Browse Device Recalls
5,543 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 5,543 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 5,543 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Dec 1, 2021 | Hemashield Gold Knitted Bifurcated, 18 mm x 9 mm; reference number M002020851890 | There is a probable mislabeling of product. A Hemashield Platinum Woven Double Velour Bifurcated... | Class II | Maquet Cardiovascular, LLC |
| Nov 30, 2021 | activforce 2 package labeling: Model: Activ5-M R 201-200563 | Due to: 1) Manufacturing issue that result in inaccurate force measurement which may lead to may ... | Class II | Activbody, Inc. |
| Nov 30, 2021 | Box Label: activ5 TINY GYM IN YOUR POCKET activbody Model: Activ5 User Manual... | Due to: 1) Manufacturing issue that result in inaccurate force measurement which may lead to may ... | Class II | Activbody, Inc. |
| Nov 30, 2021 | Neodent Easypack Helix GM Acqua 3.5X8/Smart 4.5X2.5 -intended for dental impl... | Mislabeled: Carton box item 138.089- Easypack Helix GM Acqua 3.5X8/Smart 4.5X2.5 has an implant w... | Class II | Straumann USA LLC |
| Nov 30, 2021 | Neodent Easypack Helix GM Acqua 3.5X13/Smart 4.5X2.5 Article Number: 138.107 | Mislabeled: Carton box item 138.089- Easypack Helix GM Acqua 3.5X8/Smart 4.5X2.5 has an implant w... | Class II | Straumann USA LLC |
| Nov 30, 2021 | Regard, T AND A - Rogers, sterilized convenience kits | Kits lacks rubber latex warning label. | Class II | ROi CPS LLC |
| Nov 29, 2021 | Cardinal Infant Heel Warmer, Reference # 989805617251 11470-010T | After the device was cleared by the FDA, Philips made changes to the labeling that do not fall wi... | Class II | Philips North America Llc |
| Nov 29, 2021 | Infant Heel Warmers w/strap, Reference # 989805603201 1223 | After the device was cleared by the FDA, Philips made changes to the labeling that do not fall wi... | Class II | Philips North America Llc |
| Nov 29, 2021 | Heel Snuggler, Reference # 989805603411 99047 | After the device was cleared by the FDA, Philips made changes to the labeling that do not fall wi... | Class II | Philips North America Llc |
| Nov 29, 2021 | Medichoice Infant Heel Warmer, Reference # 989805643721 1079906 | After the device was cleared by the FDA, Philips made changes to the labeling that do not fall wi... | Class II | Philips North America Llc |
| Nov 26, 2021 | Infa-Therm Transport Mattress, Reference Number 989805616831 1015 | After the device was cleared by the FDA, Philips made changes to the labeling that do not fall wi... | Class II | Philips North America Llc |
| Nov 24, 2021 | RefleXion Medical Radiotherapy System - System Label: "*** refleXion REF ... | Due to dose discrepancy when delivering a plan to a patient in a Non-HFS (Head First Supine) orie... | Class II | Reflexion Medical, Inc. |
| Nov 22, 2021 | Electri-Cool II Portable Cold Therapy Unit, Model Number 767, Part Number 86193 | This recall has been initiated to provide a labeling update with revised instruction how to opera... | Class II | Gentherm Medical, LLC |
| Nov 12, 2021 | Flexor Check-Flo Introducer Ansel Modification Model Number: KCFW-6.0-18/38... | Flexor Check-Flo Introducer Ansel Modification mislabeled. Products packaged with a label statin... | Class II | Cook Inc. |
| Nov 12, 2021 | Flexor Check-Flo Introducer Ansel Modification Model Number: KCFW-7.0-18/38-... | Flexor Check-Flo Introducer Ansel Modification mislabeled. Products packaged with a label statin... | Class II | Cook Inc. |
| Nov 11, 2021 | O3D ORCHESTRATE Orthodontic Technologies User Manual and Data Processing Ins... | Due to product label/labeling being altered from it's approved state. | Class II | Orchestrate Orthodontic Technologies, Inc. |
| Nov 10, 2021 | iontoPATCH On-the-Go Patch Therapy, Transdermal Iontophoretic Drug Delivery S... | The dosage information on the pouch is incorrect; the primary carton label is correct. | Class III | Tapemark Company |
| Nov 9, 2021 | Stealth Autoguide Tracker, Model: 28248, which is an instrument in the Stealt... | A tracker that holds and guides neurosurgical surgical instruments may be subject to separation/w... | Class II | Medtronic Navigation, Inc. |
| Nov 9, 2021 | Torosa Saline-Filled Testicular Prosthesis (Size Small) | Product is mislabeled for size. | Class II | Coloplast Manufacturing US, LLC |
| Nov 5, 2021 | DigniCap Delta Scalp Cooling System, Product Number: 900-1001, Labeling: The... | Instructions for Use (IFUs) updated to include use of a headband is now recommended for all patie... | Class II | Dignitana, Inc. |
| Nov 4, 2021 | INBONE Total Ankle System, INBONE POLY INSERT SZ 2 10mm SULCUS | The package contents and package labeling do not match. | Class II | Wright Medical Technology Inc |
| Nov 4, 2021 | INBONE Total Ankle System, INBONE POLY INSERT SZ 2+ 14mm SULCUS | The package contents and package labeling do not match. | Class II | Wright Medical Technology Inc |
| Oct 29, 2021 | Diversatek Health, M-Catch Retrieval Nets, Part Number REF 1175-01, Quantity ... | M-Catch Retrieval Nets, Part Number 1175-01 / Lot Number 001919, that were shipped between 9-27-2... | Class II | Diversatek Healthcare |
| Oct 25, 2021 | Smith and Nephew EVOS Self-Tapping Locking Screw SST: (1)REF 72413575, 3.5MM... | The labels on the packages of screws were switched. | Class II | Smith & Nephew, Inc. |
| Oct 20, 2021 | Aspiration Syringe Kit, REF: MVSK60 | Syringe Kits labeled for distribution OUS were inadvertently shipped to US customers. | Class II | MICROVENTION INC. |
| Oct 14, 2021 | SHIP KIT, PROCEDURE KIT, PROTEKDUO LS - DL31 for temporary Cardiopulmonary by... | Top label of the outer package of the collection kit Item 5820-3118 showed expiration date of 202... | Class III | Cardiac Assist, Inc |
| Oct 14, 2021 | These are communication systems, labeled as: a. NaviCare Nurse Call, Part Nu... | An unrecoverable error may occur where a component will fail to complete the reboot cycle, become... | Class II | Hill-Rom Inc. |
| Oct 12, 2021 | Medtronic Custom Perfusion kits, with the following product descriptions and ... | Product is labeled as non-pyrogenic but endotoxin testing was not performed. | Class II | Medtronic Perfusion Systems |
| Oct 11, 2021 | GM Helix Acqua Implant 3.5x10, Article No. 140.944 | 3.5x11.5mm implants were mislabeled as 3.5x10mm implants. In borderline cases where the bone qual... | Class II | Jjgc Industria E Comercio De Materials Dentario... |
| Oct 7, 2021 | ComposiTCP 30 Interference screw D 7- L:25 mm, REF 110004605 | Mislabeled product. | Class II | SCIENCE & BIO MATERIALS |
| Oct 1, 2021 | REF 8420.15.010, Bone Screw/Vite - Ti6AI4V, Self Tapping/Autofilettante, Dia=... | There is a potential that the length of bone screws identified on labeling may not correspond to... | Class II | Limacorporate S.p.A |
| Oct 1, 2021 | REF 8420.15.020, Bone Screw/Vite - Ti6AI4V, Self Tapping/Autofilettante, Dia=... | There is a potential that the length of bone screws identified on labeling may not correspond to... | Class II | Limacorporate S.p.A |
| Sep 23, 2021 | ImplantDirect, REF 834711, Legacy 2 Implant 4.7mmD x 11.5mmL, 4.5mmD Platform, | Packaged dental implant contains a different size then the size declared on the labeling. | Class II | Implant Direct Sybron Manufacturing LLC |
| Sep 23, 2021 | ImplantDirect, REF 834713, Legacy 2 Implant 4.7mmD x 13mmL, 4.5mmD Platform, | Packaged dental implant contains a different size then the size declared on the labeling. | Class II | Implant Direct Sybron Manufacturing LLC |
| Sep 22, 2021 | ProxiDiagnost N90 is multi-functional general R/F systems. | The Aleva monitor requires certain labels to be applied, some of which are required by FDA Electr... | Class II | Philips Healthcare |
| Sep 22, 2021 | DigitalDiagnost C90 | The Aleva monitor requires certain labels to be applied, some of which are required by FDA Electr... | Class II | Philips Healthcare |
| Sep 22, 2021 | CombiDiagnost R90 is multi-functional general R/F systems. | The Aleva monitor requires certain labels to be applied, some of which are required by FDA Electr... | Class II | Philips Healthcare |
| Sep 21, 2021 | The da Vinci Xi and X surgical systems (IS4000 and IS4200) each consist of th... | Incorrect expiration date on its package labeling (shipper box and inner carton label). | Class II | Intuitive Surgical, Inc. |
| Sep 20, 2021 | 6.5MMX165MM CANNULATED SCREW | The product label incorrectly indicated that the screws are fully threaded, but the screws contai... | Class II | Smith & Nephew, Inc. |
| Sep 14, 2021 | The MEDRAD Twist & Go Disposable Syringe 150 mL with Quick Fill Tube is a syr... | Labeling error: MEDRAD Mark 7 Arterion Injection System Syringes (ART 700 SYR) labeled as Twist &... | Class II | Bayer Medical Care, Inc. |
| Sep 13, 2021 | Medtronic Bio-Medicus Insertion Kits, Model number 96553, Pediatric Insertion... | There was a label mix-up between two model numbers resulting in the incorrect guidewire being con... | Class II | Medtronic Perfusion Systems |
| Sep 10, 2021 | Easi-Care Gait Belt Metal Buckle (54", 60", and 72" lengths) | The belt may fail at lower loads than the labeled 600lbs. | Class II | Kinsman Enterprises Inc |
| Sep 8, 2021 | Vit Kit-Freeze is intended for use in assisted reproductive procedures for vi... | Due to a component in kit being labeled with the incorrect Expiration Date | Class II | Fujifilm Irvine Scientific, Inc. |
| Sep 8, 2021 | Kit: Central Line Dres Change 20/Cs | The ChloraPrep 3ml kit component has a shorter expiry date than the labeled kit expiry date. | Class II | Medical Action Industries, Inc. 306 |
| Sep 8, 2021 | Vit Kit-Freeze is intended for use in assisted reproductive procedures for vi... | Due to a component in kit being labeled with the incorrect Expiration Date | Class II | Fujifilm Irvine Scientific, Inc. |
| Sep 7, 2021 | Heparin, GORE VIABAHN VBX, BALLOON EXPANDABLE ENDOPROTHESIS, REF BXAL085902E... | Incorrect labeling, specifically, expandable endoprosthesis labeled as 8 mm x 59mm x 135 cm, howe... | Class II | W L Gore & Associates, Inc. |
| Sep 2, 2021 | REF/Catalogue Number GSXE0025, GORE CARDIOFORM SEPTAL OCCLUDER 25 mm Diameter... | Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiratio... | Class II | W L Gore & Associates, Inc. |
| Sep 2, 2021 | REF/Catalogue Number GSX0030A, GORE CARDIOFORM SEPTAL OCCLUDER 30 mm Diameter... | Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiratio... | Class II | W L Gore & Associates, Inc. |
| Sep 2, 2021 | REF/Catalogue Number GSXE0020, GORE CARDIOFORM SEPTAL OCCLUDER 20 mm Diameter... | Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiratio... | Class II | W L Gore & Associates, Inc. |
| Sep 2, 2021 | REF/Catalogue Number GSXE0030B, GORE CARDIOFORM SEPTAL OCCLUDER 30 mm Diamete... | Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiratio... | Class II | W L Gore & Associates, 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.