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 4, 2022 | The Optima Coil System consists of an implantable embolization coil comprised... | Due to Label/Pouch mix-up. Pouches incorrectly labeled. Incorrect shelf carton label or pouch la... | Class II | BALT USA, LLC |
| Dec 23, 2021 | da Vinci Xi and X 12-8 mm Conductive Cannula Reducer, REF: 470381-11 | Conductive Cannula Reducer metal tip may get dislodged from the plastic shaft. If unnoticed, addi... | Class II | Intuitive Surgical, Inc. |
| Dec 21, 2021 | Endurant, Endurant II and Endurant IIs Stent Graft System: Medtronic Endur... | Stent Graft Systems built with specific batches of taper tip assemblies have the potential for th... | Class II | Medtronic Vascular, Inc. |
| Dec 20, 2021 | Flat Panel Detector, Model Number: TFP-800A, used with the Alphenix Systems, ... | Abnormal images such as horizontal stripes may be displayed and recovery may not not be possible ... | Class II | Canon Medical System, USA, INC. |
| Dec 17, 2021 | NobelReplace Conical Connection RP 4.3x11.5 mm REF 36707 STERILE R | Due to 16 complaints related to drivers not engaging in implants. According to the firm's invest... | Class II | Nobel Biocare Usa Llc |
| Dec 16, 2021 | Digital Angiography System Shimadzu Trinias Generator Model: D150GC-40 | Due to the inadequate adjusting criteria in installation, the system generator on two Digital Ang... | Class II | Shimadzu Medical Systems |
| Dec 16, 2021 | Digital Angiography System Bransist safire Generator Model D150GC-40 | Due to the inadequate adjusting criteria in installation, the system generator on two Digital Ang... | Class II | Shimadzu Medical Systems |
| Dec 8, 2021 | AU/DxC AU Magnesium, Catalog/REF Number OSR6189, UDI 15099590010850 | Lipemic interference for the Magnesium serum application failed to meet the performance claim as ... | Class II | Beckman Coulter Inc. |
| Nov 30, 2021 | activforce 2 package labeling: Model: Activ5-M R 201-200563 | Due to: 1) Manufacturing issue that result in inaccurate force measurement which may lead to may ... | Class II | Activbody, Inc. |
| Nov 30, 2021 | Box Label: activ5 TINY GYM IN YOUR POCKET activbody Model: Activ5 User Manual... | Due to: 1) Manufacturing issue that result in inaccurate force measurement which may lead to may ... | Class II | Activbody, Inc. |
| Nov 24, 2021 | RefleXion Medical Radiotherapy System - System Label: "*** refleXion REF ... | Due to dose discrepancy when delivering a plan to a patient in a Non-HFS (Head First Supine) orie... | Class II | Reflexion Medical, Inc. |
| Nov 19, 2021 | Simplexa Direct Amplification Disc Kit, Product Kit Code MOL1455 | A subset of affected discs are at risk of leakage when it is used more than one time with Simplex... | Class II | DiaSorin Molecular LLC |
| Nov 12, 2021 | TruDi NAV Suction Instruments: 0-Degree, REF: TDNS000Z; 70-Degree, REF: TDNS0... | Suction Instruments were incorrectly calibrated so they may not meet the system accuracy specific... | Class II | Acclarent, Inc. |
| Nov 11, 2021 | O3D ORCHESTRATE Orthodontic Technologies User Manual and Data Processing Ins... | Due to product label/labeling being altered from it's approved state. | Class II | Orchestrate Orthodontic Technologies, Inc. |
| Nov 10, 2021 | PIVO Blood Collection Device 20G, REF: 202-0005 | Incomplete sealing of blood collection device unit packages may produce a breach in the sterile b... | Class II | Velano Vascular |
| Nov 10, 2021 | SYNCHRON Systems Cholesterol (CHOL) Reagent, REF: 467825 | Cholesterol Reagent may fail with Out of Calibration Range Low (OCR Low) and/or Back to Back (B/B... | Class II | Beckman Coulter Inc. |
| Nov 9, 2021 | Miami J Select Collar, Item: MJS-101, and Miami J Select Collar Set, Item: MJ... | Instructions for use were updated to include additional information to facilitate the selection a... | Class II | Ossur Americas |
| Oct 29, 2021 | NUVASIVE PRECICE Intramedullary Limb Lengthening (IMLL) and (Short) System: ... | The Instructions for Use have been updated to include: (1) Clarification that the device is int... | Class II | NuVasive Specialized Orthopedics, Inc. |
| Oct 22, 2021 | Abbott HeartMate Touch Communication System, REF: HMT1100 (US), HMT1100-R (Re... | If LVAS communication system is trying to establish Bluetooth connection and another Bluetooth-en... | Class II | Thoratec Corp. |
| Oct 21, 2021 | Catalys Precision Laser System, Models: Catalys-U (United States), Catalys-I ... | Aberrometer and precision laser systems are affected by a remote code execution vulnerability exi... | Class II | AMO Manufacturing USA, LLC |
| Oct 21, 2021 | iDesign, Model - G300: System AWS (International), System AWS (China), Advanc... | Aberrometer and precision laser systems are affected by a remote code execution vulnerability exi... | Class II | AMO Manufacturing USA, LLC |
| Oct 20, 2021 | Aspiration Syringe Kit, REF: MVSK60 | Syringe Kits labeled for distribution OUS were inadvertently shipped to US customers. | Class II | MICROVENTION INC. |
| Oct 15, 2021 | Karl Storz Udel Sterilization Tray Instructions for Use, Tray Part Number/Des... | To ensure sterilization effectiveness, sterilization tray instructions for use were updated and n... | Class II | Karl Storz Endoscopy |
| Oct 15, 2021 | Endurant IIs Stent Graft System REF/Description: ESBF2814C103EE STENT GRAFT E... | Due to, during stent graft deployment, the spindle may detach from the distal end of the spindle ... | Class II | Medtronic Vascular, Inc. |
| Oct 15, 2021 | Endurant Stent Graft System REF/Description: ENTF2525C70EE STENT GRAFT ENTF... | During stent graft deployment, the spindle may detach from the distal end of the spindle hypotube | Class II | Medtronic Vascular, Inc. |
| Oct 15, 2021 | Endurant II Stent Graft System REF/Description: ETBF2513C145EE STENT GRAFT ET... | Due to, during stent graft deployment, the spindle may detach from the distal end of the spindle ... | Class II | Medtronic Vascular, Inc. |
| Oct 14, 2021 | T4 EIA Kit, Cat No: BC-1007, Store at 2-8C, For in vitro diagnostic use only ... | Immunoassay TEST Kit do not meet product shelf-life standards resulting in failed controls. | Class II | BioCheck, Inc. |
| Sep 23, 2021 | ImplantDirect, REF 834711, Legacy 2 Implant 4.7mmD x 11.5mmL, 4.5mmD Platform, | Packaged dental implant contains a different size then the size declared on the labeling. | Class II | Implant Direct Sybron Manufacturing LLC |
| Sep 23, 2021 | SIMPLEXA COVID-19 Positive Control Pack, REF MOL4160, IVD, Rx Only, UDI: (01)... | Due to unapproved raw materials used in the manufacturing of Covid-19 control pack, their is th... | Class II | DiaSorin Molecular LLC |
| Sep 23, 2021 | ImplantDirect, REF 834713, Legacy 2 Implant 4.7mmD x 13mmL, 4.5mmD Platform, | Packaged dental implant contains a different size then the size declared on the labeling. | Class II | Implant Direct Sybron Manufacturing LLC |
| Sep 22, 2021 | da Vinci SP Surgical systems with the following Model Name/ Model Number / UD... | Issue was identified during internal engineering evaluation. Use of the system with the affected ... | Class II | Intuitive Surgical, Inc. |
| Sep 21, 2021 | The da Vinci Xi and X surgical systems (IS4000 and IS4200) each consist of th... | Incorrect expiration date on its package labeling (shipper box and inner carton label). | Class II | Intuitive Surgical, Inc. |
| Sep 10, 2021 | FIVE S 3.5x65, Flexible Intubation Videoscope, REF: 091361-01 (1 Unit), and 0... | During a regular requalification review, affected flexible intubation video endoscopes did not ac... | Class II | Karl Storz Endoscopy |
| Sep 8, 2021 | Vit Kit-Freeze is intended for use in assisted reproductive procedures for vi... | Due to a component in kit being labeled with the incorrect Expiration Date | Class II | Fujifilm Irvine Scientific, Inc. |
| Sep 8, 2021 | Vit Kit-Freeze is intended for use in assisted reproductive procedures for vi... | Due to a component in kit being labeled with the incorrect Expiration Date | Class II | Fujifilm Irvine Scientific, Inc. |
| Sep 7, 2021 | GEL CONDUCTOR, Description/REF: 5 LITER W/DISP/4238, 24-8.5OZ BOTTLES/4248, 5... | Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial co... | Class I | DJO, LLC |
| Sep 7, 2021 | Ultra-Myossage Lotion 1-gallon bottle, REF: 4262; Myossage Lotion 1-gallon b... | Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial co... | Class I | DJO, LLC |
| Sep 2, 2021 | MOSAIQ Oncology Information System | A drug strength in MOSAIQ can be changed during the ordering process and approved, but the saved ... | Class II | Elekta, Inc. |
| Aug 27, 2021 | United Orthopedics USTAR II Knee System USTAR II Knee System Segment Part,... | Due to product not meeting specification for concentricity and failing to meet requirements of dy... | Class II | Uoc Usa Inc |
| Aug 27, 2021 | Norco Ultrasound Gel, Item/Description: NC70479/Norco Ultrasound Gel, 250 mL;... | Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial co... | Class I | North Coast Medical Inc |
| Aug 27, 2021 | EcoLotion Transmission Lotion, used in ultrasound procedures. Item/Descripti... | Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial co... | Class I | North Coast Medical Inc |
| Aug 23, 2021 | Action De Gala, FuSion Conductive Gel - Product Usage: Intended for use in ac... | Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial co... | Class I | Aesthetics Systems Usa Inc |
| Aug 13, 2021 | Imperative Care, ZOOM 71 Reperfusion Catheter, REF: ICRC071137, TRX Tip, 137... | There is a potential for distal end of catheters to fracture and become detached. | Class I | IMPERATIVE CARE INC |
| Aug 9, 2021 | Access hsTnI High Sensitivity Troponin I, REF B52699 Access Immunoassay Sy... | Through customer feedback, testing a sample with cardiac troponin I concentration that are >270,0... | Class II | Beckman Coulter Inc. |
| Aug 6, 2021 | Zoll, REF 8700-0782-03 (IC-3893AE), ICY Intravascular Heat Intravascular Heat... | Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing | Class II | ZOLL Circulation, Inc. |
| Aug 6, 2021 | Zoll REF: 8700-0783-01 (IC-4593), QUATTRO Intravascular Heat Exchange Cathete... | Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing | Class II | ZOLL Circulation, Inc. |
| Aug 6, 2021 | Zoll REF: 8700-0783-14 (IC-4593CO), QUATTRO Intravascular Heat Exchange Cath... | Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing | Class II | ZOLL Circulation, Inc. |
| Aug 6, 2021 | Zoll REF: 8700-0783-40 (IC-4593AE), QUATTRO Intravascular Heat Exchange Cathe... | Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing | Class II | ZOLL Circulation, Inc. |
| Aug 6, 2021 | Zoll REF: 8700-0782-01 (IC-3893), ICY Intravascular Heat Exchange Catheter Ki... | Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing | Class II | ZOLL Circulation, Inc. |
| Aug 6, 2021 | Zoll, REF 8700-000869-40, Cool Line (Heparin) IVTM Disposable Pack and Start ... | Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing | Class II | ZOLL Circulation, 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.