Browse Device Recalls
35,307 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 35,307 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 35,307 FDA device recalls, Class II.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Oct 24, 2023 | GRAPHENANO DENTAL G-CAM, Product Codes: a) 95 Multichroma 14LB2, REF GC00089... | Machining error on cams renders the device unusable. | Class II | GRAPHENANO DENTAL SL |
| Oct 24, 2023 | Injection Needle, 3 Fr., REF: 27030N; Injection Cannula, 6 Fr., REF: 27182A | The efficacy of the manual cleaning process cannot be assured for the affected injection needles ... | Class II | Karl Storz Endoscopy |
| Oct 24, 2023 | CardioQuip Modular Cooler-Heater, Model: MCH-1000(i), Power: 115V-60Hz, 16A | There is the potential that cooler-heater devices may contain bacterial contamination which could... | Class II | CardioQuip, LLC |
| Oct 24, 2023 | Injection Needle, curved 23 cm, REF: 8598A; Injection Needle, straight, 23 cm... | The efficacy of the manual cleaning process cannot be assured for the affected injection needles ... | Class II | Karl Storz Endoscopy |
| Oct 24, 2023 | Injection Needle, single cvd. 70 degrees, REF: 738750; Injection Needle, sing... | The efficacy of the manual cleaning process cannot be assured for the affected injection needles ... | Class II | Karl Storz Endoscopy |
| Oct 24, 2023 | Injection Needle, LUER-lock,0.8mm, REF: 26175PD | The efficacy of the manual cleaning process cannot be assured for the affected injection needles ... | Class II | Karl Storz Endoscopy |
| Oct 23, 2023 | Achieva 1.5T Conversion | Potential component failure in the Gradient Coil could product smoke and/or fire. | Class II | Philips North America Llc |
| Oct 23, 2023 | Intera 1.5T Power/Pulsar | Potential component failure in the Gradient Coil could product smoke and/or fire. | Class II | Philips North America Llc |
| Oct 23, 2023 | Intera 1.5T | Potential component failure in the Gradient Coil could product smoke and/or fire. | Class II | Philips North America Llc |
| Oct 23, 2023 | SmartPath to dStream for 1.5T | Potential component failure in the Gradient Coil could product smoke and/or fire. | Class II | Philips North America Llc |
| Oct 23, 2023 | Ingenia 1.5T CX | Potential component failure in the Gradient Coil could product smoke and/or fire. | Class II | Philips North America Llc |
| Oct 23, 2023 | Achieva 1.5T | Potential component failure in the Gradient Coil could product smoke and/or fire. | Class II | Philips North America Llc |
| Oct 23, 2023 | stryker Sage PrimaFit External Urine Management System for the Female Anatomy | A small percentage of devices in three lots of product may contain a tape with a natural rubber l... | Class II | Sage Products Inc |
| Oct 23, 2023 | Achieva 1.5T Initial System | Potential component failure in the Gradient Coil could product smoke and/or fire. | Class II | Philips North America Llc |
| Oct 19, 2023 | Integra Cranial Access Kit -For access to the subarachnoid space or the later... | Defect in the outer packaging of the Cranial Access Kits can cause the packaging to split without... | Class II | Integra LifeSciences Corp. |
| Oct 19, 2023 | Integra Cranial Access Kit-For access to the subarachnoid space or the latera... | Defect in the outer packaging of the Cranial Access Kits. can cause the packaging to split withou... | Class II | Integra LifeSciences Corp. |
| Oct 19, 2023 | Integra Cranial Access Kit- For access to the subarachnoid space or the later... | Defect in the outer packaging of the Cranial Access Kits. can cause the packaging to split withou... | Class II | Integra LifeSciences Corp. |
| Oct 19, 2023 | Para-Pak Clean Vial-For the collection, transportation, preservation, and exa... | Plastic vials contain a manufacturing defect may cause an increased risk of leakage and presents ... | Class II | Meridian Bioscience Inc |
| Oct 19, 2023 | Integra¿ Cranial Access Kit-For access to the subarachnoid space or the later... | Defect in the outer packaging of the Cranial Access Kits. can cause the packaging to split withou... | Class II | Integra LifeSciences Corp. |
| Oct 19, 2023 | Model 97745 Controller used with Models 97715 and 97716 Intellis Neurostimula... | Units distributed in Korea and Turkey that did not have the correct firmware installed to support... | Class II | Medtronic Neuromodulation |
| Oct 19, 2023 | Combo Kit Consists OF 10-110/INS-4500/INS-7040- For access to the subarachnoi... | Defect in the outer packaging of the Cranial Access Kits. can cause the packaging to split withou... | Class II | Integra LifeSciences Corp. |
| Oct 19, 2023 | Cardinal Health Clean Stool Transportation System-For the collection, transpo... | Due to a manufacturing defect, certain Para-Pak vials may be at risk for leakage. | Class II | Meridian Bioscience Inc |
| Oct 19, 2023 | Alinity c Processing Module REF 03R67-01 The Alinity c Processing Module... | The devices contain a dry natural rubber (latex) subcomponent, which are not labeled as containin... | Class II | Abbott Laboratories |
| Oct 19, 2023 | CardioQuip Modular Cooler-Heater, Model:MCH-1000(m), Power: 115V-60hz,16A | There is a potential for the heating-chamber to malfunction resulting in melting/burning of the h... | Class II | CardioQuip, LLC |
| Oct 19, 2023 | Para-Pak Zn-PVA/10% Formalin-for the routine collection, transportation, pres... | Plastic vials contain a manufacturing defect may cause an increased risk of leakage and presents ... | Class II | Meridian Bioscience Inc |
| Oct 19, 2023 | Integra Cranial Access Kit-For access to the subarachnoid space or the latera... | Defect in the outer packaging of the Cranial Access Kits. can cause the packaging to split withou... | Class II | Integra LifeSciences Corp. |
| Oct 19, 2023 | Integra Cranial Access Kit - For access to the subarachnoid space or the late... | Defect in the outer packaging of the Cranial Access Kits. can cause the packaging to split withou... | Class II | Integra LifeSciences Corp. |
| Oct 19, 2023 | Medline Leg bag, REF URO12573 | Undeclared latex | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Oct 19, 2023 | Medline Leg bag, REF DYND12574 | Undeclared latex | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Oct 19, 2023 | Integra Cranial access kit (without Prep solutions) Bit and Guard-For access ... | Defect in the outer packaging of the Cranial Access Kits can cause the packaging to split without... | Class II | Integra LifeSciences Corp. |
| Oct 19, 2023 | CardioQuip Modular Cooler-Heater, Model:MCH-1000(i), Power: 115V-60hz,16A | There is a potential for the heating-chamber to malfunction resulting in melting/burning of the h... | Class II | CardioQuip, LLC |
| Oct 19, 2023 | Alinity i Processing Module REF 03R65-01 The Alinity i Processing Module... | The devices contain a dry natural rubber (latex) subcomponent, which are not labeled as containin... | Class II | Abbott Laboratories |
| Oct 19, 2023 | epoc NXS Host Blood Analysis System, Siemens Material Numbers 11413497 (EU), ... | Siemens Healthcare Diagnostics Inc. has confirmed a potential issue that could occur under certai... | Class II | Siemens Healthcare Diagnostics Inc |
| Oct 19, 2023 | Medline Leg bag, REF DYND12578 | Undeclared latex | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Oct 19, 2023 | Abbott CELL-DYN Ruby, Model CD-Ruby, List number 08H67-01, and Abbott CELL-DY... | The devices contain a dry natural rubber (latex) subcomponent, which are not labeled as containin... | Class II | Abbott Laboratories |
| Oct 19, 2023 | ARCHITECT c4000 Processing Module REF: 02P24-01 02P24-02 02P24-40 01R24-... | The devices contain a dry natural rubber (latex) subcomponent, which are not labeled as containin... | Class II | Abbott Laboratories |
| Oct 19, 2023 | Integra¿ Cranial Access Kit-For access to the subarachnoid space or the later... | Defect in the outer packaging of the Cranial Access Kits. can cause the packaging to split withou... | Class II | Integra LifeSciences Corp. |
| Oct 18, 2023 | Monarch Platform REF MON-000005-01R, 100-240V- 50/60Hz 1440w | Their is the potential that software issues may result in flipped image of the virtual Bronchosc... | Class II | AURIS HEALTH INC |
| Oct 18, 2023 | Monarch Platform REF MON-000005-01, 100-240V- 50/60Hz 1440w | Their is the potential that software issues may result in flipped image of the virtual Bronchosc... | Class II | AURIS HEALTH INC |
| Oct 18, 2023 | LYFO-DISK, P. venetum, Catalog number 0794L | A complaint investigation showed that the bulk pellets (lot 794-142) were contaminated with Asper... | Class II | Microbiologics Inc |
| Oct 18, 2023 | Monarch Platform REF MON-000006 100-240V- 50/60Hz 1440w | Their is the potential that software issues may result in flipped image of the virtual Bronchosc... | Class II | AURIS HEALTH INC |
| Oct 18, 2023 | KWIKSTIK, P. venetum, Catalog numbers: a) 0794P (2-pack), b) 0794K (6-pack) | A complaint investigation showed that the bulk pellets (lot 794-142) were contaminated with Asper... | Class II | Microbiologics Inc |
| Oct 17, 2023 | Lugol s Iodine Solution 500ML, Part Number 624-71 | Due to the incorrect packaging utilized with lot 3124, there' s an improper seal between the cap ... | Class II | EMD Millipore Corporation |
| Oct 17, 2023 | BIOFIRE Blood Culture Identification 2 (BCID2) Panel, REF: RFIT-ASY-0147, use... | Routine quality control testing of affected blood culture identification panel with affected cont... | Class II | BioFire Diagnostics, LLC |
| Oct 17, 2023 | SagiPlan 2.2, CE0344, Rx Only , Brachyterapy Treatment Planning System | Due to software malfunction, numerical values may be rounded resulting in inaccurate measurements. | Class II | Bebig Isotopentechnik Gmbh |
| Oct 17, 2023 | ARTIS icono (ceiling configuration), Fluoroscopic x-ray system; Model no. 11... | Potential hardware issue for ARTIS icono ceiling system: collision sensor may falsely signal non-... | Class II | Siemens Medical Solutions USA, Inc |
| Oct 17, 2023 | FilmArray TORCH REF HTFA-ASY-0104. HTFA-ASY-0104 is the BIOFIRE TORCH Base w... | Due to an increased risk of degradation of the power entry switch resulting from arcing inside of... | Class II | BioFire Diagnostics, LLC |
| Oct 16, 2023 | GIF-H190, EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE | Specific devices may have an improperly repaired light guide connector due to missing adhesive to... | Class II | Aizu Olympus Co., Ltd. |
| Oct 16, 2023 | GIF-HQ190, EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE | Specific devices may have an improperly repaired light guide connector due to missing adhesive to... | Class II | Aizu Olympus Co., Ltd. |
| Oct 16, 2023 | Vitality Polyaxial Screw, 7.5mmx 50mm, REF: 07.02000.118, used with Vitality ... | Spinal fixation system 7.5mmx 50mm screws are packaged with the correct labeling, but the screws ... | Class II | Zimmer Biomet Spine Inc. |
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.