Browse Device Recalls
2,968 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,968 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 2,968 FDA device recalls in PA.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Nov 25, 2024 | Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument P... | The probe tips of the hand instruments are being damaged or breaking including pad damage and det... | Class II | Olympus Corporation of the Americas |
| Nov 25, 2024 | Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument P... | The probe tips of the hand instruments are being damaged or breaking including pad damage and det... | Class II | Olympus Corporation of the Americas |
| Nov 22, 2024 | Citric Complete - Dry Citric Acid Concentrate Model Number: DCA+225-25 | The outer case is mislabeled as 3.0 K, 2.0 Ca instead of 2.0 K, 3.0 Ca. | Class II | Nipro Renal Soultions USA, Corporation |
| Nov 19, 2024 | Duravent Silicone Ventilation Tube. Model Number: 240075. | Potential that Duravent Silicone Ventilation Tubes may contain incorrect product, specifically, 1... | Class II | Olympus Corporation of the Americas |
| Oct 31, 2024 | EVIS EXERA III Gastrointestinal Videoscope GIF-1TH190. Model Number: GIF-1TH190 | High-level disinfection ("HLD") with Acecide-C disinfectant in the Olympus OER-Pro Automated Endo... | Class II | Olympus Corporation of the Americas |
| Oct 15, 2024 | Brand Name: Atlan Product Name: Atlan A300 Model/Catalog Number: 8211300 ... | The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use o... | Class I | Draeger Medical, Inc. |
| Oct 15, 2024 | Brand Name: Atlan Product Name: Atlan A350 Model/Catalog Number: 8211500 S... | The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use o... | Class I | Draeger Medical, Inc. |
| Oct 15, 2024 | Brand Name: Atlan Product Name: Atlan A350XL Model/Catalog Number: 8621600 ... | The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use o... | Class I | Draeger Medical, Inc. |
| Oct 15, 2024 | Brand Name: Atlan Product Name: Atlan A300XL Model/Catalog Number: 862140... | The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use o... | Class I | Draeger Medical, Inc. |
| Oct 7, 2024 | Trilogy Evo. Model Numbers: DS2110X11B, UDS2110X11B, RDS2110X11B, CA2110X12B,... | Potential for in-line nebulizer configuration in certain locations to result in aerosol deposit a... | Class I | Philips Respironics, Inc. |
| Oct 7, 2024 | Trilogy Evo O2. Model Numbers: FP2100X10, DS2100X11B, IN2100X15B, DE2100X13B,... | Potential for in-line nebulizer configuration in certain locations to result in aerosol deposit a... | Class I | Philips Respironics, Inc. |
| Oct 7, 2024 | LifeVent EVO2. Model Number: SP2100X26B. Intended for invasive and non-invas... | Potential for in-line nebulizer configuration in certain locations to result in aerosol deposit a... | Class I | Philips Respironics, Inc. |
| Oct 7, 2024 | Garbin Evo. Model Number: LD2110X23B. Intended for invasive and non-invasiv... | Potential for in-line nebulizer configuration in certain locations to result in aerosol deposit a... | Class I | Philips Respironics, Inc. |
| Oct 7, 2024 | Aeris EVO. Model Number: VT2110X24B. Intended for invasive and non-invasive... | Potential for in-line nebulizer configuration in certain locations to result in aerosol deposit a... | Class I | Philips Respironics, Inc. |
| Oct 7, 2024 | Trilogy EV300. Model Numbers: DS2200X11B, IN2200X15B, BL2200X15B, BR2200X18B,... | Potential for in-line nebulizer configuration in certain locations to result in aerosol deposit a... | Class I | Philips Respironics, Inc. |
| Oct 7, 2024 | Trilogy Evo Universal Ventilator. Model Number DS2000X11B. Intended for inva... | Potential for in-line nebulizer configuration in certain locations to result in aerosol deposit a... | Class I | Philips Respironics, Inc. |
| Sep 24, 2024 | Quest Spectrum 3 Fluorescent Imaging System Model/Catalog Number: ART-SYS-00... | Does not meet the requirements for electromagnetic compatibility (EMC) of the standard IEC 60601-... | Class II | Olympus Corporation of the Americas |
| Sep 18, 2024 | Brand Name: EVIS EXERA III Gastrointestinal Videoscope GIF-1TH190 Product Na... | To better define the drying procedures described in the IFU to improve the instructions for easie... | Class II | Olympus Corporation of the Americas |
| Sep 13, 2024 | Olympus Cystoscope Outer Sheath; Model/Catalog number: WA22810A; | Product being removed due to incompatibility when used in conjunction with a GreenLight Laser for... | Class II | Olympus Corporation of the Americas |
| Sep 13, 2024 | EZDilate Wire Guided Balloon- Indicated for use in adult and adolescent (> 12... | Mislabeled Glo Cath Label (attached to the device) states: 11 mm, 12 mm, 13 mm however the balloo... | Class II | Olympus Corporation of the Americas |
| Sep 13, 2024 | Brand Name: Olympus Product Name: Cystoscope Outer Sheath Model/Catalog Num... | Olympus is removing the statement of compatibility with a GreenLight Laser for BPH therapy from t... | Class II | Olympus Corporation of the Americas |
| Sep 11, 2024 | Brand Name: UroPass Ureteral Access Sheaths Product Name: Ureteral Access Sh... | Exposure of the UroPass product to Ultraviolet ( UV ) Radiation can cause brittleness of the devi... | Class II | Olympus Corporation of the Americas |
| Sep 4, 2024 | Olympus Electrosurgical Generator, Model Number ESG-410 (SEP) Version WA91327U | There was an increase in complaints indicating an occurrence of system error E1226 "Could not wri... | Class II | Olympus Corporation of the Americas |
| Aug 23, 2024 | Olympus Endoscopic Flushing Pump, Model/Catalog Number: OFP-2 (K10001141) | During product testing, Olympus identified an intermittent loss of function of the OFP-2 Flushing... | Class II | Olympus Corporation of the Americas |
| Aug 21, 2024 | Olympus Gastrointestinal Videoscope, Model/Catalog Number: GIF-1100 | It was discovered during device performance testing that the CCD imaging sensors were programmed ... | Class II | Olympus Corporation of the Americas |
| Aug 15, 2024 | STREAMLINE BLOODLINE SET FOR DIALOG DR-Tubing to be used to transfer blood be... | Incomplete insertion of the patient connector of the Streamline Airless System Hemodialysis Bloo... | Class II | B Braun Medical Inc |
| Aug 15, 2024 | STREAMLINE BLOODLINE LONG VERSION, FMC-Tubing to be used to transfer blood be... | Incomplete insertion of the patient connector of the Streamline Airless System Hemodialysis Bloo... | Class II | B Braun Medical Inc |
| Aug 15, 2024 | STREAMLINE LONG-Tubing to be used to transfer blood between a patient and a h... | Incomplete insertion of the patient connector of the Streamline Airless System Hemodialysis Bloo... | Class II | B Braun Medical Inc |
| Aug 15, 2024 | STREAMLINE BLOODLINE SET FOR DIALOG-Tubing to be used to transfer blood betwe... | Incomplete insertion of the patient connector of the Streamline Airless System Hemodialysis Bloo... | Class II | B Braun Medical Inc |
| Aug 15, 2024 | STREAMLINE FRESENIUS FOR DAVITA-Tubing to be used to transfer blood between a... | Incomplete insertion of the patient connector of the Streamline Airless System Hemodialysis Bloo... | Class II | B Braun Medical Inc |
| Aug 15, 2024 | STREAMLINE FRESENIUS FOR DAVITA-Tubing to be used to transfer blood between a... | Incomplete insertion of the patient connector of the Streamline Airless System Hemodialysis Bloo... | Class II | B Braun Medical Inc |
| Aug 15, 2024 | SL BLOODLINE FOR FMC 2008 SERIES-Tubing to be used to transfer blood between ... | Incomplete insertion of the patient connector of the Streamline Airless System Hemodialysis Blood... | Class II | B Braun Medical Inc |
| Aug 13, 2024 | Soltive Pro SuperPulsed Laser Systems-Intended for incision, excision, resect... | The term Bladder Stone was incorrectly translated in both Spanish and Portuguese to Kidney Stone(... | Class II | Olympus Corporation of the Americas |
| Aug 13, 2024 | Soltive Premium SuperPulsed Laser - Intended for incision, excision, resectio... | The term Bladder Stone was incorrectly translated in both Spanish and Portuguese to Kidney Stone(... | Class II | Olympus Corporation of the Americas |
| Aug 8, 2024 | AET36 ANESTH EXT SET - Anesthesia Extension Set - Normally Closed Dual Manifo... | Potential for product leakage from the Spin Lock Connector on the distal end of the device due to... | Class II | B. Braun Medical, Inc. |
| Aug 7, 2024 | Infusomat Space Infusion System/ Large Volume Pump, Product Code 8713050U | Extension of previous recall RES 92978. Pumps have the potential for upstream occlusion sensor to... | Class I | B Braun Medical Inc |
| Jul 18, 2024 | prodisc C SK, Total cervical disc replacement, Model/Catalog Number: PDSM5 | During the assembly of Prodisc C, a blue discoloration was observed on a Prodisc C inlay. The dis... | Class II | Centinel Spine, Inc. |
| Jul 18, 2024 | prodisc C SK, Total cervical disc replacement, medical device, Model/Catalog... | During the assembly of Prodisc C, a blue discoloration was observed on a Prodisc C inlay. The dis... | Class II | Centinel Spine, Inc. |
| Jul 16, 2024 | Trilogy Evo EV300 -- Model Number/ Model Description: BL2200X15B Trilogy Ev... | Firm has released a mandatory software update Version 1.05.10.00 and a User Manual addendum for a... | Class I | Philips Respironics, Inc. |
| Jul 16, 2024 | Trilogy Evo Universal Ventilator, Model No. DS2000X11B | Firm has released a mandatory software update Version 1.05.10.00 and a User Manual addendum for a... | Class I | Philips Respironics, Inc. |
| Jul 16, 2024 | Trilogy Evo; Model No./Model Description -- AU2110X15B Trilogy Evo, Aust... | Firm has released a mandatory software update Version 1.05.10.00 and a User Manual addendum for a... | Class I | Philips Respironics, Inc. |
| Jul 3, 2024 | Sensis Vibe systems with software version VD15B-Intended to be used as a diag... | If the Sensis documentation functionality is used during adding of once-per-study reporting event... | Class II | Siemens Medical Solutions USA, Inc |
| Jul 3, 2024 | Sensis Vibe systems with software version VD15B in combination with AXIOM Se... | If the Sensis documentation functionality is used during adding of once-per-study reporting event... | Class II | Siemens Medical Solutions USA, Inc |
| Jul 3, 2024 | Sensis Vibe systems with software version VD15B in combination with VM VIRTUA... | If the Sensis documentation functionality is used during adding of once-per-study reporting event... | Class II | Siemens Medical Solutions USA, Inc |
| Jul 3, 2024 | Sensis Vibe systems with software version VD15B in combination with Sensis Hi... | If the Sensis documentation functionality is used during adding of once-per-study reporting event... | Class II | Siemens Medical Solutions USA, Inc |
| Jul 2, 2024 | Multitom Rax -Intended to visualize anatomical structures by converting an x-... | The support arm may unintentionally lower resulting in injury to persons when they are under the ... | Class II | Siemens Medical Solutions USA, Inc |
| Jul 2, 2024 | Luminos dRF Max- Intended to visualize anatomical structures by converting an... | The support arm may unintentionally lower resulting in injury to persons when they are under the ... | Class II | Siemens Medical Solutions USA, Inc |
| Jul 2, 2024 | Luminos Agile Max -Intended to visualize anatomical structures by converting ... | The support arm may unintentionally lower resulting in injury to persons when they are under the ... | Class II | Siemens Medical Solutions USA, Inc |
| Jul 2, 2024 | LUMINOS Lotus Max -Intended to visualize anatomical structures by converting ... | The support arm may unintentionally lower resulting in injury to persons when they are under the ... | Class II | Siemens Medical Solutions USA, Inc |
| Jul 1, 2024 | The Everest Bipolar Cutting Forceps are intended to be passed through a 5-mm ... | Fractures and breakages in packaging trays and Tyvek covers, which may result in a sterility breach | 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.