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 |
|---|---|---|---|---|
| Sep 7, 2022 | CENTURION SnagFree Chest Tube insertion Tray, Reorder CHT545 | One lot of chest tube insertion trays, containing a silk suture component that is restricted to 1... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Sep 7, 2022 | Optima Coil System Model Number OPTI0208CSS10, Model Number OPTI0308... | Product pouch label does not match up with carton label | Class II | BALT USA, LLC |
| Sep 6, 2022 | MR Patient Care Portal 5000 (Desktop Unit), Model Number 453564792561 This... | Device may intermittently fail to produce audio. Turning the unit off and on does not resolve the... | Class II | Philips North America Llc |
| Sep 2, 2022 | Hu-Friedy K360 Scalpel Handle, 360 Degree Scalpel Handle, REF K360 | The scalpel holder may separate from the handle for certain lots. If the tip falls off during use... | Class II | Steris Corporation |
| Sep 2, 2022 | Clip COVID Rapid Antigen Test Kit (25-pack), Catalog Number: MDL002 | COVID test kit shelf life was periodically extended, as real-time stability test timepoints passe... | Class II | LUMINOSTICS, INC dba CLIP HEALTH |
| Sep 1, 2022 | VENCLOSE, VENCLOSE PROCEDURE PACK, 7VM, REF VC-PPH-67A. Cardiovascular proc... | Impacted Venclose Procedure Packs contain a 12cm introducer/sheath component, either component #1... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Sep 1, 2022 | Veritas Advanced Infusion Packs. Used in ophthalmic procedures. | As a result of returned product complaints for Veritas Phaco packs related to broken or cracked i... | Class II | Johnson & Johnson Surgical Vision, Inc. |
| Sep 1, 2022 | Introcan Safety FEP 14G, 2.2x32MM-US, Product Code 4251890-02. A passive ant... | Potential for leakage at the catheter hub. | Class II | B Braun Medical Inc |
| Sep 1, 2022 | Disposable Surgical Level 3 Gown, Size/Product Code: Large/GWS-03-L-B, XLarge... | Surgical gowns recalled due to gown fabric failing to pass the hydrostatic pressure test so the f... | Class II | Texas Medical Technology Inc. |
| Sep 1, 2022 | Recreo Hair Growth Laser Comb | The firm distributed the laser products without affixing the warning, aperture, certification, an... | Class II | OMM Imports, Inc. dba Zero Gravity |
| Aug 31, 2022 | MICRO-X ROVER MOBILE X-RAY SYSTEM, MXU-RV19 | Software calibration error with product equip with a Dose Area Product (DAP) meter. This results... | Class II | Micro-X Ltd. |
| Aug 31, 2022 | FULL VISION INC. TRACKMASTER, TREADMILL TMX428CP 220V, Model #317-07929 | This has been identified a rare occurrence, under a specific scenario, where the circuit is found... | Class II | Full Vision Inc |
| Aug 31, 2022 | FULL VISION INC. TRACKMASTER,TREADMILL TMX428 220V, Model #317-07927 | This has been identified a rare occurrence, under a specific scenario, where the circuit is found... | Class II | Full Vision Inc |
| Aug 31, 2022 | FULL VISION INC. TRACKMASTER, TREADMILL GE T2100-ST1 110V, Model #317-07926GE | This has been identified a rare occurrence, under a specific scenario, where the circuit is found... | Class II | Full Vision Inc |
| Aug 31, 2022 | FULL VISION INC. TRACKMASTER, TREADMILL GE T2100-ST2 220V, Model #317-07927GE... | This has been identified a rare occurrence, under a specific scenario, where the circuit is found... | Class II | Full Vision Inc |
| Aug 31, 2022 | FULL VISION INC. TRACKMASTER, TREADMILL GE T2100-ST2 220V, Model #317-07927GE | This has been identified a rare occurrence, under a specific scenario, where the circuit is found... | Class II | Full Vision Inc |
| Aug 31, 2022 | FULL VISION INC. TRACKMASTER, TREADMILL TMX428CP 110V, Model #317-07928 | This has been identified a rare occurrence, under a specific scenario, where the circuit is found... | Class II | Full Vision Inc |
| Aug 31, 2022 | FULL VISION INC. TRACKMASTER, TREADMILL TMX428 110V, Model #317-07926 | This has been identified a rare occurrence, under a specific scenario, where the circuit is found... | Class II | Full Vision Inc |
| Aug 30, 2022 | The product is a handheld ultraviolet-C germicidal wand and contains narrow-d... | Excessive ultraviolet-C radiation | Class II | PHONESOAP |
| Aug 30, 2022 | Hammertoe Continuous Compression Implant (CCI) Kit Part Number: 46.239.001 | Drill Pin (drill bit) is not compatible with the Drill Template included in the kit due to a pack... | Class II | Synthes (USA) Products LLC |
| Aug 30, 2022 | Pinnacle3 Radiation Therapy Planning System, Model numbers 870231 and 870237. | When computing a radiation dose in the system, the exported dose information is incorrect when th... | Class II | Philips Medical Systems (Cleveland) Inc |
| Aug 30, 2022 | N Antiserum to Human IgG, 2mL Variant for BN II System and BN ProSpec System-... | N Antiserum to Human IgG are not meeting the current High-Dose Hook Effect expectation of up to 6... | Class II | SIEMENS HEALTHCARE DIAGNOSTICS INC |
| Aug 30, 2022 | N Antiserum to Human IgG, 5mL Variant for BN II System and BN ProSpec System-... | N Antiserum to Human IgG are not meeting the current High-Dose Hook Effect expectation of up to 6... | Class II | SIEMENS HEALTHCARE DIAGNOSTICS INC |
| Aug 29, 2022 | Intersurgical Solus Standard, laryngeal mask airway, size 3, small adult, 30-... | Printing error on the device, size 3 Solus Standard laryngeal mask airway has been incorrectly ma... | Class II | Intersurgical Inc |
| Aug 29, 2022 | OSSUR Power Knee REF PKA10003 OSSUR Power Knee REF PKA10003 OSSUR Power... | Battery may dislodge from the Power Knee | Class II | Ossur Americas |
| Aug 26, 2022 | Leica Surgical Operating Microscopes, PROvido Part Numbers: a. 10448976, b. ... | During internal testing, Leica Microsystems has become aware of a component change on the photodi... | Class II | Leica Microsystems, Inc. |
| Aug 26, 2022 | Leica Surgical Operating Microscopes, ARveo 8, Part Number 10449063 | During internal testing, Leica Microsystems has become aware of a component change on the photodi... | Class II | Leica Microsystems, Inc. |
| Aug 26, 2022 | Leica Surgical Operating Microscopes, Arveo, Part Number 10448999 | During internal testing, Leica Microsystems has become aware of a component change on the photodi... | Class II | Leica Microsystems, Inc. |
| Aug 26, 2022 | Leica Surgical Operating Microscopes, M530 OHX, Part Number 10448737 | During internal testing, Leica Microsystems has become aware of a component change on the photodi... | Class II | Leica Microsystems, Inc. |
| Aug 25, 2022 | G7 Acetabular System, Acetabular Shell, Item numbers Item Numbers: 010000663 ... | The outer sterile package cavity has a corner wall thickness that is below the specification. The... | Class II | Zimmer, Inc. |
| Aug 24, 2022 | Dimension Vista High Density Lipoprotein Cholesterol (HDLC) Flex reagent cart... | Dimension Vista¿ High Density Lipoprotein Cholesterol (HDLC) Potential for Erroneous Result. If a... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Aug 24, 2022 | Short tibial bearing MK4 - Std, STM, Catalog No. SMMLTB02. Knee prosthesis co... | A MK4 Tibial Bearing was supplied with the intention to mate with the Tibial Metal Casing in-situ... | Class II | Howmedica Osteonics Corp. |
| Aug 22, 2022 | sentec 24 / MARe-SF Multi-Site Attachment Ring Easy, For sensitive / fragile ... | Weak skin adhesion. | Class II | SenTec AG |
| Aug 19, 2022 | Puritan Bennett 560 Ventilator, PB560, CFN 4096600 | Medtronic has confirmed six reports from customers outside the US where the ventilator became ino... | Class II | Covidien Llc |
| Aug 19, 2022 | Abbott Alinity m SARS-CoV-2 CTRL Kit, REF 09N78-085, each kit contains 12 x 1... | Reports received of an increase of message code 9186 (internal control failed) when using the kit. | Class II | Abbott Molecular, Inc. |
| Aug 17, 2022 | Fungitell STAT- IVD Assay for (1 ¿ 3)-~-D-Glucan in Serum Ref: FT007 | Incorrect information on the Fungitell STAT clamshells containing the Fungitell STAT Standard, re... | Class II | Associates of Cape Cod, Inc. |
| Aug 17, 2022 | Dimension Magnesium (MG) Flex reagent cartridge Siemens Material Number (SM... | Dimension Magnesium (MG) Flex reagent cartridge lots may exhibit imprecision for Quality Control ... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Aug 16, 2022 | ConvaTec Active Life, One-Piece Drainable Pouch, 3/4-2 1/2 in., 19-64mm, REF ... | impaired functionality of the release liner | Class II | ConvaTec, Inc |
| Aug 16, 2022 | Roadrunner PC Wire Guide (Nimble), Guidewire Reference Part Number/GPN: RFS... | Cook Medical identified that devices from the affected device lots may have a complete breach of ... | Class II | Cook Incorporated |
| Aug 16, 2022 | Cope Mandril Wire Guide (Nitinol), Nitinol Guidewire; Reference Part Number/... | Cook Medical identified that devices from the affected device lots may have a complete breach of ... | Class II | Cook Incorporated |
| Aug 16, 2022 | Fixed Core Wire Guide (Safe-T-J Curved), Guidewire Reference Part Number/GPN... | Cook Medical identified that devices from the affected device lots may have a complete breach of ... | Class II | Cook Incorporated |
| Aug 16, 2022 | Heavy Double Flexible Tipped Wire Guide, Guidewire Reference Part Number/GPN... | Cook Medical identified that devices from the affected device lots may have a complete breach of ... | Class II | Cook Incorporated |
| Aug 16, 2022 | Vinyl Connecting Tube, Connecting Tube Reference Part Number/GPN CTU14.0-30... | Cook Medical identified that devices from the affected device lots may have a complete breach of ... | Class II | Cook Incorporated |
| Aug 16, 2022 | Newton Wire Guide (LT Taper/10cm Distal Flexibility), Guidewire Reference Pa... | Cook Medical identified that devices from the affected device lots may have a complete breach of ... | Class II | Cook Incorporated |
| Aug 16, 2022 | Bentson Plus Wire Guide (Extra Body/20cm Distal Flexibility with Softened Tip... | Cook Medical identified that devices from the affected device lots may have a complete breach of ... | Class II | Cook Incorporated |
| Aug 16, 2022 | Roadrunner PC Wire Guide (The Firm LT), Guidewire Reference Part Number/GPN ... | Cook Medical identified that devices from the affected device lots may have a complete breach of ... | Class II | Cook Incorporated |
| Aug 16, 2022 | ConvaTec Active Life, One-Piece Drainable Pouch, 3/4-2 1/2 in., 19-64mm, REF ... | impaired functionality of the release liner | Class II | ConvaTec, Inc |
| Aug 16, 2022 | Rosen Curved Wire Guide, Guidewire Reference Part Number/GPN THSCF-35-220-1... | Cook Medical identified that devices from the affected device lots may have a complete breach of ... | Class II | Cook Incorporated |
| Aug 16, 2022 | ConvaTec Esteem+ Durahesive Plus, Drainable Pouch, 3/4-2 1/4 in., 19-64mm, RE... | impaired functionality of the release liner | Class II | ConvaTec, Inc |
| Aug 16, 2022 | Roadrunner PC Wire Guide (Nimble Floppy), Guidewire RFPC-35-145 G07914 | Cook Medical identified that devices from the affected device lots may have a complete breach of ... | Class II | Cook 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.