19-9), A83873D, Catalog No. 387687 | The Access immunoassays are susceptible to biotin interference. | Class II | Beckman Coulter Inc. |
| May 8, 2017 | MiniMed 640G Insulin Infusion Pump, Catalog No. MMT-1511, MMT-1711, MMT-1512,... | Medtronic MiniMed is recalling the MiniMed 600 series insulin pump because it may become temporar... | Class II | Medtronic Inc. |
| May 8, 2017 | MiniMed 630G Insulin Infusion Pump, Catalog No. MMT-1715, MMT-1755. | Medtronic MiniMed is recalling the MiniMed 600 series insulin pump because it may become temporar... | Class II | Medtronic Inc. |
| May 8, 2017 | MiniMed 670G Insulin Infusion Pump, Catalog No. MMT-1580, MMT-1780, MMT-1782,... | Medtronic MiniMed is recalling the MiniMed 600 series insulin pump because it may become temporar... | Class II | Medtronic Inc. |
| May 8, 2017 | MiniMed 620G Insulin Infusion Pump, Catalog No. MMT-1510, MMT-1710, MMT-1550,... | Medtronic MiniMed is recalling the MiniMed 600 series insulin pump because it may become temporar... | Class II | Medtronic Inc. |
| May 5, 2017 | Her2/Neu (c-erbB-2) (CB-1 1); 7.0 mL Catalog number 237M-18. In vitro diagn... | Cell Marque has determined the need to issue a product recall after identifying product intended ... | Class II | Cell Marque Corporation |
| May 5, 2017 | Estrogen Receptor (EP1) 7.0 mL Catalog number 249R-28; 1.0 mL Catalog num... | Cell Marque has determined the need to issue a product recall after identifying product intended ... | Class II | Cell Marque Corporation |
| May 5, 2017 | SV40 (MRQ-4) 0.5 ml catalog number 351 M-15. Microbiology - Analyte Spec... | Cell Marque has determined the need to issue a product recall after identifying product intended ... | Class II | Cell Marque Corporation |
| May 5, 2017 | Estrogen Receptor (SP1) 7.0 mL Catalog number 249R-18; Hematology - Anal... | Cell Marque has determined the need to issue a product recall after identifying product intended ... | Class II | Cell Marque Corporation |
| May 5, 2017 | Arsenal Spinal Fixation System, Set Screw, Part No. 47027 Product Usage:... | Alphatec Spine is recalling the Arsenal Spinal Fixation System Set Screw due to a trend in set sc... | Class II | Alphatec Spine, Inc. |
| May 5, 2017 | CD117, c-kit (YR145) 1.0 ml catalog number 117R-16 7.0 ml catalog number-18... | Cell Marque has determined the need to issue a product recall after identifying product intended ... | Class II | Cell Marque Corporation |
| May 5, 2017 | Adenovirus (20/11 & 2/6); 0.5 mL Catalog # 212M-15; and 7.0 mL Catalog nu... | Cell Marque has determined the need to issue a product recall after identifying product intended ... | Class II | Cell Marque Corporation |
| May 5, 2017 | Herpes Simplex Virus II 0.5 ml catalog number 362A-15 7.0 mL Catalog number... | Cell Marque has determined the need to issue a product recall after identifying product intended ... | Class II | Cell Marque Corporation |
| May 5, 2017 | Her2/Neu (EP3); 0.5 mL Catalog number 237R-25; 1.0 mL Catalog number 237R-2... | Cell Marque has determined the need to issue a product recall after identifying product intended ... | Class II | Cell Marque Corporation |
| May 5, 2017 | Herpes Simplex Virus I; 7.0 mL Catalog number 361A-18. Microbiology - Ana... | Cell Marque has determined the need to issue a product recall after identifying product intended ... | Class II | Cell Marque Corporation |
| May 5, 2017 | Varicella Zoster Virus 7.0 ml catalog number 364M-18 Microbiology - Analy... | Cell Marque has determined the need to issue a product recall after identifying product intended ... | Class II | Cell Marque Corporation |
| May 5, 2017 | H. pylori (polyclonal} 1.0 mL Catalog number 215A-76; Hematology - Analyt... | Cell Marque has determined the need to issue a product recall after identifying product intended ... | Class II | Cell Marque Corporation |
| May 5, 2017 | HHV-8 (13810); 1.0 ml catalog number 265M-16; 7.0 ml catalog number-265M-18... | Cell Marque has determined the need to issue a product recall after identifying product intended ... | Class II | Cell Marque Corporation |
| May 4, 2017 | Kii Shielded Bladed trocars (CTB14), Kii Low profile trocars (CTB23), and K... | Due to possibility of insufficient sterilization. | Class II | Applied Medical Resources Corp |
| May 2, 2017 | Legacy Full Contour Laboratory Abutment: 3.5mmD Platform/5.5mmD | Implant Direct Sybron Manufacturing is recalling the Legacy Full-Contour Abutment 3.5mmD Assembly... | Class II | Implant Direct Sybron Manufacturing, LLC |
| May 1, 2017 | APLIO 300 TUS-A300 diagnostic ultrasound system | When Continuous Trace method is used as the tracing method on Spectral Doppler in velocity trace ... | Class II | Toshiba American Medical Systems Inc |
| May 1, 2017 | APLIO i-series: a) APLIO i700 TUS AI700 b) APLIO i800 TUS AI800 diagnostic... | When Continuous Trace method is used as the tracing method on Spectral Doppler in velocity trace ... | Class II | Toshiba American Medical Systems Inc |
| May 1, 2017 | XARIO 100 TUS-X100 diagnostic ultrasound system | When Continuous Trace method is used as the tracing method on Spectral Doppler in velocity trace ... | Class II | Toshiba American Medical Systems Inc |
| May 1, 2017 | APLIO 500 TUS-A500 diagnostic ultrasound system | When Continuous Trace method is used as the tracing method on Spectral Doppler in velocity trace ... | Class II | Toshiba American Medical Systems Inc |
| May 1, 2017 | XARIO 200 TUS-X200 diagnostic ultrasound system | When Continuous Trace method is used as the tracing method on Spectral Doppler in velocity trace ... | Class II | Toshiba American Medical Systems Inc |
| Apr 26, 2017 | Absorb Bioresorbable Vascular Scaffold (BVS) system (Australia). The Absorb ... | Abbott Vascular is initiating a recall of the Absorb Bioresorbable Vascular Scaffold (BVS) System... | Class I | Abbott Vascular |
| Apr 24, 2017 | UniCel DxH 800 Coulter Cellular Analysis System, Catalog No. 629029, B24465, ... | There is a possibility of a data acquisition disruption that may cause an unusual light scatter e... | Class II | Beckman Coulter Inc. |
| Apr 24, 2017 | UniCel DxH 600 Coulter Cellular Analysis System, Catalog No. B23858. | There is a possibility of a data acquisition disruption that may cause an unusual light scatter e... | Class II | Beckman Coulter Inc. |
| Apr 24, 2017 | Philips V60 Ventilators, Material No. 850008, 1053613, 1053614, 1053615, 1053... | Over time, low-frequency vibrations can cause the pins within the female connectors on the Motor... | Class I | Respironics California 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.