Browse Device Recalls
2,437 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,437 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 2,437 FDA device recalls in 2013.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Mar 6, 2013 | CoaguChek XS Pro meters (catalog number 05530199160)bar code scanner. Used... | Roche investigation into complaints found Accu-Chek Inform II and CoaguChek XS Pro System barcode... | Class II | Roche Diagnostics Operations, Inc. |
| Mar 6, 2013 | TRIGEN (TM) L-P SCREW, 4.5 MM X 37.5 MM, TI-6AL-4V, QTY: (1), STERILE R, REF ... | One batch of 4.5 mm diameter Trigen Low-Profile Bone Screws were incorrectly anodized with a gold... | Class II | Smith & Nephew Inc |
| Mar 5, 2013 | 1488 HD 3-Chip Camera; Model Number 1488-610-122 - HD 3-Chip Camera Head wit... | In certain operating room environments, a colored screen image occurs with the 1488 Cameras that ... | Class II | Stryker Endoscopy |
| Mar 5, 2013 | Philips IntellVue Info Center iX 866023; PIIC iX Upgrade 866024; IntellVue Se... | If a customer creates customized trend scales in the trend review tile and the iX or primary serv... | Class II | Philips Healthcare Inc. |
| Mar 5, 2013 | SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT... | Siemen's issued a Customer Information Letter under Update Instruction TH016/12S to alert all its... | Class II | Siemens Medical Solutions USA, Inc |
| Mar 5, 2013 | SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT... | Siemen's issued a Customer Information Letter under Update Instruction TH016/12S to alert all its... | Class II | Siemens Medical Solutions USA, Inc |
| Mar 5, 2013 | SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT... | Siemen's issued a Customer Information Letter under Update Instruction TH016/12S to alert all its... | Class II | Siemens Medical Solutions USA, Inc |
| Mar 5, 2013 | SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT... | Siemen's issued a Customer Information Letter under Update Instruction TH016/12S to alert all its... | Class II | Siemens Medical Solutions USA, Inc |
| Mar 5, 2013 | 20-Pole Eco Cable, Catalog #EM-5050-060 Product Usage: The 20-Pole Eco Ca... | Biosense is recalling the 20-Pole Eco Cable because it was incorrectly calibrated. When a cathet... | Class II | Biosense Webster, Inc. |
| Mar 5, 2013 | SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT... | Siemen's issued a Customer Information Letter under Update Instruction TH016/12S to alert all its... | Class II | Siemens Medical Solutions USA, Inc |
| Mar 5, 2013 | 1488 HD 3-Chip Inline Camera; Model Number 1488-710-105 - HD 3-Chip Inline C... | In certain operating room environments, a colored screen image occurs with the 1488 Cameras that ... | Class II | Stryker Endoscopy |
| Mar 5, 2013 | SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT... | Siemen's issued a Customer Information Letter under Update Instruction TH016/12S to alert all its... | Class II | Siemens Medical Solutions USA, Inc |
| Mar 5, 2013 | SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT... | Siemen's issued a Customer Information Letter under Update Instruction TH016/12S to alert all its... | Class II | Siemens Medical Solutions USA, Inc |
| Mar 5, 2013 | SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT... | Siemen's issued a Customer Information Letter under Update Instruction TH016/12S to alert all its... | Class II | Siemens Medical Solutions USA, Inc |
| Mar 5, 2013 | SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT... | Siemen's issued a Customer Information Letter under Update Instruction TH016/12S to alert all its... | Class II | Siemens Medical Solutions USA, Inc |
| Mar 5, 2013 | 1488 HD 3-Chip Camera; Model Number 1488-210-105 - C-Mount. Product Usa... | In certain operating room environments, a colored screen image occurs with the 1488 Cameras that ... | Class II | Stryker Endoscopy |
| Mar 4, 2013 | Sepp, Compound Benzoin Tincture Packaged and Tincture 3,000 Bulk. Product... | An internal review of CareFusion's labeling for preoperative skin prep product codes was recently... | Class III | CareFusion 213, LLC |
| Mar 4, 2013 | REF 8229705 x1 NIM TriVantage EMG Endotracheal Tube 5.0 mm I.D. x 6.5 mm O.D.... | In March 2013, Medtronic issued a recall of the NIM TriVantage EMG Endotracheal Tube due to cuff ... | Class I | Medtronic Xomed, Inc. |
| Mar 4, 2013 | NeuViz Dual series CT Scanner System, Part number (PN): 989605651321. This... | User error of the NeuViz 16 or NeuViz Dual may cause personnel injuries. There was a report wher... | Class II | Philips And Neusoft Medical Systems Co., Ltd. |
| Mar 4, 2013 | Siemens syngo.plaza SW version VA20 with Mammography license. image proce... | Siemens issued a Customer Safety Notice to inform customers of a potential problem when using syn... | Class II | Siemens Medical Solutions USA, Inc |
| Mar 4, 2013 | Quick Connect QLC1677E, QRC1699E, QPC1721E and QFC1683E. STERIS Corporation, ... | During a routine label review, the firm identified four SYSTEM 1E Quick Connects that will be upd... | Class II | Steris Corporation |
| Mar 4, 2013 | NeuViz 16 Multi-Slice CT Scanner System, Part number (PN): 989605858501, Mode... | User error of the NeuViz 16 or NeuViz Dual may cause personnel injuries. There was a report wher... | Class II | Philips And Neusoft Medical Systems Co., Ltd. |
| Mar 4, 2013 | Arrow/Teleflex Medical Berman Angiographic Balloon Catheter and Reverse Berma... | The product specifications sheet, part of the Instructions for Use (IFU), for the specified produ... | Class II | Arrow International Inc |
| Mar 1, 2013 | AMS 800¿ Urinary Control System. The AMS 800¿ Urinary Control System is u... | American Medical Systems, Inc. is initiating a recall on two components of the AMS 800¿ Urinary C... | Class II | American Medical Systems, Inc. |
| Mar 1, 2013 | AMS 800¿ Urinary Control System. The AMS 800¿ Urinary Control System is ... | American Medical Systems, Inc. is initiating a recall on two components of the AMS 800¿ Urinary C... | Class II | American Medical Systems, Inc. |
| Mar 1, 2013 | Roche Molecular Systems cobas x 480 System 50 mL reagent reservoir, Catalog n... | Certain lots of Reagent reservoirs, may not have a separation in the lower part of the reservoir... | Class II | Roche Diagnostics Operations, Inc. |
| Mar 1, 2013 | Boston Scientific/Cameron Health SQ-RX Model 1010 subcutaneous pulse generato... | An internal protective fuse can be unintentionally activated while the device is charging its cap... | Class II | Boston Scientific CRM Corp |
| Mar 1, 2013 | Diacap(R) Ultra Dialysis Fluid Filter, Catalog Number 7107367. Intended to... | There is the potential of the residual moisture of the Diacap Ultra membrane being reduced over t... | Class II | B. Braun Medical, Inc. |
| Feb 28, 2013 | Allen Traction Boot, Modular, OT 1000 Traction Device Boot Assembly, Fractur... | Some units may have been assembled incorrectly which could result in the boot breaking free from ... | Class II | Allen Medical Systems, Inc. |
| Feb 28, 2013 | Siemens Mammomat Inspiration - full-field digital mammography Product Usa... | Firm became aware of an unintended behavior when using the Mammomat Inspiration. The possibility... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 27, 2013 | The LifeCare PCA infusion system with Hospira MedNet software allows clinicia... | The infusion pump has a clear plastic door that, due to its design, allows for excessive flexing.... | Class II | Hospira Inc. |
| Feb 27, 2013 | The PCA 3 infusion pump allows clinicians, or patients, to (self) Administer ... | The infusion pump has a clear plastic door that, due to its design, allows for excessive flexing.... | Class II | Hospira Inc. |
| Feb 27, 2013 | CDI Blood Parameter Monitoring System 500 with Arterial and Venous blood para... | Terumo discovered through its own testing that CDI 500 Blood Parameter Monitoring System software... | Class II | Terumo Cardiovascular Systems Corporation |
| Feb 27, 2013 | Sirtex SIR-yttrium 90 microspheres (Radionuclide); SIR-Y001. Indicated for... | Incorrect expiration date | Class III | Sirtex Medical Limited |
| Feb 27, 2013 | Siemens Dimension(R) EXL(TM) LM (Siemens Material Number 10486890). Intend... | Through investigation of customer complaints, Siemens Healthcare Diagnostics has confirmed an inc... | Class III | Siemens Healthcare Diagnostics, Inc. |
| Feb 27, 2013 | Vascular Solutions, Inc., Guardian II and Guardian II NC Hemostasis Valve, us... | Risk that air may be introduced into the device which may lead to an air embolism. | Class I | Vascular Solutions, Inc. |
| Feb 27, 2013 | CDI Blood Parameter Monitoring System 500 with Arterial and Venous blood para... | Terumo discovered through its own testing that CDI 500 Blood Parameter Monitoring System software... | Class II | Terumo Cardiovascular Systems Corporation |
| Feb 27, 2013 | CDI Blood Parameter Monitoring System 500 with Venous blood parameter module.... | Terumo discovered through its own testing that CDI 500 Blood Parameter Monitoring System software... | Class II | Terumo Cardiovascular Systems Corporation |
| Feb 27, 2013 | CDI Blood Parameter Monitoring System 500 with Arterial blood parameter modul... | Terumo discovered through its own testing that CDI 500 Blood Parameter Monitoring System software... | Class II | Terumo Cardiovascular Systems Corporation |
| Feb 27, 2013 | Medtronic Prostiva RF Therapy Generator. The Prostiva RF system is indicat... | Medtronic has found through device testing that if the optional footswitch is not connected to th... | Class II | Medtronic Neuromodulation |
| Feb 27, 2013 | Siemens Dimension(R) EXL(TM) 200 (Siemens Material Number 10636929). Inten... | Through investigation of customer complaints, Siemens Healthcare Diagnostics has confirmed an inc... | Class III | Siemens Healthcare Diagnostics, Inc. |
| Feb 27, 2013 | Siemens Dimension(R) EXL(TM) LM STM (Siemens Material Number 106393377). I... | Through investigation of customer complaints, Siemens Healthcare Diagnostics has confirmed an inc... | Class III | Siemens Healthcare Diagnostics, Inc. |
| Feb 27, 2013 | CDI Blood Parameter Monitoring System 500 with Arterial blood parameter modul... | Terumo discovered through its own testing that CDI 500 Blood Parameter Monitoring System software... | Class II | Terumo Cardiovascular Systems Corporation |
| Feb 27, 2013 | Nicolet EEG Wireless Amplifier 32/64 Channel. Catalog/Part Numbers : 515-0154... | Natus Neurology Incorporated is recalling the Nicolet EEG Wireless Amplifier which may overheat a... | Class II | Natus Neurology Incorporated |
| Feb 26, 2013 | Neurotherm Curved Radiofrequency (RF) cannnula 10 cm 18 gauge, 10 mm activ... | Straight needle labeled as a curved needle | Class II | Neurotherm, Inc. |
| Feb 26, 2013 | Cooper Surgical Incontinence Dish w/ Support Pessary #5, 80mm. Milex :Part N... | Pessary mislabeled outer package may not reflect the size of the product contained in the package | Class III | Cooper Surgical, Inc. |
| Feb 26, 2013 | Cooper Surgical Gellhorn Flexible Pessary -2 3/4", 70mm. Milex Part Number: ... | Pessary mislabeled outer package may not reflect the size of the product contained in the package | Class III | Cooper Surgical, Inc. |
| Feb 26, 2013 | Cooper Surgical Incontinence Ring Flexible Pessary #4, 2 3/4", 70mm. Milex P... | Pessary mislabeled outer package may not reflect the size of the product contained in the package | Class III | Cooper Surgical, Inc. |
| Feb 26, 2013 | Cooper Surgical Incontinence Dish Folding Pessary #0, 55mm. Milex Part Numbe... | Pessary mislabeled outer package may not reflect the size of the product contained in the package | Class III | Cooper Surgical, Inc. |
| Feb 26, 2013 | Cooper Surgical Cube Pessary 1 5/8"", 41mm. Milex Part Number: MXKPEC04 ... | Pessary mislabeled outer package may not reflect the size of the product contained in the package | Class III | Cooper Surgical, 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.