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.

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DateProductReasonClassFirm
Jan 31, 2025 Numerous models of nonsterile hemostatic forceps: (1) REF BH100R, Carrel Art... The forceps have been used in ways not covered by the design resulting in breakage of the clamps. Class II Aesculap Inc
Jan 31, 2025 Numerous models of nonsterile hemostatic forceps: (1) REF BJ500R, Phaneuf ... The forceps have been used in ways not covered by the design resulting in breakage of the clamps. Class II Aesculap Inc
Jan 31, 2025 Numerous models of nonsterile hemostatic forceps: (1) REF BH951R, Negus To... The forceps have been used in ways not covered by the design resulting in breakage of the clamps. Class II Aesculap Inc
Jan 27, 2025 Osstem Implant System - Abutment: ET Multi AbutmentSize: 4.8D 5.0GH - Abutme... Patient chart stickers provided inside the packaging may incorrectly identify ET Rigid Abutments ... Class II Hiossen Inc.
Jan 27, 2025 ET Rigid Abutment (Mini) Size: 4.5D 2.0G/H 4.0H- Intended for use with a dent... Patient chart stickers provided inside the packaging may incorrectly identify ET Rigid Abutments ... Class II Hiossen Inc.
Jan 27, 2025 ET Rigid Abutment (Mini) SIze: 4.5D 3.0G/H 7.0H - Intended for use with a den... Patient chart stickers provided inside the packaging may incorrectly identify ET Rigid Abutments ... Class II Hiossen Inc.
Jan 27, 2025 ET Rigid Abutment (Mini) Size 4.5D 1.0G/H 5.0H - Intended for use with a den... Patient chart stickers provided inside the packaging may incorrectly identify ET Rigid Abutments ... Class II Hiossen Inc.
Jan 27, 2025 Osstem Implant System - Abutment ET Multi Abutment Size: 4.8D 3.0G/H- Abutme... Patient chart stickers provided inside the packaging may incorrectly identify ET Rigid Abutments ... Class II Hiossen Inc.
Jan 27, 2025 ET Rigid Abutment (Mini) SIze: 4.5D 4.0G/H 4.0H - Intended for use with a den... Patient chart stickers provided inside the packaging may incorrectly identify ET Rigid Abutments ... Class II Hiossen Inc.
Jan 21, 2025 A.L.P.S. mvX-P: ANATOMIC LAT FIB PLATE 12H LT- Anatomic Lateral Fibula Plate,... Complaints of the locking screw passing through the locking hole intra-operatively during use of ... Class II Tyber Medical
Jan 21, 2025 A.L.P.S. mvX -ANATOMIC LAT FIB PLATE 6H LT- Anatomic Lateral Fibula Plate, 6-... Complaints of the locking screw passing through the locking hole intra-operatively during use of ... Class II Tyber Medical
Jan 21, 2025 A.L.P.S. mvX- MEDIAL TIBIA PLATE 16H LT-Medial Tibia Plate, 16-Hole, Left In... Complaints of the locking screw passing through the locking hole intra-operatively during use of ... Class II Tyber Medical
Jan 21, 2025 A.L.P.S. mvX- ANATOMIC LAT FIB PLATE 10H RT- Anatomic Lateral Fibula Plate, 1... Complaints of the locking screw passing through the locking hole intra-operatively during use of ... Class II Tyber Medical
Jan 21, 2025 A.L.P.S. mvX- ANATOMIC LAT FIB PLATE 8H RT: Anatomic Lateral Fibula Plate, 8-... Complaints of the locking screw passing through the locking hole intra-operatively during use of ... Class II Tyber Medical
Jan 21, 2025 A.L.P.S. mvX- MEDIAL TIBIA PLATE 6H RT-Medial Tibia Plate, 6-Hole, Right Mod... Complaints of the locking screw passing through the locking hole intra-operatively during use of ... Class II Tyber Medical
Jan 21, 2025 A.L.P.S. mvX -ANATOMIC LAT FIB PLATE 4H RT: Anatomic Lateral Fibula Plate, 4-... Complaints of the locking screw passing through the locking hole intra-operatively during use of ... Class II Tyber Medical
Jan 21, 2025 A.L.P.S. mvX- MEDIAL TIBIA PLATE 16H RT -Medial Tibia Plate, 16-Hole, Right ... Complaints of the locking screw passing through the locking hole intra-operatively during use of ... Class II Tyber Medical
Jan 21, 2025 A.L.P.S. mvX- ANATOMIC LAT FIB PLATE 12H RT- Anatomic Lateral Fibula Plate, 1... Complaints of the locking screw passing through the locking hole intra-operatively during use of ... Class II Tyber Medical
Jan 21, 2025 A.L.P.S. mvX - ANATOMIC LAT FIB PLATE 4H LT: Anatomic Lateral Fibula Plate, 4... Complaints of the locking screw passing through the locking hole intra-operatively during use of ... Class II Tyber Medical
Jan 21, 2025 A.L.P.S. mvX- ANATOMIC LAT FIB PLATE 8H LT: Anatomic Lateral Fibula Plate, 8-... Complaints of the locking screw passing through the locking hole intra-operatively during use of ... Class II Tyber Medical
Jan 21, 2025 A.L.P.S. mvX- ANATOMIC LAT FIB PLATE 6H RT: Anatomic Lateral Fibula Plate, 6-... Complaints of the locking screw passing through the locking hole intra-operatively during use of ... Class II Tyber Medical
Jan 21, 2025 A.L.P.S. mvX- MEDIAL TIBIA PLATE 10H LT- Medial Tibia Plate, 10-Hole, Left. ... Complaints of the locking screw passing through the locking hole intra-operatively during use of ... Class II Tyber Medical
Jan 21, 2025 A.L.P.S. mvX- Product Name: ANATOMIC LAT FIB PLATE 10H LT Anatomic Lateral Fi... Complaints of the locking screw passing through the locking hole intra-operatively during use of ... Class II Tyber Medical
Jan 21, 2025 A.L.P.S. mvX-MEDIAL TIBIA PLATE 10H RT-Medial Tibia Plate, 10-Hole, Right In... Complaints of the locking screw passing through the locking hole intra-operatively during use of ... Class II Tyber Medical
Jan 21, 2025 A.L.P.S. mvX--MEDIAL TIBIA PLATE 12H RT-Medial Tibia Plate, 12-Hole, Right I... Complaints of the locking screw passing through the locking hole intra-operatively during use of ... Class II Tyber Medical
Jan 21, 2025 A.L.P.S. mvX-MEDIAL TIBIA PLATE 6H LT-Medial Tibia Plate, 6-Hole, Left Inten... Complaints of the locking screw passing through the locking hole intra-operatively during use of ... Class II Tyber Medical
Jan 21, 2025 A.L.P.S. mvX-MEDIAL TIBIA PLATE 12H LT-Medial Tibia Plate, 12-Hole, Left Int... Complaints of the locking screw passing through the locking hole intra-operatively during use of ... Class II Tyber Medical
Jan 15, 2025 Olympus Single Use Guide Sheath Kits with the following product descriptions ... Potential for the radiopaque tip of the guide sheath component to disassociate and fall off into ... Class I Olympus Corporation of the Americas
Dec 18, 2024 Olympus MAJ-891 Forceps/Irrigation Plug (Isolated Type). Model/Catalog Number... Potential for inadvertent retention of biomaterial when the reprocessing procedure is not perform... Class I Olympus Corporation of the Americas
Dec 16, 2024 LithoCrushV Single Use Mechanical Lithotriptor V. Model Number: BML-V442QR-30... Potential for distal tip tearing of the Mechanical Lithotriptor V. Class II Olympus Corporation of the Americas
Dec 4, 2024 Design Options COMBINED SPINAL/EPIDURAL TRAY- Intended for administration of... Incorrect catheter connector within the kit resulting in inability to provide a secure connection... Class II B. Braun Medical, Inc.
Dec 3, 2024 ECONO STERILE medical procedure kits labeled as: ECONO STERILE IUD EXTRACT... Reports of various packaging issues that may result in a breach of the sterile barrier. Class II Sklar Instruments
Dec 3, 2024 ECONO STERILE medical procedure kits labeled as: ECONO STERILE CEMENT SPAT... Reports of various packaging issues that may result in a breach of the sterile barrier. Class II Sklar Instruments
Dec 3, 2024 ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE MINI TIS... Reports of various packaging issues that may result in a breach of the sterile barrier. Class II Sklar Instruments
Dec 3, 2024 ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE IRIS SCI... Reports of various packaging issues that may result in a breach of the sterile barrier. Class II Sklar Instruments
Dec 3, 2024 ECONO STERILE medical procedure kits labeled as: ECONO STERILE BLAKE GALLS... Reports of various packaging issues that may result in a breach of the sterile barrier. Class II Sklar Instruments
Dec 3, 2024 ECONO STERILE medical procedure kits labeled as: ECONO STERILE IRIS HOOK Q... Reports of various packaging issues that may result in a breach of the sterile barrier. Class II Sklar Instruments
Dec 3, 2024 ECONO STERILE medical procedure kits labeled as: ECONO STERILE SCHAMBERG E... Reports of various packaging issues that may result in a breach of the sterile barrier. Class II Sklar Instruments
Dec 3, 2024 ECONO STERILE brand medical procedure kits labeled as: 1) ECONO STERILE" B... Reports of various packaging issues that may result in a breach of the sterile barrier. Class II Sklar Instruments
Dec 3, 2024 ECONO STERILE medical procedure kits labeled as: ECONO STERILE SIMS UTERIN... Reports of various packaging issues that may result in a breach of the sterile barrier. Class II Sklar Instruments
Dec 3, 2024 ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE VEIN HOO... Reports of various packaging issues that may result in a breach of the sterile barrier. Class II Sklar Instruments
Dec 3, 2024 ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE D/A NAIL... Reports of various packaging issues that may result in a breach of the sterile barrier. Class II Sklar Instruments
Dec 3, 2024 ECONO STERILE medical procedure kits labeled as: ECONO STERILE SCALPEL HDL... Reports of various packaging issues that may result in a breach of the sterile barrier. Class II Sklar Instruments
Dec 3, 2024 Medical procedure kits labeled as: 1) ECONO STERILE STRABIS SCISS STR 4.5"... Reports of various packaging issues that may result in a breach of the sterile barrier. Class II Sklar Instruments
Dec 3, 2024 ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE GRAVES... Reports of various packaging issues that may result in a breach of the sterile barrier. Class II Sklar Instruments
Dec 3, 2024 ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE ARMY RET... Reports of various packaging issues that may result in a breach of the sterile barrier. Class II Sklar Instruments
Dec 3, 2024 ECONO STERILE medical procedure kits labeled as: ECONO STERILE LEMPERT BON... Reports of various packaging issues that may result in a breach of the sterile barrier. Class II Sklar Instruments
Dec 3, 2024 ECONO STERILE brand medical procedure kits labeled as: 1) ECONO STERILE FR... Reports of various packaging issues that may result in a breach of the sterile barrier. Class II Sklar Instruments
Dec 3, 2024 ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE PROBE W/... Reports of various packaging issues that may result in a breach of the sterile barrier. Class II Sklar Instruments
Dec 3, 2024 ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE WEITLANE... Reports of various packaging issues that may result in a breach of the sterile barrier. Class II Sklar Instruments

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.