Browse Device Recalls
1,550 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 1,550 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 1,550 FDA device recalls in 2012.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Oct 24, 2012 | Sekisui Diagnostics, Spectrolyse PAI-1 In-Vitro Diagnostic Use for the quant... | Spectrolyse PAI-1 activity assay, producing lower than expected absorbance values 0 IU/ml standa... | Class II | Sekisui Diagnostics Llc |
| Oct 24, 2012 | Nidek MC-500 Multicolor Laser Photocoagulator using software version 2.20. O... | When the MC-500 is turned on and coagulation is performed without changing the laser color, the d... | Class II | Nidek Inc |
| Oct 24, 2012 | Superstat Modified Collagen Hemostatic Sponge, 50mm Disc, 3.0%, Part# 9200-30... | The recall was initiated because Superstat Corporation has confirmed that no documentation are av... | Class II | Superstat Corp |
| Oct 24, 2012 | Philips Medical Systems, Brilliance Computed Tomography (CT) X-Ray Scanners, ... | Software anomaly. Philips determined that the TumorLOC software program for the referenced PET/C... | Class II | Philips Medical Systems (Cleveland) Inc |
| Oct 24, 2012 | Superstat Modified Collagen Hemostatic Sponge, 2x2 Pledget, 1.5%, Part# 9105-... | The recall was initiated because Superstat Corporation has confirmed that no documentation are av... | Class II | Superstat Corp |
| Oct 24, 2012 | Superstat Modified Collagen Hemostatic Sponge, 85mm x 85mm Pledget, 1.5%, Par... | The recall was initiated because Superstat Corporation has confirmed that no documentation are av... | Class II | Superstat Corp |
| Oct 24, 2012 | Superstat Modified Collagen Hemostatic Sponge, 4x4 Pledget, 3.0%, Part# 9102-... | The recall was initiated because Superstat Corporation has confirmed that no documentation are av... | Class II | Superstat Corp |
| Oct 24, 2012 | Superstat Modified Collagen Hemostatic Sponge, 32mm Disc, 3.0%, Part# 9100-30... | The recall was initiated because Superstat Corporation has confirmed that no documentation are av... | Class II | Superstat Corp |
| Oct 23, 2012 | The Siemens Symbia T series is intended to aid in detecting, localizing, diag... | There is a potential for the linear bearing car to fail allowing the ball bearings to fall out. | Class II | Siemens Medical Solutions USA, Inc. |
| Oct 23, 2012 | The Siemens Symbia S series is intended to aid in detecting, localizing, diag... | There is a potential for the linear bearing car to fail allowing the ball bearings to fall out. | Class II | Siemens Medical Solutions USA, Inc. |
| Oct 23, 2012 | Accolade TMZF Plus 127 degree Neck Angle V40 Hip Stem #2.5 and Accolade TMZF... | Stryker has received a report that single size 3.5 stem was packaged as size 2.5 stem resulting i... | Class II | Stryker Howmedica Osteonics Corp. |
| Oct 22, 2012 | Alere Cholestech LDX Multianalyte Control, 2 vial set, Catalog Number: 88769 ... | Out of range (increased) HDL Cholesterol results. | Class III | Alere San Diego, Inc. |
| Oct 22, 2012 | BD BBL Taxo XV Factor Strips, Catalog number 231104, in shelf pack vials, fif... | In vitro diagnostic test kit was not manufactured according to specifications and may cause false... | Class II | Becton Dickinson & Co. |
| Oct 22, 2012 | Alere Cholestech LDX Calibration Verification, 4 vial set, Catalog Number: 88... | Out of range (increased) HDL Cholesterol results. | Class III | Alere San Diego, Inc. |
| Oct 19, 2012 | qube Compact Monitor (Patient Monitor) 91390. The monitor is 26.2 cm x 31.5 ... | Spacelabs Healthcare has learned through several reports that the input circuit may fail and the... | Class II | Spacelabs Healthcare, Llc |
| Oct 19, 2012 | AMS AdVance" Male Sling System 720088-01 AMS AdVance" Male Sling System (US)... | American Medical Systems¿ (AMS) is issuing a voluntary recall on a number of lots of the AdVance¿... | Class II | American Medical Systems, Inc. |
| Oct 19, 2012 | IMRIS ORT100 (Part Number 110470-000) and ORT200 (Part Number 112216-00), are... | IMRIS Inc. initiated a recall of their OR Tables ORT100 and ORT200. When proper procedure is not ... | Class II | Innovative Magnetic Resonance Imaging Systems Inc. |
| Oct 19, 2012 | TriVascular brand Fill Polymer Kit, Endovascular Graft, Aneurysm Treatment Sy... | Selected lots of the Fill Polymer Kit (European Model Number: TVFP14- B) in European distributor... | Class II | Trivascular, Inc |
| Oct 19, 2012 | Titan Spine Endoskeleton TA Implant products. 2107-0118 18mm Standard Endo... | Titan Spine LLC, is conducting a recall on the Endoskeleton TA VBR products. The labeling accompa... | Class II | TITAN SPINE, LLC |
| Oct 18, 2012 | 4.5mm PLEO Osteotomy Guide. OrthoPediatrics Corp. markets a pediatric, ext... | Complaint received from sales representative that the drill guide tubes would not screw into repl... | Class II | OrthoPediatrics Corp |
| Oct 18, 2012 | NeuViz 16 Multi-Sliced CT Scanner System, part number 989605858501. NeuViz D... | The four screws that secure the patient table top to the carrier pulled out and caused the table ... | Class II | Philips And Neusoft Medical Systems Co., Ltd. |
| 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 17, 2012 | 0.9% Sodium Chloride Injections, USP, 1000ml, VWR/Baxter Product Usage: T... | The firm inventoried and distributed 0.9% Sodium Chloride Saline bags as 0.45% Sodium Chloride Sa... | Class II | Biomerieux Inc |
| Oct 16, 2012 | bioMerieux Kit, Instrument & Update, 3D IND ZIP-ML 01, Industry instrument so... | The product may mislabel patient information on culture specimen bottles due to a software miscom... | Class II | Biomerieux Inc |
| Oct 16, 2012 | bioMerieux Kit, Instrument & Update, 3D B.40 USB-ML02, Clinical instrument s... | The product may mislabel patient information on culture specimen bottles due to a software miscom... | Class II | Biomerieux Inc |
| Oct 16, 2012 | bioMerieux BacT/ALERT Combo Module, catalog number, 200290, Clinical instrume... | The product may mislabel patient information on culture specimen bottles due to a software miscom... | Class II | Biomerieux Inc |
| Oct 16, 2012 | bioMerieux BacT/ALERT 3D 60, catalog number, 248009, Clinical instrument T... | The product may mislabel patient information on culture specimen bottles due to a software miscom... | Class II | Biomerieux Inc |
| Oct 16, 2012 | bioMerieux Kit, Instrument & Update, 3D B.40 USB-ML04, Clinical instrument so... | The product may mislabel patient information on culture specimen bottles due to a software miscom... | Class II | Biomerieux Inc |
| Oct 16, 2012 | bioMerieux Kit, Instrument & Update, B.40, 3D I USB-ML02, Industry instrument... | The product may mislabel patient information on culture specimen bottles due to a software miscom... | Class II | Biomerieux Inc |
| Oct 16, 2012 | bioMerieux Kit, Instrument & Update, 3D B.40 USB-ML06, Clinical instrument so... | The product may mislabel patient information on culture specimen bottles due to a software miscom... | Class II | Biomerieux Inc |
| Oct 16, 2012 | bioMerieux Kit, Instrument & Update, 3D B.40 BTA3D-ZH01, Clinical instrument... | The product may mislabel patient information on culture specimen bottles due to a software miscom... | Class II | Biomerieux Inc |
| Oct 16, 2012 | bioMerieux Kit, Instrument & Update, 3D B.40 ZIP-ML06, Clinical instrument s... | The product may mislabel patient information on culture specimen bottles due to a software miscom... | Class II | Biomerieux Inc |
| Oct 16, 2012 | bioMerieux BacT/ALERT Control Module, catalog number 210147, Clinical instrum... | The product may mislabel patient information on culture specimen bottles due to a software miscom... | Class II | Biomerieux Inc |
| Oct 16, 2012 | bioMerieux Kit, USB HDW, BTA3D CONTROL-B-B.40, Clinical instrument software, ... | The product may mislabel patient information on culture specimen bottles due to a software miscom... | Class II | Biomerieux Inc |
| Oct 16, 2012 | bioMerieux Kit, Instrument & Update, B.40, 3D I ZIP-ML01, Industry instrument... | The product may mislabel patient information on culture specimen bottles due to a software miscom... | Class II | Biomerieux Inc |
| Oct 16, 2012 | bioMerieux Kit, Instrument & Update, 3D B.40 ZIP-ML03, Clinical instrument s... | The product may mislabel patient information on culture specimen bottles due to a software miscom... | Class II | Biomerieux Inc |
| Oct 16, 2012 | bioMerieux Kit, Instrument & Update, B.40, 3D IND USB-ML02, Industry instrume... | The product may mislabel patient information on culture specimen bottles due to a software miscom... | Class II | Biomerieux Inc |
| Oct 16, 2012 | bioMerieux Kit, USB Instrument & Update, 3D B.40 USB-ML03, Clinical instrumen... | The product may mislabel patient information on culture specimen bottles due to a software miscom... | Class II | Biomerieux Inc |
| Oct 16, 2012 | bioMerieux Kit, Instrument & Update, B.40, 3D IND USB-ML01, Industry instrume... | The product may mislabel patient information on culture specimen bottles due to a software miscom... | Class II | Biomerieux Inc |
| Oct 16, 2012 | bioMerieux BacT/ALERT Combo Module, catalog number 200291, Industrial instrum... | The product may mislabel patient information on culture specimen bottles due to a software miscom... | Class II | Biomerieux Inc |
| Oct 16, 2012 | bioMerieux BacT/ALERT Control Module, catalog number 210148, Industrial instr... | The product may mislabel patient information on culture specimen bottles due to a software miscom... | Class II | Biomerieux Inc |
| Oct 16, 2012 | bioMerieux BacT/ALERT Combo Module, catalog number 247014, Industrial instrum... | The product may mislabel patient information on culture specimen bottles due to a software miscom... | Class II | Biomerieux Inc |
| Oct 16, 2012 | bioMerieux Kit, USB HDW, BTA3D60-B-B.40, Clinical instrument software, USB up... | The product may mislabel patient information on culture specimen bottles due to a software miscom... | Class II | Biomerieux Inc |
| Oct 16, 2012 | bioMerieux Kit, USB HDW, BTA3D COMBO-B-B.40, Clinical instrument software, US... | The product may mislabel patient information on culture specimen bottles due to a software miscom... | Class II | Biomerieux Inc |
| Oct 16, 2012 | Tested AC Control BD, 120V, X2 The Terumo HX2 Temperature Management Syste... | Based on a retrospective review of quality data, AC Control boards used in the manufacture of the... | Class II | Terumo Cardiovascular Systems Corporation |
| Oct 16, 2012 | HX2 Temp Manage SYS 120V The Terumo HX2 Temperature Management System is a... | Based on a retrospective review of quality data, AC Control boards used in the manufacture of the... | Class II | Terumo Cardiovascular Systems Corporation |
| Oct 16, 2012 | bioMerieux Kit, Instrument & Update, 3D B.40 USB-ML01, Clinical instrument s... | The product may mislabel patient information on culture specimen bottles due to a software miscom... | Class II | Biomerieux Inc |
| Oct 16, 2012 | Corometrics Qwik Connect Plus Spiral Electrode- Model #7000AA0 A fetal s... | Thirty fetal scalp electrodes were found to have an incomplete package seal and lacked the printe... | Class II | Vital Signs Devices, a GE Healthcare Company |
| Oct 16, 2012 | bioMerieux Kit, Instrument & Update, 3D B.40 ZIP-ML01, Clinical instrument s... | The product may mislabel patient information on culture specimen bottles due to a software miscom... | Class II | Biomerieux Inc |
| Oct 16, 2012 | bioMerieux Kit, Instrument & Update, 3D B.40 ZIP-ML 02, Clinical instrument ... | The product may mislabel patient information on culture specimen bottles due to a software miscom... | Class II | Biomerieux 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.