Browse Device Recalls
4,606 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 4,606 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 4,606 FDA device recalls in CA.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| May 6, 2013 | da Vinci 5 mm Instrument Cannulae for use with the da Vinci S and Si Surgical... | Intuitive Surgical is implementing a voluntary Field Action to implement a modified inspection pr... | Class II | Intuitive Surgical, Inc. |
| May 2, 2013 | Siemens brand MicroScan Dried Negative Breakpoint Combo 47 panels (B1017-417)... | The product has the potential for false negative or delayed reaction for Arginine (ARG) results. ... | Class II | Siemens Healthcare Diagnostics, Inc. |
| May 1, 2013 | Applied Medicals Epix¿ and Direct Drive Laparoscopic Graspers, Model Numbers... | Applied Medical is conducting a voluntary recall on specific lot numbers of its Epix¿ and Direct ... | Class II | Applied Medical Resources Corp |
| Apr 30, 2013 | TX1 Tissue Removal System disposable handpieces. Product Usage: The TX1 T... | American Optisurgical, Inc. is recalling certain lots of TX1 Tissue Removal System disposable han... | Class II | American Optisurgical Inc |
| Apr 30, 2013 | uTASWako DCP, Lot TG340 2013.11, REF 995-60701, Wako Pure Chemical Industries... | Product fails to meet the accuracy at the low end of the measuring range. | Class II | Wako Life Sciences, Inc. |
| Apr 30, 2013 | FAST Procedure Kit. Intended for use as a Minor Surgical Procedures Tray. | American Optisurgical, Inc initiated a recall of ChloraPrep Hi-Lite Orange 3mL Applicator, in re... | Class II | American Optisurgical Inc |
| Apr 26, 2013 | AU2700 Clinical Chemistry Analyzer AU5400 Clinical Chemistry Analyzer Per... | Beckman Coulter is recalling AU2700/AU2700 Plus & AU5400 Clinical Chemistry Analyzers becuase it ... | Class II | Beckman Coulter Inc. |
| Apr 22, 2013 | STERRAD CYCLESURE 24 Biological Indicator (BI) The STERRAD CYCLESURE 24 Bi... | Advanced Sterilization Products is recalling certain lots of STERRAD CYCLESURE 24 Biological Indi... | Class II | Advanced Sterilization Products |
| Apr 18, 2013 | Zeiss brand OPMI Pentero C, Surgical microscope and accessories, Model: OPMI ... | Carl Zeiss Meditec is conducting a field corrective action for its OPMI Pentero C surgical micros... | Class II | Carl Zeiss Meditec, Inc. |
| Apr 17, 2013 | Synchron LX System(s) and UniCel DxC 600/800 System(s) Lactate Reagent, Part ... | Beckman Coulter initiated the recall for the Lactate Assay (LACT) Lot M206209 as they received a ... | Class II | Beckman Coulter Inc. |
| Apr 17, 2013 | Xlumena brand NAVIX Access Device, Model/Catalogue Number: NVX-10-03, Part Nu... | A complaint investigation has found that product fractures can occur at the distal end of the cat... | Class II | Xlumena, Inc. |
| Apr 16, 2013 | Alere" hCG Combo Cassette (20/10 mIU/mL) Kit. Product Usage: The AlereT... | The firm initiated recall of Alere" hCG Combo Cassette (20/10 mIU/mL) kit PN 92215, lots hCG11101... | Class II | Alere San Diego, Inc. |
| Apr 15, 2013 | Liquichek" ToRCH Plus IgM Control - Positive Liquichek ToRCH Plus IgM Cont... | The Liquichek" ToRCH Plus IgM Control - Positive, contains detectable levels of HCV RNA which ori... | Class III | Bio-rad Laboratories, Inc. |
| Apr 15, 2013 | FreeStyle InsuLinx Blood Glucose Monitoring System: For In Vitro Diagnostic ... | AT rare, extremely high glucose levels (1024 mg/dL and above), the FreeStyle InsuLinx Blood Gluco... | Class I | Abbott Diabetes Care, Inc. |
| Apr 5, 2013 | Newport Medical Instruments HT70 and HT70 Plus ventilator Power Pac batterie... | Newport Medical Instruments is conducting a voluntary recall on certain Newport Medical Instrumen... | Class I | Newport Medical Instruments Inc |
| Apr 4, 2013 | QuietCare-Networked. Intended for use in monitoring the environmental cond... | Customers at 4 facilities reported receiving duplicate alerts using the QuietCare-Networked product. | Class II | Intel-GE Care Innovations LLC |
| Apr 4, 2013 | QuietCare. Intended for use in monitoring the environmental conditions and... | Customers at 4 facilities reported receiving duplicate alerts using the QuietCare-Networked product. | Class II | Intel-GE Care Innovations LLC |
| Apr 4, 2013 | Software correction applies to customers who use the RT Therapist RTT4.2.108... | Software update to fix multiple safety related issues. | Class II | Siemens Medical Solutions USA, Inc |
| Apr 3, 2013 | TOSHIBA Kalare Diagnostic X-Ray System K110785 | Firm initiated recall because when radiographic conditions with the small focus are set and the r... | Class II | Toshiba American Medical Systems Inc |
| Apr 2, 2013 | Product is distributed by Zimmer (Warsaw, Indiana)/Synvasive Technology, Inc.... | Various reciprocating and oscillating saw blades were incorrectly labeled. The labeling errors in... | Class II | Synvasive Technology Inc |
| Mar 30, 2013 | American Optisurgical's TX1 Tissue Removal System Console. The console is a s... | The recall has been initiated due to an overheating protection voltage suppressor on the redundan... | Class II | American Optisurgical Inc |
| Mar 28, 2013 | Siemens brand ACUSON SC2000 Ultrasound System, Model 10433816, hardware that ... | When using the V5M transducer, the display of the temperature on the ACUSON SC2000 system can be ... | Class II | Siemens Medical Solutions USA, Inc. |
| Mar 28, 2013 | EVOTECH Endoscope Cleaner and Reprocessor System, P/N 50004. Designed to a... | Advanced Sterilization Products (ASP) is recalling the EVOTECH Endoscope Cleaner and Reprocessor ... | Class II | Advanced Sterilization Products |
| Mar 27, 2013 | Stryker Irrigator Reusable Tips: 5mm X 32cm Regular Tip, Vented, Metal Finis... | The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incor... | Class II | Stryker Endoscopy |
| Mar 27, 2013 | Stryker Irrigator Reusable Tips: 2mm X 32cm Regular Tip with 1 Hole, Metal F... | The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incor... | Class II | Stryker Endoscopy |
| Mar 27, 2013 | Stryker Irrigator Reusable Tips: 5mm X 32cm Regular Tip with No Holes, Non-R... | The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incor... | Class II | Stryker Endoscopy |
| Mar 27, 2013 | Stryker Irrigator Reusable Tips: 3mm X 32cm Regular Tip, Vented, Metal Finis... | The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incor... | Class II | Stryker Endoscopy |
| Mar 27, 2013 | Stryker Irrigator Reusable Tips: 2mm X 34cm Regular Tip with No Hole, Metal ... | The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incor... | Class II | Stryker Endoscopy |
| Mar 27, 2013 | Stryker Irrigator Reusable Tips: 10mm X 32cm Regular Tip, vented, Non-Reflec... | The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incor... | Class II | Stryker Endoscopy |
| Mar 27, 2013 | Stryker Irrigator Reusable Tips: 5mm X 32cm Regular Tip, Vented, Metal Finis... | The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incor... | Class II | Stryker Endoscopy |
| Mar 27, 2013 | Stryker Irrigator Reusable Tips: 5mm X 28cm Regular Tip, vented, Non-Reflect... | The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incor... | Class II | Stryker Endoscopy |
| Mar 27, 2013 | Stryker Irrigator Reusable Tips: 5mm X 32cm Regular Tip , Non-Vented, Metal ... | The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incor... | Class II | Stryker Endoscopy |
| Mar 27, 2013 | Stryker Irrigator Reusable Tips: 5mm X 32cm Aspiration Needle Tip. Suctio... | The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incor... | Class II | Stryker Endoscopy |
| Mar 27, 2013 | Stryker Irrigator Reusable Tips: 5mm X 45cm Regular Tip, Vented, Metal Finis... | The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incor... | Class II | Stryker Endoscopy |
| Mar 27, 2013 | Stryker Irrigator Reusable Tips: 5mm X 45cm Regular Tip, vented, Non-Reflect... | The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incor... | Class II | Stryker Endoscopy |
| Mar 27, 2013 | Stryker Irrigator Reusable Tips: 5mm X 32cm Tip Hydrodissection Tip, Metal F... | The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incor... | Class II | Stryker Endoscopy |
| Mar 27, 2013 | Stryker Irrigator Reusable Tips: Vented Tip, 5mm X 45cm Non-Reflective with ... | The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incor... | Class II | Stryker Endoscopy |
| Mar 27, 2013 | Stryker Irrigator Reusable Tips: 5mm X 32cm Regular Tip, vented, Non-Reflect... | The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incor... | Class II | Stryker Endoscopy |
| Mar 27, 2013 | Stryker Irrigator Reusable Tips: 2mm X 32cm Regular Tip with 2 Hole, Metal F... | The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incor... | Class II | Stryker Endoscopy |
| Mar 27, 2013 | Stryker Irrigator Reusable Tips: 3mm X 32cm Regular Tip, Non-Vented, Metal F... | The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incor... | Class II | Stryker Endoscopy |
| Mar 27, 2013 | Stryker Irrigator Reusable Tips: 10mm X 32cm Pool Suction Tip, Metal Finish.... | The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incor... | Class II | Stryker Endoscopy |
| Mar 27, 2013 | Stryker Irrigator Reusable Tips: 5mm X 32cm Hydrodissection Tip, Non-Reflect... | The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incor... | Class II | Stryker Endoscopy |
| Mar 27, 2013 | Stryker Irrigator Reusable Tips: 5mm X 24cm Regular Tip, Vented, Metal Finis... | The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incor... | Class II | Stryker Endoscopy |
| Mar 27, 2013 | RoboCouch Patient Positioning System Product Usage: is intended for use... | A5 gearboxes responsible for pitch (head up and head down) and roll (patient left and right) moti... | Class II | Accuray Incorporated |
| Mar 26, 2013 | Varian brand RPM Respiratory Gating System, RPM Gating v1.7.5 with 3D Option,... | Varian has identified an anomaly with the RPM Respiratory Gating System version I.7.5 with 3D Op... | Class II | Varian Medical Systems, Inc. Oncology Systems |
| Mar 22, 2013 | STERRAD 100NX Sterilization System, P/N 10104 Product Usage: The STERRAD ... | The recall was initiated because Advanced Sterilization Products (ASP) has determined that the ST... | Class II | Advanced Sterilization Products |
| Mar 22, 2013 | EVOTECH Endoscope Cleaner & Reprocessor System, P/N 50004 Designed to auto... | Advanced Sterilization Products (ASP) has determined that a limited number of EVOTECH ECRs manufa... | Class II | Advanced Sterilization Products |
| Mar 22, 2013 | Medtronic MiniMed Paradigm Insulin Infusion Pumps Model Numbers: MMT-511, ... | Medtronic is recalling the Medtronic Paradigm Insulin Pump because the pump's drive support cap m... | Class II | Medtronic MiniMed |
| Mar 22, 2013 | STERRAD 200 Sterilization System, P/N 10201 Product Usage: The STERRAD 20... | The recall was initiated because Advanced Sterilization Products (ASP) has determined that the ST... | Class II | Advanced Sterilization Products |
| Mar 20, 2013 | AU5800 Clinical Chemistry Analyzer The Beckman Coulter AU5800 Clinical Che... | Beckman Coulter, Inc. initiated this recall because there is a software error that has the potent... | Class II | Beckman Coulter 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.