Browse Device Recalls
2,522 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,522 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 2,522 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Apr 11, 2017 | PARADYM Models: VR 8250, DR 8550, CRT-D 8750, RF VR 9250, RF DR 9550, RF CRT... | Sorin is notifying physicians that certain defibrillators' battery depletion may be undetectable. | Class II | Sorin Group Italia SRL - CRF |
| Apr 11, 2017 | INTENSIA Models: VR 124, DR 154, CRT-D 174 Product Usage: OVATIO VR 6250... | Sorin is notifying physicians that certain defibrillators' battery depletion may be undetectable. | Class II | Sorin Group Italia SRL - CRF |
| Apr 11, 2017 | OVATIO Models: VR 6250, DR 6550, CRT 6750. Product Usage: OVATIO VR 625... | Sorin is notifying physicians that certain defibrillators' battery depletion may be undetectable. | Class II | Sorin Group Italia SRL - CRF |
| Mar 31, 2017 | Endopath ETS-FLEX Endoscopic Articulating Linear Cutter, VASCULAR/THIN 35MM | There is a risk that the pinion gear in the device could fail under extreme use cases. | Class II | Ethicon Endo-Surgery Inc |
| Mar 30, 2017 | HeartMate¿ II LVAS with Pocket Controller; 106015 - HMII LVAD SEALED KIT-PC... | St. Jude Medical is providing all users of their HeartMate II LVAS with Pocket Controller with ne... | Class I | Thoratec Corporation |
| Mar 30, 2017 | HeartMate¿ II LVAS with Pocket Controller; 106762 - HMII POCKET CONTROLLER,... | St. Jude Medical is providing all users of their HeartMate II LVAS with Pocket Controller with ne... | Class I | Thoratec Corporation |
| Mar 30, 2017 | HeartMate¿ II LVAS with Pocket Controller; 107801 - HMII PUMP & POCKET CTRL... | St. Jude Medical is providing all users of their HeartMate II LVAS with Pocket Controller with ne... | Class I | Thoratec Corporation |
| Mar 28, 2017 | GP161R; ELAN 4 1-RING DIAMOND BURR COARSE D2.0; GP162R; ELAN 4 1-RING DIAM... | Diamond particulates may break off the burr and fall into the surgical site. If the particles ar... | Class II | Aesculap Implant Systems LLC |
| Mar 28, 2017 | GP321R; ELAN 4 2-RING DIAMOND BURR COARSE D2.3; GP322R; ELAN 4 2-RING DIAM... | Diamond particulates may break off the burr and fall into the surgical site. If the particles ar... | Class II | Aesculap Implant Systems LLC |
| Mar 28, 2017 | GE426R; HI-LINE XS DIAMOND BURR X-CRS.I D4.5MM; GE426SU; HI-LINE XS DISP.D... | Diamond particulates may break off the burr and fall into the surgical site. If the particles ar... | Class II | Aesculap Implant Systems LLC |
| Mar 22, 2017 | NC Tenku RX PTCA Balloon Catheter, Part No. 1012448-08T, 1012448-12T, 101244... | Products from the identified lots may exhibit difficulty in removing the protective balloon sheat... | Class I | Abbott Vascular |
| Mar 22, 2017 | NC Traveler RX Coronary Dilatation Catheter, Part No. 1013152-12, 1013152-15... | Products from the identified lots may exhibit difficulty in removing the protective balloon sheat... | Class I | Abbott Vascular |
| Mar 22, 2017 | NC Trek RX Coronary Dilatation Catheter, Part No. 1012448-06, 1012448-08, 101... | Products from the identified lots may exhibit difficulty in removing the protective balloon sheat... | Class I | Abbott Vascular |
| Mar 10, 2017 | HeartWare Ventricular Assist System (HVAD) Pump Driveline Splice Kit Prod... | In April 2015, HeartWare, now a part of Medtronic, notified users of a safety issue related to th... | Class I | Heartware |
| Mar 7, 2017 | AESCULAP MINOP InVent 30 Trocar System, non-sterile Product Usage:The Mi... | Aesculap Implant Systems LLC is recalling the Minop Trocar due to the possibility it may have sh... | Class II | Aesculap Implant Systems LLC |
| Mar 3, 2017 | The PreludeSYNC Radial Compression Device is a sterile, single use disposable... | Merit Medical Systems, Inc. announces a voluntary field action for the PreludeSYNC Radial Compres... | Class II | Merit Medical Systems, Inc. |
| Mar 2, 2017 | KWIK-STIK(TM) labeled as containing Actinomyces odontolyticus. Each KWIK... | Potential for product labeled as Actinomyces odontolyticus is actually Eggerthella lenta. | Class III | Microbiologics Inc |
| Mar 2, 2017 | eCare Coordinator Product Usage: is software intended for use in data ag... | eCareCoordinator (eCC) is intended for use in data aggregation, patient interaction facilitation,... | Class II | Philips Visicu |
| Mar 2, 2017 | LYSO Disk(TM) labeled as containing Actinomyces odontolyticus. Each LYSO... | Potential for product labeled as Actinomyces odontolyticus is actually Eggerthella lenta. | Class III | Microbiologics Inc |
| Feb 22, 2017 | The Medtronic StrataMR adjustable valves and shunts are designed to provide c... | Incorrect valve rotor orientation due to misalignment and/or off-center positioning of the Strata... | Class I | Medtronic Neurosurgery |
| Feb 20, 2017 | Poly Component Trial, MPCS, packaged in the following sizes and configuration... | The dovetails of poly trials, Beta 2.0, were observed as either cracked or broken. | Class II | Medtronic Sofamor Danek USA Inc |
| Feb 20, 2017 | Poly Component Trial, PS, packaged in the following sizes and configurations:... | The dovetails of poly trials, Beta 2.0, were observed as either cracked or broken. | Class II | Medtronic Sofamor Danek USA Inc |
| Feb 20, 2017 | Poly Component Trial, CR, packaged in the following sizes and configurations:... | The dovetails of poly trials, Beta 2.0, were observed as either cracked or broken. | Class II | Medtronic Sofamor Danek USA Inc |
| Feb 20, 2017 | Poly Component Trial, UCCS, packaged in the following sizes and configuration... | The dovetails of poly trials, Beta 2.0, were observed as either cracked or broken. | Class II | Medtronic Sofamor Danek USA Inc |
| Feb 17, 2017 | various polyethylene implants Hips Active Articulation ArComXL Bearings A... | Endotoxin levels higher than process maximum limits were discovered in the identified polyethylen... | Class II | Zimmer Biomet, Inc. |
| Feb 16, 2017 | Cordis S.M.A.R.T. Flex Vascular Stent System | Deployment Difficulty. | Class II | Cordis Corporation |
| Feb 10, 2017 | StarClose SE Vascular Closure System, Part No. 14679-01, 14679-02. The UDI... | Abbott Vascular is recalling the StarClose SE Vascular Closure System because it may exhibit diff... | Class II | Abbott Vascular |
| Feb 3, 2017 | HeartWare HVAD System Controller The HeartWare Ventricular Assist System (V... | Product recall of all HVAD Controllers currently on the market and to exchange them for the next... | Class I | Heartware |
| Jan 10, 2017 | LIMA Modular Revision Hip Stem Model 428-01-050_110 Product Usage: The Mo... | Lima Proximal Bodies were inadvertently re-sterilized. The safety screw which affixes the distal ... | Class II | Encore Medical, Lp |
| Dec 19, 2016 | Active Articulation ArComXL Polyethylene Bearings Active Articulation ArComX... | Product complaints indicated that the part and lot numbers on the packaging differed from the phy... | Class II | Zimmer Biomet, Inc. |
| Dec 19, 2016 | NEOVIEW(R) SCREWS SET, REF W27 ST900, STERILE R The NEOVIEW¿ Plating System... | Dimensional non-conformity of the thread on the screw head. | Class II | In2Bones, SAS |
| Dec 19, 2016 | NEO SCREW 02.7-14MM LOCKING, REF W27 ST114, In2Bones, 28 chemin du petit bois... | Dimensional non-conformity of the thread on the screw head. | Class II | In2Bones, SAS |
| Dec 19, 2016 | SCREW 02.7-12MM LOCKING, REF W27 ST112: a) DRP, b) NEO, In2Bones, 28 chemin ... | Dimensional non-conformity of the thread on the screw head. | Class II | In2Bones, SAS |
| Dec 15, 2016 | ETEST¿ Ceftriaxone TXL32 SPB, Product Name: ETEST¿ Ceftriaxone TX 0.002-32(lo... | Product Stability issues: The current shelf-life claims of the ETEST products are not supported ... | Class II | BioMerieux SA |
| Dec 15, 2016 | ETEST Imipenem IP32 Foam packaging, Product Name: ETEST Imipenem IP 0.002-32.... | Product Stability issues: The current shelf-life claims of the ETEST products are not supported ... | Class II | BioMerieux SA |
| Dec 15, 2016 | ETEST Fosfomycin FM1024 Blister packaging, Product Name: ETEST Fosfomycin FM ... | Product Stability issues: The current shelf-life claims of the ETEST products are not supported ... | Class II | BioMerieux SA |
| Dec 15, 2016 | ETEST Tobramycin TM256 FOAM packaging, Product Name: ETEST Tobramycin TM 0.01... | Product Stability issues: The current shelf-life claims of the ETEST products are not supported ... | Class II | BioMerieux SA |
| Dec 15, 2016 | ETEST Benzyl Penicillin PG256 FOAM packaging, Product Name: Etest Benzylpenic... | Product Stability issues: The current shelf-life claims of the ETEST products are not supported ... | Class II | BioMerieux SA |
| Dec 15, 2016 | ETEST Cephalotin CE 256 Foam packaging, Product Name: ETEST Cephalothin CE 0.... | Product Stability issues: The current shelf-life claims of the ETEST products are not supported ... | Class II | BioMerieux SA |
| Dec 15, 2016 | Ciprofloxacin CI 32 Foam packaging, Product Name: ETEST Ciprofloxacin CI 0.00... | Product Stability issues: The current shelf-life claims of the ETEST products are not supported ... | Class II | BioMerieux SA |
| Dec 15, 2016 | ETEST Gentamicin GM256 FOAM packaging, Product Name: ETEST Gentamicin GM 0.01... | Product Stability issues: The current shelf-life claims of the ETEST products are not supported ... | Class II | BioMerieux SA |
| Dec 15, 2016 | ETEST Ceftazidime TZ256 Foam packaging, Product Name: ETEST Ceftazidime TZ 0.... | Product Stability issues: The current shelf-life claims of the ETEST products are not supported ... | Class II | BioMerieux SA |
| Dec 15, 2016 | ETEST Vancomycin VA 256 FOAM packaging, Product Name: ETEST Vancomycin VA 0.0... | Product Stability issues: The current shelf-life claims of the ETEST products are not supported ... | Class II | BioMerieux SA |
| Dec 15, 2016 | ETEST Ceftriaxone TXL32 FOAM packaging, Product Name: ETEST Ceftriaxone TX 0.... | Product Stability issues: The current shelf-life claims of the ETEST products are not supported ... | Class II | BioMerieux SA |
| Dec 15, 2016 | ETEST Doripenem DOR32 FOAM packaging, Product Name: Etest Doripenem DOR 0.00... | Product Stability issues: The current shelf-life claims of the ETEST products are not supported ... | Class II | BioMerieux SA |
| Dec 13, 2016 | Chord-X Chordal Sizer is designed to assist in determining the proper length ... | Four issues were uncovered by the recalling firm's CAPA: 1) Burrs were found to be present on Lef... | Class II | On-X Life Technologies, Inc. |
| Dec 9, 2016 | Amplia MRI" CRT -D SureScan", Amplia MRI" Quad CRT -D SureScan", Claria M... | During internal testing conducted as part of next generation product development, it was discover... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failure |
| Dec 6, 2016 | Oxford Fixed Lateral Bearing Size F Right, Part Number 154375 Lot 744260, Ste... | Zimmer Biomet is initiating a removal of a single lot of Oxford Fixed Lateral Bearings due to mis... | Class II | Zimmer Biomet, Inc. |
| Nov 30, 2016 | 133" 60 Drop 24 Hour Primary Set w/2 Bravo24¿, 2 Gang 1o2¿ Manifold, Rotating... | ICU Medical Inc. has identified an isolated event involving a 15 drop drip chamber assembled on a... | Class II | ICU Medical, Inc. |
| Nov 30, 2016 | AtriClip" LAA Exclusion System with preloaded Gillinov-Cosgrove" Clip - A sin... | A complaint of the PRO2 jaw breaking prior to surgery being performed. | Class II | AtriCure, Inc. |
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.