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 |
|---|---|---|---|---|
| Feb 11, 2016 | KAMRA Inlay, ACI 7000 Corneal Inlay, Part No. 76195-01 and 76195-10 (OUS) ... | AcuFocus is recalling KAMRA ACI 7000 Corneal Inlays due to concerns with the labeled shelf life. | Class II | AcuFocus, Inc. |
| Feb 10, 2016 | Simplexa Flu A/B & RSV Direct (MOL2650) with Direct Amplification Disc (MOL14... | Focus Diagnostics is recalling the Direct Amplification Discs (DAD) supplied with the Simplexa HS... | Class II | Focus Diagnostics Inc |
| Feb 10, 2016 | Simplexa HSV 1&2 Direct (MOL2150) with Direct Amplification Disc (MOL1451, MO... | Focus Diagnostics is recalling the Direct Amplification Discs (DAD) supplied with the Simplexa HS... | Class I | Focus Diagnostics Inc |
| Feb 10, 2016 | Simplexa Group A Strep Direct (MOL2850) with Direct Amplification Disc (MOL14... | Focus Diagnostics is recalling the Direct Amplification Discs (DAD) supplied with the Simplexa HS... | Class I | Focus Diagnostics Inc |
| Feb 8, 2016 | TF Adaptive Gutta Percha Point Size SM3 50pk, Part No. 815-1541 Intended t... | Ormco Corporation is recalling the TF Adaptive Gutta Percha Point Size SM3-50pk because the inner... | Class II | Ormco/Sybronendo |
| Feb 5, 2016 | Allegra X-5 rotor yoke, Catalog No. (Instruments) B30589 and B30590 (Rotor) B... | A defective rotor yoke on Allegra X-5 allows improper rotor seating on the hub resulting in possi... | Class II | Beckman Coulter Inc. |
| Feb 5, 2016 | Volcano SpinVision Sterile Equip cover II; Sterile; General Hospital: Thes... | Volcano Corporation has identified that certain lot numbers of Volcano R-100 Sterile Equipment Co... | Class II | Volcano Corporation |
| Feb 5, 2016 | Volcano R100 Sterile Equipment Cover; Sterile; General Hospital: These Ste... | Volcano Corporation has identified that certain lot numbers of Volcano R-100 Sterile Equipment Co... | Class II | Volcano Corporation |
| Feb 4, 2016 | MitraClip Clip Delivery System, product number MSK0101. The MitraClip System ... | Abbott Vascular has recently received reports of cases on Clip Delivery System devices that conta... | Class I | Abbott Vascular |
| Jan 27, 2016 | Karma Flexx Wheelchair Manual Wheelchair. | Karman Healthcare, Inc. is recalling Karma Flexx Wheelchair because incorrect size screws and cor... | Class II | Karman Healthcare Inc |
| Jan 25, 2016 | BD FMC7 FITC: Model 430918. FMC7 is intended for in vitro diagnostic use in ... | Becton, Dickinson and Company (BD) has determined that the FMC7 FITC (ASR) has an incorrect expi... | Class III | Becton, Dickinson and Company, BD Biosciences |
| Jan 22, 2016 | CyberKnife Robotic; Catalog/part number 032000 and 033000 Cosmetic cover pack... | The gun box mounting bracket may fail to support the weight of the gun box when in vertical (inve... | Class II | Accuray Incorporated |
| Jan 18, 2016 | CEA / CD66e Ab-2, Product code RB-368-R7, RB-368-R1; 7 ml each. Descript... | Certain lots of CEA/CD66e Ab2 were produced with a dilution factor of 1:100 instead of the recomm... | Class III | Lab Vision Corporation |
| Jan 15, 2016 | Jadak Barcode Scanner, Part No. 350587-32, 350587-41, 351377-32. Product... | Customers reported issues when scanning medications with the scanners. When a user scans a medic... | Class II | CareFusion 303, Inc. |
| Jan 14, 2016 | Toshiba DRAD-3000E FPD Wireless System Product Usage The DRAD-3000¿ is i... | When a user performed radiography using the wireless FPD, a message window appeared on the monit... | Class II | Toshiba American Medical Systems Inc |
| Jan 13, 2016 | iChem VELOCITY Automated Urine Chemistry, Catalog No. 800-3049, 800-3050, 800... | Iris International noted loose or missing analyte pads found in several locations (strip vial, s... | Class II | Beckman Coulter Inc. |
| Jan 13, 2016 | Astral 100, 150 Model: 27001, 27003 In the US, Astral devices are primarily... | Resmed Corporation is recalling Astral 100, 150 External Battery because of a start-up issue. | Class II | Resmed Corporation |
| Jan 11, 2016 | ABX PENTRA Enzymatic Creatinine CP ref. A11A01907 reagent is intended for the... | N-Acetylcysteine (NAC) present in the blood of patients treated for paracetamol overdose can inte... | Class II | Horiba Instruments Inc |
| Jan 11, 2016 | The ABX PENTRA Cholesterol CP ref. A11A01634 is an in vitro diagnostic assay ... | N-Acetylcysteine (NAC) present in the blood of patients treated for paracetamol overdose can inte... | Class II | Horiba Instruments Inc |
| Jan 11, 2016 | Eclipse Treatment Planning System versions 11, 13.0, 13.5 and 13.6; Model nu... | When using PBC 11.0.31 to calculate the dose for a conventional arc field with more than 100 segm... | Class II | Varian Medical Systems, Inc. |
| Jan 11, 2016 | ABX PENTRA Lactic Acid CP ref. A11A01721 reagent is intended for the quantit... | N-Acetylcysteine (NAC) present in the blood of patients treated for paracetamol overdose can inte... | Class II | Horiba Instruments Inc |
| Jan 11, 2016 | ABX PENTRA Uric Acid CP ref. A11A01670 is an in vitro diagnostic assay for t... | N-Acetylcysteine (NAC) present in the blood of patients treated for paracetamol overdose can inte... | Class II | Horiba Instruments Inc |
| Jan 11, 2016 | ABX PENTRA Triglycerides CP ref. A11A01640 is an in vitro diagnostic assay fo... | N-Acetylcysteine (NAC) present in the blood of patients treated for paracetamol overdose can inte... | Class II | Horiba Instruments Inc |
| Jan 11, 2016 | ABX PENTRA Glucose PAP CP ref. A11A01668 reagent is intended for the quantit... | N-Acetylcysteine (NAC) present in the blood of patients treated for paracetamol overdose can inte... | Class II | Horiba Instruments Inc |
| Jan 6, 2016 | IMPLANT,TM, MTX FULL 4.1 mm x 13 mm diameter 3.5 mm Catalog #TMT4B13 Pr... | Information specific to the 3.7 mmD and 4.1 mmD Trabecular Metal Zimmer Dental Implants was omitt... | Class II | Zimmer Dental Inc |
| Jan 6, 2016 | IMPLANT,TM, MTX FULL 3.7 mm x 10 mm diameter 3.5 mm Catalog #TMTB10 Pro... | Information specific to the 3.7 mmD and 4.1 mmD Trabecular Metal Zimmer Dental Implants was omitt... | Class II | Zimmer Dental Inc |
| Jan 6, 2016 | IMPLANT,TM, MTX FULL 3.7 mm x 13 mm diameter 3.5 mm Catalog #TMTB13 Pro... | Information specific to the 3.7 mmD and 4.1 mmD Trabecular Metal Zimmer Dental Implants was omitt... | Class II | Zimmer Dental Inc |
| Jan 6, 2016 | IMPLANT,TM, MTX FULL 3.7 mm x 16 mm diameter 3.5 mm Catalog #TMTB16 Pro... | Information specific to the 3.7 mmD and 4.1 mmD Trabecular Metal Zimmer Dental Implants was omitt... | Class II | Zimmer Dental Inc |
| Jan 6, 2016 | IMPLANT,TM, MTX 4.1 mm x 10 mm diameter 3.5 mm Catalog #TMM4B10 Product... | Information specific to the 3.7 mmD and 4.1 mmD Trabecular Metal Zimmer Dental Implants was omitt... | Class II | Zimmer Dental Inc |
| Jan 6, 2016 | IMPLANT,TM, MTX FULL 4.1 mm x 11.5 mm diameter 3.5 mm Catalog #TMT4B11 ... | Information specific to the 3.7 mmD and 4.1 mmD Trabecular Metal Zimmer Dental Implants was omitt... | Class II | Zimmer Dental Inc |
| Jan 6, 2016 | IMPLANT,TM, MTX 4.1 mm x 13 mm diameter 3.5 mm Catalog #TMM4B13 Product... | Information specific to the 3.7 mmD and 4.1 mmD Trabecular Metal Zimmer Dental Implants was omitt... | Class II | Zimmer Dental Inc |
| Jan 6, 2016 | IMPLANT,TM, MTX 3.7 mm x 10 mm diameter 3.5 mm Catalog #TMMB10 Product ... | Information specific to the 3.7 mmD and 4.1 mmD Trabecular Metal Zimmer Dental Implants was omitt... | Class II | Zimmer Dental Inc |
| Jan 6, 2016 | IMPLANT,TM, MTX FULL 3.7 mm x 11.5 mm diameter 3.5 mm Catalog #TMTB11 P... | Information specific to the 3.7 mmD and 4.1 mmD Trabecular Metal Zimmer Dental Implants was omitt... | Class II | Zimmer Dental Inc |
| Jan 6, 2016 | IMPLANT,TM, MTX 3.7 mm x 13 mm diameter 3.5 mm Catalog #TMMB13 Product ... | Information specific to the 3.7 mmD and 4.1 mmD Trabecular Metal Zimmer Dental Implants was omitt... | Class II | Zimmer Dental Inc |
| Jan 6, 2016 | IMPLANT,TM, MTX 4.1 mm x 11.5 mm diameter 3.5 mm Catalog #TMM4B11 Produ... | Information specific to the 3.7 mmD and 4.1 mmD Trabecular Metal Zimmer Dental Implants was omitt... | Class II | Zimmer Dental Inc |
| Jan 6, 2016 | IMPLANT,TM, MTX 3.7 mm x 11.5 mm diameter 3.5 mm Catalog #TMMB11 Produc... | Information specific to the 3.7 mmD and 4.1 mmD Trabecular Metal Zimmer Dental Implants was omitt... | Class II | Zimmer Dental Inc |
| Jan 6, 2016 | IMPLANT,TM, MTX FULL 4.1 mm x 10 mm diameter 3.5 mm Catalog #TMT4B10 Pr... | Information specific to the 3.7 mmD and 4.1 mmD Trabecular Metal Zimmer Dental Implants was omitt... | Class II | Zimmer Dental Inc |
| Jan 5, 2016 | T-piece Nebulizer with in-line connectors, Part number 8915-7-50. Single pat... | Reports that the T-piece does not fit on the nebulizer. | Class II | Salter Labs |
| Dec 29, 2015 | AQURE System; Model Number: 933-599. The AQURE System manages blood gas and ... | The AQURE System has a design error regarding sample type in which sample type may be specified f... | Class II | Radiometer America Inc |
| Dec 23, 2015 | Battery Pack KLS-SD-1000 Case (40 ct) Models: KLS-BP-040 Used to power ... | The sterile battery may contain particulates within the sterile package. | Class II | Pro-Dex Inc |
| Dec 23, 2015 | Battery Pack KLS-SD-1000 Single Models: KLS-BP-001 Used to power the KLS ... | The sterile battery may contain particulates within the sterile package. | Class II | Pro-Dex Inc |
| Dec 22, 2015 | CA500 Epix Universal Clip Applier Product Usage: The Epix disposable lap... | Applied Medical Resources Corporation is recalling CA500 Epix Universal Clip Applier, kit models ... | Class II | Applied Medical Resources Corp |
| Dec 22, 2015 | STD GK258, AME Standard Kit 44 Product Usage: The Epix disposable laparo... | Applied Medical Resources Corporation is recalling CA500 Epix Universal Clip Applier, kit models ... | Class II | Applied Medical Resources Corp |
| Dec 22, 2015 | STD KIT GK213, AME Standard Kit 15 Product Usage: The Epix disposable la... | Applied Medical Resources Corporation is recalling CA500 Epix Universal Clip Applier, kit models ... | Class II | Applied Medical Resources Corp |
| Dec 22, 2015 | STD KIT GK260, Standard Set 360 Z Product Usage: The Epix disposable lap... | Applied Medical Resources Corporation is recalling CA500 Epix Universal Clip Applier, kit models ... | Class II | Applied Medical Resources Corp |
| Dec 15, 2015 | D-10 Rack Loader; Model Number 220-0600; Hematology: The D-10 is a fully ... | On a rare occasion, there is a potential to assign a patient result to an incorrect sample ID whe... | Class II | Bio-Rad Laboratories, Inc. |
| Dec 14, 2015 | FMC7 FITC, Catalog No. 340918 Analyte Specific Reagent. | Becton, Dickinson and Company (BD) has determined that the FMC7 FITC (ASR) is exhibiting function... | Class III | Becton, Dickinson and Company, BD Biosciences |
| Dec 14, 2015 | Mizuho OSI Trios, Table Base; Voltage: 100-240V ~ 50/60 Hz Amps: 5,0-5.0A; ... | Table Bases may have been assembled incorrectly, missing a retaining ring from the head end assem... | Class II | Mizuho OSI |
| Dec 8, 2015 | Zimmer Oscillating Flat - TS ST Hub; 75mm x 19mm x 1.00/1.27mm; Synvasive... | Two lots of oscillating saw blades incorrectly identify the blade cutting width as 25mm instead ... | Class II | Synvasive Technology Inc |
| Dec 1, 2015 | MicroScan Pos Combo Panel Type 34, Part No. B1017-214 MicroScan Pos (Posit... | Beckman Coulter has confirmed falsely negative results for Voges-Proskauer (VP) (pale-pink/brown/... | 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.