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 |
|---|---|---|---|---|
| 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 |
| Feb 15, 2018 | SOMATOM Sensation 40 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 Perspective 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 (2003) 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 Sensation 64 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 Scope Intended to produce cross-sections images of the body by com... | 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 Open 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 Spirit Intended to produce cross-sections images of the body by co... | to inform customers of possible incorrect tube current calculations by the CARE Dose4D algorithm ... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 14, 2018 | ONCOR Expression, Digital Linear Accelerator, Model No. 07360717 Product U... | Control Console software has been updated to reduce the risk for collision when delivering automa... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 14, 2018 | ONCOR Avant-garde, Digital Linear Accelerator, Model No. 05863472 Product ... | Control Console software has been updated to reduce the risk for collision when delivering automa... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 14, 2018 | ONCOR Impression Plus, Digital Linear Accelerator, Model No. 05857912 Prod... | Control Console software has been updated to reduce the risk for collision when delivering automa... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 14, 2018 | ONCOR Impression , Digital Linear Accelerator, Model No. 05857920 Product ... | Control Console software has been updated to reduce the risk for collision when delivering automa... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 14, 2018 | MEVATRON M2 / PRIMUS Mid-Energy, Digital Linear Accelerator, Model No. 019400... | Control Console software has been updated to reduce the risk for collision when delivering automa... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 14, 2018 | PRIMUS HI, Digital Linear Accelerator, Model No. 04504200 Product Usage: ... | Control Console software has been updated to reduce the risk for collision when delivering automa... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 1, 2018 | SOMATOM Scope ( Model 10967666) | A potential risk of unnecessary radiation exposure due to a software issue | Class II | Siemens Medical Solutions USA, Inc |
| Feb 1, 2018 | SOMATOM Emotion 16 (10165977) | A potential risk of unnecessary radiation exposure due to a software issue | Class II | Siemens Medical Solutions USA, Inc |
| Feb 1, 2018 | SOMATOM Spirit(Model 10045692 ) | A potential risk of unnecessary radiation exposure due to a software issue | Class II | Siemens Medical Solutions USA, Inc |
| Feb 1, 2018 | SOMATOM Scope Power (Model 10967888) | A potential risk of unnecessary radiation exposure due to a software issue | Class II | Siemens Medical Solutions USA, Inc |
| Feb 1, 2018 | SOMATOM Perspective (Model 10495568) | A potential risk of unnecessary radiation exposure due to a software issue | Class II | Siemens Medical Solutions USA, Inc |
| Feb 1, 2018 | SOMATOM Perspective 16 (Model 10891666) | A potential risk of unnecessary radiation exposure due to a software issue | Class II | Siemens Medical Solutions USA, Inc |
| Feb 1, 2018 | SOMATOM Emotion 6 (Model 10165888) | A potential risk of unnecessary radiation exposure due to a software issue | Class II | Siemens Medical Solutions USA, Inc |
| Jan 22, 2018 | DS Titanium Ligation Clip Appliers, used in laparoscopic surgery | Added a contraindication to IFU: Do not use the DS clips for living donor nephrectomies. Added o... | Class II | Aesculap Implant Systems LLC |
| Jan 22, 2018 | DS Titanium Ligation Clip, used in laparoscopic surgery | Added a contraindication to IFU: Do not use the DS clips for living donor nephrectomies. Added o... | Class II | Aesculap Implant Systems LLC |
| Jan 17, 2018 | Uretero-reno fiberscope URF-P6 | Breakage of the endoscope's insertion tube bending section during surgical procedures. | Class II | Olympus Corporation of the Americas |
| Jan 17, 2018 | Uretero-reno fiberscope URF-P6RP6 | Breakage of the endoscope's insertion tube bending section during surgical procedures. | Class II | Olympus Corporation of the Americas |
| Jan 17, 2018 | Uretero-reno videoscope URF-V2 Uretero-reno videoscope URF-V2R | Potential breakage of the endoscope s insertion tube bending section during surgical procedures | Class II | Olympus Corporation of the Americas |
| Jan 12, 2018 | Artis one fluoroscopic x-ray system and patient table Artis one is an an... | Certain patient table systems may have a missing or incorrectly installed snap ring that could ca... | Class II | Siemens Medical Solutions USA, Inc |
| Jan 10, 2018 | Syngo.via software is intended to be used for viewing, manipulation, communic... | When the archiving configuration is changed, data received/created after the upgrade may be flagg... | Class II | Siemens Medical Solutions USA, Inc |
| Jan 8, 2018 | Syngo.via. Medical Device Software. Picture archiving and communications sys... | A software functionality in the report sections Findings Information and Summary of Measured F... | Class II | Siemens Medical Solutions USA, Inc |
| Jan 5, 2018 | AXIOM Artis angiographic x-ray system, Model Numbers: 7412807, 7413078, 77283... | Certain systems may have leaking of the plastic coolant couplings, the liquid can enter into the ... | Class II | Siemens Medical Solutions USA, Inc |
| Dec 22, 2017 | Pressure Injectable ARROW(R) PICC Kit with Chlorag+ard Technology, Part Numbe... | Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the pro... | Class II | Arrow International 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.