Browse Device Recalls
5,321 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 5,321 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 5,321 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Sep 19, 2024 | NovoHip Biolox Ball Head 32mmL Ref: 1345-2803 NovoHip Total Hip System - ... | Mislabeled: Packaged in a box labeled as 32 long but containing a 28 long head by physical markin... | Class II | Novosource, LLC |
| Sep 19, 2024 | AD-TECH Spencer Probe Depth Electrode, REF SD04R-AP58X-000 4-Contact 1.12mm (... | Ad-Tech is recalling these A-Style SD Depth Electrodes because a label discrepancy was identified... | Class II | Ad-Tech Medical Instrument Corporation |
| Sep 19, 2024 | AD-TECH Spencer Probe Depth Electrode, REF SD08R-AP58X-000 8-Contact 1.12mm (... | Ad-Tech is recalling these A-Style SD Depth Electrodes because a label discrepancy was identified... | Class II | Ad-Tech Medical Instrument Corporation |
| Sep 17, 2024 | MEGA 7.5Fr. 40cc Intra-Aortic Balloon with Accessories, Model Number 0684-00-... | There is discrepant labeling on the inner and outer packaging of the device. | Class II | Datascope Corp. |
| Sep 13, 2024 | EZDilate Wire Guided Balloon- Indicated for use in adult and adolescent (> 12... | Mislabeled Glo Cath Label (attached to the device) states: 11 mm, 12 mm, 13 mm however the balloo... | Class II | Olympus Corporation of the Americas |
| Sep 13, 2024 | 17-OH Progesterone ELISA 96 well kit- An enzyme immunoassay for the quantitat... | The High and Low Control acceptance ranges in the Certificate of Analysis (CofA) did not match th... | Class III | DRG International, Inc. |
| Sep 9, 2024 | iCast Covered Stent, 6MMx16MMx120CM, Model Number 42616 | There is an error in the Unique Device Identifier (UDI) printed on the product's distribution label. | Class II | Atrium Medical Corporation |
| Sep 4, 2024 | Medline brand medical procedure convenience kits, labeled as: a) CONE BIOP... | It has been determined that certain Convenience kits that were packaged in breather pouch lot 323... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Sep 4, 2024 | Centurion brand, medical procedure convenience kits, labeled as: a) FLOOR ... | It has been determined that certain Convenience kits that were packaged in breather pouch lot 323... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Sep 4, 2024 | Medline brand medical procedure convenience kits, labeled as: a) OB PACK-L... | It has been determined that certain Convenience kits that were packaged in breather pouch lot 323... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Sep 4, 2024 | Medline brand medical procedure convenience kits, labeled as: a) KIT LINE ... | It has been determined that certain Convenience kits that were packaged in breather pouch lot 323... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Sep 4, 2024 | Medline brand medical procedure convenience kits, labeled as: a) NEURO PAC... | It has been determined that certain Convenience kits that were packaged in breather pouch lot 323... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Sep 4, 2024 | Medline brand medical procedure convenience kits, labeled as: 1) T&A CDS-L... | It has been determined that certain Convenience kits that were packaged in breather pouch lot 323... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Sep 4, 2024 | Medline brand, medical procedure convenience kits, labeled as: a) SET UP PAC... | It has been determined that certain Convenience kits that were packaged in breather pouch lot 323... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Sep 4, 2024 | Medline brand medical procedure convenience kits, labeled as: 1) CYSTO CDS... | It has been determined that certain Convenience kits that were packaged in breather pouch lot 323... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Sep 4, 2024 | Medline brand medical procedure convenience kits, labeled as: 1) L&D/OB PACK... | It has been determined that certain Convenience kits that were packaged in breather pouch lot 323... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Sep 4, 2024 | Medline brand medical procedure convenience kits, labeled as: a) ABDOMINAL... | It has been determined that certain Convenience kits that were packaged in breather pouch lot 323... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Sep 4, 2024 | Medline brand medical procedure convenience kits, labeled as: a) UNIVERSAL... | It has been determined that certain Convenience kits that were packaged in breather pouch lot 323... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Sep 4, 2024 | Medline brand, medical procedure convenience kits, labeled as: a) RADIOLOG... | It has been determined that certain Convenience kits that were packaged in breather pouch lot 323... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Sep 4, 2024 | Leica Biosystems Cryostat Model Number CM1950, Material Numbers: a) 14047742... | As part of our post market surveillance, we recognized that some customers are using flammable fr... | Class II | LEICA BIOSYSTEMS NUSSLOCH GMBH |
| Sep 4, 2024 | Leica Biosystems Cryostat Model Number CM1510 S, Material Numbers: a) 491510... | As part of our post market surveillance, we recognized that some customers are using flammable fr... | Class II | LEICA BIOSYSTEMS NUSSLOCH GMBH |
| Sep 4, 2024 | Medline brand medical procedure convenience kits, labeled as: 1) THORACENTESI... | XXX | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Sep 4, 2024 | Leica Biosystems Cryostat Model Number CM3050 S, Material Numbers: a) 140470... | As part of our post market surveillance, we recognized that some customers are using flammable fr... | Class II | LEICA BIOSYSTEMS NUSSLOCH GMBH |
| Sep 4, 2024 | Leica Biosystems Cryostat Model Number CM1850, Material Numbers: a) 14047131... | As part of our post market surveillance, we recognized that some customers are using flammable fr... | Class II | LEICA BIOSYSTEMS NUSSLOCH GMBH |
| Sep 4, 2024 | Medline brand medical procedure convenience kit, labeled as: a) PAIN PROCEDU... | It has been determined that certain Convenience kits that were packaged in breather pouch lot 323... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Sep 4, 2024 | Medline brand medical procedure convenience kits, labeled as: 1) EYE PACK, ... | It has been determined that certain Convenience kits that were packaged in breather pouch lot 323... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Sep 4, 2024 | Medline brand medical procedure convenience kits, labeled as: 1) NEW LONDO... | It has been determined that certain Convenience kits that were packaged in breather pouch lot 323... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Sep 4, 2024 | Leica Biosystems Cryostat Model Number CM1100, Material Number 14046931130, f... | As part of our post market surveillance, we recognized that some customers are using flammable fr... | Class II | LEICA BIOSYSTEMS NUSSLOCH GMBH |
| Sep 4, 2024 | Medline brand, medical procedure convenience kits, labeled as: a) CUH OPEN... | It has been determined that certain Convenience kits that were packaged in breather pouch lot 323... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Sep 4, 2024 | Medline brand medical procedure convenience kits, labeled as: a) TRAY ADD ... | It has been determined that certain Convenience kits that were packaged in breather pouch lot 323... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Sep 4, 2024 | Medline brand medical procedure convenience kits, labeled as: a) PLASTIC P... | It has been determined that certain Convenience kits that were packaged in breather pouch lot 323... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Sep 4, 2024 | Medline brand medical procedure convenience kits, labeled as: a) LITHOTOMY... | It has been determined that certain Convenience kits that were packaged in breather pouch lot 323... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Sep 4, 2024 | Leica Biosystems Cryostat Model Number CM1900, Material Numbers: a) 14045227... | As part of our post market surveillance, we recognized that some customers are using flammable fr... | Class II | LEICA BIOSYSTEMS NUSSLOCH GMBH |
| Sep 3, 2024 | Product Name: Insight Base Flex - 8, Ref 608-3TX; The device consists of a st... | The patient label stickers may have the wrong expiration date recorded. The contract manufacturer... | Class III | Trackx Technology Inc |
| Sep 1, 2024 | Implant Epikut S Plus CM 16-Degrees 4,5 X 18,0 mm, REF: ILM 4518N | Dental implant box incorrectly labels the diameter as 4,5 X 18,0 mm, but the internal label corre... | Class II | SIN SISTEMA DE IMPLANTE NACIONAL S.A |
| Aug 30, 2024 | The Trevo Trak 21 Microcatheter is a single-lumen, braided shaft, variable st... | Stryker Neurovascular has observed that devices with Out of United States (OUS) approved Instruct... | Class II | Stryker Neurovascular |
| Aug 28, 2024 | MEDLINE OPEN HEART NIMC KIT, REF DYNJ908840 | Medline Industries, LP. has identified certain kits containing the recalled Medtronic lots of the... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Aug 28, 2024 | MEDLINE HEART OVERHEAD TABLE PACK, REF DYNJ0778508J | Medline Industries, LP. has identified certain kits containing the recalled Medtronic lots of the... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Aug 28, 2024 | MEDLINE HEART CABG CDS, REF CDS983376R | Medline Industries, LP. has identified certain kits containing the recalled Medtronic lots of the... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Aug 28, 2024 | MEDLINE OPEN HEART PACK, REF DYNJ66216C | Medline Industries, LP. has identified certain kits containing the recalled Medtronic lots of the... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Aug 28, 2024 | MEDLINE OPEN HEART, REF DYNJ904261B | Medline Industries, LP. has identified certain kits containing the recalled Medtronic lots of the... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Aug 28, 2024 | MEDLINE KIT CV I II, REF DYNJ906071B | Medline Industries, LP. has identified certain kits containing the recalled Medtronic lots of the... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Aug 27, 2024 | Kits of Convenience containing 1 of the 2 Item Numbers: 1. Item Number: 59-3... | Incorrect expiration date. | Class II | Safeguard US Operating LLC |
| Aug 23, 2024 | AVS Anchor-C Cervical Cage System Instructions For Use (IFU)- eIFU (revision ... | Labeling Correction: Instructions For Use (IFU)-Updated electronic Rev 5, specific language for ... | Class II | Stryker Spine |
| Aug 23, 2024 | Diode Laser Hair Removal model: WLA-01 | All model WLA-01 systems sold to US customers are found to have labeling non-compliances | Class II | WINGDERM ELECTRO-OPTICS LTD. |
| Aug 23, 2024 | Non-ablative Fractional Laser Systems, Model: WFB-01 | Model WFB-01 sold to US customers before Aug 23, 2022 has been found to have a software bug (6 un... | Class II | WINGDERM ELECTRO-OPTICS LTD. |
| Aug 21, 2024 | Percussionaire, Inc., REF: P5-TEE, Qty: 1, Rx Only. IPV (Intrapulmonary Perc... | Updated labeling to ensure that blue cap on in-line valve is removed, prior to delivery of (Intra... | Class I | Percussionaire Corporation |
| Aug 21, 2024 | Percussionaire, Inc., REF: P5-TEE-20, Qty: 20, Rx Only. IPV (Intrapulmonary ... | Updated labeling to ensure that blue cap on in-line valve is removed, prior to delivery of (Intra... | Class I | Percussionaire Corporation |
| Aug 13, 2024 | Spacelabs Ultraview DM4 Vital Signs Monitor (all variations -M, -N, -MF, -NF,... | This product labeling does not adequately provide warning about the risks associated with the use... | Class II | Zoe Medical Incorporated |
| Aug 13, 2024 | Spacelabs Ultraview DM3 Vital Signs Monitor (all variations -M, -MT, -N, -NT)... | This product labeling does not adequately provide warning about the risks associated with the use... | Class II | Zoe Medical Incorporated |
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.