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 23, 2019 | Arrowg+ard Blue Advance PICC pre loaded with Arrow¿ VPS" Precision Stylet ... | Lidstock states the incorrect expiration date for the product | Class II | Arrow International Inc |
| Apr 23, 2019 | Arrow PICC with Chlorag+ard Technology Product Code: CDA 455... | Lidstock states the incorrect expiration date for the product | Class II | Arrow International Inc |
| Apr 23, 2019 | Arrowg+ard Blue Advance JACC Product Code: CDC 41552 JX1A | Lidstock states the incorrect expiration date for the product | Class II | Arrow International Inc |
| Apr 23, 2019 | Arrow¿ JACC with Chlorag+ard¿ Technology Jugular Axillo subclavian Central Ca... | Lidstock states the incorrect expiration date for the product | Class II | Arrow International Inc |
| Apr 23, 2019 | Arrow¿ PICC with Chlorag+ard Technology Product Code:PR 45541 HPHNM | Lidstock states the incorrect expiration date for the product | Class II | Arrow International Inc |
| Apr 23, 2019 | Arrow PICC with Chlorag+ard Technology Product Code: CDA 45552 VPS2 | Lidstock states the incorrect expiration date for the product | Class II | Arrow International Inc |
| Apr 23, 2019 | Arrow¿ PICC with Chlorag+ard¿ Technology Product Code: PR 45552 HPHNL | Lidstock states the incorrect expiration date for the product | Class II | Arrow International Inc |
| Apr 23, 2019 | Arrow PICC with Chlorag+ard Technology Product Code: CDA 450... | Lidstock states the incorrect expiration date for the product | Class II | Arrow International Inc |
| Apr 23, 2019 | Arrow PICC Kit Product Code: ASK 45541 RWJ4 | Lidstock states the incorrect expiration date for the product | Class II | Arrow International Inc |
| Apr 23, 2019 | Arrowg+ard Blue Advance PICC pre loaded with Arrow¿ VPS" Precision Stylet ... | Lidstock states the incorrect expiration date for the product | Class II | Arrow International Inc |
| Apr 23, 2019 | Arrow¿ PICC Kit Product Code: ASK 45541 LVH1 | Lidstock states the incorrect expiration date for the product | Class II | Arrow International Inc |
| Apr 23, 2019 | Arrow¿ JACC with Chlorag+ard Technology Product Code:JR 42563 HPHNM | Lidstock states the incorrect expiration date for the product | Class II | Arrow International Inc |
| Apr 23, 2019 | Arrow¿ JACC with Chlorag+ard¿ Technology Jugular Axillosubclavian Central Cat... | Lidstock states the incorrect expiration date for the product | Class II | Arrow International Inc |
| Apr 23, 2019 | Arrow PICC with Chlorag+ard Technology Product Code: CDA 45041 H... | Lidstock states the incorrect expiration date for the product | Class II | Arrow International Inc |
| Apr 23, 2019 | Arrowg+ard Blue Advance JACC Product Code: CDC 42063 JX1A | Lidstock states the incorrect expiration date for the product | Class II | Arrow International Inc |
| Apr 23, 2019 | Arrow JACC with Chlorag+ard Technology Jugular Axillo subclavian Central Cath... | Lidstock states the incorrect expiration date for the product | Class II | Arrow International Inc |
| Apr 9, 2019 | Artis Zee (material # 10094135, 10094137, 10094141) - Product Usage: AXIOM Ar... | In affected Artis systems the movement of the floating tabletop may be blocked after a collision ... | Class II | Siemens Medical Solutions USA, Inc |
| Apr 9, 2019 | Artis Q (material 10848280, 10848281, 10848282) - Product Usage: AXIOM Artis ... | In affected Artis systems the movement of the floating tabletop may be blocked after a collision ... | Class II | Siemens Medical Solutions USA, Inc |
| Apr 9, 2019 | Artis Q (material 10848280, 10848281, 10848282) - Product Usage: AXIOM Artis ... | In affected Artis systems the movement of the floating tabletop may be blocked after a collision ... | Class II | Siemens Medical Solutions USA, Inc |
| Apr 9, 2019 | Artis Zeego (material 10280959) - Product Usage: AXIOM Artis zee and Q/ Q.zen... | In affected Artis systems the movement of the floating tabletop may be blocked after a collision ... | Class II | Siemens Medical Solutions USA, Inc |
| Apr 1, 2019 | Olympus MAJ-209 Single Use Suction Valves, Model Number MAJ-209 Product Us... | There is a potential for the single use suction valve to come apart and/or remain stuck inside th... | Class II | Olympus Corporation of the Americas |
| Mar 22, 2019 | Cios Alpha with software version VA30-mobile C-arm x-ray Material # 11105200... | Continuous operation of the Cios Alpha at high tube outputs may result in increased wear of radia... | Class II | Siemens Medical Solutions USA, Inc |
| Mar 21, 2019 | syngo.via syngo.CT Cardiac Planning, Model Number 10496180 Product Usage: ... | There is a potential risk of a wrong measurement in the annulus plane during a TAVI planning proc... | Class II | Siemens Medical Solutions USA, Inc |
| Mar 21, 2019 | syngo.via syngo.CT Cardiac Function, Model Number 10496180 Product Usage: ... | There is a potential risk of a wrong measurement in the annulus plane during a TAVI planning proc... | Class II | Siemens Medical Solutions USA, Inc |
| Mar 20, 2019 | Siemens Digital Linear Accelerators of type: ARTISTE MV System MEVATRON M2/... | Advisory issued not to disable or bypass the AMP function. Disabling or bypassing the AMP functio... | Class II | Siemens Medical Solutions USA, Inc |
| Mar 18, 2019 | Cios Alpha, Model Number 10308191 Mobile X-ray system - Product Usage: The C... | Continuous operation at very high tube output may result in increased wear of the radiation emitt... | Class II | Siemens Medical Solutions USA, Inc |
| Mar 13, 2019 | 14F x 30CM SLX Double Lumen Full Tray Hemodialysis catheter insertion kits, I... | Tray label indicates the kits are packaged with a 15F "valved" peelable introducer, but the kits ... | Class II | Medical Components, Inc dba MedComp |
| Mar 13, 2019 | 14F x 20CM SLX Double Lumen Full Tray Hemodialysis catheter insertion kits, I... | Tray label indicates the kits are packaged with a 15F "valved" peelable introducer, but the kits ... | Class II | Medical Components, Inc dba MedComp |
| Mar 13, 2019 | 14F x 24CM SLX Double Lumen Full Tray Hemodialysis catheter insertion kits, I... | Tray label indicates the kits are packaged with a 15F "valved" peelable introducer, but the kits ... | Class II | Medical Components, Inc dba MedComp |
| Mar 13, 2019 | 14F SLX Double Lumen Full Tray Hemodialysis catheter insertion kits, Item No.... | Tray label indicates the kits are packaged with a 15F "valved" peelable introducer, but the kits ... | Class II | Medical Components, Inc dba MedComp |
| Feb 14, 2019 | SOMATOM Edge Plus, Model Number 10267000 Product Usage: Computed tomograp... | Potential risk of scans being aborted when using the optional Dual Spiral Dual Engery mode due to... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 14, 2019 | SOMATOM Definition Edge, Model Number 10590000 Product Usage: Computed to... | Potential risk of scans being aborted when using the optional Dual Spiral Dual Engery mode due to... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 14, 2019 | SOMATOM Confidence, Model Number 10590100 Product Usage: Computed tomogra... | Potential risk of scans being aborted when using the optional Dual Spiral Dual Engery mode due to... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 14, 2019 | SOMATOM Definition AS with Option syngo DE Scan for Single Source (Dual Spira... | Potential risk of scans being aborted when using the optional Dual Spiral Dual Engery mode due to... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 8, 2019 | Uroskop Omnia -fluoroscopic X-ray system Model # 10094910 The Uroskop Omn... | The swivel arm holding the monitors may become dislodged from the carrying arm. | Class II | Siemens Medical Solutions USA, Inc |
| Feb 8, 2019 | Uroskop Omnia Max -fluoroscopic X-ray system Model # 10762473 Uroskop Om... | The swivel arm holding the monitors may become dislodged from the carrying arm. | Class II | Siemens Medical Solutions USA, Inc |
| Jan 10, 2019 | Arrow¿ Two-Lumen Central Venous Catheterization Kit with Blue FlexTip¿ Cathe... | The product lidstock contains a labelling error. The lidstock states the incorrect priming volume... | Class II | Arrow International Inc |
| Jan 10, 2019 | Arrow¿ Two-Lumen Central Venous Catheterization Set with Blue FlexTip¿ Cathe... | The product lidstock contains a labelling error. The lidstock states the incorrect priming volume... | Class II | Arrow International Inc |
| Dec 21, 2018 | VentStar Anesthesia WT(P) 180, Catalog Number MP00374 Breathing Circuits/... | Incorrectly pre-assembled breathing circuit has potential for incorrect connection/short circuit ... | Class I | Draeger Medical, Inc. |
| Dec 21, 2018 | ID Circuit Basic 250, Catalog Number MP01348 Breathing Circuits/Anesthesi... | Incorrectly pre-assembled breathing circuit has potential for incorrect connection/short circuit ... | Class I | Draeger Medical, Inc. |
| Dec 21, 2018 | VentStar Basic (P) 180, Catalog Number MP00351 Breathing Circuits/Anesthe... | Incorrectly pre-assembled breathing circuit has potential for incorrect connection/short circuit ... | Class I | Draeger Medical, Inc. |
| Dec 21, 2018 | VentStar Basic 180, Catalog Number MP00349 Breathing Circuits/Anesthesia ... | Incorrectly pre-assembled breathing circuit has potential for incorrect connection/short circuit ... | Class I | Draeger Medical, Inc. |
| Dec 21, 2018 | VentStar Basic (P) 250, Catalog Number MP00352 Breathing Circuits/Anesthe... | Incorrectly pre-assembled breathing circuit has potential for incorrect connection/short circuit ... | Class I | Draeger Medical, Inc. |
| Dec 21, 2018 | ID Circuit Watertrap (P) 180, Catalog Number MP01341 Breathing Circuits/... | Incorrectly pre-assembled breathing circuit has potential for incorrect connection/short circuit ... | Class I | Draeger Medical, Inc. |
| Dec 21, 2018 | VentStar Basic 250, Catalog Number MP00350 Breathing Circuits/Anesthesia S... | Incorrectly pre-assembled breathing circuit has potential for incorrect connection/short circuit ... | Class I | Draeger Medical, Inc. |
| Dec 21, 2018 | VentStar Watertrap (P) 180, Catalog Number MP00361 Breathing Circuits/Ane... | Incorrectly pre-assembled breathing circuit has potential for incorrect connection/short circuit ... | Class I | Draeger Medical, Inc. |
| Dec 21, 2018 | ID Circuit Basic 180, Catalog Number MP01350 Breathing Circuits/Anesthesi... | Incorrectly pre-assembled breathing circuit has potential for incorrect connection/short circuit ... | Class I | Draeger Medical, Inc. |
| Dec 17, 2018 | Olympus GF-UCT180 Ultrasound Gastrovideoscope - Product Usage: These endoscop... | The adhesive used in the repair of the endoscope was incorrectly prepared. It is unknown what af... | Class II | Olympus Corporation of the Americas |
| Dec 17, 2018 | Olympus GIF-H180J Gastrointestinal Videoscope - Product Usage: These endoscop... | The adhesive used in the repair of the endoscope was incorrectly prepared. It is unknown what af... | Class II | Olympus Corporation of the Americas |
| Dec 17, 2018 | Olympus TJF-Q180V Duodenoscope - Product Usage: These endoscopes are intended... | The adhesive used in the repair of the endoscope was incorrectly prepared. It is unknown what af... | Class II | Olympus Corporation of the Americas |
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.