Browse Device Recalls
2,276 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,276 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 2,276 FDA device recalls in 2022.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 | 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 | 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 |
| 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 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 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 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 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 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 | 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 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 | The product is a handheld ultraviolet-C germicidal wand and contains narrow-d... | Excessive ultraviolet-C radiation | Class II | PHONESOAP |
| 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 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 | 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 29, 2022 | Iso-Gard Filter S with Expandi-Flex/Elbow: a) REF 19012, OUS only, b) REF 19... | Incidents of device splitting or detaching during use | Class I | TELEFLEX LLC |
| Aug 29, 2022 | Iso-Gard Filter S, with Expandi-Flex, REF: a) 19261, OUS only; b) 19272, OUS... | Incidents of device splitting or detaching during use | Class I | TELEFLEX LLC |
| 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 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 | Filter + Catheter Mount, REF 191667-000100, OUS only. Catheter mount for circ... | Incidents of device splitting or detaching during use | Class I | TELEFLEX LLC |
| Aug 29, 2022 | Iso-Gard Filter S, REF : a) 19211, OUS only; b) 19212; Microbial medical ga... | Incidents of device splitting or detaching during use | Class I | TELEFLEX LLC |
| Aug 29, 2022 | Iso-Gard Filter S, with Expandi-Flex, Tethered Cap, REF: a) 19261T, OUS only;... | Incidents of device splitting or detaching during use | Class I | TELEFLEX LLC |
| Aug 29, 2022 | Iso-Gard Filter S, Tethered Cap, REF: a) 19211T, OUS only; b) 19212T, OUS on... | Incidents of device splitting or detaching during use | Class I | TELEFLEX LLC |
| Aug 26, 2022 | Philips OmniLab Advanced+, Rx Only. To provide noninvasive ventilation suppo... | Motor assemblies manufactured with nonconforming plastic that contributes to off-gassing of VOCs. | Class I | Philips Respironics, Inc. |
| 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 | Philips BiPAP A40, Rx Only. To provide noninvasive ventilation support for p... | Motor assemblies manufactured with nonconforming plastic that contributes to off-gassing of VOCs. | Class I | Philips Respironics, 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 | Philips OmniLab Advanced + with Heated Tube Humidifier, Rx Only. To provide ... | Motor assemblies manufactured with nonconforming plastic that contributes to off-gassing of VOCs. | Class I | Philips Respironics, Inc. |
| Aug 26, 2022 | Philips OmniLab Advanced+ Intl (Flow Gen), Rx Only. To provide noninvasive v... | Motor assemblies manufactured with nonconforming plastic that contributes to off-gassing of VOCs. | Class I | Philips Respironics, Inc. |
| Aug 26, 2022 | Philips BiPAP V30 Auto, Rx Only. To provide noninvasive ventilation support ... | Motor assemblies manufactured with nonconforming plastic that contributes to off-gassing of VOCs. | Class I | Philips Respironics, 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, 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 26, 2022 | Philips BiPAP A30, Rx Only. To provide noninvasive ventilation support for p... | Motor assemblies manufactured with nonconforming plastic that contributes to off-gassing of VOCs. | Class I | Philips Respironics, 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 | 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 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 22, 2022 | sentec 24 / MARe-SF Multi-Site Attachment Ring Easy, For sensitive / fragile ... | Weak skin adhesion. | Class II | SenTec AG |
| 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 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 | MED-RX UROLOGICAL CYSTO/BLADDER IRRIGATION SET, REF 10-4001 | Some of the labels of the kits for product code 10-4001 in the specified lots have an illegible b... | Class III | Canadian Hospital Specialties |
| 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 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 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 | 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 | 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 | Fixed Core Wire Guide (Straight), Guidewire Reference Part Number/GPN: C-SF... | 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 (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 |
| Aug 16, 2022 | PTS Panels CHOL+GLU Test Strips (REF 1765) | Incorrect instructions for use were packaged into the final product. | Class III | Polymer Technology Systems, Inc. dba PTS Diagno... |
| Aug 16, 2022 | Movable Core Wire Guide (Tapered Tefcor) (OUS ONLY), Guidewire Reference Par... | 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.