Browse Device Recalls
45 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 45 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 45 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jan 10, 2019 | AutoDELFIA¿ hCG Kit, In Vitro Diagnostic for the determination of human gonad... | hCG analyte concentrations may be decreased up to 15- 20% at the lower measuring range of hCG con... | Class II | PerkinElmer Life and Analytical Sciences, Walla... |
| Jan 10, 2019 | DELFIA¿ hCG Kit, In Vitro Diagnostic for the determination of human gonadotro... | hCG analyte concentrations may be decreased up to 15- 20% at the lower measuring range of hCG con... | Class II | PerkinElmer Life and Analytical Sciences, Walla... |
| Jan 10, 2019 | AutoDELFIA¿ hCG Kit, In Vitro Diagnostic for the determination of human gonad... | hCG analyte concentrations may be decreased up to 15- 20% at the lower measuring range of hCG con... | Class II | PerkinElmer Life and Analytical Sciences, Walla... |
| Sep 24, 2018 | PerkinElmer QSight 210 MD Mass Spectrometer Simplicity 3Q MD v1.0 with Hot Fi... | Under certain conditions when using PerkinElmer QSight 210 MD mass spectrometer with Simplicity 3... | Class II | PerkinElmer Health Sciences Canada, Inc. |
| Dec 19, 2017 | PerkinElmer 226 Sample Collection Device | PerkinElmer 226 Sample Collection Devices Lot Number 40020001 had serial numbers printed on the p... | Class III | PerkinElmer Health Sciences, Inc. |
| Nov 17, 2017 | Specimen Gate Screening Center, Part Number 5002-0500, All software versions ... | Potential errors in patient results generated by the Screening Center product that include both f... | Class II | PerkinElmer Life and Analytical Sciences, Walla... |
| Nov 2, 2017 | NeoBase Succinylacetone Assay Solution, Product Number: 3042-0020; Affected U... | There is a potential for leaking vials for certain lot numbers where, if proper attire is not use... | Class II | PerkinElmer Life and Analytical Sciences, Walla... |
| Sep 25, 2017 | AutoDELFIA Neonatal immunoreactive trypsin(ogen) (IRT) kit, intended for the ... | The Quality Control Certificate for certain AutoDELFIA Neonatal IRT Kits is missing information r... | Class III | PerkinElmer Life and Analytical Sciences, Walla... |
| Aug 2, 2017 | JANUS & JANUS G3 Automated Workstation is an automated programmable liquid h... | We have become aware through internal testing that JANUS and Janus G3 Automated Workstations were... | Class III | Perkinelmer Life Sciences, Inc. |
| May 31, 2017 | PerkinElmer 226 Sample Collection Device The PerkinElmer 226 Sample Collec... | PerkinElmer 226 Sample Collection Devices Lot Number 317114 had serial numbers printed on the pac... | Class III | PerkinElmer Health Sciences, Inc. |
| May 15, 2017 | Multiphor II Electrophoresis System GE HealthCare Product Number: 18-1018-0... | Potential for electric shock in the case of a failure to install the grommets, supplied with the ... | Class II | Perkinelmer Life Sciences, Inc. |
| Mar 7, 2017 | Specimen Gate Laboratory; Product Number: 5002-0180 Specimen Gate Laboratory... | Potential for errors in patient results generated by the Specimen Gate Laboratory Software. | Class II | PerkinElmer Life and Analytical Sciences, Walla... |
| Jan 5, 2017 | Genetic Screening Processor (GSP); PerkinElmer Part Number= 2021-0010 Inte... | The firm became aware that the ball bushing axels are defective in the GSP instrument. During exp... | Class II | PerkinElmer Life and Analytical Sciences, Walla... |
| Jan 5, 2017 | Spare Disk Remover Module; Product Number: 61001820 Intended for in vitro ... | The firm became aware that the ball bushing axels are defective in the GSP instrument. During exp... | Class II | PerkinElmer Life and Analytical Sciences, Walla... |
| Dec 21, 2016 | AutoDELFIA¿ Plate Processor , Fluorometer, for clinical use Product Number:... | AutoDELFIA System with Version 3.0 Software: Potential plate loading failures | Class III | PerkinElmer Health Sciences, Inc. |
| Dec 21, 2016 | DELFIA¿ PC with V3.0 Software, Fluorometer, for clinical use Product Number... | AutoDELFIA System with Version 3.0 Software: Potential plate loading failures | Class III | PerkinElmer Health Sciences, Inc. |
| Dec 21, 2016 | Program Update Package AutoDELFIA¿ 3.0, Fluorometer, for clinical use Produc... | AutoDELFIA System with Version 3.0 Software: Potential plate loading failures | Class III | PerkinElmer Health Sciences, Inc. |
| Dec 5, 2016 | EnLite Neonatal TREC Kit;an in vitro diagnostic device intended for the semi-... | Unique Device Identifier (UDI) is missing from outer kit box label. | Class III | PerkinElmer Health Sciences, Inc. |
| Dec 1, 2016 | Specimen Gate Laboratory 5002-0180, Specimen Gate eReports 5002-0370, Softwar... | Issue may cause eReports to consume an excessive amount of disk space causing the software to sto... | Class II | PerkinElmer Health Sciences, Inc. |
| Nov 16, 2016 | DELFIA hFSH kit. In Vitro Diagnostic for the determination of hFSH in serum | A DELFIA hFSH kit lot failed real time stability testing. The real time stability data demonstrat... | Class III | PerkinElmer Health Sciences, Inc. |
| Oct 13, 2016 | PerkinElmer 20ul Clear RoboRack Tip, Pipette (Qty 960) Item Number: 6000677.... | Defective tips have the potential to pipette/dispense volumes 50-100% lower than is specified for... | Class II | PerkinElmer, Inc |
| Jun 24, 2016 | Perkin Elmer RoboRack 25ul, Clear, Non-Conductive, Filter Tips, Pre-steriliz... | Filter Tips molded incorrectly and may not seal to the Varispan tip adaptor properly causing inac... | Class II | PerkinElmer, Inc |
| Dec 8, 2015 | Perkin Elmer ClWIZARD2 5-detector, 550 samples Product Code: 2470-0050, 3470... | The content of the second #023 barcode ID label in the Barcode ID Label Binder is incorrect. The... | Class II | Perkinelmer |
| Dec 8, 2015 | Perkin Elmer WIZARD2 2-detector, 550 samples Product Code: 2470-0020 The Wiz... | The content of the second #023 barcode ID label in the Barcode ID Label Binder is incorrect. The... | Class II | Perkinelmer |
| Dec 8, 2015 | Perkin Elmer WIZARD2 10-detector, 1000 samples. Product Code: 2470-0200, 347... | The content of the second #023 barcode ID label in the Barcode ID Label Binder is incorrect. The... | Class II | Perkinelmer |
| Dec 8, 2015 | Perkin Elmer WIZARD2 5-detector, 1000 samples Product Code: 2470-0150, 3470-... | The content of the second #023 barcode ID label in the Barcode ID Label Binder is incorrect. The... | Class II | Perkinelmer |
| Dec 8, 2015 | Perkin Elmer WIZARD2 1-detector,3", 1000 samples. Product Code: 2480-0010 T... | The content of the second #023 barcode ID label in the Barcode ID Label Binder is incorrect. The... | Class II | Perkinelmer |
| Dec 8, 2015 | Perkin Elmer WIZARD2 1-detector, 550 samples Product Code: 2470-0010 The Wiz... | The content of the second #023 barcode ID label in the Barcode ID Label Binder is incorrect. The... | Class II | Perkinelmer |
| Dec 8, 2015 | Perkin Elmer WIZARD2 10-detector, 550 samples Product Code: 2470-0100, 3470-0... | The content of the second #023 barcode ID label in the Barcode ID Label Binder is incorrect. The... | Class II | Perkinelmer |
| Jun 3, 2015 | WIZARD2 5-detector, 550 samples Product Code: 2470-0050, 3470-0050 The Wi... | Error in WIZARD2 Barcode ID Label #023 Content may produce erroneous results | Class II | Perkinelmer |
| Jun 3, 2015 | WIZARD2 2-detector, 550 samples Product Code: 2470-0020 The Wizard¿" gamm... | Error in WIZARD2 Barcode ID Label #023 Content may produce erroneous results | Class II | Perkinelmer |
| Jun 3, 2015 | Perkin Elmer WIZARD2 10-detector, 1000 samples Product Code: 2470-0200, 3470... | Error in WIZARD2 Barcode ID Label #023 Content may produce erroneous results | Class II | Perkinelmer |
| Jun 3, 2015 | Perkin Elmer WIZARD2 1-detector, 550 samples Product Code: 2470-0010 The ... | Error in WIZARD2 Barcode ID Label #023 Content may produce erroneous results | Class II | Perkinelmer |
| Jun 3, 2015 | Perkin Elmer WIZARD2 5-detector, 1 000 samples Product Code: 2470-0150, 3470... | Error in WIZARD2 Barcode ID Label #023 Content may produce erroneous results | Class II | Perkinelmer |
| Jun 3, 2015 | Perkin Elmer WIZARD2 1-detector,3", 1000 samples Product Code: 2480-0010 ... | Error in WIZARD2 Barcode ID Label #023 Content may produce erroneous results | Class II | Perkinelmer |
| Jun 3, 2015 | Perkin Elmer WIZARD2 10-detector, 550 samples Product Code: 2470-0100, 3470-... | Error in WIZARD2 Barcode ID Label #023 Content may produce erroneous results | Class II | Perkinelmer |
| Jul 1, 2014 | Panthera-Puncher 9 . Panthera-Puncher 9 is a sample transfer instrument ... | Risk of incorrect results from samples prepared with Panthera-Puncher 9 | Class II | PerkinElmer Health Sciences, Inc. |
| Jun 27, 2014 | PerkinElmer Specimen Gate Screening Center software, version 1.4 and 1.6; Pro... | Potential for demographic information and test result to be mismatch. | Class II | PerkinElmer Health Sciences, Inc. |
| Sep 5, 2013 | Perkin Elmer 226 Sample Collection Device, Serial numbers: 06132903 - 0619890... | Some devices may be contaminated on the back side of the device with glue in the blood applicatio... | Class II | Perkin Elmer Health Sciences, Inc. |
| Nov 26, 2012 | NEOBASE NON-DERIVATIZED MSMS KIT Product Number: ... | Truncated V-Bottomed Microplate Wells used in assays contain defective wells. | Class II | Perkinelmer |
| Nov 26, 2012 | Microplate, truncated V-bottomed lots included in the above listed products ... | Truncated V-Bottomed Microplate Wells used in assays contain defective wells. | Class II | Perkinelmer |
| Nov 26, 2012 | NEOGRAM AMINO ACIDS AND ACYLCARNITINES TANDEM MASS SPECTROMETRY KIT Produc... | Truncated V-Bottomed Microplate Wells used in assays contain defective wells. | Class II | Perkinelmer |
| Nov 26, 2012 | DBS MICROPLATE, TRUNCATED V-BOTTOMED Product Number: 3033-0010 | Truncated V-Bottomed Microplate Wells used in assays contain defective wells. | Class II | Perkinelmer |
| Nov 26, 2012 | NEONATAL TOTAL GALACTOSE KIT Product Numb... | Truncated V-Bottomed Microplate Wells used in assays contain defective wells. | Class II | Perkinelmer |
| Jun 27, 2012 | Perkin Elmer Genetic Screening Processor (GSP) Product Code: 2021-0010 Pr... | Contamination from GSP Shaker unit results in decreased signal activity of assay measurements for... | Class II | Perkinelmer |
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.