Browse Device Recalls
3,264 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,264 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 3,264 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Apr 23, 2020 | BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND"XL Alternate Sit... | Saline Flush Syringe compromised sterility due to holes in the packaging. | Class II | Access Scientific LLC |
| Apr 23, 2020 | BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 3Fr 6cm Pedia... | Saline Flush Syringe compromised sterility due to holes in the packaging. | Class II | Access Scientific LLC |
| Apr 23, 2020 | BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 5Fr 8cm Max B... | Saline Flush Syringe compromised sterility due to holes in the packaging. | Class II | Access Scientific LLC |
| Apr 22, 2020 | Pump Tube Set for MMS Libra and Solar Systems - Product Usage: Intended for u... | This field correction is being initiated to address potentially damaged seals in the packaging of... | Class II | LABORIE MEDICAL TECHNOLOGIES, CANADA ULC |
| Apr 16, 2020 | Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 68 right,... | The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging whi... | Class II | Howmedica Osteonics Corp. |
| Apr 16, 2020 | Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 66 left, ... | The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging whi... | Class II | Howmedica Osteonics Corp. |
| Apr 16, 2020 | Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 68 left, ... | The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging whi... | Class II | Howmedica Osteonics Corp. |
| Apr 16, 2020 | Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 66 right,... | The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging whi... | Class II | Howmedica Osteonics Corp. |
| Apr 16, 2020 | Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 58 Right,... | The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging whi... | Class II | Howmedica Osteonics Corp. |
| Apr 16, 2020 | Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 58 Left, ... | The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging whi... | Class II | Howmedica Osteonics Corp. |
| Apr 16, 2020 | Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 64 right,... | The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging whi... | Class II | Howmedica Osteonics Corp. |
| Apr 16, 2020 | Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 62 left, ... | The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging whi... | Class II | Howmedica Osteonics Corp. |
| Apr 16, 2020 | BD Posiflush SF Saline Flush Syringe (US Distributed Catalog 306553), UDI 503... | This product has been confirmed to exhibit holes in the packaging, which impacts package integrit... | Class II | Becton Dickinson & Company |
| Apr 16, 2020 | Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 56 Left, ... | The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging whi... | Class II | Howmedica Osteonics Corp. |
| Apr 16, 2020 | Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 60 Left, ... | The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging whi... | Class II | Howmedica Osteonics Corp. |
| Apr 16, 2020 | Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 62 right,... | The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging whi... | Class II | Howmedica Osteonics Corp. |
| Apr 16, 2020 | Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 60 right,... | The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging whi... | Class II | Howmedica Osteonics Corp. |
| Apr 16, 2020 | Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 54 Left, ... | The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging whi... | Class II | Howmedica Osteonics Corp. |
| Apr 16, 2020 | Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 56 Right,... | The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging whi... | Class II | Howmedica Osteonics Corp. |
| Apr 16, 2020 | Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 64 left, ... | The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging whi... | Class II | Howmedica Osteonics Corp. |
| Apr 16, 2020 | Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 54 Right,... | The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging whi... | Class II | Howmedica Osteonics Corp. |
| Mar 27, 2020 | Sterile Oxymetry Oligon Catheter Kit. Pressure injectable. REF/UDI:XA3816SAFK... | Sterile catheter kit packaging compromised. | Class II | Edwards Lifesciences, LLC |
| Mar 17, 2020 | Smith & Nephew FOOTPRINT ULTRA PK SUTURE ANCHOR 4.5 Part Number: 72202901 | Space between the device and the packaging permits excessive movement which could potentially lea... | Class II | Smith & Nephew, Inc. |
| Mar 17, 2020 | Jamshidi Bone Marrow Biopsy/Aspiration Needle, with Luer Lock Adapter 11GX4 A... | Sterility compromised due to packaging pouches that may not be sealed properly | Class II | Bard Peripheral Vascular Inc |
| Mar 17, 2020 | Smith & Nephew FOOTPRINT Ultra PK Suture Anchor, 5.5mm Part Number: 72202902 | Space between the device and the packaging permits excessive movement which could potentially lea... | Class II | Smith & Nephew, Inc. |
| Mar 9, 2020 | Custom convenience kits containing Medline brand Sterile Pre-Saturated Povido... | Medline identified that there may be a potential for voids in the packaging seal and loss of ster... | Class II | Medline Industries Inc |
| Feb 21, 2020 | R-F Injector Cannula. 20gx10cm-STERILE. REF/UDI: 257-2010/(01)10818788022124;... | Incorrect expiration date on introduction cannula packaging. | Class II | Epimed International |
| Feb 21, 2020 | R-F Injector Cannula. 18gx10cm-STERILE. REF/UDI: 257-1810/(01)00828788021496;... | Incorrect expiration date on introduction cannula packaging. | Class II | Epimed International |
| Feb 11, 2020 | NelDerm Hydrogel Dressing (Dressing: 6 x 6 ; Pad: 4 x 4 ) Product #: HB66T | Foreign material near or along the edge of the hydrogel adhesive within the pouch packaging | Class II | Nelson Innovaions, Llc |
| Feb 10, 2020 | Medline Winged Sponges Presaturated W/PVP REF DYND70289 DYND70289H Expiration... | Voids were discovered in the packaging seal and loss of sterility on the outside of the contents ... | Class II | Medline Industries Inc |
| Feb 10, 2020 | Covidien Force TriVerse Electrosurgical Devices, Product numbers FT3000 and F... | Sterile packaging may potentially be compromised, and use of products may result in increased ris... | Class II | Covidien Llc |
| Feb 10, 2020 | Medline Sterile 3mL Syringes with 21GA x 1 Inch Needle 80 each REF DYND3ML21G... | Voids were discovered in the packaging seal and loss of sterility on the outside of the contents ... | Class II | Medline Industries Inc |
| Feb 10, 2020 | Medline Stick Sponge Presaturated W/PVP REF DYND70288 DYND70288H 2/PK Expirat... | Voids were discovered in the packaging seal and loss of sterility on the outside of the contents ... | Class II | Medline Industries Inc |
| Feb 10, 2020 | Kits containing Covidien Force TriVerse Electrosurgical Devices. Distributed ... | Sterile packaging may potentially be compromised, and use of products may result in increased ris... | Class II | Covidien Llc |
| Feb 6, 2020 | Teleflex Pilling Aortic Punch, 4.0mm. Sterile, Rx Only, disposable. Included... | The sterile packaging has the potential to be compromised. | Class II | Deroyal Industries, Inc. Lafollette |
| Jan 21, 2020 | COLUMBUS REV F TIBIA OFFSET CEMENTED, Knee implant components, various sizes,... | Low Density Polyethylene (LDPE) particles may be present on the surface of the implant upon the o... | Class II | Aesculap Implant Systems LLC |
| Jan 21, 2020 | AS COLUMBUS CR/PS TIB.PLAT.CEMENTED,Knee implant components, various sizes, ... | Low Density Polyethylene (LDPE) particles may be present on the surface of the implant upon the o... | Class II | Aesculap Implant Systems LLC |
| Jan 21, 2020 | COLUMBUS CR/PS TIB.PLAT.PLASMAPORE, Knee implant components, various sizes, m... | Low Density Polyethylene (LDPE) particles may be present on the surface of the implant upon the o... | Class II | Aesculap Implant Systems LLC |
| Jan 21, 2020 | COLUMBUS CRA/PSA TIB.PLAT.CEMENTED, Knee implant components, various sizes, m... | Low Density Polyethylene (LDPE) particles may be present on the surface of the implant upon the o... | Class II | Aesculap Implant Systems LLC |
| Jan 21, 2020 | Columbus R/PS TIB.PLATEAU Cemented, various sizes, Knee implant components, m... | Low Density Polyethylene (LDPE) particles may be present on the surface of the implant upon the o... | Class II | Aesculap Implant Systems LLC |
| Jan 14, 2020 | Ormco Damon Q2 Orthodontic Metal Bracket, Part No. 491-9834, L3R Hi Tq Hook, ... | The bracket torque was mislabeled on the packaging. | Class II | Ormco/Sybronendo |
| Jan 13, 2020 | Teleflex Medical Disposable Aortic Punch, in the following sizes: a) 2.8 mm,... | There is a potential for the device packaging to become compromised; thus, the sterility of the d... | Class II | TELEFLEX MEDICAL INC |
| Jan 13, 2020 | Pilling Aortic Punch, 4.0 mm Standard Tip, REF 353440 | There is a potential for the device packaging to become compromised; thus, the sterility of the d... | Class II | TELEFLEX MEDICAL INC |
| Jan 7, 2020 | THP Hip Plating System, Item Nos. 14-451070 14-451075 14-451080 14-451085 ... | Potential increase in fracture rate was detected during internal testing, in addition to potentia... | Class II | Zimmer Biomet, Inc. |
| Dec 18, 2019 | Polysorb Braided Absorbable Suture 1 36 VIOLET GS-21, Item Code CL925 - Produ... | There is a potential for packaging integrity issues impacting the humidity or sterility barrier o... | Class II | Covidien LLC |
| Dec 18, 2019 | Polysorb Braided Absorbable Suture 1 36 VIOLET GS-24, Item Code CL915 - Produ... | There is a potential for packaging integrity issues impacting the humidity or sterility barrier o... | Class II | Covidien LLC |
| Dec 18, 2019 | Polysorb Braided Absorbable Suture UD 4/0 18 P-13, Item Code SL5690 - Product... | There is a potential for packaging integrity issues impacting the humidity or sterility barrier o... | Class II | Covidien LLC |
| Dec 18, 2019 | Polysorb Braided Absorbable Suture UD 3/0 30 P-14, Item Code SL5679 - Product... | There is a potential for packaging integrity issues impacting the humidity or sterility barrier o... | Class II | Covidien LLC |
| Dec 18, 2019 | Polysorb Braided Absorbable Suture 0 VIOLET 30" V-20, Item Code GL124 - Produ... | There is a potential for packaging integrity issues impacting the humidity or sterility barrier o... | Class II | Covidien LLC |
| Dec 18, 2019 | Polysorb Braided Absorbable Suture 2-0 UNDYED 36" GS-21, Item Code CL953 - Pr... | There is a potential for packaging integrity issues impacting the humidity or sterility barrier o... | 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.