Browse Device Recalls
3,191 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,191 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 3,191 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jan 7, 2026 | Medline Convenience Kits: 1) ADMIT KIT, Model Number: DYKA1343A | Medline has identified issues related to calibration of the equipment used to sterilize and packa... | Class II | Medline Industries, LP |
| Jan 7, 2026 | Medline Convenience Kits: 1) LVAD DRIVELINE TRAY, Model Number: DM1035; 2)... | Medline has identified issues related to calibration of the equipment used to sterilize and packa... | Class II | Medline Industries, LP |
| Jan 7, 2026 | Medline Convenience Kits: 1) DRAPE PACK-CHOICE, Model Number: DYNJ63118A | Medline has identified issues related to calibration of the equipment used to sterilize and packa... | Class II | Medline Industries, LP |
| Jan 7, 2026 | Medline Convenience Kits: 1) KIT ACES INSERT PEG, Model Number: DYKMBNDL130;... | Medline has identified issues related to calibration of the equipment used to sterilize and packa... | Class II | Medline Industries, LP |
| Jan 7, 2026 | Medline Convenience Kits: 1) KIT TRIPLE LUMEN INSERTION, Model Number: DYNDM... | Medline has identified issues related to calibration of the equipment used to sterilize and packa... | Class II | Medline Industries, LP |
| Jan 7, 2026 | Medline Convenience Kits: 1) KIT SURG ONC EXCISION BREAST, Model Number: DYK... | Medline has identified issues related to calibration of the equipment used to sterilize and packa... | Class II | Medline Industries, LP |
| Jan 5, 2026 | EMPOWR Acetabular System: Liner, 10 degree Hooded, HXe+, 36H, REF: 942-01-36H... | 942-01-40G acetabular system package was found to contain 942-01-36H acetabular system; and sever... | Class II | Encore Medical, LP |
| Jan 5, 2026 | EMPOWR 3D Knee Tibial Insert 5R 14MM, VE, REF: 342-14-705 | 942-01-40G acetabular system package was found to contain 942-01-36H acetabular system; and sever... | Class II | Encore Medical, LP |
| Dec 24, 2025 | Medline medical convenience kits packaged as: MERCY CIRCUMCISION TRAY, Kit S... | Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing... | Class II | Medline Industries, LP |
| Dec 24, 2025 | Medline medical convenience kits packaged as: ADULT CATH SECUREMENT DRSG, Ki... | Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing... | Class II | Medline Industries, LP |
| Dec 24, 2025 | Medline medical convenience kits packaged as: BLOOD CULTURE KIT NS, Kit SKU ... | Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing... | Class II | Medline Industries, LP |
| Dec 24, 2025 | 1) UNIVERSAL KIT, Kit SKU DT22010B; 2) VAD ACCESS KIT, Kit SKU DT22790C; ... | Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing... | Class II | Medline Industries, LP |
| Dec 24, 2025 | Medline medical convenience kits packaged as: 1) CANCER SERVICE PORT KIT, ... | Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing... | Class II | Medline Industries, LP |
| Dec 24, 2025 | Medline medical convenience kits packaged as: STERILE RESUTURE PACK, Kit SKU... | Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing... | Class II | Medline Industries, LP |
| Dec 24, 2025 | Medline medical convenience kits packaged as: ) LVAD DRESSING CHANGE TRAY,... | Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing... | Class II | Medline Industries, LP |
| Dec 24, 2025 | Medline medical convenience kits packaged as: ANESTHESIA ARTLINE PACK, Kit S... | Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing... | Class II | Medline Industries, LP |
| Dec 24, 2025 | Medline medical convenience kits packaged as: SUTURE REMOVAL TRAY, Kit SKU D... | Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing... | Class II | Medline Industries, LP |
| Dec 24, 2025 | Medline medical convenience kits packaged as: PEDIATRIC CATH SECUREMENT DRSG... | Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing... | Class II | Medline Industries, LP |
| Dec 24, 2025 | Medline medical convenience kits packaged as: 1) POWERGLIDE DRESSING CHANG... | Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing... | Class II | Medline Industries, LP |
| Dec 22, 2025 | LSL Healthcare, Central Line Dressing Kit, Model/Catalog Number: 2519CP, medi... | BD ChloraPrep Triple Swabsticks, a component within the kits, exhibit an open seal on the packagi... | Class II | LSL Healthcare Inc. |
| Dec 18, 2025 | Gelsoft Plus, REF: 635024PE, 631514PE, 631222PE, 633008PE, 633010PE, 633007PE... | Gelatin sealed woven polyester prostheses devices, designed for vascular repair, were incorrectly... | Class II | Vascutek, Ltd. |
| Dec 17, 2025 | Genesis Screw-In Anchor | Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture bre... | Class II | Aju Pharm Co., Ltd. |
| Dec 17, 2025 | Genesis Dual Thread Screw-In Anchor | Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture bre... | Class II | Aju Pharm Co., Ltd. |
| Dec 17, 2025 | AlternatiV+ Max Knotless Anchor | Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture bre... | Class II | Aju Pharm Co., Ltd. |
| Dec 17, 2025 | Genesis Knotless Anchor | Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture bre... | Class II | Aju Pharm Co., Ltd. |
| Dec 17, 2025 | Fixone Hybrid Anchor | Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture bre... | Class II | Aju Pharm Co., Ltd. |
| Dec 17, 2025 | Fixone Biocomposite Anchor | Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture bre... | Class II | Aju Pharm Co., Ltd. |
| Dec 17, 2025 | Genesis Push-In Suture Anchor | Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture bre... | Class II | Aju Pharm Co., Ltd. |
| Dec 17, 2025 | AlternatiV+ Screw-In Anchor | Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture bre... | Class II | Aju Pharm Co., Ltd. |
| Nov 27, 2025 | Brand Name: HiResolution Bionic Ear System Product Name: Sky CI M90 Sound Pr... | Behind-the-ear sound processer packaging label is different then included product. | Class II | Advanced Bionics, LLC |
| Nov 13, 2025 | FORCEP, STD STR, STERILE KELLY, 5.5 IN, Item Number DYNJ04048 | The items may have weak packaging seals that may result in a breach of sterility if the seal fail... | Class II | Medline Industries, LP |
| Nov 13, 2025 | SCISSORS, OR, SHARP/BLUNT, 5.5", STERILE, Item Number DYND04000 | The items may have weak packaging seals that may result in a breach of sterility if the seal fail... | Class II | Medline Industries, LP |
| Nov 12, 2025 | ChemoPlus gowns: Product Code Product Description CT5500T ChemoPlus Full Co... | Affected gowns have the incorrect expiration date on the product packaging. Product has a shelf-l... | Class II | Cardinal Health 200, LLC |
| Oct 31, 2025 | NICO Myriad Illumination Pack Product No. NN-1000 11g Illumination Sleeve... | Tape used to secure components within packaging contains latex, despite products being labeled as... | Class II | Stryker Corporation |
| Oct 31, 2025 | NICO Myriad Handpiece Product Number/Product Name: NN-8000 15x10 MHP; ... | Tape used to secure components within packaging contains latex, despite products being labeled as... | Class II | Stryker Corporation |
| Oct 31, 2025 | NICO BrainPath; Product Number/Product Name NN-8024 BrainPath Shephard's... | Tape used to secure components within packaging contains latex, despite products being labeled as... | Class II | Stryker Corporation |
| Oct 27, 2025 | Quick Strip Plastic Sterile Adhesive Bandages, 1" x 3", Medline Item Number N... | Medline has identified that all lots of the Curad Touch-Free and Quick-Strip Bandages may exhibit... | Class II | Medline Industries, LP |
| Oct 27, 2025 | Curad Quick Strip Fabric Bandages Containing 30 Bandages of 3/4" x 3", Medlin... | Medline has identified that all lots of the Curad Touch-Free and Quick-Strip Bandages may exhibit... | Class II | Medline Industries, LP |
| Oct 27, 2025 | CURAD Germ-Shield Touch-Free Fabric Bandages, Sterile, 0.75" x 3", 30/Box, Me... | Medline has identified that all lots of the Curad Touch-Free and Quick-Strip Bandages may exhibit... | Class II | Medline Industries, LP |
| Oct 27, 2025 | Fur Friends Plastic Sterile Adhesive Bandages, 0.75" x 3", Medline Item Numbe... | Medline has identified that all lots of the Curad Touch-Free and Quick-Strip Bandages may exhibit... | Class II | Medline Industries, LP |
| Oct 27, 2025 | Quick Strip Plastic Sterile Adhesive Bandages, 0.75" x 3", Medline Item Numbe... | Medline has identified that all lots of the Curad Touch-Free and Quick-Strip Bandages may exhibit... | Class II | Medline Industries, LP |
| Oct 27, 2025 | Quick Strip Fabric Sterile Adhesive Bandages, 0.75" x 3", Medline Item Number... | Medline has identified that all lots of the Curad Touch-Free and Quick-Strip Bandages may exhibit... | Class II | Medline Industries, LP |
| Oct 27, 2025 | Quick Strip Fabric Sterile Adhesive Bandages, 1" x 3", Medline Item Number NO... | Medline has identified that all lots of the Curad Touch-Free and Quick-Strip Bandages may exhibit... | Class II | Medline Industries, LP |
| Oct 17, 2025 | MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Straight Extensions ... | A potential issue with the seal integrity of header bag packaging. | Class II | Mozarc Medical US LLC |
| Oct 17, 2025 | MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Straight Extensions ... | A potential issue with the seal integrity of header bag packaging. | Class II | Mozarc Medical US LLC |
| Oct 17, 2025 | MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Curved Extensions wi... | A potential issue with the seal integrity of header bag packaging. | Class II | Mozarc Medical US LLC |
| Oct 17, 2025 | MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Curved Extensions wi... | A potential issue with the seal integrity of header bag packaging. | Class II | Mozarc Medical US LLC |
| Oct 17, 2025 | MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Straight Extensions ... | A potential issue with the seal integrity of header bag packaging. | Class II | Mozarc Medical US LLC |
| Oct 17, 2025 | MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Curved Extensions wi... | A potential issue with the seal integrity of header bag packaging. | Class II | Mozarc Medical US LLC |
| Oct 6, 2025 | Brand Name: Olympus Single Use Electrosurgical Snare SD-400 Product Name: Si... | Sterility compromised from small holes that may occur during packaging of the device pouches into... | Class II | Olympus Corporation of the Americas |
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.