Browse Device Recalls
2,969 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,969 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 2,969 FDA device recalls in PA.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Apr 11, 2018 | Arrow-Flex(R) Percutaneous Sheath Introducer Kit with ARROWg+ard Blue(R) Shea... | Product sterility may be compromised due to unsealed packaging. | Class II | Arrow International Inc |
| Apr 11, 2018 | Pressure Injectable ARROWg+ard Blue PLUS(R) Multi-Lumen Central Venous Cathet... | Product sterility may be compromised due to unsealed packaging. | Class II | Arrow International Inc |
| Apr 11, 2018 | Maximal Barrier Drape; Product Code: ASK-04000-HMC | Product sterility may be compromised due to unsealed packaging. | Class II | Arrow International Inc |
| Apr 11, 2018 | 8Fr. Catheter Clamp with Fastener; Product Code: CC-00008 | Product sterility may be compromised due to unsealed packaging. | Class II | Arrow International Inc |
| Apr 11, 2018 | 4Fr. Catheter Clamp with Fastener; Product Code: CC-00004 | Product sterility may be compromised due to unsealed packaging. | Class II | Arrow International Inc |
| Apr 4, 2018 | CELLSEARCH¿ CIRCULATING Tumor Cell Kits (IVD) (Product Code 7900001) CELLS... | Unusually high number of total images/unassigned events may require additional time and effort fo... | Class II | Menarini Silicon Biosystems |
| Apr 2, 2018 | Retractor f/Sciatic Nerve Long; Part number: 03.100.014; UDI: 10886982070630 | There is a potential for microspores to form on the hollow handle of the Sciatic Nerve Retractor.... | Class II | Synthes (USA) Products LLC |
| Apr 2, 2018 | Retractor f/Sciatic Nerve; Part number: 03.100.013; UDI: 10886982070623 | There is a potential for microspores to form on the hollow handle of the Sciatic Nerve Retractor.... | Class II | Synthes (USA) Products LLC |
| Mar 27, 2018 | Syngo.Via VB20A model 1049610 | Functionality in the report sections "Findings Information" and "Summary of Measured Findings" no... | Class II | Siemens Medical Solutions USA, Inc |
| Mar 20, 2018 | Epic Extremity Plate System, Midfoot/Flatfoot Insert, Part 2111-0005 with Ext... | There is an error in the caddy artwork that misidentifies a specific plate and screw. | Class II | Epic Extremity, LLC |
| Mar 20, 2018 | Epic Extremity Plate System,10x10 Plate Caddy, Part 2111-1010 with 2.7 and 3.... | There is an error in the caddy artwork that misidentifies a specific plate and screw. | Class II | Epic Extremity, LLC |
| Mar 19, 2018 | Stem Extractor f/Guide Bar, Part number 03.401.072. Instrumentation for extr... | There is a potential for the connection screw of the stem extractor to break. | Class II | Synthes, Inc. |
| Mar 5, 2018 | Part no. 690.375, Graphic Case F/6.5mm & 7.3mm Combined Cannulated Screw Set | Affected screw gauges incorrectly measure screws 5.41mm shorter than the actual overall screw len... | Class II | Synthes (USA) Products LLC |
| Mar 5, 2018 | Part no. 690.380, Graphic Case F/7.3mm Cannulated Screw Set | Affected screw gauges incorrectly measure screws 5.41mm shorter than the actual overall screw len... | Class II | Synthes (USA) Products LLC |
| Mar 5, 2018 | Flex Arm Product Usage: The Synthes Flex Arm is a component of the Synthe... | Quick connect feature of instruments may be unable to connect to the male features of Flex Arm Ad... | Class II | Synthes, Inc. |
| Mar 5, 2018 | Part no. 690.379, Graphic Case F/6.5mm Cannulated Screw Set | Affected screw gauges incorrectly measure screws 5.41mm shorter than the actual overall screw len... | Class II | Synthes (USA) Products LLC |
| Mar 1, 2018 | Fabius Tiro M, anesthesia machine, catalog no. 8608400 Product Usage: The... | The automatic ventilation may fail if the position detection of the motor is disturbed. If the ve... | Class I | Draeger Medical, Inc. |
| Mar 1, 2018 | Fabius Tiro, anesthesia machine, catalog no. 8606000 Product Usage: The p... | The automatic ventilation may fail if the position detection of the motor is disturbed. If the ve... | Class I | Draeger Medical, Inc. |
| Mar 1, 2018 | Fabius GS Premium, anesthesia machine, catalog no. 8607000 Product Usage: ... | The automatic ventilation may fail if the position detection of the motor is disturbed. If the ve... | Class I | Draeger Medical, Inc. |
| Mar 1, 2018 | Fabius MRI, anesthesia machine, catalog no. 8607300 Product Usage: The pr... | The automatic ventilation may fail if the position detection of the motor is disturbed. If the ve... | Class I | Draeger Medical, Inc. |
| Feb 28, 2018 | PICC Kit, Product Code: AMS-7063-1 Convenience kit for the insertion of PI... | Potential friction holes may affect the sterility of the product. | Class II | Vygon U.S.A. |
| Feb 28, 2018 | Neonatal PICC Tray, Product Code: AMS-8010CP-1 Convenience kit for the ins... | Potential friction holes may affect the sterility of the product. | Class II | Vygon U.S.A. |
| Feb 28, 2018 | PICC Insertion Tray, Product Code: AMS-7192CS-3 Convenience kit for the in... | Potential friction holes may affect the sterility of the product. | Class II | Vygon U.S.A. |
| Feb 28, 2018 | Maximum Barrier Tray, Product Code: MCITX-1 Convenience kit for the insert... | Potential friction holes may affect the sterility of the product. | Class II | Vygon U.S.A. |
| Feb 28, 2018 | Maximum Barrier Tray, Product Code: AMS-9018CP Convenience kit for the ins... | Potential friction holes may affect the sterility of the product. | Class II | Vygon U.S.A. |
| Feb 28, 2018 | Maximum Barrier Insertion Tray, Product Code: AMS-9152CP Convenience kit f... | Potential friction holes may affect the sterility of the product. | Class II | Vygon U.S.A. |
| Feb 28, 2018 | PICC Insertion Tray, Product Code: AMS-7192CS-4 Convenience kit for the in... | Potential friction holes may affect the sterility of the product. | Class II | Vygon U.S.A. |
| Feb 28, 2018 | PICC Tray, Product Code: AMS-9093CP Convenience kit for the insertion of ... | Potential friction holes may affect the sterility of the product. | Class II | Vygon U.S.A. |
| Feb 23, 2018 | 12F MODIFIED Tesio CATHETER SET, REF MCTC1235SM, UDI 884908027259 Product ... | There is the potential for connection failures related to the female two-part luer to hemodialysi... | Class II | Medical Components, Inc dba MedComp |
| Feb 23, 2018 | REPAIR KIT, REF ARA101, UDI 884908083637 Product Usage: The Medcomp Repair ... | There is the potential for connection failures related to the female two-part luer to hemodialysi... | Class II | Medical Components, Inc dba MedComp |
| Feb 23, 2018 | CATHETER REPAIR KIT, REF AAC52001, UDI 884908001891 Product Usage: The M... | There is the potential for connection failures related to the female two-part luer to hemodialysi... | Class II | Medical Components, Inc dba MedComp |
| Feb 23, 2018 | TWO PART ADAPTER, REF MCTLA2000, UDI 884908027310 Product Usage: The Medc... | There is the potential for connection failures related to the female two-part luer to hemodialysi... | Class II | Medical Components, Inc dba MedComp |
| Feb 23, 2018 | CATHETER REPAIR KIT, REF RMS52001, UDI 884908039658 Product Usage: The Me... | There is the potential for connection failures related to the female two-part luer to hemodialysi... | Class II | Medical Components, Inc dba MedComp |
| Feb 23, 2018 | REPAIR KIT, REF RPK-01, UDI 884908039856 Product Usage: The Medcomp Repai... | There is the potential for connection failures related to the female two-part luer to hemodialysi... | Class II | Medical Components, Inc dba MedComp |
| Feb 23, 2018 | 12F Tesio CATHETER SET (CUFF 22CM FROM TIP), REF MCTC1235SD, UDI 884908027242... | There is the potential for connection failures related to the female two-part luer to hemodialysi... | Class II | Medical Components, Inc dba MedComp |
| Feb 23, 2018 | 12F X 60CM TESIO CATHETER SET WITH "Y" ADAPTOR, REF CMD757, UDI 884908005554 ... | There is the potential for connection failures related to the female two-part luer to hemodialysi... | Class II | Medical Components, Inc dba MedComp |
| Feb 23, 2018 | 12F X 40CM TESIO CATHETER SET WITH "Y" ADAPTOR, REF CMD755, UDI 884908005530 ... | There is the potential for connection failures related to the female two-part luer to hemodialysi... | Class II | Medical Components, Inc dba MedComp |
| Feb 23, 2018 | 12F Tesio CATHETER SET (CUFF 32CM FROM TIP), REF MCTC1247SD, UDI 884908027266... | There is the potential for connection failures related to the female two-part luer to hemodialysi... | Class II | Medical Components, Inc dba MedComp |
| Feb 20, 2018 | Syngo.plaza software Syngo.Plaza is a Picture Archiving and Communicati... | Software upgrade to correct format of study dates and issues with Legacy Presentation States (ann... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 20, 2018 | Syngo.plaza software VB10A model numbers: 10863171, 10863172, 10863173 Syn... | Software upgrade to correct format of study dates and issues with Legacy Presentation States (ann... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 16, 2018 | Doyen-Collin Mouth Gag 120MM/ General Instruments | The plastic sleeves of the Penis Clamp and Mouth Gag may stick together during or after reprocess... | Class III | Aesculap Implant Systems LLC |
| Feb 16, 2018 | Strauss Penis Clamp 130MM/General Instruments | The plastic sleeves of the Penis Clamp and Mouth Gag may stick together during or after reprocess... | Class III | Aesculap Implant Systems LLC |
| Feb 15, 2018 | SOMATOM Sensation 16 Intended to produce cross-sections images of the body... | to inform customers of possible incorrect tube current calculations by the CARE Dose4D algorithm ... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 15, 2018 | SOMATOM Sensation 10 Intended to produce cross-sections images of the body... | to inform customers of possible incorrect tube current calculations by the CARE Dose4D algorithm ... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 15, 2018 | SOMATOM Emotion 6 Intended to produce cross-sections images of the body by... | To inform customers of possible incorrect tube current calculations by the CARE Dose4D algorithm ... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 15, 2018 | SOMATOM Emotion Duo (2003) Intended to produce cross-sections images of th... | To inform customers of possible incorrect tube current calculations by the CARE Dose4D algorithm ... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 15, 2018 | SOMATOM Perspective 16 Intended to produce cross-sections images of the bo... | to inform customers of possible incorrect tube current calculations by the CARE Dose4D algorithm ... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 15, 2018 | SOMATOM Emotion 16 Intended to produce cross-sections images of the body b... | to inform customers of possible incorrect tube current calculations by the CARE Dose4D algorithm ... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 15, 2018 | SOMATOM Scope Power Intended to produce cross-sections images of the body ... | to inform customers of possible incorrect tube current calculations by the CARE Dose4D algorithm ... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 15, 2018 | SOMATOM Sensation Cardiac Intended to produce cross-sections images of the... | to inform customers of possible incorrect tube current calculations by the CARE Dose4D algorithm ... | Class II | Siemens Medical Solutions USA, 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.