Browse Device Recalls
1,029 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 1,029 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 1,029 FDA device recalls, Class III.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Apr 16, 2015 | Mallory/Head Primary Hip System; Size 11, 160 mm, Lateralized Femoral Stem; T... | Biomet hip joint, knee joint and shoulder joint replacement components device labeling contains i... | Class III | Biomet, Inc. |
| Apr 16, 2015 | MCK Maximum Congruent Knee System, BIOMET FINNED PRI STEM 40MM; 80 x 10MM; 80... | Biomet hip joint, knee joint and shoulder joint replacement components device labeling contains i... | Class III | Biomet, Inc. |
| Apr 9, 2015 | Spinal Elements 5.5 x 45MM Mercury lordosed rod. A component of the Mercury ... | Some rods may not meet the appropriate traceability requirements including the lot number. Some ... | Class III | Spinal Elements, Inc |
| Mar 27, 2015 | BBL Trypticase Soy Agar with 5% Sheep Blood (TSA II) and Chocolate II Agar (G... | BD has confirmed that one lot of TSA II and Chocolate Agar I-Plates may fail to recover Haemophil... | Class III | Becton Dickinson & Co. |
| Mar 25, 2015 | Universal Charger Product Usage: The Stryker Universal Battery Charg... | The Stryker Universal Battery Charger is not transmitting usage data to the Stryker Cloud as desi... | Class III | Stryker Instruments Div. of Stryker Corporation |
| Mar 13, 2015 | Pointe Scientific autoHDL Reagent H7545 H7545-R1 in a bulk cube container ... | Crystals may be observed in the R1 reagent. Crystals may be a result of the reagent being frozen ... | Class III | Pointe Scientific, Inc. |
| Feb 27, 2015 | Volk 25D Large Clear BIO Lens with case UPC: 8 11608 01010 6, VOLK OPTICAL IN... | Mislabeling. The incorrect lot number was engraved on the anodized aluminum ring. | Class III | Volk Optical Inc |
| Feb 27, 2015 | Lombart 90D Clear with case Visualization during diagnosis and laser therapy... | Mislabeling. The incorrect lot number was engraved on the anodized aluminum ring. The correct l... | Class III | Volk Optical Inc |
| Feb 25, 2015 | Vitek 2 AST-P640 REF 418 579 Gram Positive Susceptibility Card, 20 cards per ... | The outer carton label and package insert for the recalled product incorrectly lists Streptococcu... | Class III | Biomerieux Inc |
| Feb 25, 2015 | Vitek 2 AST-P635 REF 416 911 Gram Positive Susceptibility Card, 20 cards per ... | The outer carton label and package insert for the recalled product incorrectly lists Streptococcu... | Class III | Biomerieux Inc |
| Feb 25, 2015 | Vitek 2 AST-P641 REF 418 590 Gram Positive Susceptibility Card, 20 cards per ... | The outer carton label and package insert for the recalled product incorrectly lists Streptococcu... | Class III | Biomerieux Inc |
| Feb 24, 2015 | LeMaitre Vascular Tumescent Catheter Inversion (TCI) System. The TCI Syste... | Mislabeled with an incorrect expiration date | Class III | LeMaitre Vascular, Inc. |
| Feb 19, 2015 | Carton: Richard-Allan Scientific CYTO-STAIN; REF 7501R; Quantity: 1x1 Gallon... | The case was correctly labeled as REF 7501R, however the gallon bottle was incorrectly labeled as... | Class III | Richard-Allan Scientific Company |
| Feb 19, 2015 | ThermoFlo 1 HME, Disposable, Non-sterile, Expiry date 04/17. Used as a hu... | Outer shipping carton was marked with an incorrect expiry date, however inner product carton was ... | Class III | Arc Medical Inc |
| Feb 11, 2015 | Milestone Wand STA Handpiece for the delivery of local anesthesia to dental t... | Wand Handpiece was mislabeled as STA handpiece. The Wand handpiece cannot be installed in the ST... | Class III | Milestone Scientific, Inc. |
| Feb 10, 2015 | G7 Variant Elution Buffer HiS no. 1 (M) component of the Tosoh Automated Glyc... | The G7 Variant Elution Buffer HiS no. 1 (M) is incorrectly labeled with an expiration date of Oct... | Class III | Tosoh Bioscience, Inc. |
| Jan 15, 2015 | N Latex IgM; In-vitro diagnostic reagent for the quantitative determination o... | Complaints have been confirmed on failed proficiency testing due to serum samples recovering too ... | Class III | Siemens Healthcare Diagnostics, Inc. |
| Jan 13, 2015 | cobas¿ EGFR Mutation Test epidermal growth factor receptor (EGFR) gene DNA a... | False positive results for Exon 20 insertion mutations are being detected with the cobas¿ EGFR Mu... | Class III | Roche Molecular Systems, Inc. |
| Jan 9, 2015 | Arrow Select Kits (ASK), Maximal Barrier Precautions Kits (CDC) and Arterial ... | Certain product codes and lot numbers of Kits with Biopatch Dressing were packaged with the inco... | Class III | Arrow International Inc |
| Jan 9, 2015 | Alive ECG App 2.1.2 ( a medical device application for the Apple iOS operatin... | Alive ECG App version 2.1.2 (intended to be used with the AliveCor Heart Monitor) crashed upon us... | Class III | Alivecor SFO |
| Dec 22, 2014 | Flyte Togas are components of the Stryker Flyte System and are intended to be... | A single lot (11121171) of Flyte Toga Peel-away X-Large (catalog number 0408-830-100) was labeled... | Class III | Stryker Instruments Div. of Stryker Corporation |
| Dec 18, 2014 | cobas 4800 KRAS AMP/DET 24T CE-IVD Mutation Test; CE-IVD 5852170190. Inten... | cobas KRAS Mutation Kit T10786 is generating invalid results for the Mutant Control and/or KRAS C... | Class III | Roche Molecular Systems, Inc. |
| Dec 17, 2014 | Portex Anaerobic Pulsator Arterial Blood Sampling Kit, with Liquid Sodium Hep... | The outer box label is marked with the correct expiration date of 08/2016. The inner Tyvek Unit L... | Class III | Smiths Medical ASD, Inc. |
| Dec 12, 2014 | Pointe Scientific Creatinine Reagent Catalog number C7539-150 in vitro dia... | Creatinine kit C7539-150 contains Creatinine reagent R1 that is labeled as Creatinine reagent R2 ... | Class III | Pointe Scientific, Inc. |
| Nov 26, 2014 | VisiPlugST for the Lacrimal Efficiency Test. It is also sold in the EU as Co... | Moisture level may cause the VisiPlugST (or CollaSyn Plugs) to break apart, or crumble upon conta... | Class III | Lacrimedics Inc |
| Nov 17, 2014 | Trinity biotech Captia (TM) Syphilis IgM Capture Test Kit, Product No./REF 80... | Through in-house routine real time stability monitoring of Trinity's Captia Syphilis IgM Capture ... | Class III | Clark Laboratories, Inc. (dba,Trinity Biotech USA) |
| Nov 11, 2014 | Aesculap Miethke Shunt System, miniNAV Valve: The Miethke Shunt System is int... | Aesculap Inc. (AIC (USA)) initiated a recall of Miethke Shunt System accessories due to missing p... | Class III | Aesculap, Inc. |
| Nov 10, 2014 | CareLink Pro Medtronic CareLink Pro MMT-7335 is a personal computer software... | The firm is informing customers of a software error that might result in an inaccurate display of... | Class III | Medtronic MiniMed Inc. |
| Nov 10, 2014 | Infinite 200PRO The Tecan Infinite 200 is a multifunctional microplate reade... | Incorrect lumi firmware version installed (E.027 instead of V2.00) | Class III | Tecan US, Inc. |
| Nov 10, 2014 | Infinite 200 The Tecan Infinite 200 is a multifunctional microplate reader w... | Incorrect lumi firmware version installed (E.027 instead of V2.00) | Class III | Tecan US, Inc. |
| Nov 6, 2014 | Illumina MiSeqDx Cystic Fibrosis Clinical Sequencing Assay in vitro diagnost... | Illumina has confirmed a software limitation with MiSeq Reporter software (version 2.2.31) when u... | Class III | Illumina Inc |
| Nov 4, 2014 | LUNA Chest, Model No. LU4006 | Non sterile-drape LUNA drape was inadvertently mislabeled with an additional contents sterile label. | Class III | Novadaq Technologies, Inc. |
| Nov 4, 2014 | Non-sterile drape | Non sterile-drape LUNA drape was inadvertently mislabeled with an additional contents sterile label. | Class III | Novadaq Technologies, Inc. |
| Oct 27, 2014 | Cooper Surgical CANNULA-CURETTE 12MM; Model Number: MX562 The CooperSurgic... | The product has been identified to contain an incorrect curette type. | Class III | CooperSurgical, Inc. |
| Oct 24, 2014 | Radiomat M+ NIF 14 x 17, Radiomat M+ NIF 35CM x 43CM, Radiomat M+ NIF 10 x 12... | Some material of the coating Type CXCPMV3 has potential artifacts showing a small bright thin lin... | Class III | AGFA Healthcare Corp. |
| Oct 23, 2014 | MedTest DX Assayed Human Multi Sera Control Level 1 (HNC200) and Level 2 (HEC... | MedTest DX Assayed Human Multi Sera Control Level 1 (HNC200) and Level 2 (HEC200) control values... | Class III | Medtest Holdings, Inc. |
| Oct 20, 2014 | IMMULITE Calcitonin Control Module (IMMULITE, IMMULITE 1000, IMMULITE 2000, I... | A typographical error regarding the expiration date was identified in the control module instruct... | Class III | Siemens Healthcare Diagnostics, Inc. |
| Oct 16, 2014 | Etest¿ Ceftaroline (CPT32) US B100. Etest¿ (Antimicrobial Susceptibility T... | The products have a wrong expiration date on their labeling, 5 years instead of 2 years. | Class III | Biomerieux |
| Oct 16, 2014 | Etest¿ Ceftaroline (CPT32) WW B30. Etest¿ (Antimicrobial Susceptibility Te... | The products have a wrong expiration date on their labeling, 5 years instead of 2 years. | Class III | Biomerieux |
| Oct 16, 2014 | Etest¿ Ceftaroline (CPT32) US B30. Etest¿ (Antimicrobial Susceptibility Te... | The products have a wrong expiration date on their labeling, 5 years instead of 2 years. | Class III | Biomerieux |
| Oct 16, 2014 | Etest¿ Ceftaroline (CPT32) WWB100. Etest¿ (Antimicrobial Susceptibility Te... | The products have a wrong expiration date on their labeling, 5 years instead of 2 years. | Class III | Biomerieux |
| Oct 16, 2014 | Etest¿ Ceftaroline (CPT32) US B30. Etest¿ (Antimicrobial Susceptibility Te... | The products have a wrong expiration date on their labeling, 5 years instead of 2 years. | Class III | Biomerieux |
| Oct 6, 2014 | ADVIA Centaur BNP Assay for in vitro diagnostic use in the quantitative deter... | Siemens Healthcare Diagnostics has confirmed that approximately 2000 ReadyPacks from the ADVIA Ce... | Class III | Siemens Healthcare Diagnostics, Inc |
| Sep 30, 2014 | CooperSurgical MILEX PESSARY KITS- Hodge w/Support Folding Pessary- #1 Mode... | Incorrect expiration date printed on the MILEX PESSARY KIT packaging | Class III | CooperSurgical, Inc. |
| Sep 30, 2014 | CooperSurgical MILEX PESSARY KITS-Ring w/Support Folding Pessary- #1 Model: ... | Incorrect expiration date printed on the MILEX PESSARY KIT packaging | Class III | CooperSurgical, Inc. |
| Sep 29, 2014 | VITROS Software Version 3.1 utilized on the following systems: 1) 4600 Chemis... | Calibration may not occur when using calibrator barcode labels supplied with VITROS Chemisty Prod... | Class III | Ortho-Clinical Diagnostics |
| Sep 17, 2014 | ProClear Toric contact lenses are made from a material containing 62%... | Routine quality monitoring system has identified that a limited number of lots were manufactured... | Class III | Cooper Vision Caribbean Corp. |
| Sep 12, 2014 | Omni Micro-electrode/reference electrode for cobas b221 analyzer. The Roch... | The default references for normal values are inconsistent between cobas b 221 and other blood gas... | Class III | Roche Diagnostics Operations, Inc. |
| Sep 12, 2014 | ADVIA Centaur¿ and ADVIA Centaur¿ XP and ADVIA Centaur¿ CP Cleaning Solution ... | Stability of the ADVIA Centaur Cleaning Solution is not assured | Class III | Siemens Healthcare Diagnostics, Inc |
| Sep 8, 2014 | Biatain Super Non-Adhesive, Catalog number 46300, 10 pcs, REF 0463001400. Cou... | Coloplast is conducting a recall for one lot (4201931) of the Biatain Super Non-Adhesive wound d... | Class III | Coloplast Manufacturing US, LLC |
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.