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 |
|---|---|---|---|---|
| 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. |
| Feb 9, 2022 | The DARCO¿ Locking Bone Plate System is designed with rhombus (parallelogram... | Product was labelled with the incorrect manufacturing and distribution dates. | Class II | Wright Medical Technology, Inc. |
| Feb 9, 2022 | Ultima Activator II Reusable Drive Mechanism, part # C-UA-5001. Labeled REF ... | Potential for corrosion on the pins of the Ultima Activator II Reusable Drive Mechanism. Harms ma... | Class II | Maquet Cardiovascular, LLC |
| Feb 7, 2022 | PERFUSOR SPACE - US VERSION. Intended Use: syringe infusion pump that can be ... | Units not properly inspected prior to release to the market, may not function as indicated in the... | Class II | B Braun Medical Inc |
| Feb 1, 2022 | (1) JOBST Compri2, REF 76271-01, containing 2 components, one plastic-wrapped... | The folding boxes within the shipping case are mislabeled. The shipping case and immediate packa... | Class II | BSN Medical Inc |
| Jan 27, 2022 | MiniMed 630G: MMT-1715, MMT-1754, MMT-1755; MiniMed 670G: MMT-1740, MMT-1741... | New or replacement insulin pumps are not pre-programmed with basal rates or other verified settin... | Class II | Medtronic MiniMed |
| Jan 27, 2022 | LineSider Spinal System 5.5/6.0mm, Non-mod Standard 7.1mm - Dual Lead, Non-ca... | Potential for weld separation of the Upper Tulip Head component from the Lower Tulip Head compone... | Class II | Integrity Implants Inc. |
| Jan 27, 2022 | LineSider Spinal System 5.5/6.0mm, Non-mod MIS 7.1mm - Dual Lead, Cannulated.... | Potential for weld separation of the Upper Tulip Head component from the Lower Tulip Head compone... | Class II | Integrity Implants Inc. |
| Jan 27, 2022 | LineSider Spinal System 5.5/6.0mm, Non-mod Standard 7.1mm - Dual Lead, Cannul... | Potential for weld separation of the Upper Tulip Head component from the Lower Tulip Head compone... | Class II | Integrity Implants Inc. |
| Jan 24, 2022 | IntraSight Mobile IVUS Systems, Model: 797415, Part numbers: 300002018101, 30... | Multi-Modality Touch Screen Modules (MM-TSM), which are bedside/secondary control units, used as ... | Class III | Volcano Corp |
| Jan 21, 2022 | Codman Cranial Access Kits- indicated when a craniotomy is required for place... | Incorrect extended expiration dates identified on the outer box label only, if product is used pa... | Class II | Integra LifeSciences Corp. |
| Jan 21, 2022 | REF: 5921-018-135, Stryker Color Cuff, 18" (Red), Quick Connect Single Port, ... | Mislabeling; dual-bladder tourniquet cuffs are labeled as single-bladder inflatable cuffs. | Class II | Stryker Sustainability Solutions |
| Jan 21, 2022 | NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Test Strip, Ref # 300900 (marketed und... | A risk for product contamination was identified for the affected product lot. If used, there is a... | Class II | NeuMoDx Molecular Inc |
| Jan 21, 2022 | Codman Cranial Access Kits- indicated when a craniotomy is required for place... | Incorrect extended expiration dates identified on the outer box label only, if product is used pa... | Class II | Integra LifeSciences Corp. |
| Jan 20, 2022 | Product/Part: YelloPort Elite 12x75 Pencil Point Trocar/ET1207503; Yell... | Laparoscopic devices have a sterile symbol included on labels but devices are non-sterile. | Class II | Surgical Innovations Ltd |
| Jan 20, 2022 | Product/Part: YelloPort Plus 5x70 Cannula + Luer/YC0507001. For use in lapar... | Laparoscopic devices have a sterile symbol included on labels but devices are non-sterile. | Class II | Surgical Innovations Ltd |
| Jan 18, 2022 | Merete PediatrOS RigidTack, REF CP20120, Size 20 mm, Sterile, Rx Only | Incorrect marketing label (25 mm) was applied to product size 20 mm. | Class II | Merete Medical GmbH |
| Jan 18, 2022 | Del(5q) Deletion FISH Probe Kit: In-Vitro Diagnostic to detect deletions in c... | individual components have been labelled with incorrect colours. The red and green colours are op... | Class II | Cytocell Ltd. |
| Jan 14, 2022 | HEMASHIELD GOLD KNITTED MICROVEL DOUBLE VELOUR VASCULAR GRAFT- D: 7 mm; L: 6... | Outer labelling (HEMASHIELD GOLD Knitted Microvel Double Velour Bifurcated Vascular Graft, D: 16 ... | Class II | Maquet Cardiovascular, LLC |
| Jan 14, 2022 | Biolox delta Ceramic V40 Femoral Head 32/ -4.0mm Catalog Number: 6570-0-032 | Potential product mix where the size and/or offset of the Biolox delta Ceramic V40 Femoral Head i... | Class II | Howmedica Osteonics Corp. |
| Jan 14, 2022 | Biolox delta Ceramic V40 Femoral Head 32/ +4.0mm Catalog Number: 6570-0-232 | Potential product mix where the size and/or offset of the Biolox delta Ceramic V40 Femoral Head i... | Class II | Howmedica Osteonics Corp. |
| Jan 13, 2022 | Regard, TOTAL HIP - SPRINGFIELD, Item No. 8800297010, Case Quantity: 2, Sterile | Products are mislabeled with the incorrect product identification on individual kit labeling. | Class II | ROi CPS LLC |
| Jan 6, 2022 | FLEXCERA BASE -a Dental resins for the fabrication of artificial teeth | Manufactured in a non-FDA-registered manufacturing facility and product mislabeled as being of Ge... | Class II | Envisiontec US Llc |
| Jan 6, 2022 | FLEXCERA SMILE -a Dental resins for the fabrication of artificial teeth | Manufactured in a non-FDA-registered manufacturing facility and product mislabeled as being of Ge... | Class II | Envisiontec US Llc |
| Jan 4, 2022 | The Optima Coil System consists of an implantable embolization coil comprised... | Due to Label/Pouch mix-up. Pouches incorrectly labeled. Incorrect shelf carton label or pouch la... | Class II | BALT USA, LLC |
| Dec 30, 2021 | Exeter V40 Cemented Hip (125mm) Stem, Part Number 0580-1-044 | There is a potential label mix between certain lots of Exeter V40 Cemented Hip (125mm) Stem and E... | Class II | Howmedica Osteonics Corp. |
| Dec 30, 2021 | Exeter V40 Cemented Hip (150mm) Stem, Part Number 0580-1-440 | There is a potential label mix between certain lots of Exeter V40 Cemented Hip (125mm) Stem and E... | Class II | Howmedica Osteonics Corp. |
| Dec 29, 2021 | YOUNG DH Dry Heat Indicators, PRESSURE SENSITIVE LABELS with COLOR INDICATOR ... | The Dry Heat Indicator Labels packaging may contain TTS Indicator Labels instead of Dry Heat Ind... | Class II | Young Dental Mfg Co I LLC |
| Dec 28, 2021 | Bronchial Microbiology Brush, Catalog Number 4310 and 4320. Microbial samplin... | The labeling for the Microbiology Brush identifies the device as a Bronchial Microbiology Brush. ... | Class II | Hobbs Medical, Inc. |
| Dec 23, 2021 | Spiration Valve System (SVS) Valve in Cartridge -A one-way endobronchial valv... | Mislabeled Patient Charge Label indicating model number SVS-V7-00 (7mm) instead of SVS-V9-00 (9mm) | Class II | Olympus Corporation of the Americas |
| Dec 15, 2021 | CURAD REUSABLE GEL HOT/COLD PACK | The product contains natural rubber latex but the label states that it does not. | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Dec 1, 2021 | Celltrion DiaTrust COVID-19 Ag Rapid Test, REF CT-P60 D-2 01. Contains 25 dis... | The European version of the DiaTrust COVID-19 Ag Rapid Test is not approved for marketing in the ... | Class II | CELLTRION USA 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.