Browse Device Recalls
1,040 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 1,040 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 1,040 FDA device recalls, Class III.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Oct 16, 2013 | Nanosphere Verigene Each CDF test consists of a Verigene CDF Nucleic Acid... | Nanosphere has received report of an increased rate of "No Call - INT CTL 2" results for the Inte... | Class III | Nanosphere, Inc. |
| Oct 3, 2013 | ENDOBON XENOGRAFT GRANULES 0.5 ML (Bovine bone substitute) Endobon is a bo... | Individual pieces of a batch of Biomet's Endobon Xenograft Granules 0.5 ML (Bovine Bone substitut... | Class III | Biomet 3i, LLC |
| Oct 3, 2013 | Single Analyte Urine DAU Control (5 m L Norbuprenorphine, Level II control ... | Product catalog # A68825 Norbuprenorphine 13 ng/mL Level 2 Controls gives a decreased concentrati... | Class III | Lin-Zhi International Inc |
| Oct 3, 2013 | STERITITE Containers: STERITITE Container Kit, 1/4 size, 3" high, product cod... | Advanced Sterilization Products (ASP) is recalling the SteriTite containers because they do not ... | Class III | Advanced Sterilization Products |
| Oct 1, 2013 | Blom-Singer Adjustable Tracheostoma Valve II Models: BE8025H and BE8025H-R3 | InHealth Technologies (IHT) is recalling the Blom-Singer Adjustable Tracheostoma Valve II (ATSV I... | Class III | Helix Medical LLC |
| Sep 23, 2013 | Alere Triage¿ TOX Drug Screen Control 1 Product Generic Name: Quality Cont... | Alere San Diego, Inc. initiated a voluntary recall of Alere Triage TOX Drug Screen Control 1 (PN ... | Class III | Alere San Diego, Inc. |
| Sep 6, 2013 | ABX PENTRA Calcium CP Reagent, Model # A11A01633 Calcium plays an essentia... | HORIBA Medical is informing all PENTRA 200 and PENTRA 400 customers of a potential for reporting ... | Class III | Horiba Instruments, Inc dba Horiba Medical |
| 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. |
| Aug 20, 2013 | FSE Image Upgrade Kit, Catalog # 92019C This kit is used to install and/or... | The FSE Image Upgrade kit (part 92019C) is recalled due to issue related to the export of data fr... | Class III | Bio-Rad Laboratories |
| Aug 16, 2013 | ADVIA Centaur Intact PTH Calibrator (6 pack); Catalog Number: SMN 10492387 ... | PTH Calibrator packaged with only high calibrator. | Class III | Siemens Healthcare Diagnostics, Inc |
| Aug 9, 2013 | WASP (Walk Away Specimen Process). Automatic Planting and Streaking Instrumen... | The recall of the WASP (Walk Away Specimen Process) instrument was initiated because Copan Italia... | Class III | Copan Italia |
| Jul 24, 2013 | ORBIT PT. The ORBIT PT works in conjunction with an TRUMPF mobile operatin... | An odor and smoke developed - The cause was determined to be a power supply unit sitting in the c... | Class III | Trumpf Medical Systems |
| Jul 16, 2013 | Zoll Circulation LifeBand Single Pack (accessory), and Nickel-metal hydride (... | Typographical error in the Japanese legal label of the AutoPulse Resuscitation System Model 100. ... | Class III | Zoll Circulation, Inc. |
| Jul 12, 2013 | OLA Buffer For Laboratory Use; Contents: 1 tube with buffered solution cont... | The package insert for FG OLA Buffer, GPR displayed the wrong concentration of ¿M instead of the ... | Class III | Celera Corporation |
| Jun 28, 2013 | ADVIA Centaur Calibrator A. Cat. #04800735, SMN 10285904 (6 pack); Cat. # 04... | Calibrator A lot CA77 is under-recovering to the assigned target for the ADVIA Centaur Total T4 A... | Class III | Siemens Healthcare Diagnostics, Inc |
| Jun 25, 2013 | ConvaTec Flexi-Seal SIGNAL +, Rx Only Product Usage: For use to manage f... | ConvaTec notified their customers on 6/25/2013 regarding the manufacturing irregularity that occu... | Class III | Convatec Inc. |
| Jun 25, 2013 | ConvaTec Flexi-Seal SIGNAL Fecal Management System, Rx Only Product Usage:... | ConvaTec notified their customers on 6/25/2013 regarding the manufacturing irregularity that occu... | Class III | Convatec Inc. |
| Jun 20, 2013 | TDHistology/Cytology Classification name: Calculator/data processing modul... | A recall was initiated by Technidata because use of symbols (less than or equal to or greater tha... | Class III | Technidata S.A. |
| Jun 19, 2013 | Beekley Spots Light Image O-Spots for Mammography Catalog Number: 252 Pro... | Light Image O-Spots Dispenser mislabeled as Soft n' Stretchy Light Image S-Spots | Class III | Beekley Corporation |
| Jun 5, 2013 | 3M ESPE, Unitek Stainless Steel Permanent Molar Crowns Stainless Steel Cro... | 3M is recalling specific lots of 3M ESPE Unitek Primary Stainless Steel Crowns - Series UR4 cont... | Class III | 3M Company - Health Care Business |
| Jun 3, 2013 | CMC Saddle Product Usage: The Ascension CMC is intended to resurface the ... | As a result of a quality review, labelling content discrepancies were identified between the Inst... | Class III | Integra LifeSciences Corp. |
| May 31, 2013 | BD MAX Instrument, catalog #441916 Product Usage: The BD MAX System, use... | Electrical power module installed on some in vitro diagnostic instruments does not meet industry ... | Class III | Becton Dickinson & Co. |
| May 28, 2013 | RigiflexTM 11 Single-Use Achalasia Balloon Dilator, Material Number (UPN) M00... | Product labeled with incorrect expiration date. | Class III | Boston Scientific Corporation |
| May 14, 2013 | Optovue iVue with Normative Database (NDB) with Software Version 3.0 and 3.1.... | Colors from the NDB comparison for Ganglion Cell Complex thickness in the singular OU report in i... | Class III | Optovue, Inc. |
| May 9, 2013 | VITROS Chemistry Products CRP Slides (Reagent), REF/Catalog Number 192 6740 a... | While performing interval testing Ortho Clinical Diagnostics (OCD) determined that an excess amou... | Class III | Ortho-Clinical Diagnostics |
| May 9, 2013 | VITROS Chemistry Products K+ (Potassium) Slides (Reagent), REF/Catalog Number... | While performing interval testing, Ortho Clinical Diagnostics (OCD) determined that a surfactant ... | Class III | Ortho-Clinical Diagnostics |
| May 8, 2013 | DePuy LifeLiner Stick & Cut Resistant Gloves Rt, Lg Part No. 5200-68-000 ... | LifeLiner Stick and Cut Resistant Gloves are being recalled because cases and individual glove pa... | Class III | DePuy Orthopaedics, Inc. |
| Apr 15, 2013 | Liquichek" ToRCH Plus IgM Control - Positive Liquichek ToRCH Plus IgM Cont... | The Liquichek" ToRCH Plus IgM Control - Positive, contains detectable levels of HCV RNA which ori... | Class III | Bio-rad Laboratories, Inc. |
| Apr 12, 2013 | Curity I.V. Start Kit, Product ID: 80530 and Curity I.V. Start Kit Product ID... | On March 26, 2013 Covidien received a recall notice from one of their suppliers CareFusion. Care... | Class III | Covidien LLC |
| Apr 12, 2013 | Curity Staple Remover Kit; Product Code: 66701. Staple Remover Kit. | On March 26, 2013 Covidien received a recall notice from one of their suppliers CareFusion. Care... | Class III | Covidien LLC |
| Apr 9, 2013 | Dermalight 80 Model Number UVB-080, one unit per box. The Dermalight 80 i... | The incorrect manual may have been packaged with this product. UVB-080 devices may have included ... | Class III | National Biological Corp |
| Apr 8, 2013 | Dermalight 80 Model Number UVB-083, one unit per box. The Dermalight 80 is... | The incorrect manual may have been packaged with this product. UVB-083 devices may have included... | Class III | National Biological Corp |
| Apr 3, 2013 | VITROS Immunodiagnostic Products CK-MB Calibrators, REF 128 6293, IVD, Ortho... | Internal testing demonstrated that opened-reconstituted VITROS CK-MB Calibrators stored at -20 de... | Class III | Ortho-Clinical Diagnostics |
| Mar 28, 2013 | The CEP 8 SpectrumGreen (SG) ASR Probe Kit, 20ul (list 06J37-018) is an Analy... | 20 kits of CEP 8 SG ASR Probe (list 06J37-018, lot 440023), contained Vysis CEP 4 (Alpha Satellit... | Class III | Abbott Molecular |
| Mar 25, 2013 | KWIK-STIK(TM), Quality control kit for culture media, sold as: KWIK-STIK(... | Some of the KWIK-STIK Catalog #01023P Campylobacter coli, Lot# 1023-05-7, contained an inner labe... | Class III | Microbiologics Inc |
| Mar 25, 2013 | Oxoid Antimicrobial Susceptibility Test Discs F300 (Nitrofurantoin), Cat. #CT... | Use of affected lots may give false indication of susceptibility to Nitrofurantoin. | Class III | Remel Inc |
| Mar 22, 2013 | LHB, First Aid Type III, NSN # 6545-00-656-1094, Kit number: 2114011. Fi... | The product contains an iodine 10% Ampule (10% Povidone Iodine swab) which is being recalled by t... | Class III | Lighthouse For The Blind |
| Mar 22, 2013 | LHB, Antiseptic Kit, Povidone Swab, Gauze Pads, and non-stick pads. Kit Numb... | The product contains an iodine 10% Ampule (10% Povidone Iodine swab) which is being recalled by t... | Class III | Lighthouse For The Blind |
| Mar 22, 2013 | LHB, First Aid Type IV Belt Type, NSN #6545-01-010-7754. Kit number: 114016... | The product contains an iodine 10% Ampule (10% Povidone Iodine swab) which is being recalled by t... | Class III | Lighthouse For The Blind |
| Mar 22, 2013 | LHB, Type I First Aid Kit Perishable, Non-Aspirin 4/pg, Aspirin 4/pg and Povi... | The product contains an iodine 10% Ampule (10% Povidone Iodine swab) which is being recalled by t... | Class III | Lighthouse For The Blind |
| Mar 22, 2013 | LHB, Perishable Items Pack Type I , Kit Number: 2114002-100. First Aid ... | The product contains an iodine 10% Ampule (10% Povidone Iodine swab) which is being recalled by t... | Class III | Lighthouse For The Blind |
| Mar 22, 2013 | LHB, Perishable Items Pack Type IV. Kit number: 2114016-100. First Aid Kit. | The product contains an iodine 10% Ampule (10% Povidone Iodine swab) which is being recalled by t... | Class III | Lighthouse For The Blind |
| Mar 22, 2013 | LHB, Perishable Item Pack Type III. Kit number: 2114011-100. First Aid Kit. | The product contains an iodine 10% Ampule (10% Povidone Iodine swab) which is being recalled by t... | Class III | Lighthouse For The Blind |
| Mar 22, 2013 | LHB, First Aid Type I Individual Kit, NSN: 6545-00-656-1092, antiseptics, Kit... | The product contains an iodine 10% Ampule (10% Povidone Iodine swab) which is being recalled by t... | Class III | Lighthouse For The Blind |
| Mar 4, 2013 | Sepp, Compound Benzoin Tincture Packaged and Tincture 3,000 Bulk. Product... | An internal review of CareFusion's labeling for preoperative skin prep product codes was recently... | Class III | CareFusion 213, LLC |
| Feb 27, 2013 | Siemens Dimension(R) EXL(TM) LM STM (Siemens Material Number 106393377). I... | Through investigation of customer complaints, Siemens Healthcare Diagnostics has confirmed an inc... | Class III | Siemens Healthcare Diagnostics, Inc. |
| Feb 27, 2013 | Siemens Dimension(R) EXL(TM) 200 (Siemens Material Number 10636929). Inten... | Through investigation of customer complaints, Siemens Healthcare Diagnostics has confirmed an inc... | Class III | Siemens Healthcare Diagnostics, Inc. |
| Feb 27, 2013 | Siemens Dimension(R) EXL(TM) LM (Siemens Material Number 10486890). Intend... | Through investigation of customer complaints, Siemens Healthcare Diagnostics has confirmed an inc... | Class III | Siemens Healthcare Diagnostics, Inc. |
| Feb 27, 2013 | Sirtex SIR-yttrium 90 microspheres (Radionuclide); SIR-Y001. Indicated for... | Incorrect expiration date | Class III | Sirtex Medical Limited |
| Feb 26, 2013 | CLINITEK Status+ Analyzer (portable urine chemistry analyzer). Catalog number... | Device with Sample Interference Notes (SIN) enabled not cleared for US marketing. | Class III | 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.