Medical devices, 2020
Shortlist up to four to read them side by side.
3,055 medical device recalls FDA’s Enforcement Report published in 2020, 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.
3,055of 3,055 medical device recallsshown with your filters
The list
- Medical device recall Pentax Video Colonoscope Distributed in the USA without an approved 510K Class IIFDA’s classFeb 26, 2020in FDA’s Enforcement Report2 statesnamed in where it went PublishedFeb 26, 2020ClassClass IIStatusTerminatedWhereMassachusetts and North Carolina
- Medical device recall Pilling Aortic Punch, 4.0 mm Standard Tip There is a potential for the device packaging to become compromised; thus, the sterility of the device cannot be guaranteed. Class IIFDA’s classFeb 26, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 26, 2020ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall 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 device cannot be guaranteed. Class IIFDA’s classFeb 26, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 26, 2020ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Philips HeartStart FRx AED Affected devices contain a Printed Circuit Assembly (PCA) that was not manufactured/repaired in accordance to quality standards. Class IIFDA’s classFeb 26, 2020in FDA’s Enforcement Report13 statesnamed in where it went PublishedFeb 26, 2020ClassClass IIStatusTerminatedWhereCalifornia, Connecticut, Florida, Illinois, Michigan, Missouri, Mississippi, New Jersey, New York, Tennessee, Texas, Washington and Wisconsin
- Medical device recall Philips HeartStart HS1 Onsite (Model M5066A) and HSI Home (Model M5068A) AED Affected devices contain a Printed Circuit Assembly (PCA) that was not manufactured/repaired in accordance to quality standards. Class IIFDA’s classFeb 26, 2020in FDA’s Enforcement Report13 statesnamed in where it went PublishedFeb 26, 2020ClassClass IIStatusTerminatedWhereCalifornia, Connecticut, Florida, Illinois, Michigan, Missouri, Mississippi, New Jersey, New York, Tennessee, Texas, Washington and Wisconsin
- Medical device recall TwinFix Ti 2.8 mm HS Suture Anchor - Product Usage: A fixation device intended to provide secure attachment… Due to a potential for sterile barrier breach. Class IIFDA’s classFeb 26, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedFeb 26, 2020ClassClass IIStatusTerminatedWhereNationwide, and Arizona, Idaho, Missouri, North Carolina, North Dakota, Nebraska, Oklahoma, South Carolina and Tennessee named
- Medical device recall Polysorb Braided Absorbable Suture 3/0 VIOLET 30” CV-24 There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots. Class IIFDA’s classFeb 26, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 26, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Polysorb Braided Absorbable Suture 0 30” UNDYED HOS-11 There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots. Class IIFDA’s classFeb 26, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 26, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Polysorb Braided Absorbable Suture 2/0 30 VIOLET GS-21 There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots. Class IIFDA’s classFeb 26, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 26, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Polysorb Braided Absorbable Suture 3/0 30 VIOLET GS-11 There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots. Class IIFDA’s classFeb 26, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 26, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Polysorb Braided Absorbable Suture 1 30 VIOLET GS-22 There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots. Class IIFDA’s classFeb 26, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 26, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Polysorb Braided Absorbable Suture 13-0 VIOLET 30” GS-23 There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots. Class IIFDA’s classFeb 26, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 26, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Polysorb Braided Absorbable Suture 2 36” VIOLET GS-24 There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots. Class IIFDA’s classFeb 26, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 26, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Polysorb Braided Absorbable Suture 0 36 VIOLET GS-24 There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots. Class IIFDA’s classFeb 26, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 26, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Polysorb Braided Absorbable Suture 1 36 VIOLET GS-24 There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots. Class IIFDA’s classFeb 26, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 26, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Polysorb Braided Absorbable Suture 2-0 VIOLET 36” GS-21 There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots. Class IIFDA’s classFeb 26, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 26, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Polysorb Braided Absorbable Suture 1 36 VIOLET GS-21 There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots. Class IIFDA’s classFeb 26, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 26, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Polysorb Braided Absorbable Suture 2-0 UNDYED 36” GS-21 There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots. Class IIFDA’s classFeb 26, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 26, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Polysorb Braided Absorbable Suture 2-0 VIOLET 30” V-20 There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots. Class IIFDA’s classFeb 26, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 26, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Polysorb Braided Absorbable Suture 0 VIOLET 30” V-20 There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots. Class IIFDA’s classFeb 26, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 26, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Polysorb Braided Absorbable Suture 2/0 UNDYED 30” V-30 There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots. Class IIFDA’s classFeb 26, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 26, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Polysorb Braided Absorbable Suture 2-0 UNDYED 30” V-20 There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots. Class IIFDA’s classFeb 26, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 26, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Polysorb Braided Absorbable Suture 3/0 30” UNDYED V-20 There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots. Class IIFDA’s classFeb 26, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 26, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Polysorb Braided Absorbable Suture 6/0 12”” VL SS-24 D/A There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots. Class IIFDA’s classFeb 26, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 26, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Polysorb Braided Absorbable Suture 6-0 18” UNDYED SS-24 D/A There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots. Class IIFDA’s classFeb 26, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 26, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Polysorb Braided Absorbable Suture 6/0 18” UNDYED P-10 There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots. Class IIFDA’s classFeb 26, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 26, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Polysorb Braided Absorbable Suture UD 3/0 30 P-14 There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots. Class IIFDA’s classFeb 26, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 26, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Polysorb Braided Absorbable Suture UD 4/0 18 P-13 There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots. Class IIFDA’s classFeb 26, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 26, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Polysorb Braided Absorbable Suture 4/0 30 VIO SC-2 124K There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots. Class IIFDA’s classFeb 26, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 26, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Polysorb Braided Absorbable Suture 4/0 30 VIOLET CVF23 There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots. Class IIFDA’s classFeb 26, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 26, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Polysorb Braided Absorbable Suture 0 30” VIOLET GU-46 There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots. Class IIFDA’s classFeb 26, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 26, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Polysorb Braided Absorbable Suture 2/0 30”VIOLET GU-46 There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots. Class IIFDA’s classFeb 26, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 26, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Biosyn Monofilament Absorbable Suture 6/0 30” VIOLET CV-23 There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots. Class IIFDA’s classFeb 26, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 26, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Presource Procedure Packs containing AAMI Level 3 surgical gowns, Multiple The kits contained recalled surgical gowns. Class IIFDA’s classFeb 26, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 26, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Guided Start Drills/Counterbore NobRpl NP - Product Usage: The Guided Drills (Twist (Step) Drills, Guided… Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the… Class IIFDA’s classFeb 26, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 26, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Drill Tapered NP 3.5x8 mm Single-Pat - Product Usage: The Guided Drills (Twist (Step) Drills, Guided Tapered… Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the… Class IIFDA’s classFeb 26, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 26, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Dense Bone Drill 6.0 6x16 mm Single-Pat- Product Usage: The Guided Drills (Twist (Step) Drills, Guided… Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the… Class IIFDA’s classFeb 26, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 26, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Screw Tap Tapered WP Single-Pat - Product Usage: The Guided Drills (Twist (Step) Drills, Guided Tapered… Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the… Class IIFDA’s classFeb 26, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 26, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Drill Tapered NP 3.5x10 mm Single-Pat - Product Usage: The Guided Drills (Twist (Step) Drills, Guided Tapered… Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the… Class IIFDA’s classFeb 26, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 26, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Drill Tapered NP 3.5x11.5 mm Single-Pat - Product Usage: The Guided Drills (Twist (Step) Drills, Guided… Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the… Class IIFDA’s classFeb 26, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 26, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Drill Tapered RP 4.3x10 mm Single-Pat - Product Usage: The Guided Drills (Twist (Step) Drills, Guided Tapered… Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the… Class IIFDA’s classFeb 26, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 26, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Drill Tapered RP 4.3x11.5 mm Single-Pat - Product Usage: The Guided Drills (Twist (Step) Drills, Guided… Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the… Class IIFDA’s classFeb 26, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 26, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Drill Tapered RP 4.3x13 mm Single-Pat - Product Usage: The Guided Drills (Twist (Step) Drills, Guided Tapered… Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the… Class IIFDA’s classFeb 26, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 26, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Drill Tapered WP 5x10 mm Single-Pat - Product Usage: Drills are intended to be used in the upper and lower… Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the… Class IIFDA’s classFeb 26, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 26, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Drill Tapered WP 5x11.5 mm Single-Pat - Product Usage: Drills are intended to be used in the upper and lower… Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the… Class IIFDA’s classFeb 26, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 26, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Drill Tapered 6.0 6x8 mm Single-Pat - Product Usage: Drills are intended to be used in the upper and lower… Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the… Class IIFDA’s classFeb 26, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 26, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Dense Bone Drill NP 3.5x16 mm Single-Pat - Product Usage: Drills are intended to be used in the upper and… Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the… Class IIFDA’s classFeb 26, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 26, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Dense Bone Drill WP 5x13 mm Single-Pat - Product Usage: Drills are intended to be used in the upper and lower… Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the… Class IIFDA’s classFeb 26, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 26, 2020ClassClass 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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