Browse Device Recalls
2,888 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,888 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 2,888 FDA device recalls in PA.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Sep 7, 2023 | Real Intelligence CORI RI.KNEE v2.0 TKA (Total Knee Arthroplasty) software ve... | CORI software was missing a planning stage that appears in cases of significant knee deformation ... | Class II | Blue Belt Technologies, Inc |
| Sep 1, 2023 | (1) Over-ear headphones used with the MAGNETOM Amira MAGNETOM Free.Star MAGNE... | In some cases, when lubricating grease is present within the headband of the over-ear headphones... | Class II | Siemens Medical Solutions USA, Inc |
| Aug 29, 2023 | Coventus Flower Orthopedics Flex-Thread TM 3.2mm Cannulated Reamer-used to re... | Device is breaking while in use, potential for patients to require a revision surgery. | Class II | Flower Orthopedics Corporation |
| Aug 25, 2023 | Philips Respironics V60/V60 Plus Ventilator, PCBA Part Number: 4535615444... | Power Management PCBAs may malfunction, causing a power failure leading to ventilator loss of fun... | Class I | Philips Respironics, Inc. |
| Aug 10, 2023 | Veran Endobronchial: Models: INS-5925 SPiN Access Catheter¿ 180 Degree for ... | Non-conformances in Veran devices (ig4 Image Guided System, SPiN Thoracic Navigation System, SPiN... | Class II | Olympus Corporation of the Americas |
| Aug 10, 2023 | Veran : Endobronchial Models: INS-5500 View Optical Probe INS-5450 SP... | Non-conformances in Veran devices (ig4 Image Guided System, SPiN Thoracic Navigation System, SPiN... | Class II | Olympus Corporation of the Americas |
| Aug 10, 2023 | Veran : Percutaneous Models: INS-5620 SPiN Perc Biopsy Needle Guide Kit - 2... | Non-conformances in Veran devices (ig4 Image Guided System, SPiN Thoracic Navigation System, SPiN... | Class II | Olympus Corporation of the Americas |
| Aug 10, 2023 | Veran:SPiN Thoracic Navigation System Models: SYS-4230 SPiN Thoracic Naviga... | Non-conformances in Veran devices (ig4 Image Guided System, SPiN Thoracic Navigation System, SPiN... | Class II | Olympus Corporation of the Americas |
| Aug 10, 2023 | Veran : Percutaneous Always on Track Models: INS-5040 Always-On vTrack Univ... | Non-conformances in Veran devices (ig4 Image Guided System, SPiN Thoracic Navigation System, SPiN... | Class II | Olympus Corporation of the Americas |
| Aug 10, 2023 | Veran : Endobronchial Always on Track Models: INS-0392 AOTT 21ga Needle, 12... | Non-conformances in Veran devices (ig4 Image Guided System, SPiN Thoracic Navigation System, SPiN... | Class II | Olympus Corporation of the Americas |
| Aug 7, 2023 | B. Braun NORM-JECT Luer Solo, 10 ml, Sterile-Intended to be used to deliver (... | The sterile blister packaging may be damaged, and sterility may be compromised | Class II | B. Braun Medical, Inc. |
| Aug 7, 2023 | B.Braun NORM-JECT Luer Lock Solo, 10 ml, Sterile-Intended to be used to deli... | The sterile blister packaging may be damaged, and sterility may be compromised | Class II | B. Braun Medical, Inc. |
| Jul 31, 2023 | Perifix¿ / Epidural anesthesia set, medicated | Product may be mislabeled with an incorrect lid stock label. | Class II | B. Braun Medical, Inc. |
| Jul 27, 2023 | Olympus Airway Mobilescope, Models MAF-GM & MAF-TM. | Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter b... | Class II | Olympus Corporation of the Americas |
| Jul 27, 2023 | Olympus Bronchovideoscope, Models BF-XT190. | Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter b... | Class II | Olympus Corporation of the Americas |
| Jul 27, 2023 | Olympus Bronchovideoscope, Models BF-1T180, BF-1TQ180, BF-P180, & BF-Q180. | Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter b... | Class II | Olympus Corporation of the Americas |
| Jul 27, 2023 | Olympus Bronchovideoscope, Models BF-1TH190, BF-H190, BF-Q170, & BF-Q190. | Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter b... | Class II | Olympus Corporation of the Americas |
| Jul 27, 2023 | EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V | Recent reports of patient infection. | Class II | Olympus Corporation of the Americas |
| Jul 27, 2023 | Olympus Bronchovideoscope, Models BF-MP190F. | Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter b... | Class II | Olympus Corporation of the Americas |
| Jul 27, 2023 | Olympus Bronchovideoscope, Model BF-Q180-AC | Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter b... | Class II | Olympus Corporation of the Americas |
| Jul 27, 2023 | Olympus Tracheal Intubation Fiberscope, Models LF-DP, LF-GP, & LF-TP. | Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter b... | Class II | Olympus Corporation of the Americas |
| Jul 27, 2023 | Olympus Bronchovideoscope, Models BF-UC180F & BF-UC190F. | Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter b... | Class II | Olympus Corporation of the Americas |
| Jul 27, 2023 | Olympus Airway Mobilescope, Models MAF-DM2, MAF-GM2, & MAF-TM2. | Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter b... | Class II | Olympus Corporation of the Americas |
| Jul 27, 2023 | Olympus Bronchovideoscope, Models BF-P190 & BF-XP190. | Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter b... | Class II | Olympus Corporation of the Americas |
| Jul 27, 2023 | Olympus Bronchovideoscope, Models BF-MP160F, BF-XP160F, BF-XP60. | Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter b... | Class II | Olympus Corporation of the Americas |
| Jul 27, 2023 | Olympus Bronchovideoscope, Models BF-1T150, BF-1T60, BF-MP60, BF-P150, BF-P60... | Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter b... | Class II | Olympus Corporation of the Americas |
| Jul 27, 2023 | Olympus Tracheal Intubation Fiberscope, Models LF-P & LF-V. | Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter b... | Class II | Olympus Corporation of the Americas |
| Jul 27, 2023 | Olympus Bronchovideoscope, Models BF-3C160. | Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter b... | Class II | Olympus Corporation of the Americas |
| Jul 27, 2023 | Olympus Bronchovideoscope, Models BF-3C40 & BF-N20. | Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter b... | Class II | Olympus Corporation of the Americas |
| Jul 24, 2023 | Cook Lead Clipper- An auxiliary tool indicated for use in patients requiring ... | Sterility of device may be compromised due to breach of the chevron seal of the packaging | Class II | Cook Vandergrift, Inc. |
| Jul 20, 2023 | For intraventricular indications mainly used for operations within the brain ... | Trocar manufactured with the shaft too long and does not meet manufacturing specifications. As a ... | Class II | Aesculap Implant Systems LLC |
| Jul 20, 2023 | Visera Hysterovideoscope Olympus HYF Type V | IFU labeling is being updated to revise EtO gas mixture and elimination of reusable cleaning brus... | Class II | Olympus Corporation of the Americas |
| Jul 12, 2023 | Carina Sub-Acute Care Ventilator | Presence of polyether polyurethane (PE-PUR) and emission of 1,3-Dichloropropan-2-ol that exceed t... | Class I | Draeger Medical, Inc. |
| Jul 12, 2023 | The Air/Water Valve is provided/used with the following Endoscopes: ULTRASON... | The air/water valve MAJ-1444 used with OER-Pro and OER-Elite may become damaged and result in lo... | Class II | Olympus Corporation of the Americas |
| Jun 30, 2023 | LifeSPARC Pump (part number 5800-0000) contained within TandemLife LifeSPARC ... | Epoxy used during manufacturing of the LifeSPARC Pump may have uncured epoxy. if undetectable cu... | Class II | Cardiac Assist, Inc |
| Jun 28, 2023 | Alcon Custom Pak | Reports of patient injury during use in procedures due to potential for plastic debris from over-... | Class II | Alcon Research, LTD. |
| Jun 28, 2023 | Phaco Standalone Tips | Reports of patient injury during use in procedures due to potential for plastic debris from over-... | Class II | Alcon Research, LTD. |
| Jun 28, 2023 | Infinity FMS Pak | Reports of patient injury during use in procedures due to potential for plastic debris from over-... | Class II | Alcon Research, LTD. |
| Jun 28, 2023 | Constellation Procedure Pak | Reports of patient injury during use in procedures due to potential for plastic debris from over-... | Class II | Alcon Research, LTD. |
| Jun 28, 2023 | Legion FMS Pak | Reports of patient injury during use in procedures due to potential for plastic debris from over-... | Class II | Alcon Research, LTD. |
| Jun 28, 2023 | Centurion FMS Pak | Reports of patient injury during use in procedures due to potential for plastic debris from over-... | Class II | Alcon Research, LTD. |
| Jun 19, 2023 | ARTIS icono biplane -Angiography systems developed for single and biplane dia... | Due to a hardware issue in the cable connectors of the system generator, a thermal overload in th... | Class II | Siemens Medical Solutions USA, Inc |
| Jun 19, 2023 | ARTIS icono floor-Angiography systems developed for single and biplane diagno... | Due to a hardware issue in the cable connectors of the system generator, a thermal overload in th... | Class II | Siemens Medical Solutions USA, Inc |
| Jun 19, 2023 | ARTIS pheno-Angiography systems developed for single and biplane diagnostic i... | Due to a hardware issue in the cable connectors of the system generator, a thermal overload in th... | Class II | Siemens Medical Solutions USA, Inc |
| Jun 12, 2023 | Oxylog 3000 Plus emergency and transport ventilator | Draeger has become aware of instances where the device stopped working when in use when transitio... | Class I | Draeger Medical, Inc. |
| Jun 8, 2023 | Olympus EVIS EXERA II BRONCHOVIDEOSCOPE BF TYPE, Model Numbers BF-P180, BF-Q1... | There have been complaints of endobronchial combustion during therapeutic laser procedures with t... | Class I | Olympus Corporation of the Americas |
| Jun 8, 2023 | Olympus BRONCHOVIDEOSCOPE BF Type, Model Numbers BF-P150, BF-1T150 | There have been complaints of endobronchial combustion during therapeutic laser procedures with t... | Class I | Olympus Corporation of the Americas |
| Jun 8, 2023 | Olympus OES BRONCHOFIBERSCOPE BF Type, Model Numbers BF-XT40, BF-P60, BF-MP60... | There have been complaints of endobronchial combustion during therapeutic laser procedures with t... | Class I | Olympus Corporation of the Americas |
| Jun 8, 2023 | Olympus EVIS EXERA BRONCHOVIDEOSCOPE BF TYPE, Model Number BF-XT160 | There have been complaints of endobronchial combustion during therapeutic laser procedures with t... | Class I | Olympus Corporation of the Americas |
| Jun 8, 2023 | Olympus BRONCHOVIDEOSCOPE, Model Numbers BF-Q170 | There have been complaints of endobronchial combustion during therapeutic laser procedures with t... | Class I | 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.