Browse Device Recalls
2,276 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,276 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 2,276 FDA device recalls in 2022.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jul 4, 2022 | Medicina ENFit 5ml Reusable Enteral Syringe Code: LHE05 | Plunger component has been manufactured with an unapproved material (Polyethylene not Polypropyle... | Class II | Medicina Uk Ltd |
| Jul 4, 2022 | Medicina Oral Tip Syringe 2.5ml Code: OT25 | Plunger component has been manufactured with an unapproved material (Polyethylene not Polypropyle... | Class II | Medicina Uk Ltd |
| Jul 4, 2022 | Medicina ENFit 1ml Reusable Low Dose Enteral Syringe Code: LHE01LD | Plunger component has been manufactured with an unapproved material (Polyethylene not Polypropyle... | Class II | Medicina Uk Ltd |
| Jul 4, 2022 | Medicina Oral Tip Syringe 0.5ml Code: OT005 | Plunger component has been manufactured with an unapproved material (Polyethylene not Polypropyle... | Class II | Medicina Uk Ltd |
| Jul 1, 2022 | Da Vinci X/Xi Large Clip Applier, Model 470230 Da Vinci X/Xi Medium-Large Cl... | Due to the potential for unexpected motion caused by the partial disengagement of the instrument ... | Class II | Intuitive Surgical, Inc. |
| Jul 1, 2022 | Da Vinci S/Si Large Clip Applier, Model 420230 Da Vinci S/Si Medium-Large Cl... | Due to the potential for unexpected motion caused by the partial disengagement of the instrument ... | Class II | Intuitive Surgical, Inc. |
| Jun 30, 2022 | Echelon -14 Micro Catheter, REF: 105-5092-150, sterile EO, Rx Only | Outer carton packaging of microcatheters were exposed to wet substance during transport. | Class II | Micro Therapeutics, Inc. |
| Jun 30, 2022 | Echelon -14, 45 Tip Shape, REF 145-5092150, sterile EO, Rx Only | Outer carton packaging of microcatheters were exposed to wet substance during transport. | Class II | Micro Therapeutics, Inc. |
| Jun 29, 2022 | Wolf-Pak Premium Dressing Kit with GuardVA Cs/30 Ref: DC5030LF | Kits mislabeled as latex-free, the packaging for component 94-7002 Non-Adherent Dressing contains... | Class II | Trinity Sterile, Inc. |
| Jun 29, 2022 | CARTO VIZIGO 8.5F Bi-Directional Guiding Sheath, REF: D138501. Used to intro... | Outside packaging for a device indicated for introducing cardiovascular catheters into the heart,... | Class II | Biosense Webster, Inc. |
| Jun 29, 2022 | MEDLINE MICRO-KILL GERMICIDAL BLEACH WIPES, Model numbers MSC351420AN, MSC351... | stability failure | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Jun 29, 2022 | SX-One MicroKnife | Potential of dull blade | Class II | SONEX HEALTH LLC |
| Jun 29, 2022 | Wolf Pak Premium Dressing Change Kit with Statlock CS/30 Ref: DC5040LF | Kits mislabeled as latex-free, the packaging for component 94-7002 Non-Adherent Dressing contains... | Class II | Trinity Sterile, Inc. |
| Jun 29, 2022 | Orthex External Fixation Wire Sharp Bayonet 1.8 x 400 mm Model: K400-18BN | Manufacturing variance near transition of tip is increasing the likelihood the wire tip may fract... | Class II | OrthoPediatrics Corp |
| Jun 29, 2022 | Wolf Pak Premium Dressing Change Kit with GuardVA and Statlok Cs/30 Ref: DC5... | Kits mislabeled as latex-free, the packaging for component 94-7002 Non-Adherent Dressing contains... | Class II | Trinity Sterile, Inc. |
| Jun 29, 2022 | ATTUNE Measured Sizing and Rotation Guide-to size the femur and align rotatio... | Manufactured with a Galvanized High Carbon Steel spring instead of the correct 302 Stainless stee... | Class II | DePuy Orthopaedics, Inc. |
| Jun 29, 2022 | Sklar Instruments IV Cath Dressing Tray Cs/25 Re-Order Number: 96-1708 | Kits mislabeled as latex-free, the packaging for component 94-7002 Non-Adherent Dressing contains... | Class II | Trinity Sterile, Inc. |
| Jun 28, 2022 | HeartWare Ventricular Assist Device (HVAD) System Batteries, Product Number 1... | Battery performance issues. Battery electrical faults render it unable to power the controller, u... | Class I | Heartware, Inc. |
| Jun 28, 2022 | BIOPHEN UFH Control Plasma | Incorrect product labeling was included in the package. | Class III | Aniara Diagnostica LLC |
| Jun 28, 2022 | Atellica CH Iron_2 (Iron_2) is for in vitro diagnostic use in the quantitativ... | Falsely Elevated Atellica CH Microalbumin_2 (¿ALB_2) Results due to Reagent Carryover from the Ir... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jun 27, 2022 | X-Stream Irrigation System (Catalog No. 5551000) and X-Stream Irrigation Syst... | The device may potentially cause a fire, leading to a safety risk. | Class II | Davol, Inc. |
| Jun 27, 2022 | Product Description/Item: ChemoLock Vial Spike, 20mm/011-CL-80S; ChemoLock B... | Ports have a potential for unintended disconnection, inability to connect to or fully engage with... | Class II | ICU Medical, Inc. |
| Jun 27, 2022 | HAMILTON-C6 Intensive Care Ventilator, REF: 160021 | Ventilator status indicator board can become loose, which could lead to water ingress (disinfecta... | Class I | Hamilton Medical AG |
| Jun 27, 2022 | (1) Genesis II Non-Porous Tibial Baseplate Size 5 Right, Product #71420186. ... | The product was mispackaged (swapped). The devices within the inner tray matches the inner tray ... | Class II | Smith & Nephew, Inc. |
| Jun 27, 2022 | Product Description/Item: ChemoLock Bag Spike, 10 units/CL-10-10; ChemoLock ... | Ports have a potential for unintended disconnection, inability to connect to or fully engage with... | Class II | ICU Medical, Inc. |
| Jun 24, 2022 | Medline Sprinter OTW, Model/Catalog Number SPR2512W; The Sprinter Over-the-Wi... | Luer has balloon diameter printed as "2.25mmx12mm" instead of the correct diameter, "2.5mmx12mm" ... | Class II | Medtronic Inc |
| Jun 24, 2022 | Hill-Rom PRO+ 36" MRS Surface mattress, REF P7924A03. | The failure mode on the affected mattresses can cause a reduction in the performance of the Micro... | Class II | Baxter Healthcare Corporation |
| Jun 24, 2022 | Hill-Rom PRO+ MRS Surface For Versacare mattress, REF P3255A02. | The failure mode on the affected mattresses can cause a reduction in the performance of the Micro... | Class II | Baxter Healthcare Corporation |
| Jun 24, 2022 | Hill-Rom Centrella Pro+ 36" Surface With X-Ray mattress, REF P7923A01. | The failure mode on the affected mattresses can cause a reduction in the performance of the Micro... | Class II | Baxter Healthcare Corporation |
| Jun 24, 2022 | Hill-Rom Centrella Pro+ 36" Surface mattress, REF P7923A03. | The failure mode on the affected mattresses can cause a reduction in the performance of the Micro... | Class II | Baxter Healthcare Corporation |
| Jun 24, 2022 | ZEISS Axio Observer 5 microscope, Product material no. 431006-9901-000 | An incorrect Unique Device Identification (UDI) label was installed on some ZEISS Axio Observer 5... | Class III | Zeiss, Carl Inc |
| Jun 24, 2022 | Stryker 2.3mm Tapered Router, Catalog no. 5820-071-023 instrument used in cra... | There is a potential for the core diameter to be undersized, which may lead to the router breakin... | Class II | Stryker Instruments |
| Jun 24, 2022 | LumiraDx SARS-CoV-2 Antibody (Ab) Test Strip | Modification to the LumiraDx SARS-CoV-2 Antibody (Ab) test that was made outside the scope of the... | Class II | LumiraDx |
| Jun 24, 2022 | Hill-Rom Centrella Pro+ 40" Surface mattress, REF P7923A04. | The failure mode on the affected mattresses can cause a reduction in the performance of the Micro... | Class II | Baxter Healthcare Corporation |
| Jun 24, 2022 | UroLift System REF UL400-4, QTY 4 Urolfit System with Handle Release Tool | There is the potential that during implant deployment, the device may not properly deliver a imp... | Class II | Neotract Inc |
| Jun 24, 2022 | Hill-Rom PRO+ MRS Surface For Versacare With X-Ray mattress, REF P3255A01. | The failure mode on the affected mattresses can cause a reduction in the performance of the Micro... | Class II | Baxter Healthcare Corporation |
| Jun 24, 2022 | Hill-Rom PRO+ 36" MRS Surface With X-Ray mattress, REF P7924A01; and REF P79... | The failure mode on the affected mattresses can cause a reduction in the performance of the Micro... | Class II | Baxter Healthcare Corporation |
| Jun 24, 2022 | LumiraDx SARS-CoV-2 Antibody (Ab) Liquid Quality Control | Modification to the LumiraDx SARS-CoV-2 Antibody (Ab) test that was made outside the scope of the... | Class II | LumiraDx |
| Jun 24, 2022 | SIGNA Premier magnetic resonance scanner, model 5748519. | Under rare conditions, SIGNA Premier gradient coils could result in elevated acoustic noise durin... | Class II | GE Healthcare, LLC |
| Jun 24, 2022 | The Cholestech LDX¿ System combines enzymatic methodology and solidphase tec... | Cholesterol test cassettes package insert is to be updated with new bilirubin interference inform... | Class II | Alere San Diego, Inc. |
| Jun 23, 2022 | NEW SKIN LIQUID BANDAGE CLEAR .3FL OZ, SKU 999417 | Affected product was not appropriately stored in temperature-controlled areas between April 30, 2... | Class II | Family Dollar Stores, Llc. |
| Jun 23, 2022 | SKYN ORIGINAL NON LATEX CONDOM 12CT, SKU 903409 LS SKYN NON LATEX LUBRICAT... | Affected product was not appropriately stored in temperature-controlled areas between April 30, 2... | Class II | Family Dollar Stores, Llc. |
| Jun 23, 2022 | INOmax DSIR -(delivery system) delivers INOMAX (nitric oxide for inhalation) ... | The INOmax DSIR Delivery System, manufactured by Mallinckrodt Pharmaceuticals, is not compatible ... | Class II | Mallinckrodt, LLC. |
| Jun 23, 2022 | AT HOME MARIJUANA TEST STRIP, SKU 900752 | Affected product was not appropriately stored in temperature-controlled areas between April 30, 2... | Class II | Family Dollar Stores, Llc. |
| Jun 23, 2022 | Ambra PACS, Ambra ProViewer. Software for use as a primary diagnostic and an... | A race condition between the storage system and services database has the potential to revert edi... | Class II | DICOM Grid, Inc. d/b/a Ambra Health |
| Jun 23, 2022 | B L BIOTRU MULTI PURPOSE SOLUTION 4 FLOZ, SKU 999009 | Affected product was not appropriately stored in temperature-controlled areas between April 30, 2... | Class II | Family Dollar Stores, Llc. |
| Jun 23, 2022 | GS DENTURE CLEANSER GRN TAB 40CT, SKU 906312 GS DENTURE CLEAN OVRNT TAB 40CT... | Affected product was not appropriately stored in temperature-controlled areas between April 30, 2... | Class II | Family Dollar Stores, Llc. |
| Jun 23, 2022 | Veriquick Pregnancy Test 2CT, SKU 903756 | Affected product was not appropriately stored in temperature-controlled areas between April 30, 2... | Class II | Family Dollar Stores, Llc. |
| Jun 23, 2022 | LIFESTYLES ULTRA SENSITIVE CONDOMS 12CT, SKU 900265 | Affected product was not appropriately stored in temperature-controlled areas between April 30, 2... | Class II | Family Dollar Stores, Llc. |
| Jun 23, 2022 | FIXODENT ORG CREAM 2.4OZ, SKU 906018 FIXODENT ORG CREAM TRAVEL .75OZ, SKU 90... | Affected product was not appropriately stored in temperature-controlled areas between April 30, 2... | Class II | Family Dollar Stores, Llc. |
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.