Medical devices, 2012
Shortlist up to four to read them side by side.
1,310 medical device recalls FDA’s Enforcement Report published in 2012, 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 5, 2026.
1,310of 1,310 medical device recallsshown with your filters
The list
- Medical device recall bioMerieux Kit, Instrument & Update, 3D B.40 USB-ML04, Clinical instrument software, Czech, Estonian,… The product may mislabel patient information on culture specimen bottles due to a software miscommunication. Class IIFDA’s classNov 28, 2012in FDA’s Enforcement Report19 statesnamed in where it went PublishedNov 28, 2012ClassClass IIStatusTerminatedWhereArkansas, Arizona, California, Florida, Kansas, Louisiana, Maryland, Minnesota, Montana, North Carolina, Nevada, New York, Oregon, Pennsylvania, Rhode Island, South Carolina, Texas, Virginia and Washington
- Medical device recall bioMerieux Kit, Instrument & Update, 3D B.40 USB-ML05, Clinical instrument software, Lithuanian, Latvian,… The product may mislabel patient information on culture specimen bottles due to a software miscommunication. Class IIFDA’s classNov 28, 2012in FDA’s Enforcement Report19 statesnamed in where it went PublishedNov 28, 2012ClassClass IIStatusTerminatedWhereArkansas, Arizona, California, Florida, Kansas, Louisiana, Maryland, Minnesota, Montana, North Carolina, Nevada, New York, Oregon, Pennsylvania, Rhode Island, South Carolina, Texas, Virginia and Washington
- Medical device recall bioMerieux Kit, Instrument & Update, 3D B.40 USB-ML06, Clinical instrument software, Japanese, Korean,… The product may mislabel patient information on culture specimen bottles due to a software miscommunication. Class IIFDA’s classNov 28, 2012in FDA’s Enforcement Report19 statesnamed in where it went PublishedNov 28, 2012ClassClass IIStatusTerminatedWhereArkansas, Arizona, California, Florida, Kansas, Louisiana, Maryland, Minnesota, Montana, North Carolina, Nevada, New York, Oregon, Pennsylvania, Rhode Island, South Carolina, Texas, Virginia and Washington
- Medical device recall bioMerieux BacT/ALERT Control Module The product may mislabel patient information on culture specimen bottles due to a software miscommunication. Class IIFDA’s classNov 28, 2012in FDA’s Enforcement Report19 statesnamed in where it went PublishedNov 28, 2012ClassClass IIStatusTerminatedWhereArkansas, Arizona, California, Florida, Kansas, Louisiana, Maryland, Minnesota, Montana, North Carolina, Nevada, New York, Oregon, Pennsylvania, Rhode Island, South Carolina, Texas, Virginia and Washington
- Medical device recall bioMerieux BacT/ALERT Combo Module The product may mislabel patient information on culture specimen bottles due to a software miscommunication. Class IIFDA’s classNov 28, 2012in FDA’s Enforcement Report19 statesnamed in where it went PublishedNov 28, 2012ClassClass IIStatusTerminatedWhereArkansas, Arizona, California, Florida, Kansas, Louisiana, Maryland, Minnesota, Montana, North Carolina, Nevada, New York, Oregon, Pennsylvania, Rhode Island, South Carolina, Texas, Virginia and Washington
- Medical device recall bioMerieux BacT/ALERT Combo Module The product may mislabel patient information on culture specimen bottles due to a software miscommunication. Class IIFDA’s classNov 28, 2012in FDA’s Enforcement Report19 statesnamed in where it went PublishedNov 28, 2012ClassClass IIStatusTerminatedWhereArkansas, Arizona, California, Florida, Kansas, Louisiana, Maryland, Minnesota, Montana, North Carolina, Nevada, New York, Oregon, Pennsylvania, Rhode Island, South Carolina, Texas, Virginia and Washington
- Medical device recall bioMerieux Kit, Instrument & Update, 3D IND ZIP-ML 01, Industry instrument software update, English, Spanish,… The product may mislabel patient information on culture specimen bottles due to a software miscommunication. Class IIFDA’s classNov 28, 2012in FDA’s Enforcement Report19 statesnamed in where it went PublishedNov 28, 2012ClassClass IIStatusTerminatedWhereArkansas, Arizona, California, Florida, Kansas, Louisiana, Maryland, Minnesota, Montana, North Carolina, Nevada, New York, Oregon, Pennsylvania, Rhode Island, South Carolina, Texas, Virginia and Washington
- Medical device recall bioMerieux Kit, Instrument & Update, 3D IND USB-ML 02, Industry instrument software update, English, Spanish,… The product may mislabel patient information on culture specimen bottles due to a software miscommunication. Class IIFDA’s classNov 28, 2012in FDA’s Enforcement Report19 statesnamed in where it went PublishedNov 28, 2012ClassClass IIStatusTerminatedWhereArkansas, Arizona, California, Florida, Kansas, Louisiana, Maryland, Minnesota, Montana, North Carolina, Nevada, New York, Oregon, Pennsylvania, Rhode Island, South Carolina, Texas, Virginia and Washington
- Medical device recall bioMerieux Kit, Instrument & Update, B.40 Dualt-ML, Industry instrument software update, English, Spanish,… The product may mislabel patient information on culture specimen bottles due to a software miscommunication. Class IIFDA’s classNov 28, 2012in FDA’s Enforcement Report19 statesnamed in where it went PublishedNov 28, 2012ClassClass IIStatusTerminatedWhereArkansas, Arizona, California, Florida, Kansas, Louisiana, Maryland, Minnesota, Montana, North Carolina, Nevada, New York, Oregon, Pennsylvania, Rhode Island, South Carolina, Texas, Virginia and Washington
- Medical device recall bioMerieux Kit, Instrument & Update, B.40, 3D IND USB-ML01, Industry instrument software update, English,… The product may mislabel patient information on culture specimen bottles due to a software miscommunication. Class IIFDA’s classNov 28, 2012in FDA’s Enforcement Report19 statesnamed in where it went PublishedNov 28, 2012ClassClass IIStatusTerminatedWhereArkansas, Arizona, California, Florida, Kansas, Louisiana, Maryland, Minnesota, Montana, North Carolina, Nevada, New York, Oregon, Pennsylvania, Rhode Island, South Carolina, Texas, Virginia and Washington
- Medical device recall bioMerieux Kit, Instrument & Update, B.40, 3D IND USB-ML02, Industry instrument software update, German,… The product may mislabel patient information on culture specimen bottles due to a software miscommunication. Class IIFDA’s classNov 28, 2012in FDA’s Enforcement Report19 statesnamed in where it went PublishedNov 28, 2012ClassClass IIStatusTerminatedWhereArkansas, Arizona, California, Florida, Kansas, Louisiana, Maryland, Minnesota, Montana, North Carolina, Nevada, New York, Oregon, Pennsylvania, Rhode Island, South Carolina, Texas, Virginia and Washington
- Medical device recall bioMerieux Kit, Instrument & Update, B.40, 3D I USB-ML01, Industry instrument software update, English,… The product may mislabel patient information on culture specimen bottles due to a software miscommunication. Class IIFDA’s classNov 28, 2012in FDA’s Enforcement Report19 statesnamed in where it went PublishedNov 28, 2012ClassClass IIStatusTerminatedWhereArkansas, Arizona, California, Florida, Kansas, Louisiana, Maryland, Minnesota, Montana, North Carolina, Nevada, New York, Oregon, Pennsylvania, Rhode Island, South Carolina, Texas, Virginia and Washington
- Medical device recall bioMerieux Kit, Instrument & Update, B.40, 3D I USB-ML02, Industry instrument software update, German, French The product may mislabel patient information on culture specimen bottles due to a software miscommunication. Class IIFDA’s classNov 28, 2012in FDA’s Enforcement Report19 statesnamed in where it went PublishedNov 28, 2012ClassClass IIStatusTerminatedWhereArkansas, Arizona, California, Florida, Kansas, Louisiana, Maryland, Minnesota, Montana, North Carolina, Nevada, New York, Oregon, Pennsylvania, Rhode Island, South Carolina, Texas, Virginia and Washington
- Medical device recall bioMerieux Kit, Instrument & Update, B.40, 3D I ZIP-ML01, Industry instrument software update, English,… The product may mislabel patient information on culture specimen bottles due to a software miscommunication. Class IIFDA’s classNov 28, 2012in FDA’s Enforcement Report19 statesnamed in where it went PublishedNov 28, 2012ClassClass IIStatusTerminatedWhereArkansas, Arizona, California, Florida, Kansas, Louisiana, Maryland, Minnesota, Montana, North Carolina, Nevada, New York, Oregon, Pennsylvania, Rhode Island, South Carolina, Texas, Virginia and Washington
- Medical device recall bioMerieux Kit, Instrument & Update, B.40, 3D I ZIP-ML02, Industry instrument software update, English,… The product may mislabel patient information on culture specimen bottles due to a software miscommunication. Class IIFDA’s classNov 28, 2012in FDA’s Enforcement Report19 statesnamed in where it went PublishedNov 28, 2012ClassClass IIStatusTerminatedWhereArkansas, Arizona, California, Florida, Kansas, Louisiana, Maryland, Minnesota, Montana, North Carolina, Nevada, New York, Oregon, Pennsylvania, Rhode Island, South Carolina, Texas, Virginia and Washington
- Medical device recall Corometrics Qwik Connect Plus Spiral Electrode Thirty fetal scalp electrodes were found to have an incomplete package seal and lacked the printed lot number stamped on during sealing. Class IIFDA’s classNov 28, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 21 states named PublishedNov 28, 2012ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Connecticut, Florida, Georgia, Illinois, Kansas, Kentucky, Massachusetts, Maryland, Minnesota, Missouri, New Jersey, New Mexico, New York, Ohio, Pennsylvania, South Carolina, Texas, Washington and Wyoming named
- Medical device recall Superstat Modified Collagen Hemostatic Sponge.115mmx115mm Pledget, 1.5%, Part#9500-15 The recall was initiated because Superstat Corporation has confirmed that no documentation are available to verify that quarterly dose sterility audits were… Class IIFDA’s classNov 28, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 28, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Superstat Modified Collagen Hemostatic Sponge, 50mm Disc, 1.5%, Part# 9200-15 The recall was initiated because Superstat Corporation has confirmed that no documentation are available to verify that quarterly dose sterility audits were… Class IIFDA’s classNov 28, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 28, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Superstat Modified Collagen Hemostatic Sponge, 115mm x 115mm Pledget, 3.0%, Part# 9500-30 The recall was initiated because Superstat Corporation has confirmed that no documentation are available to verify that quarterly dose sterility audits were… Class IIFDA’s classNov 28, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 28, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Superstat Modified Collagen Hemostatic Sponge, 50mm Disc, 3.0%, Part# 9200-30 The recall was initiated because Superstat Corporation has confirmed that no documentation are available to verify that quarterly dose sterility audits were… Class IIFDA’s classNov 28, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 28, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Superstat Modified Collagen Hemostatic Sponge, 85mm x 85mm Pledget, 3.0%, Part# 9300-30 The recall was initiated because Superstat Corporation has confirmed that no documentation are available to verify that quarterly dose sterility audits were… Class IIFDA’s classNov 28, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 28, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Superstat Modified Collagen Hemostatic Sponge, 2x2 Pledget, 1.5%, Part# 9105-00 The recall was initiated because Superstat Corporation has confirmed that no documentation are available to verify that quarterly dose sterility audits were… Class IIFDA’s classNov 28, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 28, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Superstat Modified Collagen Hemostatic Sponge, 2x2 Pledget, 3.0%, Part# 9106-00 The recall was initiated because Superstat Corporation has confirmed that no documentation are available to verify that quarterly dose sterility audits were… Class IIFDA’s classNov 28, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 28, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Superstat Modified Collagen Hemostatic Sponge, 4x4 Pledget, 3.0%, Part# 9102-00 The recall was initiated because Superstat Corporation has confirmed that no documentation are available to verify that quarterly dose sterility audits were… Class IIFDA’s classNov 28, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 28, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Superstat Modified Collagen Hemostatic Sponge, 32mm Disc, 1.5%, Part# 9120-15, 9100-15 The recall was initiated because Superstat Corporation has confirmed that no documentation are available to verify that quarterly dose sterility audits were… Class IIFDA’s classNov 28, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 28, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Superstat Modified Collagen Hemostatic Sponge, 85mm x 85mm Pledget, 1.5%, Part# 9300-15 The recall was initiated because Superstat Corporation has confirmed that no documentation are available to verify that quarterly dose sterility audits were… Class IIFDA’s classNov 28, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 28, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Superstat Modified Collagen Hemostatic Sponge, 7.5mm x 19mm Cone, 3.0%, Part# 9015-30, 9003-30 The recall was initiated because Superstat Corporation has confirmed that no documentation are available to verify that quarterly dose sterility audits were… Class IIFDA’s classNov 28, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 28, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Superstat Modified Collagen Hemostatic Sponge, 32mm Disc, 3.0%, Part# 9100-30 The recall was initiated because Superstat Corporation has confirmed that no documentation are available to verify that quarterly dose sterility audits were… Class IIFDA’s classNov 28, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 28, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Superstat Modified Collagen Hemostatic Sponge, 50mm Disc, 3.0%, Part# 9200-30 The recall was initiated because Superstat Corporation has confirmed that no documentation are available to verify that quarterly dose sterility audits were… Class IIFDA’s classNov 28, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 28, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall IO Fix IntraOsseous Fixation System Product Event Reports revealed that lag screw passes through washer (e.g. Class IIFDA’s classNov 28, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 22 states named PublishedNov 28, 2012ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Florida, Georgia, Iowa, Illinois, Indiana, Massachusetts, Maryland, Michigan, Montana, North Carolina, Nebraska, New Jersey, New York, Ohio, Oklahoma, Tennessee, Texas, Virginia and Wisconsin named
- Medical device recall UniCel Dxl 800 Access Immunoassay System The recall was initiated because Beckman Coulter has confirmed that the UniCel Dxl and DxC Access Immunoassay Systems had field modifications to the aspirate… Class IIFDA’s classNov 28, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 28, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall UniCel Dxl 600 Access Immunoassay System The recall was initiated because Beckman Coulter has confirmed that the UniCel Dxl and DxC Access Immunoassay Systems had field modifications to the aspirate… Class IIFDA’s classNov 28, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 28, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall UniCel DxC 880i, 860i, 680i, and 660i Integrated Systems The recall was initiated because Beckman Coulter has confirmed that the UniCel Dxl and DxC Access Immunoassay Systems had field modifications to the aspirate… Class IIFDA’s classNov 28, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 28, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Screw Tulip , 6.25mm Rod Subsequent Codes: KWP, KWQ, MNH, MNI The tulip portion of the screw assembly can disengage from the shank after implantation. Class IIFDA’s classNov 28, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedNov 28, 2012ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Missouri, North Carolina, Oregon and Wisconsin named
- Medical device recall 5.5mm x 30mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI The tulip portion of the screw assembly can disengage from the shank after implantation. Class IIFDA’s classNov 28, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedNov 28, 2012ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Missouri, North Carolina, Oregon and Wisconsin named
- Medical device recall 5.5mm x 35mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI The tulip portion of the screw assembly can disengage from the shank after implantation. Class IIFDA’s classNov 28, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedNov 28, 2012ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Missouri, North Carolina, Oregon and Wisconsin named
- Medical device recall 5.5mm x 40mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI The tulip portion of the screw assembly can disengage from the shank after implantation. Class IIFDA’s classNov 28, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedNov 28, 2012ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Missouri, North Carolina, Oregon and Wisconsin named
- Medical device recall 5.5mm x 45mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI The tulip portion of the screw assembly can disengage from the shank after implantation. Class IIFDA’s classNov 28, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedNov 28, 2012ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Missouri, North Carolina, Oregon and Wisconsin named
- Medical device recall 5.5mm x 50mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI The tulip portion of the screw assembly can disengage from the shank after implantation. Class IIFDA’s classNov 28, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedNov 28, 2012ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Missouri, North Carolina, Oregon and Wisconsin named
- Medical device recall 5.5mm x 55mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI The tulip portion of the screw assembly can disengage from the shank after implantation. Class IIFDA’s classNov 28, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedNov 28, 2012ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Missouri, North Carolina, Oregon and Wisconsin named
- Medical device recall 6.5mm x 30mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI The tulip portion of the screw assembly can disengage from the shank after implantation. Class IIFDA’s classNov 28, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedNov 28, 2012ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Missouri, North Carolina, Oregon and Wisconsin named
- Medical device recall 6.5mm x 35mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI The tulip portion of the screw assembly can disengage from the shank after implantation. Class IIFDA’s classNov 28, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedNov 28, 2012ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Missouri, North Carolina, Oregon and Wisconsin named
- Medical device recall 6.5mm x 40mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI The tulip portion of the screw assembly can disengage from the shank after implantation. Class IIFDA’s classNov 28, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedNov 28, 2012ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Missouri, North Carolina, Oregon and Wisconsin named
- Medical device recall 6.5mm x 45mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI The tulip portion of the screw assembly can disengage from the shank after implantation. Class IIFDA’s classNov 28, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedNov 28, 2012ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Missouri, North Carolina, Oregon and Wisconsin named
- Medical device recall 6.5mm x 50mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI The tulip portion of the screw assembly can disengage from the shank after implantation. Class IIFDA’s classNov 28, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedNov 28, 2012ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Missouri, North Carolina, Oregon and Wisconsin named
- Medical device recall 6.5mm x 55mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI The tulip portion of the screw assembly can disengage from the shank after implantation. Class IIFDA’s classNov 28, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedNov 28, 2012ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Missouri, North Carolina, Oregon and Wisconsin named
- Medical device recall 7.5mm x 30mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI The tulip portion of the screw assembly can disengage from the shank after implantation. Class IIFDA’s classNov 28, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedNov 28, 2012ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Missouri, North Carolina, Oregon and Wisconsin named
- Medical device recall 7.5mm x 35mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI The tulip portion of the screw assembly can disengage from the shank after implantation. Class IIFDA’s classNov 28, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedNov 28, 2012ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Missouri, North Carolina, Oregon and Wisconsin 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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