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 |
|---|---|---|---|---|
| Apr 17, 2023 | Anesthesia Set Coax 180, MP03384 | Glued connections of the breathing circuit can become loose before or during ventilation resultin... | Class I | Draeger Medical, Inc. |
| Apr 17, 2023 | VentStar Anesthesia WT (P)180, MP00374 | Glued connections of the breathing circuit can become loose before or during ventilation resultin... | Class I | Draeger Medical, Inc. |
| Apr 17, 2023 | Seattle PAP Plus, MP02260 | Glued connections of the breathing circuit can become loose before or during ventilation resultin... | Class I | Draeger Medical, Inc. |
| Apr 17, 2023 | Set2Go Ventilation 12 (A), MP07968 | Glued connections of the breathing circuit can become loose before or during ventilation resultin... | Class I | Draeger Medical, Inc. |
| Apr 17, 2023 | VentStar Basic (P)180, MP00351 | Glued connections of the breathing circuit can become loose before or during ventilation resultin... | Class I | Draeger Medical, Inc. |
| Apr 6, 2023 | ET III Nano-HA fixture System ET NH Dental Implant Model # ET3R5010B -Intende... | Mis-labeled length of the dental implant on the Recall Implant's package. Dental implant size D5.... | Class II | Hiossen Inc. |
| Mar 31, 2023 | To be used with ultrasound endoscopes for ultrasound guided fine needle aspir... | Product non-conformance pertaining to the angle of the needle does not meet manufacturing specifi... | Class III | Olympus Corporation of the Americas |
| Mar 31, 2023 | ViziShot 2 Single Use Aspiration Needle, 21G- To be used with ultrasound endo... | Product non-conformance pertaining to the angle of the needle does not meet manufacturing specifi... | Class III | Olympus Corporation of the Americas |
| Mar 27, 2023 | Omnicell IVX Station-For use in the automated preparation of pharmaceutical a... | IVX Station does not account for inherent scale inaccuracy or variability, could result in a prep... | Class II | OmniCell, Inc. |
| Mar 21, 2023 | Aesculap Caiman Articulating D5/360MM - An electrosurgical cutting and coagul... | Potential for the spring to become loose and fall out of the device, if the spring falls out duri... | Class II | Aesculap Implant Systems LLC |
| Mar 21, 2023 | ARTIS one with a hybrid cable- An angiography system developed for diagnostic... | Examination room monitor connected with the hybrid cable may have a display issue and no image fu... | Class II | Siemens Medical Solutions USA, Inc |
| Mar 9, 2023 | DEVILBISS HEALTHCARE 1025 SERIES OXYGEN CONCENTRATOR, Model Numbers 1025DS, 1... | The instruction manual is being replaced with an updated version that is in alignment with labeli... | Class II | DeVilbiss Healthcare LLC |
| Mar 1, 2023 | Trilogy Evo O2 and LifeVentEVO2 Portable Electric Ventilator, Model Numbers D... | The accuracy of delivered oxygen may deviate below the required tolerance of 5% from setpoint whe... | Class I | Philips Respironics, Inc. |
| Mar 1, 2023 | Trilogy Evo Universal Portable Electric Ventilator, Model Number DS2000X11B | The accuracy of delivered oxygen may deviate below the required tolerance of 5% from setpoint whe... | Class I | Philips Respironics, Inc. |
| Mar 1, 2023 | Trilogy EV300 Portable Electric Ventilator, Model Numbers DS2200X11B, IN2200X... | The accuracy of delivered oxygen may deviate below the required tolerance of 5% from setpoint whe... | Class I | Philips Respironics, Inc. |
| Feb 24, 2023 | Tobii Dynavox TD I-110 Speech Device-tablet style speech generating device us... | Problem maintaining the stable placement of the battery may come loose from the housing and beco... | Class II | Tobii Dynavox Llc |
| Feb 23, 2023 | Caspar Cervical Retractor (CCR) Basket ME754 - Lid Only and ME764 Casper Cer... | Mislabeled: Product is marked with GTIN # 04046955299592 however; the correct GTIN # is 04046955... | Class II | Aesculap Implant Systems LLC |
| Feb 23, 2023 | Single Use Rotatable Clip Fixing Device Model HX 201LR 135 - Rotatable, 16... | There have been complaints that the clip did not come out of the tube sheath during the procedure. | Class II | Olympus Corporation of the Americas |
| Feb 20, 2023 | Moberg Component Neuromonitoring System (CNS Monitor)-Intended as a short-ter... | Battery leakage can cause corrosion to the metal enclosure near the electrical interface. Prolong... | Class II | Moberg Research, Inc. |
| Feb 10, 2023 | Philips DreamStation Auto BiPAP and CPAP, Model Numbers UCDSX500S11, UDSX500S... | A limited number of remediated Philips DreamStation units may experience communication issues whe... | Class I | Philips Respironics, Inc. |
| Feb 2, 2023 | ARTIS pheno systems with a Siemens Healthineers table or Trumpf/MAQUET table ... | If, during the procedure, X-ray has been released and a reference image has been stored, the foll... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 2, 2023 | ARTIS pheno systems with a Siemens Healthineers table or a Trumpf/ MAQUET tab... | In the event of any unintended table movement, the system may not detect the incorrect direction,... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 1, 2023 | TFN-Advanced Femoral Nail 12MM/130 DEG TI CANN TFNA 170MM STERILE. Intende... | TFNA Femoral Nails labeled and etched as 200mm may measure 170mm in length, and TFNA Femoral Nail... | Class II | Synthes (USA) Products LLC |
| Feb 1, 2023 | TFN-Advanced Femoral Nail 12MM/125 DEG TI CANN TFNA 170MM - STERILE. Intende... | TFNA Femoral Nails labeled and etched as 200mm may measure 170mm in length, and TFNA Femoral Nail... | Class II | Synthes (USA) Products LLC |
| Feb 1, 2023 | TFN-Advanced Femoral Nail 12MM/125 DEG TI CANN TFNA 200MM STERILE. Intende... | TFNA Femoral Nails labeled and etched as 200mm may measure 170mm in length, and TFNA Femoral Nail... | Class II | Synthes (USA) Products LLC |
| Jan 23, 2023 | NovaStar TS, Anti-Asphyxia Valve, Reusable, Material Numbers MP01576 (Size S)... | The magnets used in the swivel frame/tube set and the headgear clips might impact medical devices... | Class I | Draeger Medical, Inc. |
| Jan 23, 2023 | NovaStar TS, Standard elbow, Reusable, Material Numbers MP01579 (Size S), MP0... | The magnets used in the swivel frame/tube set and the headgear clips might impact medical devices... | Class I | Draeger Medical, Inc. |
| Dec 22, 2022 | Software : myNeedle Guide 2D license, myNeedle Guide 2D AWP only Workflow l... | In the syngo.CT VA40 and syngo.CT VA50 myNeedle Guide application, the order of the orientation l... | Class II | Siemens Medical Solutions USA, Inc |
| Dec 21, 2022 | EVIS EXERA III Colonovideoscope-For endoscopy and endoscopic surgery within t... | A single CF-Q180AL colonovideoscope was utilized in a veterinary endoscopy procedure in advance o... | Class II | Olympus Corporation of the Americas |
| Dec 21, 2022 | Luminos dRF with software VD10- A diagnostic imaging system for radiographic... | Potential risk of collision with the ceiling, wall, or objects which may result in serious injury... | Class II | Siemens Medical Solutions USA, Inc |
| Dec 21, 2022 | Luminos Agile with software VC10 - A diagnostic imaging system for radiograp... | Potential risk of collision with the ceiling, wall, or objects which may result in serious injury... | Class II | Siemens Medical Solutions USA, Inc |
| Dec 21, 2022 | Uroskop Omnia Max with software VE10 & VF11- A diagnostic imaging system for ... | Potential risk of collision with the ceiling, wall, or objects which may result in serious injury... | Class II | Siemens Medical Solutions USA, Inc |
| Dec 21, 2022 | Luminos Agile Max with software VE10 & VF11- A diagnostic imaging system for ... | Potential risk of collision with the ceiling, wall, or objects which may result in serious injury... | Class II | Siemens Medical Solutions USA, Inc |
| Dec 21, 2022 | Luminos dRF Max with software VE10, VF10, VF11- A diagnostic imaging system f... | Potential risk of collision with the ceiling, wall, or objects which may result in serious injury... | Class II | Siemens Medical Solutions USA, Inc |
| Dec 16, 2022 | System Material # Artis zee floor 10094135 Artis zee ceiling 10094137 Ar... | In rare cases, the system may only boot into backup mode after an abrupt shutdown and not reach f... | Class II | Siemens Medical Solutions USA, Inc |
| Dec 16, 2022 | ARTIS pheno, ARTIS icono biplane, and ARTIS icono floor | Mechanical connection between the tabletop and table base may be lost. | Class II | Siemens Medical Solutions USA, Inc |
| Dec 13, 2022 | SPiN Thoracic Navigation System Model: SYS-4000 (SYS-4000D) | A grainy image is observed when using a SPiN Vision Single-Use Flexible Bronchoscope (models INS-... | Class II | Olympus Corporation of the Americas |
| Dec 9, 2022 | AXIOM Luminos TF, AXIOM Iconos R100, AXIOM Iconos R200 and AXIOM Luminos dRF | There is potential for the footrest to detach from the patient table during use. | Class II | Siemens Medical Solutions USA, Inc |
| Dec 9, 2022 | AXIOM Luminos Agile | There is potential for the footrest to detach from the patient table during use. | Class II | Siemens Medical Solutions USA, Inc |
| Dec 9, 2022 | Luminos Agile Max, Luminos dRF Max, and LUMINOS Lotus Max | There is potential for the footrest to detach from the patient table during use. Device intend... | Class II | Siemens Medical Solutions USA, Inc |
| Dec 7, 2022 | Philips Garbin Ventilator, Model Number 1058180B | The replacement silicone sound abatement foam installed into some Trilogy 100 and Trilogy 200 dev... | Class I | Philips Respironics, Inc. |
| Dec 7, 2022 | Philips Trilogy 200 Ventilator, Model Numbers 1040005, U1040005, 1040005B, U1... | The replacement silicone sound abatement foam installed into some Trilogy 100 and Trilogy 200 dev... | Class I | Philips Respironics, Inc. |
| Dec 7, 2022 | Philips Trilogy 100 Ventilator, Model Numbers 1054260, 1054096, U1054260, U10... | The replacement silicone sound abatement foam installed into some Trilogy 100 and Trilogy 200 dev... | Class I | Philips Respironics, Inc. |
| Dec 5, 2022 | SHIP KIT, LIFESPARC, CONTROLLER AND ACCESSORIES - 5900-0000; SHIP KIT, LIFE... | A software update (v1.1.5) has been developed to address the issue of Critical Failure which can ... | Class I | Cardiac Assist, Inc |
| Nov 30, 2022 | Source Administration Set (SAS) used with the Medrad Intego PET Infusion Syst... | Black specks may be present on the packaged needles | Class II | Bayer Medical Care, Inc. |
| Nov 23, 2022 | LUMINOS Lotus Max (VF11) | Under certain unlikely circumstances during a fluoroscopic examination, the imaging system Fluoro... | Class II | Siemens Medical Solutions USA, Inc |
| Nov 23, 2022 | Luminos dRF Max (VE10, VF10, VF11) | Under certain unlikely circumstances during a fluoroscopic examination, the imaging system Fluoro... | Class II | Siemens Medical Solutions USA, Inc |
| Nov 23, 2022 | Luminos Agile Max (VE10, VF10, VF11) | Under certain unlikely circumstances during a fluoroscopic examination, the imaging system Fluoro... | Class II | Siemens Medical Solutions USA, Inc |
| Nov 18, 2022 | DeVilbiss, 525 5-liter Oxygen Concentrator Models 525DS, 525DS-Q | The firm has received complaints of the device becoming hot. The firm has updated the user manual... | Class II | DeVilbiss Healthcare LLC |
| Nov 16, 2022 | Programmable Diagnostic Computer | The firm will be performing a software update to address a software error which affects the liste... | 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.