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 |
|---|---|---|---|---|
| Jun 6, 2022 | Medline Custom procedural kits labeled as follows: a. GP-NEURO PACK, b. KIT ... | Kits contain leaking bottles of isopropyl alcohol | Class II | MEDLINE INDUSTRIES, LP - SPT |
| Jun 6, 2022 | Medline Convenience kits labeled as: a. WET SKIN PREP TRAY, b. SKIN PREP TRA... | Kits contain leaking bottles of isopropyl alcohol | Class II | MEDLINE INDUSTRIES, LP - SPT |
| Jun 6, 2022 | Medline Convenience kits labeled as follows: a. BEDSIDE PICC CDS, Model Numb... | Kits contain leaking bottles of isopropyl alcohol | Class II | MEDLINE INDUSTRIES, LP - SPT |
| Jun 3, 2022 | Trevo Trak 21 Microcatheter, REF: 90338. TREVO NXT 3X32+TRAK21 2-PACK - CE... | Microcatheter product label on the carton is missing the microcatheter product drawing/illustration. | Class II | Stryker Neurovascular |
| Jun 3, 2022 | SteriSpine PS kit of 2 Multi-Axial Fenestrated Screws, model numbers/REF numb... | The type of screw printed on the traceability record for the patient label is incorrect, but the ... | Class II | SAFE ORTHOPAEDICS LLC |
| May 31, 2022 | NATURALYTE Liquid Acid 2.0K 2.5Ca- indicated for use in patients undergoing e... | Alternate Bottle Caps labeled with "Sealed for your Protection" on the foil not qualified for use | Class II | Fresenius Medical Care Holdings, Inc. |
| May 31, 2022 | NATURALYTE Liquid Acid 3.0K 3.0Ca- indicated for use in patients undergoing e... | Alternate Bottle Caps labeled with "Sealed for your Protection" on the foil not qualified for use | Class II | Fresenius Medical Care Holdings, Inc. |
| May 31, 2022 | NeuRx Diaphragm Pacing System (NeuRx DPS), Affected part numbers: Part # ... | Firm has revised labeling to consistently call out storage conditions and revised the instruction... | Class III | Synapse Biomedical Inc |
| May 27, 2022 | LEAD 3387S-40 STIMLOC DBS, Model Number 3387S-40. Electrical implantable device. | There are a small number of units of the DBS Lead with StimLoc kit (3387S-40) due to a discrepanc... | Class II | Medtronic Neuromodulation |
| May 26, 2022 | SOLTIVE SuperPulsed Laser Fibers, Model# Labeled TFL-FBX150BS (Carton) - 150... | Device model and size for affected lots of Laser Fibers may be mismatched between the product's c... | Class II | Olympus Corporation of the Americas |
| May 25, 2022 | EkoSonic Kit 135cm, 12cm TZ The EkoSonic Endovascular Device is packaged a... | Product may be mislabeled. | Class II | Boston Scientific Corporation |
| May 25, 2022 | EkoSonic Kit 106cm, 12cm TZ The EkoSonic Endovascular Device is packaged a... | Product may be mislabeled. | Class II | Boston Scientific Corporation |
| May 20, 2022 | EIT CIF cage, H 6mm, 8degree, L- an intervertebral body fusion devices indica... | Label on the Outer Carton does not match the labels on the Outer Blister package, Inner Blister p... | Class II | DePuy Spine, Inc. |
| May 20, 2022 | EIT CIF cage, H 7mm, 8degree, S- an intervertebral body fusion devices indica... | Label on the Outer Carton does not match the labels on the Outer Blister package, Inner Blister p... | Class II | DePuy Spine, Inc. |
| May 20, 2022 | Kit Label: Anti-FITC-AP CISH Accessory Kit (Dako Omnis), Box A REF K589911-2... | Label provided for substrate vail contained incorrect expiration date. | Class III | Agilent Technologies, Inc. |
| May 18, 2022 | Paragon 28, Inc. System: Baby Gorilla/Gorilla Plating System, Ref: P99-100-28... | Incorrect labeling; There is potential that the drill packaging contains the incorrect part number. | Class II | Paragon 28, Inc. |
| May 13, 2022 | RayOne Preloaded Hydrophilic Acrylic IOL Injection Systems containing one MIC... | The outer package is mislabeled and the package contains a different IOL strength. | Class II | Rayner Intraocular Lenses Ltd |
| May 11, 2022 | Alcon Clareon IOL with AutonoMe Delivery System | Due to device (preloaded intraocular lens) mislabeling, associated with partial mixing of product... | Class II | Alcon Laboratories Ireland, Ltd |
| May 6, 2022 | KWIK-STIK" plus: Clostridium perfringens | Labeling error. | Class III | Microbiologics Inc |
| May 2, 2022 | Nasopharyngeal sample collection tray for COVID-19 testing, labeled as COVID ... | Affected products were assembled off-site by individuals who may not have been properly trained. | Class I | American Contract Systems, Inc. |
| Apr 29, 2022 | INTERGARD Woven Vascular Graft is a woven polyester graft coated with a bovin... | Mislabeled: Product labeled as Intergard Woven Straight graft REF IGW0032-30, D: 8 mm, L: 30 cm,... | Class II | Maquet Cardiovascular, LLC |
| Apr 28, 2022 | FIRMap" Catheter, 60mm Basket | Incorrect product labeling. | Class II | Abbott |
| Apr 27, 2022 | AXIUM DETACHABLE COIL SYSTEM REF QC-4-12-HELIX; Axium Detachable Coil Syst... | Due to incorrect size and configuration labeling of the detachable coil system. | Class II | Micro Therapeutics, Inc. |
| Apr 26, 2022 | BVI Wet -Field Eraser, 18GA Blunt Tip, 45Deg.-Intended to remove tissue and c... | Boxes labeled as Wet-Field Eraser, 18GA Blunt Tip, 45Deg., were shipped containing incorrect prod... | Class II | Beaver Visitec International, Inc. |
| Apr 22, 2022 | INTERTAN 1.5 NAIL 13mm X 42cm 130DEG. Left INTERTAN 1.5 NAIL 13mm X 42cm 13... | Right nails were anodized, marked, and labelled as left nails and vice versa | Class II | Smith & Nephew Orthopaedics GmbH |
| Apr 21, 2022 | Atrium Firm PVC Thoracic Catheter 28French-Intended to facilitate the evacuat... | Mismatch between the expiration date on the sterile barrier pouch and the expiration date on the ... | Class II | Atrium Medical Corporation |
| Apr 21, 2022 | Oakworks Bed (Emergency Field Bed); Model No. OBMPBR361980A6TTGRCS | The warning label was printed with the incorrect weight capacity. The correct weight limit is 400... | Class II | Oakworks Inc |
| Apr 21, 2022 | PX200 Emergency Relief Bed; Model No. PXEXEB362280A6TTZZH4C19 | Product label was printed without the UDI number and warning label was printed with the incorrect... | Class II | Oakworks Inc |
| Apr 19, 2022 | LEGION NARROW PS OXIN SZ 6N RT and JRNY II BCS FEMORAL OXIN LT SZ 5 | It was reported that a JOURNEY II BCS Femoral OXIN LT SZ5 was in a box labelled as a LEGION NARRO... | Class II | Smith & Nephew Inc |
| Apr 18, 2022 | Back up batteries in Ventilators labeled as the following: a. CARESCAPE R860 ... | Insufficient battery backup power resulting in premature shutdown of the ventilator when not conn... | Class I | GE Healthcare, LLC |
| Apr 14, 2022 | putty i-FACTOR Peptide Enhanced Bone Graft 1.0cc Syringe REF 700-010, PUTTY | Patient chart label contains incorrect Part Number and volume amount. | Class III | Cerapedics, Inc. |
| Apr 13, 2022 | AUTOLITH Touch 1.9F 375cm Biliary Electrohydraulic Lithotripter Probe | Product labeled incorrectly. | Class II | Northgate Technologies, Inc. |
| Apr 8, 2022 | TMJ Arthroscopy Drape, 85''x 96'' | Latex content in product was labeled incorrectly as latex free. | Class II | Microtek Medical Inc. |
| Mar 30, 2022 | Evans Wedge Disposable Trials, Large Footprint, 8mm Thickness (Model: 6101-22... | During re-work of disposable instruments to relabel for 4-year shelf-life of disposable instrumen... | Class II | restor3d Inc. |
| Mar 30, 2022 | Non-Sterile Double Ended Trial Kit, Small Footprint, (6110-N01-KTS01) for the... | Product labeled incorrectly. The lot was labeled with Small footprint when the product was Medium. | Class II | restor3d Inc. |
| Mar 30, 2022 | HydroMARK Breast Biopsy Marker, Model No. 4010-05-08-T4 | Small patient labels do not match the primary device label. The primary device label accurately i... | Class II | Devicor Medical Products Inc |
| Mar 30, 2022 | Triathlon Tritanium Tibial Component (Size 6); Catalog Number 5536-B-600 Tri... | Stryker has discovered a potential product mix where the size of the Triathlon Tritanium Tibial C... | Class II | Howmedica Osteonics Corp. |
| Mar 30, 2022 | Evans Wedge Disposable Trials, Medium Footprint, 10mm Thickness (6101-2018101... | During re-work of disposable instruments to relabel for 4-year shelf-life of disposable instrumen... | Class II | restor3d Inc. |
| Mar 28, 2022 | Smart Toe II Intramedullary Arthrodesis Implant | The nickel-sensitivity statement on the outer carton may be partially covered by a label resultin... | Class II | Stryker GmbH |
| Mar 21, 2022 | Avanos Cortrak 2 Enteral Access System (EAS) | Product labeling is being modified. STOP using the Anonymous Account Mode feature of the CORTRAK ... | Class I | Avanos Medical, Inc. |
| Mar 16, 2022 | LetsGetChecked Blood Sample Collection kit-In vitro diagnostic medical device... | Users received sample collection kits that were assigned to another user. Incorrect shipping lab... | Class II | LetsGetChecked Inc. |
| Feb 25, 2022 | Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, Yellow, REF H9386... | Product is mislabeled as self-righting Luer slip tip caps, yellow. | Class II | Baxter Healthcare Corporation |
| Feb 25, 2022 | Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02 | Kits were labeled with incorrect expiration dates. | Class II | CELLTRION USA INC |
| Feb 24, 2022 | Outer Packaging Label: Protekt Sharps Safety Knives - REF: PG 44620MU, Steri... | Surgical knives may contain incorrect description printed on handles. Specifically, some surgical... | Class II | International Science & Technology, LP, DBA Dia... |
| Feb 17, 2022 | LIPOSORBER System, Model: LA-15, consisting of: Apheresis machine, produc... | Labeling change to due to the risk of severe anaphylactoid reactions including shock in patients ... | Class II | Kaneka America Corp |
| Feb 14, 2022 | BIOMET Trauma, [Item # 13182-22-26, DVR CROSSLOCK EXTRA LONG PLATE LEFT], [It... | Packaging of various implants may not have sufficient adhesion on all sides, leading to loss of s... | Class II | Biomet, Inc. |
| Feb 14, 2022 | BIOMET TRAUMA Drill Bit, Tap, Guide Pin: [DVR Drill Bit, Item # 212000022, DV... | Packaging of various implants may not have sufficient adhesion on all sides, leading to loss of s... | Class II | Biomet, Inc. |
| Feb 14, 2022 | BIOMET Sports Medicine JUGGERLOC SLOTTED REAMER: [Item # 110010371, 6MM], [It... | Packaging of various implants may not have sufficient adhesion on all sides, leading to loss of s... | Class II | Biomet, Inc. |
| Feb 14, 2022 | BIOMET TRAUMA A.L.P.S. FIBULA COMPOSITE LOCKING PLATE 8 HOLE, Item # 85620400... | Packaging of various implants may not have sufficient adhesion on all sides, leading to loss of s... | Class II | Biomet, Inc. |
| Feb 14, 2022 | Cytocell 8 Square Template Slides (Glass)- microscope slides Reference: PCN008 | Labelled with an incorrect expiry date on the outer label with an extended expiry date than the ... | Class III | Cytocell Ltd. |
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.