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 |
|---|---|---|---|---|
| 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 |
| Dec 18, 2019 | Polysorb Braided Absorbable Suture 2-0 VIOLET 36" GS-21, Item Code CL923 - Pr... | 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 VIOLET 30" V-20, Item Code GL123 - Pro... | 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 30" V-30 (75CM), Item Code GL22... | 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 13-0 VIOLET 30" GS-23, Item Code CL892 - P... | 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 30"VIOLET GU-46, Item Code UL878 - Pro... | 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 30" VIOLET GU-46, Item Code UL877 - Prod... | 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 36 VIOLET GS-24, Item Code CL914 - 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 3/0 VIOLET 30" CV-24 (75CM), Item Code CL4... | 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 4/0 30 VIOLET CVF23, Item Code UL203 - Pro... | 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 6/0 12"" VL SS-24 D/A, Item Code L1742K - ... | 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 30 VIOLET GS-22, Item Code CL885 - 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 30" V-20, Item Code GL323 - Pro... | 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 3/0 30 VIOLET GS-11, Item Code CL815 - Pro... | 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 30 VIOLET GS-21, Item Code CL811 - Pro... | There is a potential for packaging integrity issues impacting the humidity or sterility barrier o... | Class II | Covidien LLC |
| Dec 18, 2019 | Biosyn Monofilament Absorbable Suture 6/0 30" VIOLET CV-23, Item Code UM201 | 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 3/0 30" UNDYED V-20, Item Code GLS322 - Pr... | 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 4/0 30 VIO SC-2 124K, Item Code SL654 - Pr... | 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 36" VIOLET GS-24, Item Code CL911 - Prod... | 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 30" UNDYED HOS-11, Item Code CL537 - Pro... | 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 6-0 18" UNDYED SS-24 D/A, Item Code L2752K... | 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 6/0 18" UNDYED P-10, Item Code SL1625G - P... | There is a potential for packaging integrity issues impacting the humidity or sterility barrier o... | Class II | Covidien LLC |
| Dec 16, 2019 | 2.4MM TI VA LOCKING SCREW STARDRIVE 12MM STERILE, Part Number 04.210.112TS - ... | There is a possibility that the inner cap could open when the outer cap is removed or the entire ... | Class II | Synthes, Inc. |
| Dec 16, 2019 | 2.4MM TI VA LOCKING SCREW STARDRIVE 16MM STERILE, Part Number 04.210.116TS - ... | There is a possibility that the inner cap could open when the outer cap is removed or the entire ... | Class II | Synthes, 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.