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 |
|---|---|---|---|---|
| Mar 23, 2026 | Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 20cm. Model Number: TB2... | Potential for detachment of a distal tip component of the device during use. | Class II | Olympus Corporation of the Americas |
| Mar 23, 2026 | Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 45cm. Model Number: TB2... | Potential for detachment of a distal tip component of the device during use. | Class II | Olympus Corporation of the Americas |
| Mar 20, 2026 | Prodisc C SK U.S. IMPLANT EXTRA LARGE 6MM. Model Number: PDSXL6. Total cer... | Product labeling mix up. The prodisc C SK U.S. Implant Extra Large 6mm product was labeled as a 5... | Class II | Centinel Spine, Inc. |
| Mar 20, 2026 | Prodisc C SK U.S. IMPLANT EXTRA LARGE 5MM. Model: PDSXL5 Total cervical di... | Product labeling mix up. The prodisc C SK U.S. Implant Extra Large 6mm product was labeled as a 5... | Class II | Centinel Spine, Inc. |
| Mar 19, 2026 | B. Braun Hemodialysis Bloodlines, STREAMLINE BLOODLINE SET FOR DIALOG. Model ... | Potential for the accumulation of small air bubbles in the arterial line due to adherence of bloo... | Class I | B Braun Medical Inc |
| Mar 19, 2026 | B. Braun Hemodialysis Bloodlines, LOW VOL, NO CHAMBER 2.6MM PUMP SEGMENT. Mod... | Potential for the accumulation of small air bubbles in the arterial line due to adherence of bloo... | Class I | B Braun Medical Inc |
| Mar 19, 2026 | B Braun Hemodialysis Bloodlines, LOW VOL, NO CHAMBER 4.8MM PUMP SEGMENT. Mode... | Potential for the accumulation of small air bubbles in the arterial line due to adherence of bloo... | Class I | B Braun Medical Inc |
| Mar 19, 2026 | B. Braun Hemodialysis Bloodlines, STREAMLINE FRESENIUS FOR DAVITA. Model Numb... | Potential for the accumulation of small air bubbles in the arterial line due to adherence of bloo... | Class I | B Braun Medical Inc |
| Mar 19, 2026 | B. Braun Hemodialysis Bloodlines, STREAMLINE BLOODLINE SET FOR DIALOG DR. M... | Potential for the accumulation of small air bubbles in the arterial line due to adherence of bloo... | Class I | B Braun Medical Inc |
| Mar 19, 2026 | B. Barun Hemodialysis Bloodlines, StreamLine Bloodline Long Version, FMC. Mod... | Potential for the accumulation of small air bubbles in the arterial line due to adherence of bloo... | Class I | B Braun Medical Inc |
| Mar 12, 2026 | ARTIS Pheno VE30A and VE40A, Model 10849000 | During 3D acquisitions, lighter and darker patient images may be captured, which may result in le... | Class II | Siemens Medical Solutions USA, Inc |
| Mar 10, 2026 | ARTIS pheno and ARTIS Icono biplane, floor and ceiling. Model Numbers 1084900... | During patient examinations, the system may sporadically display a major increase of the x-ray do... | Class II | Siemens Medical Solutions USA, Inc |
| Mar 9, 2026 | ARTIS pheno, Model 10849000. interventional fluoroscopic x-ray system | During patient examinations, the system may sporadically display a 0 x-ray dose administered to... | Class II | Siemens Medical Solutions USA, Inc |
| Mar 9, 2026 | ARTIS Icono biplane, floor and ceiling.: ARTIS icono biplane Model 11327600. ... | During patient examinations, the system may sporadically display a 0 x-ray dose administered to... | Class II | Siemens Medical Solutions USA, Inc |
| Mar 2, 2026 | Philips Respironics Trilogy Evo, Software Version 1.05.15.00. Continuous home... | In some situations, the Obstruction Alarm does not trigger within the timeframe dictated by the r... | Class I | Philips Respironics, Inc. |
| Mar 2, 2026 | Philips Respironics Trilogy EV300, Software Version 1.05.15.00. Continuous ho... | In some situations, the Obstruction Alarm does not trigger within the timeframe dictated by the r... | Class I | Philips Respironics, Inc. |
| Mar 2, 2026 | Philips Respironics Trilogy Evo Universal, Software Version 1.05.15.00. Conti... | In some situations, the Obstruction Alarm does not trigger within the timeframe dictated by the r... | Class I | Philips Respironics, Inc. |
| Mar 2, 2026 | Philips Respironics Trilogy Evo O2, Software Version 1.05.15.00. Continuous h... | In some situations, the Obstruction Alarm does not trigger within the timeframe dictated by the r... | Class I | Philips Respironics, Inc. |
| Mar 2, 2026 | Philips Respironics Trilogy Evo, Software Version 1.05.15.00. Continuous home... | Using non-pneumatic nebulizers with Trilogy Evo Platform ventilators may result in a discrepancy ... | Class I | Philips Respironics, Inc. |
| Mar 2, 2026 | Philips Respironics Trilogy Evo O2, Software Version 1.05.15.00. Continuous h... | Using non-pneumatic nebulizers with Trilogy Evo Platform ventilators may result in a discrepancy ... | Class I | Philips Respironics, Inc. |
| Mar 2, 2026 | Philips Respironics Trilogy EV300, Software Version 1.05.15.00. Continuous ho... | Using non-pneumatic nebulizers with Trilogy Evo Platform ventilators may result in a discrepancy ... | Class I | Philips Respironics, Inc. |
| Mar 2, 2026 | Philips Respironics Trilogy Evo Universal, Software Version 1.05.15.00. Conti... | Using non-pneumatic nebulizers with Trilogy Evo Platform ventilators may result in a discrepancy ... | Class I | Philips Respironics, Inc. |
| Feb 27, 2026 | Brand Name: Olympus SOLTIVE Pro SuperPulsed Laser System Product Name: SOLTI... | Following a complaint investigation, Olympus identified a potential defect in the 24V power suppl... | Class II | Olympus Corporation of the Americas |
| Feb 27, 2026 | Brand Name: Olympus SOLTIVE Premium SuperPulsed Laser System Product Name: S... | Following a complaint investigation, Olympus identified a potential defect in the 24V power suppl... | Class II | Olympus Corporation of the Americas |
| Feb 25, 2026 | 2.4 VOLT(TM) TAP CORTEX SCREW TO 90MM. Part Number: 03.424.126-US. | A full lot swap between VOLT Locking Screw Tap 03.424.124 lot 68900P9 and Cortical Screw Tap 03.4... | Class II | Synthes (USA) Products LLC |
| Feb 25, 2026 | 2.4 VOLT TAP LOCKING SCREW TAP TO 90MM. Part Number: 03.424.124-US. | A full lot swap between VOLT Locking Screw Tap 03.424.124 lot 68900P9 and Cortical Screw Tap 03.4... | Class II | Synthes (USA) Products LLC |
| Feb 25, 2026 | Brand Name: Olympus HALO PKS Cutting Forceps, 5mm 33cm Product Name: HALO PK... | Olympus identified that the Cutting Forceps contain components for which the supplier did not ade... | Class II | Olympus Corporation of the Americas |
| Feb 25, 2026 | Brand Name: Olympus PKS Cutting Forceps, 5mm 33cm Product Name: PKS Cutting ... | Olympus identified that the Cutting Forceps contain components for which the supplier did not ade... | Class II | Olympus Corporation of the Americas |
| Feb 25, 2026 | Brand Name: Olympus Everest Bipolar Cutting Forceps w/Cord, 5mm 33 cm Produc... | Olympus identified that the Cutting Forceps contain components for which the supplier did not ade... | Class II | Olympus Corporation of the Americas |
| Feb 25, 2026 | Brand Name: Olympus Everest Bipolar Cutting Forceps, 5 mm 33 cm Product Name... | Olympus identified that the Cutting Forceps contain components for which the supplier did not ade... | Class II | Olympus Corporation of the Americas |
| Feb 25, 2026 | Brand Name: Olympus PK Cutting Forceps, 5mm 33cm Product Name: PK Cutting Fo... | Olympus identified that the Cutting Forceps contain components for which the supplier did not ade... | Class II | Olympus Corporation of the Americas |
| Feb 25, 2026 | Brand Name: Olympus PKS Cutting Forceps w/Cord, 5mm 24cm Product Name: PKS C... | Olympus identified that the Cutting Forceps contain components for which the supplier did not ade... | Class II | Olympus Corporation of the Americas |
| Feb 25, 2026 | Brand Name: Olympus PKS Cutting Forceps, 5mm 33cm Product Name: PKS Cutting ... | Olympus identified that the Cutting Forceps contain components for which the supplier did not ade... | Class II | Olympus Corporation of the Americas |
| Feb 12, 2026 | Olympus Endoscope Air/Water Valve - MAJ-1444. Model Number: MAJ-1444. | The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite au... | Class II | Olympus Corporation of the Americas |
| Feb 12, 2026 | Olympus Endoscope Reprocessor OER-Elite. Model Number: N5789340. | The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite au... | Class II | Olympus Corporation of the Americas |
| Feb 12, 2026 | Olympus Endoscope Reprocessor OER-Pro. Model Number: N3058140. | The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite au... | Class II | Olympus Corporation of the Americas |
| Feb 12, 2026 | Olympus Endoscope Suction Valve - MAJ-1443. Model Number: MAJ-1443. | The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite au... | Class II | Olympus Corporation of the Americas |
| Feb 2, 2026 | Brand Name: B. Braun Product Name: BBraun Medical 21G X4.4CM Winged INF Mod... | The potential for the needle tip to be dull/blunt, difficult to advance, and/or break. | Class II | B Braun Medical Inc |
| Feb 2, 2026 | Brand Name: B. Braun Product Name: 21GA WINGED INFUSION, SINGLE PK Model/Ca... | The potential for the needle tip to be dull/blunt, difficult to advance, and/or break. | Class II | B Braun Medical Inc |
| Feb 2, 2026 | Brand Name: B. Braun Product Name: 21GA WINGED INF SET Model/Catalog Number... | The potential for the needle tip to be dull/blunt, difficult to advance, and/or break. | Class II | B Braun Medical Inc |
| Jan 29, 2026 | Brand Name: B. BRAUN MEDICAL INC. Product Name: SESK UPMC DOUBLE CATHETER TR... | B. Braun was notified by our supplier, Ferndale Laboratories, Inc., the manufacturer of MASTISOL... | Class II | B Braun Medical Inc |
| Jan 29, 2026 | Brand Name: B. BRAUN MEDICAL INC. Product Name: CESK RIVERSIDE HEALTH SYSTEM... | B. Braun was notified by our supplier, Ferndale Laboratories, Inc., the manufacturer of MASTISOL... | Class II | B Braun Medical Inc |
| Jan 29, 2026 | Brand Name: B. BRAUN MEDICAL INC. Product Name: LYNDON B JOHNSON HOSPITAL SP... | B. Braun was notified by our supplier, Ferndale Laboratories, Inc., the manufacturer of MASTISOL... | Class II | B Braun Medical Inc |
| Jan 29, 2026 | Brand Name: B. BRAUN MEDICAL INC. Product Name: BPSK, BLOCKJOCKS TRAY Model... | B. Braun was notified by our supplier, Ferndale Laboratories, Inc., the manufacturer of MASTISOL... | Class II | B Braun Medical Inc |
| Jan 29, 2026 | Brand Name: B. BRAUN MEDICAL INC. Product Name: NES1725KFXL SPINAL EPID CLOS... | B. Braun was notified by our supplier, Ferndale Laboratories, Inc., the manufacturer of MASTISOL... | Class II | B Braun Medical Inc |
| Jan 29, 2026 | Brand Name: B. BRAUN MEDICAL INC. Product Name: CESK SHANDS JACKSONVILLE 200... | B. Braun was notified by our supplier, Ferndale Laboratories, Inc., the manufacturer of MASTISOL... | Class II | B Braun Medical Inc |
| Jan 29, 2026 | Brand Name: B. BRAUN MEDICAL INC Product Name: CESK NORTHSIDE ANESTHESIA TRA... | B. Braun was notified by our supplier, Ferndale Laboratories, Inc., the manufacturer of MASTISOL... | Class II | B Braun Medical Inc |
| Jan 29, 2026 | Brand Name: B. BRAUN MEDICAL INC. Product Name: CESK HARRIS METHODIST Model... | B. Braun was notified by our supplier, Ferndale Laboratories, Inc., the manufacturer of MASTISOL... | Class II | B Braun Medical Inc |
| Jan 29, 2026 | Olympus Single Use Biopsy Valve. Model/Catalog Number: MAJ-1218. 20 units per... | Potential for rubber fragment detachment during use. | Class II | Olympus Corporation of the Americas |
| Jan 29, 2026 | Olympus Single use Biopsy Valve. Model/Catalog Number: MAJ-210. 20 units per ... | Potential for rubber fragment detachment during use. | 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.