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 |
|---|---|---|---|---|
| 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 |
| Dec 22, 2017 | Arrow¿ Pressure Injectable Two-Lumen PICC Kit, Product Number: EU-05052-HPMSB | Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the pro... | Class II | Arrow International Inc |
| Dec 22, 2017 | AGB+ Multi Lumen Central Venous Catheterization (CVC) Kit (1) Part Number: AK... | Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the pro... | Class II | Arrow International Inc |
| Dec 22, 2017 | (1) Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side Po... | Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the pro... | Class II | Arrow International Inc |
| Dec 22, 2017 | Arrowg+ard Blue(R) PSI Kit, (1) For use with 7 - 7.5 Fr. Catheters Part Numbe... | Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the pro... | Class II | Arrow International Inc |
| Dec 22, 2017 | (1) Arterial Catheterization Kit, Part Number (PN): ASK-04018-CC; (2) Arteria... | Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the pro... | Class II | Arrow International Inc |
| Dec 22, 2017 | (1) MAC Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr. Catheter... | Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the pro... | Class II | Arrow International Inc |
| Dec 22, 2017 | ARROWg+ard Blue¿ CVC Kit (1) Part Number (PN): CDC-24301-1A, (2) PN: CDC-2430... | Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the pro... | Class II | Arrow International Inc |
| Dec 22, 2017 | Multi-Lumen Hemodialysis Catheterization Kit for High Volume Infusions, Part ... | Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the pro... | Class II | Arrow International Inc |
| Dec 22, 2017 | (1) ARROWg+ard Blue(R) MAC(TM) Two-Lumen Central Venous Access Kit for use wi... | Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the pro... | Class II | Arrow International Inc |
| Dec 22, 2017 | ARROWg+ard Blue¿ Two-Lumen Hemodialysis Catheterization Kit for High Volume I... | Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the pro... | Class II | Arrow International Inc |
| Dec 22, 2017 | (1) Access Tray, Part Number (PN): ASK-04001-MS; Arrow Multi-Lumen CVC Kit (2... | Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the pro... | Class II | Arrow International Inc |
| Dec 22, 2017 | AGB+ Multi Lumen CVC Kit (1) Part Number (PN): CDC-42703-B1A, (2) PN: CDC-428... | Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the pro... | Class II | Arrow International Inc |
| Dec 22, 2017 | (1) Central Venous Catheterization Kit, Part Number (PN): ASK-04300-PHP; (2) ... | Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the pro... | Class II | Arrow International Inc |
| Dec 21, 2017 | ARROWg+ard Blue PLUS catheter, Catalog Number: ASK-45854-NG Product Usage:... | Certain lots may be missing information at the bottom of the lid including the lot number, expira... | Class II | Arrow International Inc |
| Dec 20, 2017 | Cocaine Metabolite MICRO-PLATE EIA, Catalog Number: 1122SC, UDI: (01006083370... | The controls and calibrators contained within the cocaine test kit may cause false positive resul... | Class III | OraSure Technologies, Inc. |
| Dec 15, 2017 | ARROW ENDURANCE" Extended Dwell Peripheral Catheter System, Catalog Numbers: ... | Certain lots of peripheral catheter systems may be missing the safety latch, intended to minimize... | Class II | Arrow International Inc |
| Dec 14, 2017 | Dynavox T15 Speech Generating Device ( including Batteries) | The battery is integral to the device. If the device sits unused and is not charged for a length... | Class II | Dynavox Systems Llc |
| Dec 14, 2017 | Dynavox T10 Speech Generating Device ( including Batteries) | The battery is integral to the device. If the device sits unused and is not charged for a length... | Class II | Dynavox Systems Llc |
| Dec 13, 2017 | 11-VI Incorporated Laser diode component Non-certified laser diode compone... | Affected diodes incorporated in the laser sights emitted greater than the 5 mW limit. | Class II | Ii - Vi Incorporated |
| Nov 28, 2017 | Vital-Port Vascular Access System, Subcutaneous, implanted, intravascular inf... | Non-coring needle provided with the Cook Vital-Port¿ Vascular Assess System (Vital-Port) may cut ... | Class II | Cook Vascular 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.