Browse Device Recalls
3,087 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,087 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 3,087 FDA device recalls in IL.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 | The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did n...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 | The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did n...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 | The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did n...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 | The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did n...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 | The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did n...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 | The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did n...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 | The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did n...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 | The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did n...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 |
| Jul 14, 2014 | ***Baxter***BURETROL Solution Set***105" (2.7 m) 150 mL Burette***Drip Chamb... | Baxter Healthcare Corporation is voluntarily issuing a recall for specific lots of Buretrol Solut... | Class II | Baxter Healthcare Corp |
| Jul 14, 2014 | ***Baxter***Non-DEHP***BURETROL Solution Set 105" (2.7 m), 150 mL Burette***... | Baxter Healthcare Corporation is voluntarily issuing a recall for specific lots of Buretrol Solut... | Class II | Baxter Healthcare Corp |
| Jul 14, 2014 | ***Baxter***Buretrol Solution Set***105" (2.7 m)***150 mL Burette***Drip Cham... | Baxter Healthcare Corporation is voluntarily issuing a recall for specific lots of Buretrol Solut... | Class II | Baxter Healthcare Corp |
| Jul 9, 2014 | The Hulka Clip is a sterile packaged medical device that carries a two year e... | Richard Wolf Medical Instrument Corporation is recalling Hulka Clip Tubal Occluding Device lot 51... | Class II | Richard Wolf Medical Instruments Corp. |
| Jul 9, 2014 | Verigene BC-GN Test Kit (Catalog number 20-005-021) includes: 1) 20 Verigene ... | Nanosphere Inc. has recently determined through four customer complaints that a small number of V... | Class II | Nanosphere, Inc. |
| Jul 2, 2014 | The Plum A+ Infusion System is designed to meet the fluid delivery requiremen... | One lot of alarm assemblies used in Plum A+ and Plum A+3 infusion pumps may fail to sound at all ... | Class I | Hospira Inc. |
| Jul 2, 2014 | The Plum A+ Infusion System is designed to meet the fluid delivery requiremen... | One lot of alarm assemblies used in Plum A+ and Plum A+3 infusion pumps may fail to sound at all ... | Class I | Hospira Inc. |
| Jul 2, 2014 | The Plum A+ Infusion System is designed to meet the fluid delivery requiremen... | One lot of alarm assemblies used in Plum A+ and Plum A+3 infusion pumps may fail to sound at all ... | Class I | Hospira Inc. |
| Jul 2, 2014 | The Plum A+ Infusion System is designed to meet the fluid delivery requiremen... | One lot of alarm assemblies used in Plum A+ and Plum A+3 infusion pumps may fail to sound at all ... | Class I | Hospira Inc. |
| Jul 2, 2014 | The Plum A+ Infusion System is designed to meet the fluid delivery requiremen... | One lot of alarm assemblies used in Plum A+ and Plum A+3 infusion pumps may fail to sound at all ... | Class I | Hospira Inc. |
| Jun 19, 2014 | 5 mL Reaction Vessels (a consumable of the Abbott m2000sp Automated Fluid Han... | Abbott Molecular identified that some of the 5 ml Reaction Vessels (RVs) contained in lots 569440... | Class II | Abbott Molecular |
| Jun 17, 2014 | Baxter MiniCap with Povidone-Iodine Solution, 5C4466P, Baxter Healthcare Corp... | Inadequate iodine and packaging related defects. | Class II | Baxter Healthcare Corp. |
| Jun 11, 2014 | Plum A+ Infusion System with Hospira MedNet List 20792-04-25, Pole Clamp Asse... | Plum A+ infusion system pole clamp assemblies were discovered to be cracked. If the knob on the p... | Class II | Hospira Inc. |
| Jun 10, 2014 | EXACTAMIX 1200 Compounder, model numbers 1200-DY, 1200-DX, 1200-DYR and 1200-... | If the universal ingredient (UI) in an active configuration is changed using the Configuration Ed... | Class II | Baxter Healthcare Corp. |
| Jun 6, 2014 | The Hospira MedNet Medication Management Suite (MMS). Product Usage: The ... | Hospira MedNet 5.5, 5.8.1, and 5.8.2 contains software defect where the dosing units of "nanog/kg... | Class II | Hospira Inc. |
| Jun 5, 2014 | DMI Duro-Med Industries Rollator Transport Chair; Wheel Size: 7 1/4"; Overall... | There have been 5 customer reports of a 501-1018 series DMI Rollator Transport Chair collapsing d... | Class II | Briggs Medical Service Company d.b.a. Mabis |
| May 30, 2014 | Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and s... | Additional caution statements have been added to the Instructions For Use for monopolar electrode... | Class II | Instrumed International, Inc. |
| May 30, 2014 | Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and s... | Additional caution statements have been added to the Instructions For Use for monopolar electrode... | Class II | Instrumed International, Inc. |
| May 30, 2014 | Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and s... | Additional caution statements have been added to the Instructions For Use for monopolar electrode... | Class II | Instrumed International, Inc. |
| May 30, 2014 | Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and s... | Additional caution statements have been added to the Instructions For Use for monopolar electrode... | Class II | Instrumed International, Inc. |
| May 30, 2014 | Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and s... | Additional caution statements have been added to the Instructions For Use for monopolar electrode... | Class II | Instrumed International, Inc. |
| May 30, 2014 | Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and s... | Additional caution statements have been added to the Instructions For Use for monopolar electrode... | Class II | Instrumed International, Inc. |
| May 30, 2014 | Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and s... | Additional caution statements have been added to the Instructions For Use for monopolar electrode... | Class II | Instrumed International, Inc. |
| May 30, 2014 | Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and s... | Additional caution statements have been added to the Instructions For Use for monopolar electrode... | Class II | Instrumed International, Inc. |
| May 30, 2014 | Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and s... | Additional caution statements have been added to the Instructions For Use for monopolar electrode... | Class II | Instrumed International, Inc. |
| May 30, 2014 | Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and s... | Additional caution statements have been added to the Instructions For Use for monopolar electrode... | Class II | Instrumed International, Inc. |
| Apr 30, 2014 | HbA1c Calibrators LN 4P52-02 consists of: 4P52-02 Hemoglobin A1c 1 x 1.6 mL a... | HbA1c Calibrators LN 4P52-02, lot 45063UQ12 may contain a value sheet for a different HbA1c calib... | Class II | Abbott Laboratories |
| Apr 28, 2014 | Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp - Extra Short. ... | Connection issues between the PD transfer set catheter connector and an adapter may lead to leaks... | Class II | Baxter Healthcare Corporation |
| Apr 24, 2014 | Baxter Amia Automated PD systems are used in the treatment of adult renal fai... | System error 01779 is produced when the battery cannot be charged due to specific voltage differe... | Class II | Baxter Healthcare Corp. |
| Apr 23, 2014 | Symbia E camera system. Emission Computed Tomography System used to detect o... | Siemens Medical Solutions USA, Inc. has received reports indicating the collimator cart rear cast... | Class II | Siemens Medical Solutions USA, 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.