Browse Device Recalls
2,939 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,939 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 2,939 FDA device recalls in PA.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jul 13, 2020 | Orasure Technologies Interept Benzodiazopene Miro-Plate EIA-Benzo EIA 2 plate... | Incorrect lot number for Standard Oral Fluid Negative Calibrator on specification sheet included ... | Class III | OraSure Technologies, Inc. |
| Jul 8, 2020 | Calcaneus Plate, Extensile, Large, Left, Catalog Number CPF 103 - Product Usa... | The contract manufacturer of the calcaneus plate inadvertently used the incorrect material to man... | Class II | Flower Orthopedics Corporation |
| Jul 8, 2020 | Calcaneus Plate, Extensile, Medium, Right, Catalog Number CPF 202 - Product U... | The contract manufacturer of the calcaneus plate inadvertently used the incorrect material to man... | Class II | Flower Orthopedics Corporation |
| Jul 8, 2020 | Calcaneus Plate, Extensile, Small, Left, Catalog Number CPF 101 - Product Usa... | The contract manufacturer of the calcaneus plate inadvertently used the incorrect material to man... | Class II | Flower Orthopedics Corporation |
| Jul 8, 2020 | Calcaneus Plate, Extensile, Small, Right, Catalog Number CPF 201 - Product Us... | The contract manufacturer of the calcaneus plate inadvertently used the incorrect material to man... | Class II | Flower Orthopedics Corporation |
| Jul 8, 2020 | Calcaneus Plate, Extensile, Large, Right, Catalog Number CPF 203 - Product Us... | The contract manufacturer of the calcaneus plate inadvertently used the incorrect material to man... | Class II | Flower Orthopedics Corporation |
| Jul 8, 2020 | Calcaneus Plate, Extensile, Medium, Left, Catalog Number CPF 102 - Product Us... | The contract manufacturer of the calcaneus plate inadvertently used the incorrect material to man... | Class II | Flower Orthopedics Corporation |
| Jul 6, 2020 | Arrow TheraCath Epidural Catheter - Product Usage: The Arrow Epidural Cathete... | The lidstock states the incorrect expiration date for the product. This issue could result in use... | Class II | Arrow International Inc |
| Jul 6, 2020 | Arrow Single Shot Epidural Anesthesia Kit - Product Usage: The Arrow Blunt Ne... | The lidstock states the incorrect expiration date for the product. This issue could result in use... | Class II | Arrow International Inc |
| Jul 6, 2020 | NextStep Retrograde Replacement Hub Set - Product Usage: is indicated for use... | The lidstock states the incorrect expiration date for the product. This issue could result in use... | Class II | Arrow International Inc |
| Jul 6, 2020 | Cannon II Plus Replacement Hub Set - Product Usage: is indicated for use in t... | The lidstock states the incorrect expiration date for the product. This issue could result in use... | Class II | Arrow International Inc |
| Jul 6, 2020 | Golden Technologies Model Number PR515 Lift Chair - Product Usage: is to prov... | Suspect poor weld on back KD bar. | Class II | Golden Technologies, Inc. |
| Jun 24, 2020 | syngo.via RT Image Suite with software versions syngo.via VB30 or VB40 | If the user modifies for any reason (e.g. reduction of artifacts) the original image orientation ... | Class II | Siemens Medical Solutions USA, Inc |
| Jun 22, 2020 | Software versions syngo.CT VB20 or VB20_SP1 in the following systems: SOMATO... | Sporadic problems with the current software may result in scanning workflow interruptions and une... | Class II | Siemens Medical Solutions USA, Inc |
| Jun 18, 2020 | MatrixNEURO Screws - Product Usage: The intended use for this device is in fi... | One lot of MatrixNEURO 5mm screws was packaged in a body clip etched "4", which indicated a 4mm s... | Class II | Synthes, Inc. |
| May 20, 2020 | Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 SPANISH, Product Code IAP-0... | A potential issue with a component within the above-referenced IABPs may impact the ability of th... | Class I | Arrow International Inc |
| May 20, 2020 | Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE SPANISH, Product Code ... | A potential issue with a component within the above-referenced IABPs may impact the ability of th... | Class I | Arrow International Inc |
| May 20, 2020 | Arrow AutoCAT2 Intra-Aortic Balloon Pump AEROAUTOCAT 2 WAVE, Product Code IAP... | A potential issue with a component within the above-referenced IABPs may impact the ability of th... | Class I | Arrow International Inc |
| May 20, 2020 | Arrow AC3 Optimus Intra-Aortic Balloon Pump AC3 Optimus IABP NA/EMEA, Product... | A potential issue with a component within the above-referenced IABPs may impact the ability of th... | Class I | Arrow International Inc |
| May 20, 2020 | Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE ITALIAN, Product Code ... | A potential issue with a component within the above-referenced IABPs may impact the ability of th... | Class I | Arrow International Inc |
| May 20, 2020 | Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE DUTCH, Product Code IA... | A potential issue with a component within the above-referenced IABPs may impact the ability of th... | Class I | Arrow International Inc |
| May 20, 2020 | Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT 2, Product Code IAP-0400 | A potential issue with a component within the above-referenced IABPs may impact the ability of th... | Class I | Arrow International Inc |
| May 20, 2020 | Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE JAPANESE, Product Code... | A potential issue with a component within the above-referenced IABPs may impact the ability of th... | Class I | Arrow International Inc |
| May 20, 2020 | Arrow AC3 Optimus Intra-Aortic Balloon Pump AC3 Optimus IABP NA/AJLA, Product... | A potential issue with a component within the above-referenced IABPs may impact the ability of th... | Class I | Arrow International Inc |
| May 20, 2020 | Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE, Product Code IAP-0500 | A potential issue with a component within the above-referenced IABPs may impact the ability of th... | Class I | Arrow International Inc |
| May 8, 2020 | Arrow FlexTip Plus Epidural Kit with NRFit Connector, catheter system, Produc... | Nine complaints reported that the rotatable collar on the filter had detached, causing a leak. | Class II | Arrow International Inc |
| May 7, 2020 | MAMMOMAT Revelation, model no. 11343300 - Product Usage: is intended to be us... | If an examination is interrupted when the InSpect Projection View (PV) is active and the vacuum b... | Class II | Siemens Medical Solutions USA, Inc |
| May 5, 2020 | ENF-GP2 Rhino-Laryngo Fiberscope - Product Usage: is indicated for use within... | Products repaired with the incorrect service manual may be missing an O ring and are subject to r... | Class II | Olympus Corporation of the Americas |
| Apr 30, 2020 | Multi Display Manager in the Artis Systems (Image-Intensified Fluoroscopic X-... | Artis systems containing a Multi Display Manager of a specific lot, the power distributor may lea... | Class II | Siemens Medical Solutions USA, Inc |
| Apr 23, 2020 | OLYMPUS ShockPulse-SE Lithotripsy System, Model SPL-T Transducer | A component of the Olympus ShockPulse Transducer was manufactured with non-conforming material th... | Class II | Olympus Corporation of the Americas |
| Apr 23, 2020 | ARTIS icono systems with Quantification Application SW (QVA/QCA) on a standal... | Using Quantification Application (QVA/QCA) on DSA images may lead to a failure in vessel detectio... | Class II | Siemens Medical Solutions USA, Inc |
| Apr 22, 2020 | ARTIS Pheno - Interventional Fluoroscopic X-Ray System Model: 10849000 - Pro... | If the C-arm leaves its intended travel path due to a fault within the drivetrain, movements may ... | Class II | Siemens Medical Solutions USA, Inc |
| Apr 20, 2020 | Siemens Cios Spin VA30-mobile X-Ray system, Material # 10308194 - Product Us... | Main cable can be plugged or unplugged from the X10 connector which is part of the main unit (c-a... | Class II | Siemens Medical Solutions USA, Inc |
| Apr 20, 2020 | Siemens Cios Alpha VA20-mobile X-Ray system Material # 10308191 The Cios Al... | Main cable can be plugged or unplugged from the X10 connector which is part of the main unit (c-a... | Class II | Siemens Medical Solutions USA, Inc |
| Apr 20, 2020 | Siemens Cios Alpha VA30-mobile X-Ray system, Material # 11105200 The Cios A... | Main cable can be plugged or unplugged from the X10 connector which is part of the main unit (c-a... | Class II | Siemens Medical Solutions USA, Inc |
| Apr 17, 2020 | Cios Alpha Image-Intensified Fluoroscopic X-Ray System, Model Numbers VA20-10... | The unplugging of the main cable on the monitor trolley from the X10 connector can cause an unsaf... | Class II | Siemens Medical Solutions USA, Inc |
| Apr 17, 2020 | Cios Spin Image-Intensified Fluoroscopic X-Ray System, Model Numbers VA30-103... | The unplugging of the main cable on the monitor trolley from the X10 connector can cause an unsaf... | Class II | Siemens Medical Solutions USA, Inc |
| Apr 13, 2020 | Sterile Custom Packs to be used in surgical procedures. | The surgical gowns were manufactured in a facility that is not registered by the FDA. | Class II | American Contract Systems |
| Apr 13, 2020 | Sterile Custom Packs to be used in surgical procedures. | The surgical gowns were manufactured in a facility that is not registered by the FDA. | Class II | American Contract Systems |
| Apr 13, 2020 | Sterile Custom Packs to be used in surgical procedures. | The surgical gowns were manufactured in a facility that is not registered by the FDA. | Class II | American Contract Systems |
| Apr 13, 2020 | Sterile Custom Packs to be used in surgical procedures. | The surgical gowns were manufactured in a facility that is not registered by the FDA. | Class II | American Contract Systems |
| Apr 13, 2020 | Sterile Custom Packs to be used in surgical procedures. | The surgical gowns were manufactured in a facility that is not registered by the FDA. | Class II | American Contract Systems |
| Apr 13, 2020 | Custom Packs to be used in surgical procedures. | The surgical gowns were manufactured in a facility that is not registered by the FDA. | Class II | American Contract Systems |
| Apr 13, 2020 | Sterile Custom Packs to be used in surgical procedures. | The surgical gowns were manufactured in a facility that is not registered by the FDA. | Class II | American Contract Systems |
| Apr 13, 2020 | Sterile Custom Packs to be used in surgical procedures. | The surgical gowns were manufactured in a facility that is not registered by the FDA. | Class II | American Contract Systems |
| Apr 13, 2020 | Sterile Custom Packs to be used in surgical procedures. | The surgical gowns were manufactured in a facility that is not registered by the FDA. | Class II | American Contract Systems |
| Apr 13, 2020 | Sterile Custom Packs to be used in surgical procedures. | The surgical gowns were manufactured in a facility that is not registered by the FDA. | Class II | American Contract Systems |
| Apr 13, 2020 | Sterile Custom Packs to be used in surgical procedures. | The surgical gowns were manufactured in a facility that is not registered by the FDA. | Class II | American Contract Systems |
| Apr 13, 2020 | Sterile Custom Packs to be used in surgical procedures. | The surgical gowns were manufactured in a facility that is not registered by the FDA. | Class II | American Contract Systems |
| Apr 13, 2020 | Sterile Custom Packs to be used in surgical procedures. | The surgical gowns were manufactured in a facility that is not registered by the FDA. | Class II | American Contract Systems |
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.