Browse Device Recalls
3,505 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,505 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 3,505 FDA device recalls in MA.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Nov 26, 2012 | Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis ... | GranuFlo Dry Acid Concentrate may show discoloration | Class III | Fresenius Medical Care Holdings, Inc. |
| Nov 26, 2012 | Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis ... | GranuFlo Dry Acid Concentrate may show discoloration | Class III | Fresenius Medical Care Holdings, Inc. |
| Nov 26, 2012 | NEONATAL TOTAL GALACTOSE KIT Product Numb... | Truncated V-Bottomed Microplate Wells used in assays contain defective wells. | Class II | Perkinelmer |
| Nov 21, 2012 | Siemens CLINITEK Atlas Positive and Negative Control Strips for Urine Chemis... | When these lots of control material are reconstituted, the positive control solution leukocyte re... | Class III | Siemens Healthcare Diagnostics Inc |
| Nov 21, 2012 | Siemens Chek-Stix Combo Pak (Distributed OUS) Catalog Number: 1364E Chek... | When these lots of control material are reconstituted, the positive control solution leukocyte re... | Class III | Siemens Healthcare Diagnostics Inc |
| Nov 21, 2012 | Siemens Chek-Stix Combo Pak Catalog Number: 1364 Chek-Stix¿ Positive and... | When these lots of control material are reconstituted, the positive control solution leukocyte re... | Class III | Siemens Healthcare Diagnostics Inc |
| Nov 21, 2012 | Siemens Chek-Stix Combo Pak (Distributed OUS only) Catalog Number: 1364N ... | When these lots of control material are reconstituted, the positive control solution leukocyte re... | Class II | Siemens Healthcare Diagnostics Inc |
| Nov 21, 2012 | Siemens Chek-Stix Positive and Negative Control Strips for Urine Chemistry (... | When these lots of control material are reconstituted, the positive control solution leukocyte re... | Class III | Siemens Healthcare Diagnostics Inc |
| Nov 21, 2012 | Siemens Chek-Stix Combo Pak (Distributed OUS only) Catalog Number: 1364M ... | When these lots of control material are reconstituted, the positive control solution leukocyte re... | Class III | Siemens Healthcare Diagnostics Inc |
| Nov 21, 2012 | Siemens Chek-Stix Positive and Negative Control Strips for Urine Chemistry C... | When these lots of control material are reconstituted, the positive control solution leukocyte re... | Class III | Siemens Healthcare Diagnostics Inc |
| Nov 16, 2012 | DePuy Mitek 11 MM Fully Fluted Reamer, Sterile Product Number: 232423 DeP... | Specific units of the DePuy Mitek Sterile Reamers are not labeled correctly, 7 units were labele... | Class II | DePuy Mitek, Inc., a Johnson & Johnson Co. |
| Nov 14, 2012 | Siemens Healthcare BNP (8-type Natriuretic Peptide) 500 Test kit 02816634 1... | Operating range of the ADVIA Centaur systems is 18¿C to 30¿C (64.4¿F to 86.0¿F), a change in room... | Class II | Siemens Healthcare Diagnostics, Inc |
| Nov 14, 2012 | Siemens Healthcare ADVIA Centaur Theophylline 2 (THE02) 250 Test ... | Operating range of the ADVIA Centaur systems is 18¿C to 30¿C (64.4¿F to 86.0¿F), a change in room... | Class II | Siemens Healthcare Diagnostics, Inc |
| Nov 14, 2012 | Siemens Healthcare BR Assay for CA 27.29 250 Test Kits 03896216 50 Test Kit... | Operating range of the ADVIA Centaur systems is 18¿C to 30¿C (64.4¿F to 86.0¿F), a change in room... | Class II | Siemens Healthcare Diagnostics, Inc |
| Nov 14, 2012 | Siemens Healthcare ADVIA Centaur DHEA-504 (DHEAS) 50 Test 06489701 The AD... | Operating range of the ADVIA Centaur systems is 18C to 30¿C (64.4¿F to 86.0¿F), a change in room ... | Class II | Siemens Healthcare Diagnostics, Inc |
| Nov 14, 2012 | Siemens Healthcare ADVIA Centaur CA 19-9 250 Test 10491244 50 Test 1049137... | Operating range of the ADVIA Centaur systems is 18C to 30¿C (64.4¿F to 86.0¿F), a change in room ... | Class II | Siemens Healthcare Diagnostics, Inc |
| Nov 14, 2012 | Siemens Healthcare ADVIA Centaur Digitoxin (DGTN) 250 Test 090464... | Operating range of the ADVIA Centaur systems is 18¿C to 30¿C (64.4¿F to 86.0¿F), a change in room... | Class II | Siemens Healthcare Diagnostics, Inc |
| Nov 14, 2012 | Siemens Healthcare ADVIA Centaur Folate (FOL) 500 Test 06891541 ... | Operating range of the ADVIA Centaur systems is 18C¿ to 30¿C (64.4¿F to 86.0¿F), a change in room... | Class II | Siemens Healthcare Diagnostics, Inc |
| Nov 9, 2012 | Philips IntelliVue Information Center/Client and Philips IntelliVue Informati... | Internal audio cable may have diminished retention force due to damaged contacts, which could lea... | Class II | Philips Healthcare Inc. |
| Nov 9, 2012 | Drill Guide - Chameleon FacetFuse Fixation System, Model: 11-00028 Rev. A ... | Prior to use in surgery, the Drill Guides were presenting noticeable degrees of denting and/or be... | Class II | SpineFrontier, Inc. |
| Nov 7, 2012 | DePuy Spine VIPER POLY SCREW 5.5 10 X 70MM Tl Product Code: 1867-15-170 ... | Polyaxial screws 8x 80 and larger may disassociate when inserting in the Ilium., VIPER large diam... | Class II | DePuy Spine, Inc. |
| Nov 7, 2012 | DePuy Spine VIPER POLY SCREW 5.5 9 X70MM Tl Product Code: 1867-15-970 ... | Polyaxial screws 8x 80 and larger may disassociate when inserting in the Ilium., VIPER large diam... | Class II | DePuy Spine, Inc. |
| Nov 7, 2012 | DePuy Spine VIPER POLY SCREW 5.5 9 X100MM Tl Product Code: 1867-15-999 ... | Polyaxial screws 8x 80 and larger may disassociate when inserting in the Ilium., VIPER large diam... | Class II | DePuy Spine, Inc. |
| Nov 7, 2012 | DePuy Spine VIPER POLY SCREW 5.5 9 X 80MM Tl Product Code: 1867-15-980 ... | Polyaxial screws 8x 80 and larger may disassociate when inserting in the Ilium., VIPER large diam... | Class II | DePuy Spine, Inc. |
| Nov 7, 2012 | DePuy Spine VIPER POLY SCREW 5.5 10X100MM Tl Product Code: 1867-15-199 ... | Polyaxial screws 8x 80 and larger may disassociate when inserting in the ilium. VIPER large diame... | Class II | DePuy Spine, Inc. |
| Nov 7, 2012 | DePuy Spine VIPER POLY SCREW 5.5 8 X70MM Tl Product Code: 1867-15-870 ... | Polyaxial screws 8x 80 and larger may disassociate when inserting in the Ilium., VIPER large diam... | Class II | DePuy Spine, Inc. |
| Nov 7, 2012 | DePuy Spine VIPER POLY SCREW 5.5 8 X100MM Tl Product Code: 1867-15-899 ... | Polyaxial screws 8x 80 and larger may disassociate when inserting in the Ilium., VIPER large diam... | Class II | DePuy Spine, Inc. |
| Nov 7, 2012 | DePuy Spine VIPER POLY SCREW 5.5 10 X 80MM Tl Product Code: 1867-15-180 ... | Polyaxial screws 8x 80 and larger may disassociate when inserting in the Ilium., VIPER large diam... | Class II | DePuy Spine, Inc. |
| Nov 7, 2012 | DePuy Spine VIPER POLY SCREW 5.5 8 X80MM Tl Product Code: 1867-15-880 ... | Polyaxial screws 8x 80 and larger may disassociate when inserting in the Ilium., VIPER large diam... | Class II | DePuy Spine, Inc. |
| Nov 5, 2012 | OmniGuide BP-ROBOTIC ( BeamPath Robotic), Single Use Cat. # BP-ROBOTIC Th... | Failure of glue joint, allowed a portion of the single use device to shift inside, may separate a... | Class II | OmniGuide, Inc. |
| Oct 30, 2012 | Philips Digital Diagnost Stationary radiographic system | When the operator for a wall stand view selects an "image rotation" different from default, or su... | Class II | Philips Healthcare Inc. |
| Oct 30, 2012 | Philips Digital Diagnost Software Version R2.0.2 Product Usage: This syst... | With Digital Diagnost R2.0.2 a mirrored "R in a circle" is burnt into the image (if mirrored) in ... | Class II | Philips Healthcare Inc. |
| Oct 26, 2012 | BiOM Rechargeable Li Ion 22.2 V Battery and BiOM Lithium Battery Charger sold... | Battery may over-heat during charging and smoke | Class II | iwalk inc |
| Oct 25, 2012 | Philips DigitalDiagnost X-Ray System with Eleva Software 2.1.3 Model numbers... | When the operator for a wall stand view selects an "image rotation" different from default, or su... | Class II | Philips Healthcare Inc. |
| Oct 17, 2012 | PARPARELLA-TYPE VENT TUBE, 1.02 MM, SILICONE, REF 240044, QTY 6, Rx Only, ST... | One lot of tympanostomy tubes were manufactured with silicon that was found to be contaminated wi... | Class II | Gyrus Acmi, Incorporated |
| Oct 12, 2012 | Fresenius Liberty Cycler Set Single Conn. Ext. DL. Part Number: 050-87216. ... | There is a small risk of a leak in Cycler Sets and if the Cycler Set is punctured, the dialysate ... | Class II | Fresenius Medical Care Holdings, Inc. |
| Oct 9, 2012 | ADVIA Centaur Ferritin Calibrator C-Used with the ADVIA Centaur Ferritin assa... | Ferritin Analytical Sensitivity and Calibrator C Realignment with kit lots ending in 22 and 23 us... | Class II | Siemens Healthcare Diagnostics, Inc |
| Oct 9, 2012 | ADVIA Centaur Calibrator C-Used with the ADVIA Centaur Ferritin assay on the ... | Ferritin Analytical Sensitivity and Calibrator C Realignment with kit lots ending in 22 and 23 us... | Class II | Siemens Healthcare Diagnostics, Inc |
| Oct 9, 2012 | ADVIA Centaur Calibrator C-Used with the ADVIA Centaur Ferritin assay on the ... | Ferritin Analytical Sensitivity and Calibrator C Realignment with kit lots ending in 22 and 23 us... | Class II | Siemens Healthcare Diagnostics, Inc |
| Oct 5, 2012 | Caddy - PedFuse, Screw Caddy, 8MM and 9MM, Part Number: 11-80009 Rev. B T... | Two sections that are designated for the 8mm and 9mm screws were switched; the holes that hold th... | Class II | SpineFrontier, Inc. |
| Sep 25, 2012 | Belmont Rapid Infuser, a Fluid Management System, Model FMS2000. | Leak from a saline bag caused saline to drip along the back of the Rapid infuser close to the Po... | Class II | Belmont Instrument Corporation |
| Sep 17, 2012 | Leveen Coaccess Needle Electrode (3.5/15) and (4.0/15). Disposable, mono... | Leveen Standard and Leveen Coaccess Needle Electrode System, Directions for Use(DFU) in Portugue... | Class II | Boston Scientific Corporation |
| Sep 17, 2012 | Siemens RAPIDLab¿ 1260 system blood gas analyzer Product Usage: RAPIDLa... | RAPIDPoint¿ 400 Series, RAPIDPoint¿ 500, or RAPIDLab¿ 1200 Series blood gas analyzer, users can ... | Class II | Siemens Healthcare Diagnostics Inc |
| Sep 17, 2012 | Siemens RAPIDPoint¿ 400 system blood gas analyzer Product Usage: These sy... | RAPIDPoint¿ 400 Series, RAPIDPoint¿ 500, or RAPIDLab¿ 1200 Series blood gas analyzer, users can ... | Class II | Siemens Healthcare Diagnostics Inc |
| Sep 17, 2012 | Siemens RAPIDLab¿ 1240 system blood gas analyzer Product Usage: RAPIDLa... | RAPIDPoint¿ 400 Series, RAPIDPoint¿ 500, or RAPIDLab¿ 1200 Series blood gas analyzer, users can ... | Class II | Siemens Healthcare Diagnostics Inc |
| Sep 17, 2012 | Siemens RAPIDLab¿ 1245 system blood gas analyzer Product Usage: RAPID... | RAPIDPoint¿ 400 Series, RAPIDPoint¿ 500, or RAPIDLab¿ 1200 Series blood gas analyzer, users can ... | Class II | Siemens Healthcare Diagnostics Inc |
| Sep 17, 2012 | Siemens RAPIDPoint¿ 500 system blood gas analyzer Product Usage: RAPIDPoi... | RAPIDPoint¿ 400 Series, RAPIDPoint¿ 500, or RAPIDLab¿ 1200 Series blood gas analyzer, users can ... | Class II | Siemens Healthcare Diagnostics Inc |
| Sep 17, 2012 | LeVeen Standard Needle Electrode System, Sterile (3.5/12), (3.5/15), (4.0/15)... | Leveen Standard and Leveen Coaccess Needle Electrode System, Directions for Use(DFU) in Portugue... | Class II | Boston Scientific Corporation |
| Sep 17, 2012 | Leveen Coaccess Introducer Set. Disposable, monopolar, electrosurgical dev... | Leveen Standard and Leveen Coaccess Needle Electrode System, Directions for Use(DFU) in Portugue... | Class II | Boston Scientific Corporation |
| Sep 17, 2012 | Siemens RAPIDPoint¿¿ 405 system blood gas analyzer Product PUsage: These ... | RAPIDPoint¿ 400 Series, RAPIDPoint¿ 500, or RAPIDLab¿ 1200 Series blood gas analyzer, users can ... | Class II | Siemens Healthcare Diagnostics 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.