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 |
|---|---|---|---|---|
| Sep 4, 2013 | Calcium Arsenazo, CALA-0250, For the Quantitative Determination of Total Calc... | Calcium Arsenazo Reagent, reference CALA-0250, is recalled due to complaint of plasma specimens r... | Class II | SEPPIM SAS |
| Sep 4, 2013 | Baxter CLEARLINK System Non-DEHP Three Lead Extension Set. 6.0" (15 cm), 1.0 ... | The firm is issuing a voluntary recall due to the potential for pinholes in the packaging. Pinhol... | Class II | Baxter Healthcare Corp. |
| Sep 3, 2013 | Siemens RAD Fluoro Uro system (Luminos dRF and Uroskop Omnia with software ve... | When using systems operating with software versions VD10A/G during a RAD examination, a malfuncti... | Class II | Siemens Medical Solutions USA, Inc |
| Sep 3, 2013 | ADVIA 2400 System Software V4.01. Performs assays for general and specialt... | Siemens Healthcare Diagnostics issued a Urgent Medical Device Correction due to Ration Parameters... | Class II | Siemens Healthcare Diagnostics |
| Sep 3, 2013 | ADVIA 1800 System Software V2.01. Performs assays for general and specialt... | Siemens Healthcare Diagnostics issued a Urgent Medical Device Correction due to Ration Parameters... | Class II | Siemens Healthcare Diagnostics |
| Sep 3, 2013 | King LT-D Oropharyngeal Airways The King LT-D is intended for use in adult... | Report that size 5 KLTD airways were packaged in pouches indicating a size of 2.5 and shipped to ... | Class III | King Systems Corp. |
| Sep 3, 2013 | BrightView XCT is a gamma camera for Single Photon Emission Computed Tomograp... | Philips received reports from the field that the Flat Panel Detector (FPD) does not always remain... | Class II | Philips Medical Systems (Cleveland) Inc |
| Sep 3, 2013 | ADVIA 1200 System Software: 1) V2.00, 2) V2.01. Performs assays for genera... | Siemens Healthcare Diagnostics issued a Urgent Medical Device Correction due to Ration Parameters... | Class II | Siemens Healthcare Diagnostics |
| Sep 3, 2013 | Blanketrol III, Model Number 233, Cincinnati Sub-Zero Products, Inc., 12011 M... | During a label review it was discovered that both the Blanketrol III Operations (57201-N) & Opera... | Class II | Cincinnati Sub-Zero Products Inc |
| Sep 3, 2013 | (Siemens Rad Fluoro Uro Systems) Ysio, Luminos Agile, Luminos dRF, and Urosko... | A potential malfunction and hazard to patients exists when using the Ysio, Luminos Agile, Luminos... | Class II | Siemens Medical Solutions USA, Inc |
| Sep 3, 2013 | ADVIA 1650 System Software: 1) V4.01, 2) V3.52. Performs assays for genera... | Siemens Healthcare Diagnostics issued a Urgent Medical Device Correction due to Ration Parameters... | Class II | Siemens Healthcare Diagnostics |
| Aug 31, 2013 | Aquatec Ocean VIP, Aquatec Ocean Dual-VIP, Aquatec Ocean E-VIP mobile shower ... | The snap-on fixtures of the backrest cushion on the Mobile Shower and Toilet Commode Aquatec Ocea... | Class II | Invacare Corporation |
| Aug 31, 2013 | Bright Embrace, a Single Bili Light for newborn phototherapy Distributed ... | Upper limit for ambient temperature for use of the device was printed incorrectly in the instruct... | Class II | Physician Engineered Products, Inc. |
| Aug 30, 2013 | CareFusion Gravity Set, Model #44000-07 The CareFusion Gravity Sets are us... | CareFusion is recalling the Gravity Set (Model 44000-07) because of an incorrect expiration date.... | Class II | CareFusion 303, Inc. |
| Aug 30, 2013 | Stryker Vision Mounting Arm, for use with other Stryker Endoscopy medical dev... | When positioning the display located on top of the video cart, it is possible for the user to app... | Class II | Stryker Endoscopy |
| Aug 30, 2013 | Natural-Knee¿ II Femoral Component | The low density polyethylene (LDPE) bag used to package implants adheres to the highly polished s... | Class II | Zimmer, Inc. |
| Aug 30, 2013 | Emit 2000 Phenobarbital Assay and Syva Emit 2000 Phenobarbital Assay | Imprecision with certain lots | Class II | Siemens Healthcare Diagnostics, Inc. |
| Aug 30, 2013 | Versys¿ Beaded Fullcoat Femoral Stem (POR FULL-CT FEM ST 11X160MM; VERSYS BEA... | The low density polyethylene (LDPE) bag used to package implants adheres to the highly polished s... | Class II | Zimmer, Inc. |
| Aug 30, 2013 | CPT¿ Femoral Stem (CPT 12/14 STEM SIZE 0 COCR; CPT 12/14 SIZE 0 COCR EXT; CPT... | The low density polyethylene (LDPE) bag used to package implants adheres to the highly polished s... | Class II | Zimmer, Inc. |
| Aug 30, 2013 | SmartSite Low Sorbing Infusion Set, Model#72313E The SmartSite Low Sorbing... | CareFusion is recalling the SmartSite Low Sorbing Infusion Set, Model 72313E, Lot Number 1301631... | Class II | CareFusion 303, Inc. |
| Aug 30, 2013 | Sidus" Head (Not distributed in the United States) | The low density polyethylene (LDPE) bag used to package implants adheres to the highly polished s... | Class II | Zimmer, Inc. |
| Aug 30, 2013 | Vented Spike Adapter Product Code 2C0471, Sterile, nopyrogenic. Manufactured ... | Potential tears in the pouch of six lots of Vented Spike Adapter Product Code 2C0471 | Class II | Baxter Healthcare Corp. |
| Aug 30, 2013 | NexGen¿ Femoral Component (CR-FLEX GSF PRECOAT SZ C-L; CR-FLEX GSF PRECOA... | The low density polyethylene (LDPE) bag used to package implants adheres to the highly polished s... | Class II | Zimmer, Inc. |
| Aug 30, 2013 | Gender Solutions" Patello-Femoral Component | The low density polyethylene (LDPE) bag used to package implants adheres to the highly polished s... | Class II | Zimmer, Inc. |
| Aug 30, 2013 | Brilliance CT Big Bore Oncology, Brilliance CT Big Bore Radiology and Brillia... | There are artifacts appearing on the Tracker images during threshold-triggered bolus scans with p... | Class II | Philips Medical Systems (Cleveland) Inc |
| Aug 30, 2013 | NexGen¿ Femoral Component (CR-FLEX GSF POR FEM, C-L; CR-FLEX GSF POR FEM, C-R... | The low density polyethylene (LDPE) bag used to package implants adheres to the highly polished s... | Class II | Zimmer, Inc. |
| Aug 30, 2013 | Multipolar¿ Bipolar Cup METAL SHELL 38 MM OD through 71 MM OD. Indicated i... | The low density polyethylene (LDPE) bag used to package implants adheres to the highly polished s... | Class II | Zimmer, Inc. |
| Aug 30, 2013 | SmartSite Low Sorbing Infusion Set, Model# 10015048. Intravascular administr... | CareFusion is recalling the SmartSite Low Sorbing Infusion Set, Model# 10015048, because there is... | Class II | CareFusion 303, Inc. |
| Aug 30, 2013 | Zimmer¿ Unicompartmental Knee Femoral Component. Indicated for patients wi... | The low density polyethylene (LDPE) bag used to package implants adheres to the highly polished s... | Class II | Zimmer, Inc. |
| Aug 30, 2013 | Metasul¿ Head. Intended for use either with or without bone cement in tota... | The low density polyethylene (LDPE) bag used to package implants adheres to the highly polished s... | Class II | Zimmer, Inc. |
| Aug 30, 2013 | NexGen CR-Flex Mobile Bearing Tibial Component 9 (Not distributed in the Unit... | The low density polyethylene (LDPE) bag used to package implants adheres to the highly polished s... | Class II | Zimmer, Inc. |
| Aug 30, 2013 | Device Name: Terino Square Chin-Style II-Medium; Catalog Number: TSCII-M. ... | Implantech initiated a voluntary recall of certain lots of Terino Square Chin-Style II-Medicum (L... | Class II | Implantech Associates Inc |
| Aug 30, 2013 | CoCr Head (Not distributed in the United States) Used in total hip replace... | The low density polyethylene (LDPE) bag used to package implants adheres to the highly polished s... | Class II | Zimmer, Inc. |
| Aug 30, 2013 | GE Healthcare, Precision 500D, Legacy, RFX, and SFX X. This table is inte... | GE Healthcare has recently become aware of a potential safety issue involving the spotfilm device... | Class II | GE Healthcare, LLC |
| Aug 30, 2013 | Natural-Knee¿ Flex Femoral Component. Provides increased flexion capability. | The low density polyethylene (LDPE) bag used to package implants adheres to the highly polished s... | Class II | Zimmer, Inc. |
| Aug 29, 2013 | Carestream DRX-Revolution Mobile X-Ray System -- Made in U.S.A. by Carestream... | It was discovered that Carestream received a report from a customer that 2 different patients wer... | Class II | Carestream Health Inc. |
| Aug 29, 2013 | Vital Diagnostics Envoy Calcium Reagent For In-Vitro Diagnostic Use. PN 5528... | High positive calcium bias on plasma sample versus results on serum | Class II | Vital Diagnostics, Inc. |
| Aug 29, 2013 | Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillat... | The performance of a low voltage capacitor in a subset of COGNIS CRT-Ds and TELIGEN ICDs manufact... | Class II | Boston Scientific CRM Corp |
| Aug 29, 2013 | Combiset Blood Line with BVM for Hemodialysis use Catalog Number: 03-2965-9.... | Updated Instructions for Use: Bloodline connections not tightened per instructions in the operato... | Class II | Fresenius Medical Care Holdings, Inc. |
| Aug 29, 2013 | DePuy Mitek FMS Outflow Tubing with One-Way valve Product Code:284649 Pro... | Pillow valve included in the FMS Duo outflow tubing set and the FMS Solo intermediary tubing set ... | Class II | DePuy Mitek, Inc., a Johnson & Johnson Co. |
| Aug 29, 2013 | Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E11... | The performance of a low voltage capacitor in a subset of COGNIS CRT-Ds and TELIGEN ICDs manufact... | Class II | Boston Scientific CRM Corp |
| Aug 29, 2013 | DePuy Mitek FMS Intermediary Tubing with One-Way valve Product Code: 281142 ... | Pillow valve included in the FMS Duo outflow tubing set and the FMS Solo intermediary tubing set ... | Class II | DePuy Mitek, Inc., a Johnson & Johnson Co. |
| Aug 29, 2013 | Reliance Endoscope Processing System (REPS), STERIS Corporation, 5960 Heisley... | The air pipe that delivers unfiltered ambient air from the procedure room into the water bottle o... | Class II | Steris Corporation |
| Aug 29, 2013 | Consult Diagnostics¿ Eon Calcium Reagent For In-Vitro Diagnostic Use PN: 142... | High positive calcium bias on plasma sample versus results on serum | Class II | Vital Diagnostics, Inc. |
| Aug 29, 2013 | BIOMET 3i Endosseous Dental Implant. | Due to residual machining fluid identified by discoloration (darker in appearance) on the externa... | Class II | Biomet 3i, LLC |
| Aug 29, 2013 | Combiset Blood Line Hemodialysis use Catalog Number: 03-2622-3. Intended... | Updated Instructions for Use: Bloodline connections not tightened per instructions in the operato... | Class II | Fresenius Medical Care Holdings, Inc. |
| Aug 29, 2013 | 2008K@ Home Blood lines Combiset True Flow Series for Hemodialysis use Catal... | Updated Instructions for Use: Bloodline connections not tightened per instructions in the operato... | Class II | Fresenius Medical Care Holdings, Inc. |
| Aug 29, 2013 | Composite Series Skull Clamp, one clamp per tote. The MAYFIELD¿ Skull Cla... | An investigation of an adverse trend of complaints for the Skull Clamp index locking knob not eas... | Class II | Integra LifeSciences Corp. |
| Aug 29, 2013 | DRX- Revolution, Catalog number: 101937, 1023415 & 1023423. Made in U.S.A. b... | Carestream Health Inc. has conducted a voluntary field action which includes the installation of ... | Class II | Carestream Health Inc. |
| Aug 29, 2013 | CARESTREAM DRX -Mobile Retrofit Kit, Catalog number: 1019397. Made in U.S.A.... | Carestream Health Inc. has conducted a voluntary field action which includes the installation of ... | Class II | Carestream Health 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.