Browse Device Recalls
5,424 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 5,424 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 5,424 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Mar 4, 2024 | NEOMED* Pharmacy Syringes - Nonsterile (Non ENFit) with below product descrip... | The expiration date was not printed on the outer shipping label, leading to expired syringes bein... | Class III | Avanos Medical, Inc. |
| Mar 4, 2024 | NEOMED* Pharmacy Syringes - Nonsterile (Non ENFit) with below product descrip... | The expiration date was not printed on the outer shipping label, leading to expired syringes bein... | Class III | Avanos Medical, Inc. |
| Mar 4, 2024 | NEOMED* Pharmacy Syringes - Nonsterile (Non ENFit) with below product descrip... | The expiration date was not printed on the outer shipping label, leading to expired syringes bein... | Class III | Avanos Medical, Inc. |
| Mar 1, 2024 | VITROS Immunodiagnostic Products Anti HBs Calibrators. The VITROS Anti-HBs Ca... | Potential for positively biased results due to signal reduction over shelf life. | Class II | Ortho-Clinical Diagnostics, Inc. |
| Mar 1, 2024 | Medline medical procedure kits, labeled as follows: a) PARACERVICAL PUD TR... | Trumpet Needle Guide ring can detach when excessive pressure is applied. | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Feb 23, 2024 | Centurion scalpel handle kits labeled as: a) STERILE # 3 SCALPEL HANDLE, Pro... | Product may have a weak seal which may result in a breach of sterility of the contents if the sea... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Feb 23, 2024 | Centurion Curette kits labeled as: a) STERILE BUCK EAR CURETTE "00" (25697)... | Product may have a weak seal which may result in a breach of sterility of the contents if the sea... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Feb 23, 2024 | Centurion Manual surgical kits labeled as: a) 15ML SAMPLING TUBE WITH CAP,... | Product may have a weak seal which may result in a breach of sterility of the contents if the sea... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Feb 23, 2024 | Centurion manual surgical kits labeled as: a) ST. VIRTUS SPLINTER FORCEP 6"... | Product may have a weak seal which may result in a breach of sterility of the contents if the sea... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Feb 23, 2024 | Centurion manual surgical kits labeled as: a) SUTURE REMOVAL TRAY, Product ... | Product may have a weak seal which may result in a breach of sterility of the contents if the sea... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Feb 23, 2024 | Centurion Manual surgical kits labeled as: a) HEGAR UTERINE DILATOR, 11-12... | Product may have a weak seal which may result in a breach of sterility of the contents if the sea... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Feb 23, 2024 | Centurion manual surgical kits labeled as: a) STERILE TUBE OCCLUDING FORCEP... | Product may have a weak seal which may result in a breach of sterility of the contents if the sea... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Feb 23, 2024 | Centurion Manual surgical kits labeled as: a) STERILE S/B WIRE SCISSOR, Pr... | Product may have a weak seal which may result in a breach of sterility of the contents if the sea... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Feb 23, 2024 | Centurion Forcep kits labeled as: a) STERILE F/P SPLINTER FORCEP (SF6141), P... | Product may have a weak seal which may result in a breach of sterility of the contents if the sea... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Feb 23, 2024 | The LeadCare¿ II Blood Lead Test System relies on electrochemistry and a uniq... | Calibration Buttons being used in the kitting process were incorrectly labeled as Lot 2323M for l... | Class II | Magellan Diagnostics, Inc. |
| Feb 23, 2024 | Centurion hook kits labeled as: a) STERILE SKIN HOOK FINE (EA3975F), Product... | Product may have a weak seal which may result in a breach of sterility of the contents if the sea... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Feb 23, 2024 | Centurion manual surgical kits labeled as: a) STERILE ALLIS TISS FCP 10", P... | Product may have a weak seal which may result in a breach of sterility of the contents if the sea... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Feb 23, 2024 | Centurion Clamp kits labeled as: a) STERILE BACKHAUS TOWEL CLAMP (BTC173), ... | Product may have a weak seal which may result in a breach of sterility of the contents if the sea... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Feb 23, 2024 | Centurion retractor kits labeled as: a) STERILE 6-1/2" SENN RETRACTOR (ST718... | Product may have a weak seal which may result in a breach of sterility of the contents if the sea... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Feb 23, 2024 | Centurion Hemostat kits labeled as: a) STERILE CURV KELLY HEMOSTAT, Product... | Product may have a weak seal which may result in a breach of sterility of the contents if the sea... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Feb 23, 2024 | Centurion manual surgical kits labeled as: a) STERILE 4-1/2" S/S SCISSOR (S... | Product may have a weak seal which may result in a breach of sterility of the contents if the sea... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Feb 21, 2024 | HydroFlock Sterile Flocked Collection Device, Part Number 25-3317-H. | It was discovered through a customer complaint that mislabeled product was distributed. Puritan d... | Class II | Puritan Medical Products Company, Llc |
| Feb 21, 2024 | ARCHITECT STAT Myoglobin Reagent Kit, LN 2K43-25 and 2K43-20. | The reason for the recall is the failure of calibration and quality controls due to a manufacturi... | Class II | Abbott Laboratories |
| Feb 20, 2024 | HALYARD SURGICAL HOOD, Universal Size, Blue, 300 count (3 x 100) | Product was mislabeled as a Surgical Cap at its dispenser level. | Class III | O&M HALYARD, INC. |
| Feb 7, 2024 | Access Substrate, REF 81906, For use with the Access Immunoassay Systems | On 07 February 2024 Beckman Coulter made the decision to conduct a field action on Access Substra... | Class II | Beckman Coulter, Inc. |
| Feb 7, 2024 | Medtronic DLP Vessel Cannula, Model Number REF 30000 | Medtronic is writing to inform you of incorrect labeling for three manufactured lots of the DLP V... | Class II | Medtronic Perfusion Systems |
| Feb 6, 2024 | SPII Model Lubinus, Hip Prosthesis Stem XL Neck, cemented | Due to two complaints, has come to our attention that additional guidance is required on the corr... | Class II | Waldemar Link GmbH & Co. KG (Mfg Site) |
| Feb 6, 2024 | SPII Model Lubinus, Hip Prosthesis Stem Standard Neck, cemented | Due to two complaints, has come to our attention that additional guidance is required on the corr... | Class II | Waldemar Link GmbH & Co. KG (Mfg Site) |
| Feb 6, 2024 | SPII Model Lubinus, Long Stem Prosthesis Standard Neck, cemented | Due to two complaints, has come to our attention that additional guidance is required on the corr... | Class II | Waldemar Link GmbH & Co. KG (Mfg Site) |
| Feb 6, 2024 | SPII Model Lubinus, Long Stem Prosthesis XL Neck, cemented | Due to two complaints, has come to our attention that additional guidance is required on the corr... | Class II | Waldemar Link GmbH & Co. KG (Mfg Site) |
| Feb 2, 2024 | BVI Visitec Irrigation Handle (20/SP)- Intended to be fit with a cannula for ... | Pack and pouch label is missing the manufacturing and expiration date. | Class II | Beaver Visitec International, Inc. |
| Jan 26, 2024 | I.B.S¿ 6.5-C Compression screw - diam 6.5mm lg 75mm,Part Number S65 ST175 | This Field Action is being conducted following the identification of a batch mix-up between I.B.S... | Class II | In2Bones, SAS |
| Jan 26, 2024 | I.B.S¿ 6.5-C Compression screw - diam 6.5mm lg 80mm,Part Number S65 ST180 | This Field Action is being conducted following the identification of a batch mix-up between I.B.S... | Class II | In2Bones, SAS |
| Jan 22, 2024 | LINK BiMobile Dual Mobility System E-Poly Liner for 28mm Head, 70mm Shell- In... | Mislabeled: Packaging incorrectly reflects a MobileLink Dual Mobility insert type F when it shoul... | Class II | Waldemar Link GmbH & Co. KG (Mfg Site) |
| Jan 19, 2024 | GORE VIABIL Short Wire Biliary Endoprosthesis, Product labeled as (1) Catal... | Devices without transmural drainage holes may be mislabeled as devices with transmural drainage h... | Class II | W.L. Gore & Associates, Inc. |
| Jan 5, 2024 | Hemostasis Probe, Model: CD-B622LA | The BICOAG Hemostasis Probe with a coaxial plug was mispackaged into the package and labeled as a... | Class II | Olympus Corporation of the Americas |
| Jan 3, 2024 | Stryker Tornier Perform Reversed Glenoid Press-Fit Short Post Ti6AI4V, REF DW... | The incorrect device is contained in the labeled package. | Class II | Tornier, Inc |
| Jan 3, 2024 | The Sofia 2 Flu + SARS Antigen FIA employs immunofluorescence technology in a... | One lot of the Sofia 2 Flu + SARS Antigen FIA (Lot 709083) was labelled with incorrect expiration... | Class II | Quidel Corporation |
| Jan 2, 2024 | 3:1 Dermacarrier, Model Number 00219501300, skin graft carrier | Due to manufacturing issue, the product is labeled as 3:1 ratio, but the ridge pattern is a 1.5:1... | Class II | Zimmer Surgical Inc |
| Dec 29, 2023 | Ingenia Ambition X, Model No. 782109 | An incorrect electrical shock warning label may have been placed on the Liquid Cooling Cabinet (L... | Class III | Philips North America |
| Dec 29, 2023 | Achieva 1.5T Conversion, Model No. 781283 | An incorrect electrical shock warning label may have been placed on the Liquid Cooling Cabinet (L... | Class III | Philips North America |
| Dec 29, 2023 | Achieva 1.5T, Model No. 781178, 781196, 781296 | An incorrect electrical shock warning label may have been placed on the Liquid Cooling Cabinet (L... | Class III | Philips North America |
| Dec 29, 2023 | Intera 1.5T, Model No. 781195 | An incorrect electrical shock warning label may have been placed on the Liquid Cooling Cabinet (L... | Class III | Philips North America |
| Dec 29, 2023 | SmartPath to dStream for 1.5T, Model No. 781260, 782112 | An incorrect electrical shock warning label may have been placed on the Liquid Cooling Cabinet (L... | Class III | Philips North America |
| Dec 29, 2023 | Achieva 3.0T, Model No. 781177 | An incorrect electrical shock warning label may have been placed on the Liquid Cooling Cabinet (L... | Class III | Philips North America |
| Dec 28, 2023 | Bubble Sensor (REF: 70105.5720) | The Bubble Sensor optional accessory to the CARDIOHELP-i extracorporeal life support system inclu... | Class II | Maquet Medical Systems USA |
| Dec 22, 2023 | ELEOS COLLAR STEM, CEMENTED, FLUTED, 13MM X 120MM. Model Number: HC-13120-03... | Mislabeling of 13mm Modular Segmental Stem package (HC-13120-03M) which included an implant that ... | Class II | Onkos Surgical, Inc. |
| Dec 22, 2023 | ELEOS COLLAR STEM, CEMENTED, FLUTED, 15MM X 120MM. Model Number: HC-15120-03... | Mislabeling of 13mm Modular Segmental Stem package (HC-13120-03M) which included an implant that ... | Class II | Onkos Surgical, Inc. |
| Dec 21, 2023 | FLEXSelect 5/16" Amber Latex Elastics-Intended use is orthodontics, braces, t... | Latex elastic bands were labeled as non-latex elastic bands, an allergic rx can occur due to pati... | Class II | G & H Wire Company |
| Dec 20, 2023 | These wipes are saturated with 0.65% bleach solution. These wipes are antimic... | There is stability concern for products dated with a 24-month shelf life. Product is safe and eff... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
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.