Browse Device Recalls
5,543 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 5,543 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 5,543 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jul 27, 2022 | Diasol Acid Concentrate REF G100325-10Dex 100 | Due to labeling issue. The box label is different that the gallon label in that gallon label sho... | Class II | Diasol, Inc |
| Jul 27, 2022 | Stryker SWANSON Flexspan Finger Joint Implant W/O Grommets Silicone, Size: 00... | An incorrect sizing label was applied to the carton packaging. | Class II | Wright Medical Technology, Inc. |
| Jul 27, 2022 | Helix Elite Inactivated Standard, labeled as: a. Inactivated SARS-CoV-2 B... | Product not registered for use in the UK | Class III | Microbiologics Inc |
| Jul 22, 2022 | Corin METAFIX HIP STEM, SIZE 3, STANDARD, 135 degrees, COLLARED HIP STEM, CEM... | One MetaFix size 7 collarless stem from batch 478179 which was incorrectly labelled as a MetaFix ... | Class II | Corin Ltd |
| Jul 18, 2022 | BD PhaSealTM Y-Site Connector (C80)- airtight and leak-proof Closed System Dr... | Incorrect expiration date listed on the product labels. The expiration date listed on the product... | Class II | Becton Dickinson & Company |
| Jul 13, 2022 | ProPlan CMF Anatomical Model, Maxilla-Cranium, Clear Identification number S... | MU22-INA-DUQ case was labeled as MU22-INA-DUQ but was shipped with the Anatomical Model of case ... | Class II | Materialise USA LLC |
| 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 | 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 | 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 | 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 | BIOPHEN UFH Control Plasma | Incorrect product labeling was included in the package. | Class III | Aniara Diagnostica LLC |
| 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 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 20, 2022 | Description/Part: Simplify Disc Size 1, Ht 5/SM-5; Simplify Disc Size 1, H... | Cervical artificial disc Unique Device Identifier (UDI) barcodes contain the incorrect Global Tra... | Class II | NuVasive Inc |
| Jun 14, 2022 | Quantikine IVD Erythropoietin Human Serum Controls for use as quantitative co... | The Instructions for Use (IFU, Part Number 750095) provided with the affected lots by the firm co... | Class III | R & D Systems, Inc. |
| Jun 10, 2022 | Invacare Platinum 5NXG Oxygen Concentrator, Model Numbers P5NXG1, P5NXGC1 (Ca... | Between March 2, 2021 and December 31, 2021, the product label used in production did not contain... | Class III | Invacare Corporation |
| Jun 6, 2022 | Medline convenience kits labeled as: a. MIDDLE EAR PACK-LF, Model DYNJ068909... | Kits contain leaking bottles of isopropyl alcohol | Class II | MEDLINE INDUSTRIES, LP - SPT |
| Jun 6, 2022 | Brand Name: Medline Product Name: convenience kits labeled as: LAP CHOLE M... | Kits contain leaking bottles of isopropyl alcohol | Class II | MEDLINE INDUSTRIES, LP - SPT |
| Jun 6, 2022 | Medline Convenience kits labeled as: a. MAJOR VASCULAR CDS, b. POST OP KIT, ... | Kits contain leaking bottles of isopropyl alcohol | Class II | MEDLINE INDUSTRIES, LP - SPT |
| 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. |
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.