Browse Device Recalls
3,367 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,367 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 3,367 FDA device recalls in IL.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Dec 8, 2014 | Baxter Integrated APD Set with Cassette 3-Prong, Sterile, nonpyrogenic fluid ... | Baxter is issuing a recall for one lot of Integrated Automated Peritoneal Dialysis set with Casse... | Class II | Baxter Healthcare Corp. |
| Nov 29, 2014 | Adult Air-Life single-limb circuit (Model AH202) with AirLife Humidification ... | Manufacturing error in humidification chamber may cause an overfill/overflow condition of the cha... | Class I | Vyaire Medical |
| Nov 29, 2014 | Infant AirLife Dual-,limb, dual-heat, high-flow circuit (Model AH265) with Ai... | Manufacturing error in humidification chamber may cause an overfill/overflow condition of the cha... | Class I | Vyaire Medical |
| Nov 29, 2014 | Infant AirLife single-limb, continuous-flow circuit (Model AH132) containing ... | Manufacturing error in humidification chamber may cause an overfill/overflow condition of the cha... | Class I | Vyaire Medical |
| Nov 29, 2014 | Adult AirLife dual-limb, dual-heat circuit (Model AH280) with AirLife Humidif... | Manufacturing error in humidification chamber may cause an overfill/overflow condition of the cha... | Class I | Vyaire Medical |
| Oct 28, 2014 | The J700 Floor Mounted Tube Stand (FMTS) is intended to support and position ... | The welds on J700 tube stands may be insufficient resulting in tube stand breakage, damage to the... | Class II | Summit Industries Inc. |
| Oct 23, 2014 | Abbott m2000sp, an automated system for performing sample preparation for nuc... | Some versions of Application Specifications (App Spec) are incompatible with m2000sp system softw... | Class II | Abbott Molecular |
| Oct 21, 2014 | HomeChoice/HomeChoice Pro Automated Personal Cycler, for Automated Peritoneal... | The keypad buttons on HomeChoice devices may be activated without the operator pressing them. | Class II | Baxter Healthcare Corp. |
| Oct 21, 2014 | The MectaLIF Oblique Handle, model number 03.22.10.0262, is used to insert th... | The MectaLIF Oblique Handle has the laser marking "MEDIAL" on the incorrect side and co... | Class II | Medacta Usa |
| Oct 6, 2014 | HomeChoice Automated PD system and HomeChoice Pro Automated PD system Baxter'... | There are additional and updated warning and cautions that are not in the Patient At-Home Guide f... | Class II | Baxter Healthcare Corp. |
| Sep 22, 2014 | GMK Intramedullary Extension Rod 100 mm is a rod to obtain correct leg alignm... | Medacta has registered in its database 3 cases of breakage of the GMK Intramedullary Extension R... | Class II | Medacta Usa |
| Sep 16, 2014 | Baxter 2B8011 Empty INTRA VIA Container with PVC Ports, Sterile fluid path, ... | Particulate matter found inside the fluid path. | Class I | Baxter Healthcare Corp |
| Sep 16, 2014 | Baxter 2B8013 Empty INTRA VIA Container with PVC Ports (Sterile, nonpyrogen... | Particulate matter found inside the fluid path. | Class I | Baxter Healthcare Corp |
| Sep 8, 2014 | Lock nuts for titanium traction tongs are used in traction skull tongs for tr... | The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did n... | Class II | Instrumed International, Inc. |
| Sep 8, 2014 | Hudson braces are bone cutting and drilling instruments that are used without... | The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did n... | Class II | Instrumed International, Inc. |
| Sep 8, 2014 | Replacement screw non-springloaded traction tongs are skull tongs for tractio... | The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did n... | Class II | Instrumed International, Inc. |
| Sep 8, 2014 | Traction tong replacement screws, non-springloaded are used in traction skull... | The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did n... | Class II | Instrumed International, Inc. |
| Sep 8, 2014 | Hudson cerebellar extensions are bone cutting and drilling instruments that a... | The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did n... | Class II | Instrumed International, Inc. |
| Sep 8, 2014 | Manual trephines are bone cutting and drilling instruments that are used with... | The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did n... | Class II | Instrumed International, Inc. |
| Sep 8, 2014 | Cushing burrs are bone cutting and drilling instruments that are used without... | The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did n... | Class II | Instrumed International, Inc. |
| Sep 8, 2014 | Tonometers are manual devices intended to measure intraocular pressure by app... | The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did n... | Class II | Instrumed International, Inc. |
| Sep 8, 2014 | An external vein stripper is an extravascular device used to remove a section... | The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did n... | Class II | Instrumed International, Inc. |
| Sep 8, 2014 | A trocar is a sharp-pointed instrument used with a cannula for piercing a ves... | The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did n... | Class II | Instrumed International, Inc. |
| Sep 8, 2014 | Hudson burrs are bone cutting and drilling instruments that are used without ... | The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did n... | Class II | Instrumed International, Inc. |
| Sep 8, 2014 | Galt trephines are bone cutting and drilling instruments that are used withou... | The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did n... | Class II | Instrumed International, Inc. |
| Sep 8, 2014 | Titanium fixation screws, springloaded are used in traction skull tongs for t... | The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did n... | Class II | Instrumed International, Inc. |
| Sep 8, 2014 | CVB distraction screws are bone cutting and drilling instruments that are use... | The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did n... | Class II | Instrumed International, Inc. |
| Sep 8, 2014 | Cushing perforating drills are bone cutting and drilling instruments that are... | The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did n... | Class II | Instrumed International, Inc. |
| Sep 8, 2014 | Cloward Spanner gauges are bone cutting and drilling instruments that are use... | The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did n... | Class II | Instrumed International, Inc. |
| Sep 8, 2014 | Gardner-Wells wrenches are used in traction skull tongs for traction used to ... | The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did n... | Class II | Instrumed International, Inc. |
| Sep 8, 2014 | Manual bunnell cranial drills are bone cutting and drilling instruments that ... | The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did n... | Class II | Instrumed International, Inc. |
| Sep 8, 2014 | McKenzie Perforator Drills are bone cutting and drilling instruments that are... | The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did n... | Class II | Instrumed International, Inc. |
| Sep 8, 2014 | An endometrial suction curette is a device used to remove material from the u... | The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did n... | Class II | Instrumed International, Inc. |
| Sep 8, 2014 | A circumcision clamp is an instrument used to compress the foreskin of the pe... | The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did n... | Class II | Instrumed International, Inc. |
| Sep 8, 2014 | Schoitz weights are manual devices used with Schoitz tonometers and are inten... | The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did n... | Class II | Instrumed International, Inc. |
| Sep 8, 2014 | A uterine tenaculum is a hook-like instrument used to seize and hold the cerv... | The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did n... | Class II | Instrumed International, Inc. |
| Sep 8, 2014 | Hudson cranial drill sets (w/ brace and 5 attachments) are bone cutting and d... | The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did n... | Class II | Instrumed International, Inc. |
| Sep 8, 2014 | Gardner-Wells traction tongs are skull tongs for traction used to immobilize ... | The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did n... | Class II | Instrumed International, Inc. |
| Sep 8, 2014 | McKenzie enlarging burrs are bone cutting and drilling instruments that are u... | The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did n... | Class II | Instrumed International, Inc. |
| Sep 8, 2014 | A zipser clamp is an instrument used to compress reduce blood flow to the pen... | The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did n... | Class II | Instrumed International, Inc. |
| Sep 8, 2014 | D'errico perforator drills are bone cutting and drilling instruments that are... | The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did n... | Class II | Instrumed International, Inc. |
| Sep 4, 2014 | Vantage Panoramic X-Ray System used to perform dental and orthodontic radiolo... | Failure of the primary collimator may result in unintentional movement of the device. The uninten... | Class II | Midmark Corp dba Progeny Inc |
| Sep 3, 2014 | SPECTRUM Pump, Model No. 35700BAX. Intended to be used for the controlled... | One Service Technician may not have correctly serviced specific Sigma Spectrum Infusion Pumps acc... | Class II | Baxter Healthcare Corp. |
| Aug 12, 2014 | The Symbia Intevo Excel is a non-diagnostic SPECT ICT system with CT support ... | Siemens Medical Solutions USA, Inc. has received reports of unintended radial motion of the detec... | Class II | Siemens Medical Solutions USA, Inc. |
| Aug 12, 2014 | The Siemens Symbia T series is intended for use by appropriately trained heal... | Siemens Medical Solutions USA, Inc. has received reports of unintended radial motion of the detec... | Class II | Siemens Medical Solutions USA, Inc. |
| Aug 12, 2014 | The Siemens Symbia S series is intended for use by appropriately trained heal... | Siemens Medical Solutions USA, Inc. has received reports of unintended radial motion of the detec... | Class II | Siemens Medical Solutions USA, Inc. |
| Jul 31, 2014 | CareFusion AirLife Heated Infant Breathing Circuit Product Usage: Respira... | The CareFusion AirLife Heated Infant Breathing Circuit is being recalled due to a regulatory comp... | Class II | Carefusion 2200 Inc |
| Jul 28, 2014 | The Symbia Intevo series consists of the Intevo 16, Intevo 6 and Intevo 2. Th... | Siemens Medical Solutions USA, Inc. is performing a field correction because we recently detected... | Class II | Siemens Medical Solutions USA, Inc. |
| Jul 28, 2014 | The Symbia T Series consists of the T16, T6, T2, and T. The Symbia T integrat... | Siemens Medical Solutions USA, Inc. is performing a field correction because we recently detected... | Class II | Siemens Medical Solutions USA, Inc. |
| Jul 22, 2014 | ICT Serum Calibrator REF 146-03. For use in the calibration of the serum ... | ICT Serum Calibrator may generate lower than expected Potassium Quality Control (QC) and patient ... | Class II | Abbott Laboratories |
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.