Browse Device Recalls
3,313 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,313 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 3,313 FDA device recalls in 2017.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Mar 9, 2017 | OPHTHALMIC DRESSING TRAY The Covidien Curity Oval Eye Pads are individuall... | Centurion Medical Products is recalling Convenience Kits that contain Covidien Curity Oval Eye Pa... | Class II | Centurion Medical Products Corporation |
| Mar 9, 2017 | EYE KIT The Covidien Curity Oval Eye Pads are individually packaged and st... | Centurion Medical Products is recalling Convenience Kits that contain Covidien Curity Oval Eye Pa... | Class II | Centurion Medical Products Corporation |
| Mar 9, 2017 | SURESTEP Tray, Bardex I.C. Complete Care Drainage Bag, 2000 ml Drainage Bag, ... | Misbranded: Product labeled, Not made with natural rubber latex, may in fact contain natural ru... | Class II | C.R. Bard, Inc. |
| Mar 9, 2017 | Keystone Dental Inc. PrimaConnex Straight Implant TC, WD Internal Connection ... | Straight PrimaConnex Implants contained Tapered PrimaConnex Implants | Class II | Keystone Dental Inc |
| Mar 9, 2017 | POST-OPERATIVE OPHTHALMIC DRESSING TRAY The Covidien Curity Oval Eye Pads ... | Centurion Medical Products is recalling Convenience Kits that contain Covidien Curity Oval Eye Pa... | Class II | Centurion Medical Products Corporation |
| Mar 9, 2017 | POST-OP EYE TRAY The Covidien Curity Oval Eye Pads are individually packag... | Centurion Medical Products is recalling Convenience Kits that contain Covidien Curity Oval Eye Pa... | Class II | Centurion Medical Products Corporation |
| Mar 9, 2017 | OPHTHALMIC DRS TRAY The Covidien Curity Oval Eye Pads are individually pac... | Centurion Medical Products is recalling Convenience Kits that contain Covidien Curity Oval Eye Pa... | Class II | Centurion Medical Products Corporation |
| Mar 9, 2017 | OPHTHALMIC DRESSING TRAY The Covidien Curity Oval Eye Pads are individually ... | Centurion Medical Products is recalling Convenience Kits that contain Covidien Curity Oval Eye Pa... | Class II | Centurion Medical Products Corporation |
| Mar 9, 2017 | Hemotherm CE, model 400CE, Heater-Cooling Device | Improperly rated fuses were used in the manufacture of the device. | Class II | Cincinnati Sub-Zero Products Inc |
| Mar 9, 2017 | D-RAD, 2.4MMX 20MM, S.T. CORTEX SCREW, QTY: (1), STERILE R, RES 74682420 Ort... | The expiration dates on the labeling are incorrect, the actual expiration dates are before the da... | Class II | Smith & Nephew, Inc. |
| Mar 9, 2017 | D-RAD, 1.8MM X 16MM, LOCKING PEG, QTY: (1), STERILE R, RES 74671816 Orthopedic | The expiration dates on the labeling are incorrect, the actual expiration dates are before the da... | Class II | Smith & Nephew, Inc. |
| Mar 9, 2017 | Peri-Loc(R) VLP 3.5 MM X 6 MM SELF-TAPPING CORTEX SCREW, QTY: (1), STERILE R,... | The expiration dates on the labeling are incorrect, the actual expiration dates are before the da... | Class II | Smith & Nephew, Inc. |
| Mar 9, 2017 | CUSTOM CADAVER KIT The Covidien Curity Oval Eye Pads are individually packag... | Centurion Medical Products is recalling Convenience Kits that contain Covidien Curity Oval Eye Pa... | Class II | Centurion Medical Products Corporation |
| Mar 9, 2017 | D-RAD, S.T. LOCKING SCREWS, T7, QTY: (1), STERILE R, in the following sizes: ... | The expiration dates on the labeling are incorrect, the actual expiration dates are before the da... | Class II | Smith & Nephew, Inc. |
| Mar 8, 2017 | enGen (TM) Laboratory Automation Systems using all TCAutomation(TM) Software ... | Software anomaly; Thermo-Fisher Scientific initially discovered and Ortho-Clinical Diagnostics, s... | Class II | Ortho-Clinical Diagnostics |
| Mar 8, 2017 | Siemens ADVIA Centaur BR assay Cat No. 09010686, SMN 10340081 (5-pack/250 te... | Potential for the ADVIA Centaur Syphilis assay to interfere with the BR (CA 27.29) a assay on the... | Class II | Siemens Healthcare Diagnostics, Inc |
| Mar 8, 2017 | Siemens ADVIA Centaur BR assay Cat No. 02419937, SMN 10333349 (1-pack/50 tes... | Potential for the ADVIA Centaur Syphilis assay to interfere with the BR (CA 27.29) a assay on the... | Class II | Siemens Healthcare Diagnostics, Inc |
| Mar 8, 2017 | Sonesta S2; Article numbers: 525-S2-110V and 525¿¿S2-220V | The user / service manual for the Sonesta S2 Chair contain wrong information concerning the maxim... | Class II | Sonesta Medical Ab |
| Mar 8, 2017 | Ferno PROFlexx¿ Model 28Z Chair Cot | The recall was initiated as a result of the detection of an incorrect nut used in manufacturing. | Class II | Ferno-Washington Inc |
| Mar 8, 2017 | BIOMET 3i LTX DENTAL IMPLANTS Model LTX610 (6x10mm) - Plastic tray within ... | A single lot of product that potentially has a single part within the lot that does not match the... | Class II | Biomet 3i, LLC |
| Mar 8, 2017 | Siemens ADVIA Centaur BR assay Cat No. 03896216, SMN 10334837 (5-pack/250 te... | Potential for the ADVIA Centaur Syphilis assay to interfere with the BR (CA 27.29) a assay on the... | Class II | Siemens Healthcare Diagnostics, Inc |
| Mar 7, 2017 | Specimen Gate Laboratory; Product Number: 5002-0180 Specimen Gate Laboratory... | Potential for errors in patient results generated by the Specimen Gate Laboratory Software. | Class II | PerkinElmer Life and Analytical Sciences, Walla... |
| Mar 7, 2017 | NucliSENS Lysis Buffer, REF 200292 NucliSENS Lysis Buffer is intended to be ... | Problem with colored eluates for whole blood extractions | Class II | BioMerieux SA |
| Mar 7, 2017 | uNion Cervical Plate System Product Usage: The uNion Cervical Plate Syste... | Surgical technique was revised to prevent static plate screws blocking mechanisms from disassocia... | Class II | Ulrich Medical USA Inc |
| Mar 7, 2017 | Bush DL Ureteral Illuminating Catheter Set Bush SL Ureteral Illuminating Cat... | Product may overheat, melt, and burn patient. | Class II | Cook Inc. |
| Mar 7, 2017 | Access 2 Immunoassay Systems, Part No. 81600N Product Usage: The Access 2... | Beckman Coulter is recalling the Access 2 Family of Immunoassay Systems because a circuit board t... | Class II | Beckman Coulter Inc. |
| Mar 7, 2017 | UniCel DxC 600i SYNCHRON Access Clinical System, Part No. A25637, A25638 P... | Beckman Coulter is recalling the Access 2 Family of Immunoassay Systems because a circuit board t... | Class II | Beckman Coulter Inc. |
| 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 7, 2017 | VITROS Immunodiagnostic Products NT-pro BNP Reagent Pack, REF/Catalog 680 215... | Increased frequency of calibration failures for VITROS Immunodiagnostic Products NT-proBNP Reagen... | Class II | ORTHO-CLINICAL DIAGNOSTICS |
| Mar 7, 2017 | Access 2 assay Immunoassay System, Remanufactured, Part No. 386220 Product... | Beckman Coulter is recalling the Access 2 Family of Immunoassay Systems because a circuit board t... | Class II | Beckman Coulter Inc. |
| Mar 6, 2017 | Syngo.via, Picture archiving and communication system Syngo via is a softwar... | Software changes now available to address several issues | Class II | Siemens Medical Solutions USA, Inc |
| Mar 6, 2017 | Philips IntelliVue MX4O WLAN Patient Wearable Monitor Product: 865352 Excha... | Philips lntelliVue MX4O WLAN Patient Wearable Monitor may not automatically switch to Monitor Mo... | Class II | Philips Electronics North America Corporation |
| Mar 6, 2017 | Syngo.x, Picture archiving and communication system Syngo via is a software ... | Software changes now available to address several issues | Class II | Siemens Medical Solutions USA, Inc |
| Mar 3, 2017 | LASEREDGE Knives, CRESCENT BLADE STRAIGHT BEVEL UP STR (6/BOX), REF/PRODUCT C... | The complaints database was reviewed and there have been an atypical volume of dull blades compla... | Class II | Bausch & Lomb Inc Irb |
| Mar 3, 2017 | LASEREDGE Knives, CLEAR CORNEAL ANGLED 2.75PAR (6/BOX), REF/PRODUCT CODE E757... | The complaints database was reviewed and there have been an atypical volume of dull blades compla... | Class II | Bausch & Lomb Inc Irb |
| Mar 3, 2017 | LASEREDGE Knives, 2.75MM THIN SLIT ANGLED BEVELED UP (6/BOX)(6/BOX), REF/PROD... | The complaints database was reviewed and there have been an atypical volume of dull blades compla... | Class II | Bausch & Lomb Inc Irb |
| Mar 3, 2017 | LASEREDGE Knives, 19 GAUGE MVR BLADE (6/BOX), REF/PRODUCT CODE E7519, STERILE... | The complaints database was reviewed and there have been an atypical volume of dull blades compla... | Class II | Bausch & Lomb Inc Irb |
| Mar 3, 2017 | LASEREDGE Knives, CRESCENT KNIFE BEVELED UP ANGLED (6/BOX), REF/PRODUCT CODE ... | The complaints database was reviewed and there have been an atypical volume of dull blades compla... | Class II | Bausch & Lomb Inc Irb |
| Mar 3, 2017 | LASEREDGE Knives, 1.8mm x 2.2mm TRAPEZOID ANGLED KNIFE (6/BOX), REF/PRODUCT C... | The complaints database was reviewed and there have been an atypical volume of dull blades compla... | Class II | Bausch & Lomb Inc Irb |
| Mar 3, 2017 | LASEREDGE Knives, 2.2 MM SLIT KNIFE ANGLED DOUBLE BEVEL (6/BOX), REF/PRODUCT ... | The complaints database was reviewed and there have been an atypical volume of dull blades compla... | Class II | Bausch & Lomb Inc Irb |
| Mar 3, 2017 | LASEREDGE Knives, 3.2MM STRAIGHT SLIT KNIFE (6/BOX), REF/PRODUCT CODE E7557, ... | The complaints database was reviewed and there have been an atypical volume of dull blades compla... | Class II | Bausch & Lomb Inc Irb |
| Mar 3, 2017 | LASEREDGE Knives, 2.0MMX2.2MM TRAPEZOID ANGLED GUARDED (6/BOX), REF/PRODUCT C... | The complaints database was reviewed and there have been an atypical volume of dull blades compla... | Class II | Bausch & Lomb Inc Irb |
| Mar 3, 2017 | LASEREDGE Knives, 2.65 MM SLIT KNIFE ANGLED (6/BOX), REF/PRODUCT CODE E7551A,... | The complaints database was reviewed and there have been an atypical volume of dull blades compla... | Class II | Bausch & Lomb Inc Irb |
| Mar 3, 2017 | LASEREDGE Knives, 3.0MM SLIT KNIFE ANGLED GUARDED (6/BOX), REF/PRODUCT CODE E... | The complaints database was reviewed and there have been an atypical volume of dull blades compla... | Class II | Bausch & Lomb Inc Irb |
| Mar 3, 2017 | LASEREDGE Knives, 22.5 DEGREE STAB BLADE (6/BOX), REF/PRODUCT CODE E7522, STE... | The complaints database was reviewed and there have been an atypical volume of dull blades compla... | Class II | Bausch & Lomb Inc Irb |
| Mar 3, 2017 | LASEREDGE Knives, 5.2MM IMPLANT BLADE ANGLED (6/BOX), REF/PRODUCT CODE E7561A... | The complaints database was reviewed and there have been an atypical volume of dull blades compla... | Class II | Bausch & Lomb Inc Irb |
| Mar 3, 2017 | LASEREDGE Knives, 15 DEGREE STAB BLADE TIP (6/BOX), REF/PRODUCT CODE E7515T, ... | The complaints database was reviewed and there have been an atypical volume of dull blades compla... | Class II | Bausch & Lomb Inc Irb |
| Mar 3, 2017 | LASEREDGE Knives, 1.6MM X 1.8MM TRAPEZOID ANGLED (6/BOX), REF/PRODUCT CODE E7... | The complaints database was reviewed and there have been an atypical volume of dull blades compla... | Class II | Bausch & Lomb Inc Irb |
| Mar 3, 2017 | LASEREDGE Knives, CRESCENT BLADE BEVELED DN (6/BOX), REF/PRODUCT CODE E7510D,... | The complaints database was reviewed and there have been an atypical volume of dull blades compla... | Class II | Bausch & Lomb Inc Irb |
| Mar 3, 2017 | Covidien Curity Sodium Chloride Dressing , 6 x 6-3/4 (15.2 cm x 17.1 cm),... | Product sterility is compromised due to breach of sterile barrier | Class II | Covidien LLC |
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.