Medical devices, 2018
Shortlist up to four to read them side by side.
3,757 medical device recalls FDA’s Enforcement Report published in 2018, newest first; 40,450 in all since 2012.
FDA’s medical device recalls, as its Enforcement Report classifies them, from June 2012. Lists of FDA’s records can’t be saved for alerts: openFDA asks that its data not be used to alert the public (openFDA); FDA’s own emails do that. Copied Nov 7, 2026.
3,757of 3,757 medical device recallsshown with your filters
The list
- Medical device recall LPS-FLEX OPTION FEMORAL C-L LPS-FLEX OPTION FEMORAL C-L LPS-FLEX OPTION FEMORAL C-R LPS-FLEX OPTION FEMORAL… The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE… Class IIFDA’s classMar 21, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 21, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall LPS-FLEX PRECOAT FEMORAL B-R LPS-FLEX PRECOAT FEMORAL C-L LPS-FLEX PRECOAT FEMORAL C-R LPS-FLEX PRECOAT… The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE… Class IIFDA’s classMar 21, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 21, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall NEXGEN LPS-FLEX PRECOAT FEMORAL SIZE E-LT This device is indicated for patients with severe knee pain and… The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE… Class IIFDA’s classMar 21, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 21, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall CR-FLEX OPT FEM C-R MINUS CR-FLEX OPT FEM D-L MINUS CR-FLEX OPT FEM D-R MINUS CR-FLEX OPT FEM E-L MINUS… The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE… Class IIFDA’s classMar 21, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 21, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall CR-FLEX OPT FEM C-L CR-FLEX OPT FEM C-R CR-FLEX OPT FEM D-L CR-FLEX OPT FEM D-R CR-FLEX OPT FEM E-L CR-FLEX… The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE… Class IIFDA’s classMar 21, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 21, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall CR-FLEX POR FEM F-L CR-FLEX POR FEM F-R MINUS CR-FLEX POR FEM G-L This device is indicated for patients with… The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE… Class IIFDA’s classMar 21, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 21, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall CR-FLEX PCT FEM C-R MINUS CR-FLEX PCT FEM D-L MINUS CR-FLEX PCT FEM D-R MINUS CR-FLEX PCT FEM E-L MINUS… The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE… Class IIFDA’s classMar 21, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 21, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall CR-FLEX PCT FEM B-R CR-FLEX PCT FEM C-L CR-FLEX PCT FEM C-R CR-FLEX PCT FEM D-L CR-FLEX PCT FEM D-R CR-FLEX… The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE… Class IIFDA’s classMar 21, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 21, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall PRCT MIS CR MOB PLT SZ 4 L¿ PRCT MIS CR MOB PLT SZ 5 L¿ PRCT MIS CR MOB PLT SZ 6 L¿ PRCT MIS CR MOB PLT SZ 7… The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE… Class IIFDA’s classMar 21, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 21, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall PATELLO-FEMORAL JOINT SYSTEM GENDER SOLUTIONS PATELLO-FEMORAL¿ Osteoarthritis, traumatic arthritis,… The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE… Class IIFDA’s classMar 21, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 21, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ZIMMER PATELLA FEMORAL JOINT¿ Osteoarthritis, traumatic arthritis, polyarthritis, and/or severe… The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE… Class IIFDA’s classMar 21, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 21, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ZUK PRC FEM SZB RMED/LLAT¿ ZUK PRC FEM SZC LMED/RLAT¿ ZUK PRC FEM SZC RMED/LLAT¿ NGU PRC FEM SZD LMED/RLAT¿… The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE… Class IIFDA’s classMar 21, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 21, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall FEM PRC LT M/RT L SML FEM PRC RT M/LT L SML FEM PRC LT M/RT L SML+ FEM PRC RT M/LT L SML+ FEM PRC LT M/RT L… The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE… Class IIFDA’s classMar 21, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 21, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall LPS-FLEX GSF OPT SZ C-L¿ LPS-FLEX GSF OPT SZ C-R¿ LPS-FLEX GSF OPT SZ D-L¿ LPS-FLEX GSF OPT SZ D-R¿ LPS-FLEX… The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE… Class IIFDA’s classMar 21, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 21, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall NEXGEN GSF POROUS FEMORAL LPS FLEX SIZE F, RIGHT¿ “ These devices are indicated for patients with: - Painful… The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE… Class IIFDA’s classMar 21, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 21, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall CR-FLEX GSF PCT SZ C-R MINUS¿ CR-FLEX GSF PCT SZ D-L MINUS¿ CR-FLEX GSF PCT SZ D-R MINUS¿ CR-FLEX GSF PCT SZ… The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE… Class IIFDA’s classMar 21, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 21, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall CR-FLEX GSF PRECOAT SZ C-L¿ CR-FLEX GSF PRECOAT SZ C-R¿ CR-FLEX GSF PRECOAT SZ D-L¿ CR-FLEX GSF PRECOAT SZ… The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE… Class IIFDA’s classMar 21, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 21, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall GENDER SOLUTIONS NATURAL-KNEE FLEX SYSTEM GENDER SOLUTIONS FEMALE (GSF) FEMORAL COMPONENT NONPOROUS¿ N-K FLX… The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE… Class IIFDA’s classMar 21, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 21, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall GENDER SOLUTIONS NATURAL-KNEE FLEX SYSTEM FEMORAL COMPONENT¿ N-K FLX GSM POR FEM SZ 2 RT N-K FLX GSM POR FEM… The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE… Class IIFDA’s classMar 21, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 21, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ZYMUTEST HIA IgGAM A voluntary recall is initiated for ZYMUTEST HIA lgGAM - Ref RK040D - Lot F1700415 and ZYMUTEST HIA MonoStrip lgGAM - Ref RK041D - Lot F1700416 because they… Class IIFDA’s classMar 21, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 21, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall ZYMUTEST HIA MonoStrip IgGAM A voluntary recall is initiated for ZYMUTEST HIA lgGAM - Ref RK040D - Lot F1700415 and ZYMUTEST HIA MonoStrip lgGAM - Ref RK041D - Lot F1700416 because they… Class IIFDA’s classMar 21, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 21, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall 6.5mm x 125mm x 16mm Cannulated Screw One lot of 3.5mm x 24mm Cortical Locking screws is labeled as 6.5mm x 125mm x 16mm Cannulated screws. Class IIFDA’s classMar 21, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 21, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall ACUSON SC2000 Ultrasound System Product Usage: The SC2000 ultrasound imaging system is intended for the… The application may underestimate the EROA (Effective Regurgitant Orifice Area) in comparison to the same patient results obtained with the 4Z1c volume… Class IIFDA’s classMar 21, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 21, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Neoplastine¿ Cl Plus @ (ref.00374) Product Usage: Manual or automated determination of the prothrombin time… Confirmed defect of homogeneity where some reagent vials will give prolonged Prothrombin Time (decreased PT%). Class IIFDA’s classMar 21, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 21, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Neoplastine¿ Cl Plus ¿ (ref. 00375) Product Usage: Manual or automated determination of the prothrombin time… Confirmed defect of homogeneity where some reagent vials will give prolonged Prothrombin Time (decreased PT%). Class IIFDA’s classMar 21, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 21, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall STA - Neoplastine¿ Cl ¿ (ref. 00605) Product Usage: Manual or automated determination of the prothrombin time… Confirmed defect of homogeneity where some reagent vials will give prolonged Prothrombin Time (decreased PT%). Class IIFDA’s classMar 21, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 21, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall STA - Neoplastine¿ Cl Plus ¿ (ref. 00606) Product Usage: Manual or automated determination of the prothrombin… Confirmed defect of homogeneity where some reagent vials will give prolonged Prothrombin Time (decreased PT%). Class IIFDA’s classMar 21, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 21, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall RaPET¿ RF Latex Reagent used as a component in the following kits: RaPET RF All patient serum samples yield a weakly positive test result. Class IIFDA’s classMar 21, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 21, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall TunneLoc Tibial Fixation Device Product Usage: To provide fixation of soft tissue grafts within the tibial… Gamma sterilization validation testing indicates the sterilization dose for the product may not be adequate. Class IIFDA’s classMar 21, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 21, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall TunneLoc Tibial Fixation Device (Within an ACL Kit) Product Usage: To provide fixation of soft tissue grafts… Gamma sterilization validation testing indicates the sterilization dose for the product may not be adequate. Class IIFDA’s classMar 21, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 21, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall PORT-A-CATH II PS/Titan, Tray PAC II Certain models and lots of PORT A CATH implantable port kits may have been misassembled. Class IIFDA’s classMar 21, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 21, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Power PORT-A-CATH II, TRAY POWER PAC II Certain models and lots of PORT A CATH implantable port kits may have been misassembled. Class IIFDA’s classMar 21, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 21, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall The GC80 Digital X-ray Imaging System An image was obtained with over exposure during a Thorax examination using the AEC function. Class IIFDA’s classMar 14, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 14, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall StrykeFlow 2 System, labeled sterile Routine bioburden testing of certain lots were found to have levels higher than internal acceptable rates. Class IIFDA’s classMar 14, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 14, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall STRYKER CASSETTE PUMP, AHTO Tube Set, labeled sterile Routine bioburden testing of certain lots were found to have levels higher than internal acceptable rates. Class IIFDA’s classMar 14, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 14, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall STRYKER WEDGE INTERFERENCE SCREW SYSTEM, ACL Interface Screw, 9MM X 25MM Routine bioburden testing of certain lots were found to have levels higher than internal acceptable rates. Class IIFDA’s classMar 14, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 14, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall ACL DISPOSABLE PACK BONE-TENDON-BONE Routine bioburden testing of certain lots were found to have levels higher than internal acceptable rates. Class IIFDA’s classMar 14, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 14, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Brilliance Big Bore Radiology CT with 4.2.0 software version Software issues including: Software errors that may result in Extended Field of View check message not displayed when Field of View is set >600 mm for a paused… Class IIFDA’s classMar 14, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 14, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Brilliance Big Bore Oncology CTwith 4.2.0 software version Software issues including: Software errors that may result in Extended Field of View check message not displayed when Field of View is set >600 mm for a paused… Class IIFDA’s classMar 14, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 14, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall IQon Spectral CT with 4.7.2 software version. 23 Software related issues for the IQon Spectral CT with 4.7.2 software version. Class IIFDA’s classMar 14, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 14, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall INFX-8000F Fluoroscopic X-Ray Systems During an examination a device error occurred and the ceiling drive operation was disabled. Class IIFDA’s classMar 14, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 14, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall INFX-8000C Fluoroscopic X-Ray Systems During an examination a device error occurred and the ceiling drive operation was disabled. Class IIFDA’s classMar 14, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 14, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall INFX-8000V Fluoroscopic X-Ray Systems During an examination a device error occurred and the ceiling drive operation was disabled. Class IIFDA’s classMar 14, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 14, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall INFX-8000H Fluoroscopic X-Ray Systems During an examination a device error occurred and the ceiling drive operation was disabled. Class IIFDA’s classMar 14, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 14, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall A-Series A3/A5 Anesthesia Delivery System A software issue may result in the previous settings being applied instead of the default settings or the unit may skip the startup leak test. Class IIFDA’s classMar 14, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 14, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall A-Series A7 Anesthesia Delivery System A software issue may result in the previous settings being applied instead of the default settings or the unit may skip the startup leak test. Class IIFDA’s classMar 14, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 14, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Concorde Lift Driver Shaft AO Potential for Intra-operative breakage of driver tips Class IIFDA’s classMar 14, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 14, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Concorde Lift Torque Limiting Handle Potential for Intra-operative breakage of driver tips Class IIFDA’s classMar 14, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 14, 2018ClassClass IIStatusTerminatedWhereNationwide
Nothing matches all of these.
Remove a filter to see more. Each one is a fact FDA’s record publishes, so a recall can be left out because its record is silent on it.
Source:
FDA, Device recall enforcement reports. Released Nov 3, 2026. Updated weekly.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.”
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