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 |
|---|---|---|---|---|
| Nov 6, 2023 | Olympus ENDOEYE HD II Rigid Videoscope Catalog Numbers: WA50040A, WA50042A ... | Reports of a pink or green coloration of the image. If the issue is encountered during a procedur... | Class II | Olympus Corporation of the Americas |
| Nov 1, 2023 | Infusomat Administration Sets as listed below: 362031 Infusomat Space Pu... | In affected products, the tubing outer diameter may vary in size or the length of tubing may be t... | Class I | B. Braun Medical, Inc. |
| Oct 17, 2023 | ARTIS icono (ceiling configuration), Fluoroscopic x-ray system; Model no. 11... | Potential hardware issue for ARTIS icono ceiling system: collision sensor may falsely signal non-... | Class II | Siemens Medical Solutions USA, Inc |
| Oct 12, 2023 | EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Model Number Q180-AC | There is a risk of endobronchial combustion if high-frequency cauterization is performed while su... | Class I | Olympus Corporation of the Americas |
| Oct 12, 2023 | EVIS EXERA III BRONCHOVIDEOSCOPE Model Numbers BF-1TH190, BF-H190, BF-Q190 an... | There is a risk of endobronchial combustion if high-frequency cauterization is performed while su... | Class I | Olympus Corporation of the Americas |
| Oct 12, 2023 | EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Model Numbers BF-1T180, BF-1T... | There is a risk of endobronchial combustion if high-frequency cauterization is performed while su... | Class I | Olympus Corporation of the Americas |
| Oct 12, 2023 | BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Model Numbers BF-1T150, BF-1T60, BF-P150 B... | There is a risk of endobronchial combustion if high-frequency cauterization is performed while su... | Class I | Olympus Corporation of the Americas |
| Oct 12, 2023 | EVIS EXERA b BRONCHOVIDEOSCOPE OLYMPUS Model Number BF-XT190 | There is a risk of endobronchial combustion if high-frequency cauterization is performed while su... | Class I | Olympus Corporation of the Americas |
| Oct 12, 2023 | EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS Model Number BF-P190 | There is a risk of endobronchial combustion if high-frequency cauterization is performed while su... | Class I | Olympus Corporation of the Americas |
| Oct 5, 2023 | Mobilett Mira wireless (VA20) mobile x-ray system(s) | Due to the incorrect mounting of the buzzer component, there is no acoustic signal during x ray a... | Class II | Siemens Medical Solutions USA, Inc |
| Oct 2, 2023 | ACMI Roller Bar Electrodes bearing incorrect pouch label of ACMI USA Elite Sy... | Incorrect pouch labels, the contents within the mislabeled pouch were Roller Bar electrodes. | Class II | Olympus Corporation of the Americas |
| Oct 2, 2023 | EVIS EXERA III Gastrointestinal Videoscope | Sterilization failures when devices are sterilized per the Reprocessing Manual due to lack of dry... | Class II | Olympus Corporation of the Americas |
| Sep 28, 2023 | TRACHEAL INTUBATION FIBERSCOPE OLYMPUS LF-GP, Model Number: LF-GP | Fiberscopes do not have adequate data to support that the suction flow rate meets the device spec... | Class II | Olympus Corporation of the Americas |
| Sep 26, 2023 | BULK LARGEBORE MALE LL FITTING, Article No. M4341750SN. IV administration com... | Devices may leak as a result of a manufacturing issue. Leakage may result in a delay of therapy, ... | Class II | B. Braun Medical, Inc. |
| Sep 26, 2023 | SA3000 VENTED MICRO SPIKE ADAPTER, REF No. 418121, for intravenous use. | Devices may leak as a result of a manufacturing issue. Leakage may result in a delay of therapy, ... | Class II | B. Braun Medical, Inc. |
| Sep 26, 2023 | FT1000S FLUID TRANSFER SET, REF No. 356048. For direct transfer of fluids bet... | Devices may leak as a result of a manufacturing issue. Leakage may result in a delay of therapy, ... | Class II | B. Braun Medical, Inc. |
| Sep 26, 2023 | ALLERGAN UNIVERSAL FILL KIT, REF No. 7M2804. for tissue expander inflation. | Devices may leak as a result of a manufacturing issue. Leakage may result in a delay of therapy, ... | Class II | B. Braun Medical, Inc. |
| Sep 26, 2023 | 30ML BURETTE ASSY WITH STOPCOCK, BNS, Article No. 7A3970. used in a contrast... | Devices may leak as a result of a manufacturing issue. Leakage may result in a delay of therapy, ... | Class II | B. Braun Medical, Inc. |
| Sep 26, 2023 | AMO ADMINISTRATION SET, Article No. 7A3817, REF OM2505191, for ophthalmologic... | Devices may leak as a result of a manufacturing issue. Leakage may result in a delay of therapy, ... | Class II | B. Braun Medical, Inc. |
| Sep 26, 2023 | 30 ML 2PORT BURETTE ASSEMBLY, Article No. 7A3950, used in a contrast manageme... | Devices may leak as a result of a manufacturing issue. Leakage may result in a delay of therapy, ... | Class II | B. Braun Medical, Inc. |
| Sep 26, 2023 | THERASPHERE ADMIN SET, Article No. 7M2650. Canada only. Sterile, single use ... | Devices may leak as a result of a manufacturing issue. Leakage may result in a delay of therapy, ... | Class II | B. Braun Medical, Inc. |
| Sep 26, 2023 | TERUMO 60" TUBE SET W/HIGH CRACK CHK VLV, Article No. 7S3070. Singapore only.... | Devices may leak as a result of a manufacturing issue. Leakage may result in a delay of therapy, ... | Class II | B. Braun Medical, Inc. |
| Sep 25, 2023 | Insufflation unit, UHI-4. | Olympus has become aware of an increased trend of both repairs and customer complaints reporting ... | Class II | Olympus Corporation of the Americas |
| Sep 22, 2023 | Olympus High-Flow Insufflation Unit, Model UHI-4. For laparoscopic surgery. | There have been reports of patients suffering arrhythmias, reported as short cardiac arrests, dur... | Class I | Olympus Corporation of the Americas |
| Sep 21, 2023 | 8713052U, Infusomat Large Volume Pump, Non-Wireless BATTERY PACK; Volumetric ... | Upstream occlusion alarm may sound when no occlusion exists, and the device will stop pumping. In... | Class I | B. Braun Medical, Inc. |
| Sep 21, 2023 | 8713051U, Infusomat Large Volume Pump, Wireless; Volumetric Infusion Pump System | Upstream occlusion alarm may sound when no occlusion exists, and the device will stop pumping. In... | Class I | B. Braun Medical, Inc. |
| Sep 14, 2023 | EVIS EXERA III Video System Center Model Number CV-190. Intended to be used w... | Certain serial numbers of the CV-190 do not start up properly because parts that deviated from th... | Class II | Olympus Corporation of the Americas |
| Sep 12, 2023 | THUNDERBEAT, 5MM, 45CM, Front-actuated Grip Type S Model: TB-0545FCS Indica... | Thunderbeats blue seal button may remain in the engaged position after the button is released and... | Class II | Olympus Corporation of the Americas |
| Sep 12, 2023 | THUNDERBEAT, 5MM, 35CM, Front-actuated Grip Type S. Model: TB-0535FCS Indic... | Thunderbeats blue seal button may remain in the engaged position after the button is released and... | Class II | Olympus Corporation of the Americas |
| Sep 12, 2023 | Siemens Cios Alpha (VA30) mobile fluoroscopic C-arm X-ray System, designed fo... | Software issue for Cios Alpha, Cios Flow, and Cios Spin VA30 systems, fulfillment of new requirem... | Class II | Siemens Medical Solutions USA, Inc |
| Sep 12, 2023 | ***Updated 12/4/23*** (1) Cios Flow (VA30) mobile fluoroscopic C-arm X-ray Sy... | Software issue for Cios Alpha, Cios Flow, and Cios Spin VA30 systems, fulfillment of new requirem... | Class II | Siemens Medical Solutions USA, Inc |
| 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 |
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.