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 Pressure Injectable Multi- Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue… Some of the products listed in the recall may be missing a sticker that contains the lot number, expiration date, and Unique Device Identification (UDI)… Class IIFDA’s classMar 21, 2018in FDA’s Enforcement Report7 statesnamed in where it went PublishedMar 21, 2018ClassClass IIStatusTerminatedWhereFlorida, Kentucky, Michigan, New Jersey, Ohio, South Carolina and Texas
- Medical device recall Pressure Injectable Multi- Lumen Central Venous Pressure Injectable ARROW(R) PICC Kit with Chlorag+ard(R)… Some of the products listed in the recall may be missing a sticker that contains the lot number, expiration date, and Unique Device Identification (UDI)… Class IIFDA’s classMar 21, 2018in FDA’s Enforcement Report7 statesnamed in where it went PublishedMar 21, 2018ClassClass IIStatusTerminatedWhereFlorida, Kentucky, Michigan, New Jersey, Ohio, South Carolina and Texas
- Medical device recall Pressure Injectable Multi- Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue… Some of the products listed in the recall may be missing a sticker that contains the lot number, expiration date, and Unique Device Identification (UDI)… Class IIFDA’s classMar 21, 2018in FDA’s Enforcement Report7 statesnamed in where it went PublishedMar 21, 2018ClassClass IIStatusTerminatedWhereFlorida, Kentucky, Michigan, New Jersey, Ohio, South Carolina and Texas
- Medical device recall AGB+ Pressure Injectable Multi- Lumen CVC Kit Product Usage: The Arrow¿ CVC is indicated to provide… Some of the products listed in the recall may be missing a sticker that contains the lot number, expiration date, and Unique Device Identification (UDI)… Class IIFDA’s classMar 21, 2018in FDA’s Enforcement Report7 statesnamed in where it went PublishedMar 21, 2018ClassClass IIStatusTerminatedWhereFlorida, Kentucky, Michigan, New Jersey, Ohio, South Carolina and Texas
- Medical device recall AGB+ Pressure Injectable Quad- Lumen CVC Kit Product Usage: The Arrow¿ CVC is indicated to provide short-term… Some of the products listed in the recall may be missing a sticker that contains the lot number, expiration date, and Unique Device Identification (UDI)… Class IIFDA’s classMar 21, 2018in FDA’s Enforcement Report7 statesnamed in where it went PublishedMar 21, 2018ClassClass IIStatusTerminatedWhereFlorida, Kentucky, Michigan, New Jersey, Ohio, South Carolina and Texas
- Medical device recall ARROWg+ard Blue¿ MAC” Two-Lumen Central Venous Access Kit Product Usage: The Arrow¿ CVC is indicated to… Some of the products listed in the recall may be missing a sticker that contains the lot number, expiration date, and Unique Device Identification (UDI)… Class IIFDA’s classMar 21, 2018in FDA’s Enforcement Report7 statesnamed in where it went PublishedMar 21, 2018ClassClass IIStatusTerminatedWhereFlorida, Kentucky, Michigan, New Jersey, Ohio, South Carolina and Texas
- Medical device recall ARROWg+ard Blue¿ Large-Bore Multi-Lumen CVC Kit Product Usage: The Arrow¿ CVC is indicated to provide… Some of the products listed in the recall may be missing a sticker that contains the lot number, expiration date, and Unique Device Identification (UDI)… Class IIFDA’s classMar 21, 2018in FDA’s Enforcement Report7 statesnamed in where it went PublishedMar 21, 2018ClassClass IIStatusTerminatedWhereFlorida, Kentucky, Michigan, New Jersey, Ohio, South Carolina and Texas
- Medical device recall ARROWg+ard Blue Product Usage: The Arrow¿ CVC is indicated to provide short-term (< 30 days) central venous… Some of the products listed in the recall may be missing a sticker that contains the lot number, expiration date, and Unique Device Identification (UDI)… Class IIFDA’s classMar 21, 2018in FDA’s Enforcement Report7 statesnamed in where it went PublishedMar 21, 2018ClassClass IIStatusTerminatedWhereFlorida, Kentucky, Michigan, New Jersey, Ohio, South Carolina and Texas
- Medical device recall AGB+ Pressure Injectable Multi- Lumen CVC Kit Product Usage: The Arrow¿ CVC is indicated to provide… Some of the products listed in the recall may be missing a sticker that contains the lot number, expiration date, and Unique Device Identification (UDI)… Class IIFDA’s classMar 21, 2018in FDA’s Enforcement Report7 statesnamed in where it went PublishedMar 21, 2018ClassClass IIStatusTerminatedWhereFlorida, Kentucky, Michigan, New Jersey, Ohio, South Carolina and Texas
- Medical device recall ARROWg+ard BLUE PLUS Pressure Injectable Two- Lumen CVC Kit Product Usage: The Arrow¿ CVC is indicated to… Some of the products listed in the recall may be missing a sticker that contains the lot number, expiration date, and Unique Device Identification (UDI)… Class IIFDA’s classMar 21, 2018in FDA’s Enforcement Report7 statesnamed in where it went PublishedMar 21, 2018ClassClass IIStatusTerminatedWhereFlorida, Kentucky, Michigan, New Jersey, Ohio, South Carolina and Texas
- Medical device recall ARROWg+ard BLUE PLUS Pressure Injectable Quad- Lumen CVC Kit Product Usage: The Arrow¿ CVC is indicated to… Some of the products listed in the recall may be missing a sticker that contains the lot number, expiration date, and Unique Device Identification (UDI)… Class IIFDA’s classMar 21, 2018in FDA’s Enforcement Report7 statesnamed in where it went PublishedMar 21, 2018ClassClass IIStatusTerminatedWhereFlorida, Kentucky, Michigan, New Jersey, Ohio, South Carolina and Texas
- Medical device recall ExacTrac versions 6.5 through 6.5 intended to be used to place patients at an accurately defined point within… The usage of workflows that deviate from the recommended specifications in the User manual for ExacTrac Patient Positioning System (versions 6.0, 6.1, 6.2,… 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 MAHURKAR”* Elite 12 FR x 16cm Acute Dual Lumen Dialysis Catheter with Curved Extensions, IC Trays Medtronic is voluntarily recalling one lot of its MAHURKAR”* Elite 12 FR x 16cm Acute Dual Lumen Dialysis Catheter with Curved Extensions, IC Trays, Lot… 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 36MM COCR MODULAR HD -6MM One piece from a different lot mixed with lot 236840 and is incorrectly etched as -6MM offset instead of +3MM offset. 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 fastener, fixation, nondegradable, soft tissue It was identified that the product was not assembled correctly causing the implant shaft to shift and fall out during the opening of the device, which… Class IIFDA’s classMar 21, 2018in FDA’s Enforcement Report11 statesnamed in where it went PublishedMar 21, 2018ClassClass IIStatusTerminatedWhereAlabama, Connecticut, Florida, Indiana, North Carolina, New Jersey, New York, Pennsylvania, Texas, Virginia and Wisconsin
- Medical device recall NaturaLyte¿ Liquid Acid Concentrate 2.0 mEq/L The label specifies the potassium concentration is 2.0 mEq/L. Class IIFDA’s classMar 21, 2018in FDA’s Enforcement Report5 statesnamed in where it went PublishedMar 21, 2018ClassClass IIStatusTerminatedWhereCalifornia, Florida, Kansas, Louisiana and Texas
- Medical device recall Vanguard CR Porous Femoral 62.5mm (Left Femur) For use in total knee arthroplasty The affected products are labeled as a 62.5mm LEFT Femur; however, the contents are a Vanguard 70mm RIGHT Femur. Class IIFDA’s classMar 21, 2018in FDA’s Enforcement Report5 statesnamed in where it went PublishedMar 21, 2018ClassClass IIStatusTerminatedWhereFlorida, Maryland, Michigan, Missouri and Wisconsin
- Medical device recall The GLOBAL UNITE Platform Shoulder System is intended for cemented or uncemented total shoulder or… The screw in specific lots of the GLOBAL UNITE Anatomic Body and GLOBAL UNITE Fracture Body was inverted during assembly to the body, which will cause the… 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 T/Pump temperature therapy pump, Models TP700 and TP700C The T/Pump Operations Manual and Maintenance Manual were incorrectly revised to add the sentence, Temperature therapy can also be for heat conservation for… Class IIIFDA’s classMar 21, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedMar 21, 2018ClassClass IIIStatusTerminatedWhereNationwide, and District of Columbia and Guam named
- Medical device recall BIPOLAR METAL SHELL 48 MM OD Use of the MultiPolar Bipolar Cup is indicated in: Total hip replacement 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 CPT 12/14 COCR REVISION SIZE 2 180MM prosthesis, hip, semi-constrained, metal/polymer, porous uncemented 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 CPT 12/14 COCR SIZE 0 STD prosthesis, hip, semi-constrained, metal/polymer, porous uncemented 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 CPT 12/14 COCR SIZE 1 EXT prosthesis, hip, semi-constrained, metal/polymer, porous uncemented 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 CPT 12/14 COCR SIZE 2 EXT prosthesis, hip, semi-constrained, metal/polymer, porous uncemented 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 CPT 12/14 COCR SIZE 2 STD prosthesis, hip, semi-constrained, metal/polymer, porous uncemented 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 VERSYS 10 INCH BEADED FC REV 13.5X250MM BWD LT and RT VERSYS BEADED FULLCOAT REVISION HIP PROSTHESIS 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 VERSYS 10 INCH BEADED FC REV 15.0X250MM BWD LT & RT VERSYS BEADED FULLCOAT REVISION HIP PROSTHESIS 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 VERSYS 6 INCH BEADED FC 12X160MM LM BODY EXT NECK VERSYS BEADED FULLCOAT REVISION HIP PROSTHESIS 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 VERSYS 6 INCH BEADED FC 13X160MM LM BODY EXT NECK & STD NECK Prosthesis, Hip, Semi-Constrained,… 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 VERSYS 6 INCH BEADED FC 14X160MM STD BODY EXT & STD NECK Prosthesis, Hip, Semi-Constrained, Metal/Polymer,… 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 VERSYS 6 INCH BEADED FC 15X160MM STD BODY STD NECK Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous… 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 VERSYS 6 INCH BEADED FC STEM 12X160MM LM 13X160MM LM 15X160MM LM 17X160MM LM Prosthesis, Hip,… 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 VERSYS 7.5 IN BEADED FC +10 CALCAR 13.5X180MM STR +10 CALCAR 15.5X180MM STR +20 CALCAR 16.5X180MM STR… 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 VERSYS 7.5 INCH BEADED FC REV 13.5X190MM STRAIGHT Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous… 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 VERSYS 8 INCH BEADED FC 12X200MM STR STD BODY/NECK 13X200MM STR STD BODY/NECK 14X200MM STR STD BODY/NECK REV… 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 POR FEM HATCP SIZE E/L SIZE F/L Knee Prosthesis 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-FLX POR HATCP FEM C-L MINUS CR-FLX POR HATCP FEM C-R MINUS CR-FLX POR HATCP FEM D-L MINUS CR-FLX POR HATCP… 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 HATCP FEM C-L CR-FLEX POR HATCP FEM C-R CR-FLEX POR HATCP FEM D-L CR-FLEX POR HATCP FEM D-R… 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 NP FEM LT SZ0 NATURAL-KNE NP FEM RT SZ0 NATURAL-KNE NP FEM LT SZ2 NATURAL-KNE NP FEM RT SZ2 NATURAL-KNE NP… 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 FEM IMPLANT SZ H-R This device is indicated for patients with severe knee pain and disability 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 OPTION FEMORAL C-L LPS OPTION FEMORAL C-R LPS OPTION FEMORAL D-L LPS OPTION FEMORAL D-R LPS OPTION… 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 FEM COMP SZ B-L LPS FEM COMP SZ B-R LPS FEM COMP SZ C-L LPS FEM COMP SZ C-R LPS FEM COMP SZ D-L LPS 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 LCCK FEM IMPLANT SZ C-L LCCK FEM IMPLANT SZ C-R LCCK FEM IMPLANT SZ D-R LCCK FEM IMPLANT SZ E-L LCCK 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 LPS POROUS FEM IMPLANT SZ G-L LPS PRECOAT FEM IMPLANT SZ 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 LPS PRECOAT SRF HDN FEM SZ D-L LPS PRECOAT SRF HDN FEM SZ D-R LPS PRECOAT SRF HDN FEM SZ E-L LPS POROUS SRF… 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 PRECOAT FEM SIZE D-RT LPS PRECOAT FEM SIZE E-RT LPS POROUS FEM SIZE F-RT This device is indicated for… 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 PRECOAT FEM COMP SIZE BMR CR PRECOAT FEM COMP SIZE C/R CR PRECOAT FEM COMP SIZE D/R CR PRECOAT FEM COMP… 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 OPTION FEM COMP SIZE C/L CR OPTION FEM COMP SIZE C/R CR OPTION FEM COMP SIZE D/L CR OPTION FEM COMP SIZE… 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
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.”
Your shortlist0 of 4
Add one more to compare.