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 3, 2017 | ViperWire Advance Peripheral Guide Wire with Flex Tip, Model No. VPR-GW-FT18.... | Cardiovascular Systems, Inc. is recalling one lot of ViperWire Advance with Flextip, model VPR-GW... | Class II | Cardiovascular Systems Inc |
| Mar 3, 2017 | Covidien Kerlix Super Sponge Saline Dressing, Sterile Item Code: 3338 Curi... | Product sterility is compromised due to breach of sterile barrier | Class II | Covidien LLC |
| Mar 3, 2017 | Dimension Vista 500 Intelligent Lab System and Dimension Vista 1500 Intellige... | Siemens Healthcare Diagnostics has confirmed that in isolated cases when ECREA is processed immed... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Mar 3, 2017 | Covidien Curity Eye Pad Oval, 1-5/8 x 2-5/8 (4.2 cm x 6.7 cm), Sterile It... | Product sterility is compromised due to breach of sterile barrier | Class II | Covidien LLC |
| Mar 3, 2017 | LASEREDGE Knives, 3.0MM SLIT KNIFE ANGLED DOUBLE BEVEL (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, 4.0MM IMPLANT BLADE ANGLED (6/BOX), REF/PRODUCT CODE E7560A... | 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, 2.65MM SLIT KNIFE ANGLED BEVEL UP GUARDED (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, 30 DEGREE STAB BLADE (6/BOX), REF/PRODUCT CODE E7530, STERI... | 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 | 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 3, 2017 | LASEREDGE Knives, 0.88MM ARROW KNIFE ANGLED (6/BOX), REF/PRODUCT CODE E7593, ... | 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 2.9MM (6/BOX), REF/PRODUCT CODE E7587A... | 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 2.85 (6/BOX), REF/PRODUCT CODE E7528, ... | 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, KNIFE ANGLED BEVELED UP 2.7(6/BOX), REF/PRODUCT CODE E7559A... | 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 2.75 (6/BOX), REF/PRODUCT CODE E7527, ... | 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 Saline Dressing 8' x 4 (20.3cm x10.2 cm), Sterile Item Code:... | Product sterility is compromised due to breach of sterile barrier | Class II | Covidien LLC |
| Mar 3, 2017 | LASEREDGE Knives, 2.6 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, 2.5 MM SLIT KNIFE BEVEL UP ANGLED GUARDED(6/BOX), REF/PRODU... | 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 DOUBLE BEVEL (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 | It is recommended for patients with weight/size between 4-22 lbs (1.8-10 kg).... | Product labeled as GVL 2 Stat (blades), lot GC32825, was physically packaged with the incorrect s... | Class II | Verathon Inc |
| Mar 3, 2017 | Covidien Curity Eye Pad Item Code: 03201 The sterile eye pad is a device t... | Product sterility is compromised due to breach of sterile barrier | Class II | Covidien LLC |
| Mar 3, 2017 | LASEREDGE Knives, CLEAR CORNEAL ANGLED 2.855MM 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, 2.0MMX2.2MM TRAPEZOID ANGLED (6/BOX), REF/PRODUCT CODE E760... | 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, 2.85MM SLIT KNIFE ANGLED (6/BOX), REF/PRODUCT CODE E7553A, ... | 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, 2.5 MM SLIT KNIFE ANGLED (6/BOX), REF/PRODUCT CODE E7550A, ... | 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 | Panta Nail, Rx only, Sterile, | Voluntary recall/Removal of Panta and Panta XI Nails because there may be the potential that the ... | Class II | Integra LifeSciences Corp. |
| Mar 3, 2017 | LASEREDGE Knives, 15 DEGREE STAB BLADE (6/BOX), REF/PRODUCT CODE E7515, STERI... | 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, 2.8MM SLIT KNIFE ANGLED DOUBLE BEVEL (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 | The CG+ Arrow PIC Catheters permit venous access to the central circulation t... | Arrow International, Inc. notified its customers who received the affected Antimicrobial/Antithro... | Class II | Arrow International Inc |
| Mar 3, 2017 | LASEREDGE Knives, CRESCENT BLADE ANGLED TIP BEVEL UP (6/BOX), REF/PRODUCT COD... | 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, 20 GAUGE MVR BLADE (6/BOX), REF/PRODUCT CODE E7520, 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, 2.65MM SLIT KNIFE ANGLED DOUBLE BEVEL GUARDED (6/BOX), REF/... | 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, 30 DEGREE STAB BLADE TIP (6/BOX), REF/PRODUCT CODE E7530T, ... | 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 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, 2.65MM 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, 2.4 MM SLIT KNIFE ANGLED DOUBLE BEVEL, REF/PRODUCT CODE E75... | 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 Eye Pad Item Code: 91650 The sterile eye pad is a device t... | Product sterility is compromised due to breach of sterile barrier | Class II | Covidien LLC |
| Mar 3, 2017 | LASEREDGE Knives, CLEAR 3.0 MM CLEAR CORNEAL ANGLED KNIFE (6/BOX), REF/PRODUC... | 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 SLIT KNIFE ANGLED (6/BOX), REF/PRODUCT CODE E7557A, S... | 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, 1.1MM ARROW KNIFE ANGLED (6/BOX), REF/PRODUCT CODE E7592, S... | 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 Wet Dressing 8 x 4 (20.3 cm x 10.2 cm), Sterile Item Code:... | Product sterility is compromised due to breach of sterile barrier | Class II | Covidien LLC |
| Mar 3, 2017 | ImplantDirect, Dental implants intended for use in partially and fully edentu... | The main vial label lists the incorrect part number, but the cap label is correct. | Class II | Implant Direct Sybron Manufacturing, LLC |
| 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 | Myelotec Video Guided Catheters, REF 2010 3.0 mm OD x 30 Cm Working Length, ... | Obstructed/blocked port from defective VGC Access Port Body component. | Class II | Myelotec, Inc. |
| Mar 2, 2017 | Vertebral Motion Analyzer (VMA), 2.3.239 - 2.3.254. Product Usage: VMA so... | Ortho Kinematics notified customers that errors were contained in Radiological Read Report and VM... | Class II | Ortho Kinematics, Inc |
| 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 |
| Mar 1, 2017 | Cobas 8100 uni-directional reformatter (BRF) module with Software Version 02-xx | Roche Diagnostics Corp. initiated a voluntary correction because a rack crash may occur on the Co... | Class II | Roche Diagnostics Corporation |
| Mar 1, 2017 | Cobas 8100 bi-directional reformatter (BRF) module with Software Version 02-xx | "Roche Diagnostics Corp. initiated a voluntary correction because a rack crash may occur on the C... | Class II | Roche Diagnostics Corporation |
| Mar 1, 2017 | Inion GRT Tack, drill bit and tack appl., 4x, Sterile. Is indicated for t... | Aluminum pouch seal was noticed to be defective (slightly open). | Class II | Inion Ltd. |
| Feb 28, 2017 | Segmental fluted stem, 18x250mm bwd, Sterile, | Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged ... | Class II | Zimmer Biomet, 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.