Medical devices, 2023
Shortlist up to four to read them side by side.
2,477 medical device recalls FDA’s Enforcement Report published in 2023, 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 6, 2026.
2,477of 2,477 medical device recallsshown with your filters
The list
- Medical device recall Monosof Monofilament Nylon sutures: Product Description CN-724 MONOSOF* 1 BLK 100CM GS25 X36 CN-791 MONOSOF*… Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact Class IIFDA’s classMar 8, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 8, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Novafil Monofilament Polybutester Suture Product Description: 8886 4002-41 NOVAFIL 3-0 BLU 90CM C14 8886… Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact Class IIFDA’s classMar 8, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 8, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Sofsilk Coated Braided Silk Suture Product Description CS-211 SOFSILK* 4-0 BLK 45CM CVF21 X36 CS211 CS-490… Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact Class IIFDA’s classMar 8, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 8, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Surgidac Uncoated Braided Polyester suture Product Description D-1764K SURGIDAC* 5-0 WHI 45CM SS24DA Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact Class IIFDA’s classMar 8, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 8, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Surgilon Braided Nylon suture Product Description: 88861883-51 SURGILON* 2-0 BLK 75CM C16 88861915-71… Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact Class IIFDA’s classMar 8, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 8, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Surgipro Monofilament Polypropylene Sutures Product Description CP-535 SURGIPRO* 1 BLU 100CM GS24 X36 CP-824… Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact Class IIFDA’s classMar 8, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 8, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Surgipro II Monofilament Polypropylene Sutures Product Description Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact Class IIFDA’s classMar 8, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 8, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Ti-Cron Coated Braided Polyester Suture Product Description 88862775-31 TICRON* 4-0 BLU 75CM CV327DA… Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact Class IIFDA’s classMar 8, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 8, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Custom Suture Pack Product Description: US1638 CUSTOM SUTURE PACK US1756 CUSTOM SUTURE PACK Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact Class IIFDA’s classMar 8, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 8, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Parietex Composite Mesh Polyester with Absorbable Collagen Film, Horseshoe- Shaped, 9 x 8 cm Collagen film was placed on the opposite side of the mesh may cause delay to treatment/therapy, adhesions, erosion/migration, pain, fistula, hernia… Class IIFDA’s classMar 8, 2023in FDA’s Enforcement Report3 statesnamed in where it went PublishedMar 8, 2023ClassClass IIStatusOngoingWhereCalifornia, Georgia and New York
- Medical device recall Finished Goods Box of 50 Inserts and Scanning Labels for Medivac Guardian 2L Triton Canister Software, Insert & Scanning Label may cause the Triton Canister System to output inaccurate blood loss estimates can lead to confusion and… Class IIFDA’s classMar 8, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 8, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Finished Goods Box of 50 Inserts and Scanning Labels for Medivac Guardian 3L Triton Canister Software, Insert & Scanning Label may cause the Triton Canister System to output inaccurate blood loss estimates can lead to confusion and… Class IIFDA’s classMar 8, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 8, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Triton Canister Software Triton Canister Software, Insert & Scanning Label may cause the Triton Canister System to output inaccurate blood loss estimates can lead to confusion and… Class IIFDA’s classMar 8, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 8, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall EMPOWR VVC KNEE TIBIAL INSERT, SIZE 6, 22MM Tibial insert implant large boxes were labeled small and the small boxes were labeled large. Class IIFDA’s classMar 8, 2023in FDA’s Enforcement Report5 statesnamed in where it went PublishedMar 8, 2023ClassClass IIStatusOngoingWhereFlorida, Illinois, Indiana, Minnesota and New York
- Medical device recall BEQ-HLS 5050 USA Firm has initiated a removal of the product due to insufficient evidence of packaging sterility. Class IIFDA’s classMar 8, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 8, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall stryker Hoffmann LRF, Transport Strut Stryker has identified a nonconformance in specific lots of Hoffmann LRF Bone Transport Struts. Class IIFDA’s classMar 8, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 8, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Alaris PC Unit 8015 utilizing 802.11 b/g or 802.11 a/b/g wireless network cards, with IP addresses from… Infusion pump PCs with specific software/network cards/IP addresses can have network/wireless connection failure. Class IIFDA’s classMar 8, 2023in FDA’s Enforcement Report50 statesnamed in where it went PublishedMar 8, 2023ClassClass IIStatusOngoingWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall MultiLab Series II 2CP & 2CP Express non-invasive vascular diagnostic device The current luer fittings and adaptors allow for the possibility of the air line to be misconnected to an intravenous line, which may cause an air embolism. Class IIFDA’s classMar 8, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 8, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall MultiLab Series II LHS TI & ERGO non-invasive vascular diagnostic device The current luer fittings and adaptors allow for the possibility of the air line to be misconnected to an intravenous line, which may cause an air embolism. Class IIFDA’s classMar 8, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 8, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall MultiLab Series II ROODRA non-invasive vascular diagnostic device The current luer fittings and adaptors allow for the possibility of the air line to be misconnected to an intravenous line, which may cause an air embolism. Class IIFDA’s classMar 8, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 8, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall MultiLab Series II REVO non-invasive vascular diagnostic device The current luer fittings and adaptors allow for the possibility of the air line to be misconnected to an intravenous line, which may cause an air embolism. Class IIFDA’s classMar 8, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 8, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Biofinity XR Toric 6-pack- Soft (hydrophilic) Contact Lens (extended wear) Manufactured with misaligned axis resulting in lenses with the incorrect power, users may experience poor visual acuity Class IIFDA’s classMar 8, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedMar 8, 2023ClassClass IIStatusOngoingWhereNationwide, and California, North Carolina, Ohio and Pennsylvania named
- Medical device recall Biofinity XR Toric Single Diagnostic lens- Soft (hydrophilic) Contact Lens (extended wear) Manufactured with misaligned axis resulting in lenses with the incorrect power, users may experience poor visual acuity Class IIFDA’s classMar 8, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedMar 8, 2023ClassClass IIStatusOngoingWhereNationwide, and California, North Carolina, Ohio and Pennsylvania named
- Medical device recall Ultracell Wick with 80cc Collection Bag, 20/box Device packaging may contain open seals, compromising product sterility. Class IIFDA’s classMar 8, 2023in FDA’s Enforcement Report27 statesnamed in where it went PublishedMar 8, 2023ClassClass IIStatusOngoingWhereAlabama, California, Colorado, District of Columbia, Florida, Georgia, Illinois, Louisiana, Maryland, Minnesota, Montana, North Carolina, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, Tennessee, Texas, Utah, Virginia, Vermont, Washington and Wisconsin
- Medical device recall CustomEyes kits Device packaging may contain open seals, compromising product sterility. Class IIFDA’s classMar 8, 2023in FDA’s Enforcement Report27 statesnamed in where it went PublishedMar 8, 2023ClassClass IIStatusOngoingWhereAlabama, California, Colorado, District of Columbia, Florida, Georgia, Illinois, Louisiana, Maryland, Minnesota, Montana, North Carolina, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, Tennessee, Texas, Utah, Virginia, Vermont, Washington and Wisconsin
- Medical device recall MYLA comprises AST Filters in conjunction with VITEK MS For users with MYLA V4.8.X / V4.9 that use VITEK MS to identify organisms as part of their workflow, AST filter rules that have been activated are not always… Class IIFDA’s classMar 8, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedMar 8, 2023ClassClass IIStatusOngoingWhereNationwide, and Alabama, California, North Carolina and Puerto Rico named
- Medical device recall Phoenix mKDR, digital mobile diagnostic x-ray system Sedecal was informed of 3 incidents of erratic movements related to X-ray mobile systems. Class IIFDA’s classMar 8, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 8, 2023ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Phoenix mKDR Xpress, digital mobile diagnostic x-ray system Sedecal was informed of 3 incidents of erratic movements related to X-ray mobile systems. Class IIFDA’s classMar 8, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 8, 2023ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Med-Riser MR600 Patient Lift Risk of boom pivot failing due to the nut securing the boom becoming loose and the bolt to be unsecure to the flange on the side. Class IIFDA’s classMar 8, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 8, 2023ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Sit to Stand STS500 Patient Lift Risk of boom pivot failing due to the nut securing the boom becoming loose and the bolt to be unsecure to the flange on the side. Class IIFDA’s classMar 8, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 8, 2023ClassClass IIStatusOngoingWhereNo state named
- Medical device recall DRX-Compass/DR-FIT X-ray Systems with Firmware version 2.3.2.0/2.3.2.4 After pressing and releasing the Z-Axis Motorized buttons on the Tube Head Display, the Overhead Tube Crane (OTC) could potentially continue the movement… Class IIFDA’s classMar 8, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedMar 8, 2023ClassClass IIStatusOngoingWhereNationwide, and California, Idaho, Illinois, Massachusetts, Minnesota, North Carolina, Nevada, Texas and Wisconsin named
- Medical device recall SciCan STATIS SL S10001 Dental Handpieces-Intended for the removal of carious material, reducing hard tooth… Screw connection between the turbine head and the push button may loosen and fall off during the treatment, and increase the risk of swallowing or inhaling… Class IIFDA’s classMar 8, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 8, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall NovaStar TS, Anti-Asphyxia Valve, Reusable, Material Numbers MP01576 (Size S), MP01577 (Size M), and MP01578… The magnets used in the swivel frame/tube set and the headgear clips might impact medical devices (implanted as well as not implanted) and metallic implants. FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 1, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 1, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall NovaStar TS, Standard elbow, Reusable, Material Numbers MP01579 (Size S), MP01580 (Size M), and MP01581 (Size… The magnets used in the swivel frame/tube set and the headgear clips might impact medical devices (implanted as well as not implanted) and metallic implants. FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 1, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 1, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall ADVIA Centaur XP and ADVIA Centaur XPT Anti-HBe2 (aHBe2) 50T- In vitro diagnostic immunoassay for the… Anti-HBe2 (aHBe2) interference with the Hepatitis B e Antigen (HBeAg) Assay, leads to elevated or reactive Hepatitis B e Antigen (HBeAg) results on samples… Class IIFDA’s classMar 1, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedMar 1, 2023ClassClass IIStatusOngoingWhereNationwide, and Georgia and Utah named
- Medical device recall Hologic 3Dimensions/Selenia Dimensions Models: RM-SDM-00001-3D SDM-00001-2D SDM-00001-3D SDM-05000-3D3… C-Arm unexpected movement may cause blunt trauma should the tube arm impinge upon an individual Class IIFDA’s classMar 1, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 1, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Atellica IM Folate 140 test kit- For in vitro diagnostic use in the quantitative determination of folate in… Negative bias occurred when whole blood calibration (Atellica IM Fol or ADVIA Centaur FolateBA/FolBA) used to test serum samples. Class IIFDA’s classMar 1, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 1, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Atellica IM Folate 700 test kit- For in vitro diagnostic use in the quantitative determination of folate in… Negative bias occurred when whole blood calibration (Atellica IM Fol or ADVIA Centaur FolateBA/FolBA) used to test serum samples. Class IIFDA’s classMar 1, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 1, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Atellica IM Folate 700 test kit (REF)-For in vitro diagnostic use in the quantitative determination of folate… Negative bias occurred when whole blood calibration (Atellica IM Fol or ADVIA Centaur FolateBA/FolBA) used to test serum samples. Class IIFDA’s classMar 1, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 1, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ADVIA Centaur Folate 100 test kit-For in vitro diagnostic use in the quantitative determination of folate in… Negative bias occurred when whole blood calibration (Atellica IM Fol or ADVIA Centaur FolateBA/FolBA) used to test serum samples. Class IIFDA’s classMar 1, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 1, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ADVIA Centaur Folate 500 test kit- For in vitro diagnostic use in the quantitative determination of folate in… Negative bias occurred when whole blood calibration (Atellica IM Fol or ADVIA Centaur FolateBA/FolBA) used to test serum samples. Class IIFDA’s classMar 1, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 1, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ADVIA Centaur Folate 500 test kit (REF)-For in vitro diagnostic use in the quantitative determination of… Negative bias occurred when whole blood calibration (Atellica IM Fol or ADVIA Centaur FolateBA/FolBA) used to test serum samples. Class IIFDA’s classMar 1, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 1, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall HydroMID 4Fr Single Lumen Maximal Barrier Kit- Indicated for short term access (<30days) to the peripheral… Product Mislabeled on the outer bag and inner kit Tyvek header bag Class IIFDA’s classMar 1, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedMar 1, 2023ClassClass IIStatusOngoingWhereNationwide, and Florida, Texas and Washington named
- Medical device recall HydroMID 4Fr Single Lumen Maximal Barrier Kit-indicated for short term access (<30days) to the peripheral… Label with the incorrect component listed on the inner kit Tyvek header bag Class IIFDA’s classMar 1, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedMar 1, 2023ClassClass IIStatusOngoingWhereNationwide, and Connecticut, Florida, Nebraska, Tennessee, Texas and Washington named
- Medical device recall Cardinal Health Presource Packs IV START KIT- Intended for IV access device Presource Kits contains the ICU MicroClave Clear Connector due to a manufacturing defect there is a gap between the connectors top and bottom housings which… Class IIFDA’s classMar 1, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedMar 1, 2023ClassClass IIStatusOngoingWhereNationwide, and Georgia and Pennsylvania named
- Medical device recall Cardinal Health Presource Packs IV START TRAY I-Intended for IV access device Presource Kits contains the ICU MicroClave Clear Connector due to a manufacturing defect there is a gap between the connectors top and bottom housings which… Class IIFDA’s classMar 1, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedMar 1, 2023ClassClass IIStatusOngoingWhereNationwide, and Georgia and Pennsylvania named
- Medical device recall Cardinal Health Presource Packs IV START KIT-Intended for IV Access Presource Kits contains the ICU MicroClave Clear Connector due to a manufacturing defect there is a gap between the connectors top and bottom housings which… Class IIFDA’s classMar 1, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedMar 1, 2023ClassClass IIStatusOngoingWhereNationwide, and Georgia and Pennsylvania named
- Medical device recall abm Respiratory Care Standart Breating Circuit with Face Mask - Toddler Incorrect expiration date on product label. Class IIIFDA’s classMar 1, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 1, 2023ClassClass IIIStatusOngoingWhereNationwide, and Minnesota named
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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