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 |
|---|---|---|---|---|
| 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 | 18 Fr 6mm Sft Flow Angled Wire The Sarns Aortic Cannula is indicated for u... | The presence of plastic flash was identified at the tip of certain lots of Sarns Soft-Flow Aortic... | Class II | Terumo Cardiovascular Systems Corporation |
| Nov 21, 2012 | 24 Fr 8mm Soft Flow Ang Wire W/L The Sarns Aortic Cannula is indicated for... | The presence of plastic flash was identified at the tip of certain lots of Sarns Soft-Flow Aortic... | Class II | Terumo Cardiovascular Systems Corporation |
| Nov 21, 2012 | 18 Fr 6mm Sft Flow Ang Wire W/L The Sarns Aortic Cannula is indicated for ... | The presence of plastic flash was identified at the tip of certain lots of Sarns Soft-Flow Aortic... | Class II | Terumo Cardiovascular Systems Corporation |
| 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 | Oxoid Antimicrobial Susceptibility Test Discs, CTO425B Ciprofloxacin CIP 5 mc... | Boxes labeled as CIP5 may contain cartridges of AMP5. | Class III | Remel 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 | Custom Procedural Trays: Merit's Custom Angio Kits A custom procedural tra... | Custom Procedural trays contain Medrad Hand Controller Sheaths which were recalled because the se... | Class II | Merit Medical Systems, 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 | 24 Fr 8mm Sft Flow Straight The Sarns Aortic Cannula is indicated for use ... | The presence of plastic flash was identified at the tip of certain lots of Sarns Soft-Flow Aortic... | Class II | Terumo Cardiovascular Systems Corporation |
| 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 21, 2012 | 24 Fr 8mm Sft Flow Str Wire W/L The Sarns Aortic Cannula is indicated for ... | The presence of plastic flash was identified at the tip of certain lots of Sarns Soft-Flow Aortic... | Class II | Terumo Cardiovascular Systems Corporation |
| Nov 21, 2012 | 24 Fr 8mm Sft Flow Straight Wir The Sarns Aortic Cannula is indicated for ... | The presence of plastic flash was identified at the tip of certain lots of Sarns Soft-Flow Aortic... | Class II | Terumo Cardiovascular Systems Corporation |
| Nov 21, 2012 | 24 Fr 8mm Soft Flow Ang W/L The Sarns Aortic Cannula is indicated for use ... | The presence of plastic flash was identified at the tip of certain lots of Sarns Soft-Flow Aortic... | Class II | Terumo Cardiovascular Systems Corporation |
| Nov 20, 2012 | WANG Transbronchial Aspiration Needles Cat. No. MW-222, WANG Cytology Needle... | ConMed received complaints from a user facility reporting that the WANG Transbronchial Aspiration... | Class II | ConMed Corporation |
| Nov 20, 2012 | The Centricity Laboratory System is intended to be an information system desi... | If environment variables MICRO_CORRECT_MSG_TYPE and CORRECT_MSG_TYPE are set to different value... | Class II | GE Healthcare It |
| Nov 20, 2012 | WANG Transbronchial Aspiration Needles Cat. No. SW-121, WANG Cytology Needle... | ConMed received complaints from a user facility reporting that the WANG Transbronchial Aspiration... | Class II | ConMed Corporation |
| Nov 20, 2012 | WANG Transbronchial Aspiration Needles Cat. No. MW-322, WANG Cytology Needle... | ConMed received complaints from a user facility reporting that the WANG Transbronchial Aspiration... | Class II | ConMed Corporation |
| Nov 20, 2012 | The Centricity Laboratory System is intended to be an information system desi... | GE Healthcare is aware of a potential safety issue associated with the use of GE Centricity Labor... | Class III | GE Healthcare It |
| Nov 20, 2012 | WANG Transbronchial Aspiration Needles Cat. No. MW-221, WANG Cytology Needle... | ConMed received complaints from a user facility reporting that the WANG Transbronchial Aspiration... | Class II | ConMed Corporation |
| Nov 20, 2012 | Centricity Laboratory Core Lab System 4.1 The Centricity Laboratory System... | The Centricity Laboratory removes free-text notes on a master panel when the user deletes the sla... | Class II | GE Healthcare It |
| Nov 19, 2012 | Medtronic Intersept Custom Tubing Pack with or without coating ( Carmeda BioA... | Medtronic is initiating an Urgent Medical Device Customer Notification. We have confirmed that c... | Class II | Medtronic Inc. Cardiac Rhythm Disease Management |
| Nov 19, 2012 | Fisher & Paykel Healthcare reusable breathing circuit. Non-heated breathing ... | FPH has become aware that one batch of tubes supplied to FPH may contain hole damage. These tubes... | Class I | Fisher & Paykel Healthcare, Ltd. |
| Nov 19, 2012 | Roche COBAS INTEGRA 400 and 400 plus Analyzer, an in vitro diagnostic ana... | A software security issue with Oracles TNS-Listener component has been identified. TNS-Listener ... | Class III | Roche Diagnostics Operations, Inc. |
| Nov 19, 2012 | Patient Circuit used with the Life Pulse High Frequency Ventilator. The Pati... | Customer complaints received indicate the heater wire insulation can melt, causing a short which ... | Class I | Bunnell, Inc. |
| Nov 19, 2012 | Titanium Tack Starter Kit, REF 400-270, Rx Only, non-sterile, BIOHORIZONS, BI... | The cleaning instructions provided may not be sufficient to remove residual contaminants after su... | Class II | BioHorizons Implant Systems Inc |
| Nov 19, 2012 | Coonrad/Morrey New Ulnar Revision Kit for Use with Non-Interchangeable Regula... | Zimmer is initiating a lot specific recall because affected lots could include an extra Small Inn... | Class II | Zimmer, Inc. |
| Nov 19, 2012 | AutoTac Delivery Handle, REF 400-200, Rx Only, non-sterile, BIOHORIZONS, BIRM... | The cleaning instructions provided may not be sufficient to remove residual contaminants after su... | Class II | BioHorizons Implant Systems Inc |
| Nov 19, 2012 | COONMAD/MORREY TOTAL ELBOW ELBOW COMPONENT REPLACEMENT SET BUSHINGS & PINS ... | Zimmer is initiating a lot specific recall because affected lots could include an extra Small Inn... | Class II | Zimmer, Inc. |
| Nov 16, 2012 | Enterprise 9000 Bed; an AC-powered adjustable hospital bed with built-in elec... | ArjoHuntleigh has received reports of unintended movement where the backrest and/or thigh section... | Class II | Arjo, Inc. dba ArjoHuntleigh |
| Nov 16, 2012 | Enterprise 8000 Bed; an AC-powered adjustable hospital bed; ArjoHuntleigh AB,... | ArjoHuntleigh has received reports of unintended movement where the backrest and/or thigh section... | Class II | Arjo, Inc. dba ArjoHuntleigh |
| Nov 16, 2012 | Centricity Enterprise Archive is a software product for receiving, archiving ... | There is a potential for data loss associated with empty path names resulting from HL-7 updates w... | Class II | Ge Healthcare It |
| 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 16, 2012 | Praxair Vantage Grab n Go - Gas Cylinder pressure regulator Catalog Number: ... | Isolated incidents of ignition inside Grab n' Go cylinders that had been knocked over or otherwis... | Class I | Praxair Inc. |
| Nov 16, 2012 | Clinical Chemistry Phenobarbital, list number 1E08 | Abbott Diagnostics is recalling Clinical Chemistry Phenobarbital reagent lots 62299UN12 and 85773... | Class II | Abbott Laboratories, Inc |
| Nov 15, 2012 | Bausch and Lomb 27G sterile cannula packed in the Bausch and Lomb Amvisc 1.2%... | Some disposable cannulas (with 4-digit lot numbers) provided with the Amvisc or Amvisc Plus OVD a... | Class I | Bausch and Lomb, Incorporated |
| Nov 15, 2012 | Viterion TeleHealth Monitor Model Number V500; Product Codes 08832984 (US) an... | Viterion telehealth monitors do not transmit "HI" (above the meter's measurable range) and "LO" (... | Class II | Viterion TeleHealthcare Llc |
| Nov 15, 2012 | Viterion TeleHealth Monitor Model Number V100, Product Codes 09377512 (US) an... | Viterion telehealth monitors do not transmit "HI" (above the meter's measurable range) and "LO" (... | Class II | Viterion TeleHealthcare Llc |
| Nov 15, 2012 | Biomet Offset Tibial Tray 2.5 mm Adaptor, REF 141490 Sterile, QTY.1 Produ... | Biomet investigation identified that the square end of the offset tibial tray adaptor locking ins... | Class II | Biomet, Inc. |
| Nov 15, 2012 | EEG NeuroAmp, Model Number: CS 10090; CS 10137. Biofeedback and Relaxation | EEG Info, Inc. is recalling the EEG Neuroamp device because they have identified a potential risk... | Class II | EEG Info |
| Nov 15, 2012 | Viterion TeleHealth Monitor Model Number V100-BGM, Product Code 81842478 (US... | Viterion telehealth monitors do not transmit "HI" (above the meter's measurable range) and "LO" (... | Class II | Viterion TeleHealthcare Llc |
| Nov 15, 2012 | GE Centricity PACS Workstation, versions 3.1.1.x through 3.2.1.x Picture Ar... | While merging exams in a test instance, merges carry forward in the production system, when the m... | Class II | GE Healthcare It |
| Nov 15, 2012 | ConMed Linvatec Biomaterials, PopLok bone Punch PKL-35M, 3.5mm Orthope... | ConMed Linvatech recalled one lot of their PopLok bone Punch 3.5mm because the metal shaft diamet... | Class II | Linvatec Corp. dba ConMed Linvatec |
| Nov 14, 2012 | Persona The Personalized Knee System, Natural Tibia, Cemented, 5 Degree Ste... | All lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, ... | Class II | Zimmer, Inc. |
| Nov 14, 2012 | Persona, The Personalized Knee System, Tibial Sizing Plate, Cemented, Nonst... | All lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, ... | Class II | Zimmer, Inc. |
| 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 | Persona The Personalized Knee System, Natural Tibia, Cemented, 5 Degree Ste... | All lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, ... | Class II | Zimmer, 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.