Browse Device Recalls
3,010 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,010 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.
Medical Device Recalls
Browse 3,010 FDA device recalls in 2019.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Apr 30, 2019 | Monoject Standard Hypodermic Needle, 18 G x 1-1/2" Item code: 8881200078 | Manufacturing defect was found for the cartridge component, which could compromise the sterility ... | Class II | Cardinal Health 200, LLC |
| Apr 30, 2019 | Monoject 201 Vet Pak Hypodermic Needle, 18 ga x 1-1/2 Item code: 8881201548 | Manufacturing defect was found for the cartridge component, which could compromise the sterility ... | Class II | Cardinal Health 200, LLC |
| Apr 30, 2019 | Monoject Blunt Cannula, 20 G x 1-1/2" (0.902 mm x 3.8 cm) Item code: 88812... | Manufacturing defect was found for the cartridge component, which could compromise the sterility ... | Class II | Cardinal Health 200, LLC |
| Apr 30, 2019 | Monoject Blunt Cannula, 15 G x 1-1/2" (1.829 mm x 3.8 cm) Item code: 88812... | Manufacturing defect was found for the cartridge component, which could compromise the sterility ... | Class II | Cardinal Health 200, LLC |
| Apr 30, 2019 | Beckman Coulter ACCESS Immunoassay Systems, Access Thyroglobulin Antibody II,... | The recalling firm characterized the potential interference effects of biotin (up to 1,200 ng/mL... | Class II | Beckman Coulter Inc. |
| Apr 30, 2019 | Beckman Coulter Access Immunoassay Systems, Access Free T3 Triiodothyronine, ... | The recalling firm characterized the potential interference effects of biotin (up to 1,200 ng/mL... | Class II | Beckman Coulter Inc. |
| Apr 30, 2019 | Monoject 201 Vet Pak Hypodermic Needle, 20 ga x 1-1/2" Item code: 8881201498 | Manufacturing defect was found for the cartridge component, which could compromise the sterility ... | Class II | Cardinal Health 200, LLC |
| Apr 30, 2019 | Monoject 201 Vet Pak Hypodermic Needle, 22 ga x 1-1/2" Item code: 8881201456 | Manufacturing defect was found for the cartridge component, which could compromise the sterility ... | Class II | Cardinal Health 200, LLC |
| Apr 30, 2019 | Monoject 201 Vet Pak Hypodermic Needle, 19 ga x 1-1/2 Item code: 8881201522 | Manufacturing defect was found for the cartridge component, which could compromise the sterility ... | Class II | Cardinal Health 200, LLC |
| Apr 30, 2019 | Monoject Blunt Cannula, 22 G x 1-1/2" (0.711 mm x 3.8 cm) Item code: 88812... | Manufacturing defect was found for the cartridge component, which could compromise the sterility ... | Class II | Cardinal Health 200, LLC |
| Apr 30, 2019 | Monoject Standard Hypodermic Needle, 14 G x 1-1/2" Item code: 8881200011 | Manufacturing defect was found for the cartridge component, which could compromise the sterility ... | Class II | Cardinal Health 200, LLC |
| Apr 30, 2019 | Monoject Blunt Cannula, 16 G x 1-1/2" (1.651 mm x 3.8 cm) Item code: 8881202322 | Manufacturing defect was found for the cartridge component, which could compromise the sterility ... | Class II | Cardinal Health 200, LLC |
| Apr 30, 2019 | Endotrac EPF/EGR Hook/Triangle Blade Kit, Catalogue Number 3056-1 | The seal integrity of the sterile bag containing the kits may be compromised. | Class II | Stryker GmbH |
| Apr 30, 2019 | Beckman Coulter ACCESS Immunoassay Systems, Access Thyroglobulin, REF 33860 (... | The recalling firm characterized the potential interference effects of biotin (up to 1,200 ng/mL... | Class II | Beckman Coulter Inc. |
| Apr 30, 2019 | Monoject Standard Hypodermic Needle, 16 G x 1-1/2" Item code:8881200045 | Manufacturing defect was found for the cartridge component, which could compromise the sterility ... | Class II | Cardinal Health 200, LLC |
| Apr 30, 2019 | Monoject Standard Hypodermic Needle Item code: 8881200029 | Manufacturing defect was found for the cartridge component, which could compromise the sterility ... | Class II | Cardinal Health 200, LLC |
| Apr 30, 2019 | Monoject Standard Hypodermic Needle, 27 G x 1-1/4" Item code: 8881200508 | Manufacturing defect was found for the cartridge component, which could compromise the sterility ... | Class II | Cardinal Health 200, LLC |
| Apr 30, 2019 | Monoject Standard Hypodermic Needle, 20 G x 1-1/2" bulk Item code: 888120... | Manufacturing defect was found for the cartridge component, which could compromise the sterility ... | Class II | Cardinal Health 200, LLC |
| Apr 30, 2019 | Beckman Coulter ACCESS Immunoassay Systems, Access GI Monitor Cancer Antigen ... | The recalling firm characterized the potential interference effects of biotin (up to 1,200 ng/mL... | Class II | Beckman Coulter Inc. |
| Apr 30, 2019 | Beckman Coulter ACCESS Immunoassay Systems, Access Total T3 Triiodothyronine ... | The recalling firm characterized the potential interference effects of biotin (up to 1,200 ng/mL)... | Class II | Beckman Coulter Inc. |
| Apr 29, 2019 | Philips Patient Information Center iX configured with a regional setting whic... | Infusion Pump Data Storage Accuracy-Data from the BBraun Space LAN or Arcomed UniqueDoc infusion ... | Class III | Philips North America, LLC |
| Apr 29, 2019 | Philips IntelliBridge System configured with a regional setting which uses a ... | Infusion Pump Data Storage Accuracy-Data from the BBraun Space LAN or Arcomed UniqueDoc infusion ... | Class III | Philips North America, LLC |
| Apr 29, 2019 | Philips EPIQ and Affiniti Ultrasound Systems with software version 4.0: Model... | There is a potential that the image of one patient could get unexpectedly moved into another pati... | Class II | Philips Ultrasound Inc |
| Apr 29, 2019 | MAHURKAR and Argyle acute hemodialysis catheters, Material numbers 8813793009... | The priming volume values printed on the MAHURKA and Argyle acute catheters and Instructions for ... | Class II | COVIDIEN LLC |
| Apr 29, 2019 | DEXIS Titanium Intraoral Sensor Product Usage: The DEXIS Titanium Intraor... | The sensor's look up calibration files were incorrectly programmed during manufacturing, which ca... | Class II | KaVo Dental Technologies LLC |
| Apr 26, 2019 | ThermaCare HEATWRAPS, ADVANCED BACK PAIN THERAPY, SKU: a) F00573301020A b)... | There is the potential that a HeatWrap could include cells that have a higher cell temperature th... | Class II | PF Consumer Healthcare 1 LLC |
| Apr 26, 2019 | SOLOPATH Re-Collapsible Access System, Model Numbers SR-1925, SR-1935, SR... | There is a potential for dislodgement of the tip from the outer diameter of the sheath resulting ... | Class I | Terumo Medical Corporation |
| Apr 26, 2019 | Zenith Alpha Abdominal Endovascular Graft, Reference Part Numbers: ZIMB-22-10... | may contain a damaged gray safety lock knob, which could potentially result in difficulty or an i... | Class II | Cook Inc. |
| Apr 26, 2019 | Inovo Single Luman Conserver Product Usage: This device is intended to re... | The pressure gauge (manometer) may dislodge from the threaded insertion/mount, creating a leak. | Class II | Inovo, Inc |
| Apr 26, 2019 | Aquarius D13S319 Plus Deletion Probe, Model LPH068-A Product Usage: The D... | There is an error in the chromomap on the package insert. | Class III | Cytocell Ltd. |
| Apr 26, 2019 | Portico Solo Re-Collapsible Access System , Model Numbers PRTSOLO-19, PRTSO... | There is a potential for dislodgement of the tip from the outer diameter of the sheath resulting ... | Class I | Terumo Medical Corporation |
| Apr 26, 2019 | Opteform Allograft Disc, 45mm x 5mm, 8cc, Catalog Number 600-03-45 | The Opteform Disc-30mm, Opteform Disc-45mm, and Opteform Disc-90mm were potentially exposed to hi... | Class II | Exactech, Inc. |
| Apr 26, 2019 | Opteform Allograft Disc, 90mm x 5mm, 22cc, Catalog Number 600-03-90 | The Opteform Disc-30mm, Opteform Disc-45mm, and Opteform Disc-90mm were potentially exposed to hi... | Class II | Exactech, Inc. |
| Apr 26, 2019 | Opteform Allograft Disc, 30mm 3mm, 2cc, Catalog Number 600-03-30 | The Opteform Disc-30mm, Opteform Disc-45mm, and Opteform Disc-90mm were potentially exposed to hi... | Class II | Exactech, Inc. |
| Apr 26, 2019 | SOLOPATH Balloon Expandable TransFemoral System, Model Numbers STFI-1425, S... | There is a potential for dislodgement of the tip from the outer diameter of the sheath resulting ... | Class I | Terumo Medical Corporation |
| Apr 26, 2019 | ThermaCare HEATWRAPS, ADVANCED BACK PAIN THERAPY, UPC 305733010037 - Product ... | There is the potential that a HeatWrap could include cells that have a higher cell temperature th... | Class II | PF Consumer Healthcare 1 LLC |
| Apr 25, 2019 | C-Reactive Protein Kit for use on the SPAplus, REF NK044.S.A, Rx only, UDI (0... | A reagent in C reactive protein kits is not performing to specification and samples with known co... | Class II | The Binding Site Group, Ltd. |
| Apr 25, 2019 | Endoscopic Cleaning Brushes sold in various Endoscopy Kits - Product Usage: T... | Potential risk of brush detachment during cleaning. If brush detachment is not identified, there... | Class II | Medline Industries Inc |
| Apr 25, 2019 | 2.7 Degree Straight Sagittal Saw attachment (Mako Total Knee Application and ... | The bearings of the saw attachments were ungreased. | Class II | Mako Surgical Corporation |
| Apr 25, 2019 | Lidar System for Erosion Flume Application Class 1 Laser Product Product ... | Failure to comply event due to incorrect labeling of a class 1 laser product. | Class II | ASTRA, LLC |
| Apr 25, 2019 | 2.7 Degree Angled Sagittal Saw attachment (Mako Total Knee Application Only) | The bearings of the saw attachments were ungreased. | Class II | Mako Surgical Corporation |
| Apr 24, 2019 | ArtisanTM 70 cm 2 x 8 Surgical Lead Kit, part number M365SC8216700. 2 x 8... | The firm is initiating a voluntary removal of certain spinal cord stimulation leads, lead extensi... | Class II | Boston Scientific Neuromodulation Corporation |
| Apr 24, 2019 | The LinearTM 3-4 70 cm 8 Contact Lead Kit, part number M365SC2352700 is part... | The firm is initiating a voluntary removal of certain spinal cord stimulation leads, lead extensi... | Class II | Boston Scientific Neuromodulation Corporation |
| Apr 24, 2019 | CENTRAL VENOUS ACCESS DEVICE BUNDLE ECVC2840 | Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the ... | Class II | Centurion Medical Products Corporation |
| Apr 24, 2019 | PEDIATRIC PICC INSERTION TRAY CVI4450 | Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the ... | Class II | Centurion Medical Products Corporation |
| Apr 24, 2019 | CAP BUNDLE KIT DYNDC2137 | Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the ... | Class II | Centurion Medical Products Corporation |
| Apr 24, 2019 | IV KIT - SORBAVIEW IVS3475 | Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the ... | Class II | Centurion Medical Products Corporation |
| Apr 24, 2019 | CENTRAL LINE BUNDLE ECVC6375 | Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the ... | Class II | Centurion Medical Products Corporation |
| Apr 24, 2019 | PORT AND IO ACCESS DRESSING KIT DT15780A | Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the ... | Class II | Centurion Medical Products Corporation |
| Apr 24, 2019 | VANTEX 7FR, 16CM, 3L CVC BUNDLE ECVC6670 | Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the ... | Class II | Centurion Medical Products Corporation |
Frequently Asked Questions
When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.
All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.
Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.