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 |
|---|---|---|---|---|
| Oct 6, 2022 | 3M Steri-Drape, Small Towel Drape, REF 1000NS, general surgery drape | During a recent investigation, 3M confirmed the liner on the adhesive component of the affected d... | Class II | 3M Healthcare Business |
| Oct 6, 2022 | 3M Steri-Drape, Small Drape with Incise Film, REF 1021NS, general surgery drape | During a recent investigation, 3M confirmed the liner on the adhesive component of the affected d... | Class II | 3M Healthcare Business |
| Oct 6, 2022 | 3M Steri-Drape, Medium Drape with Incise Film, REF 1060NS, general surgery d... | During a recent investigation, 3M confirmed the liner on the adhesive component of the affected d... | Class II | 3M Healthcare Business |
| Oct 6, 2022 | 3M Steri-Drape, Large Towel Drape, REF 1010NS, general surgery drape | During a recent investigation, 3M confirmed the liner on the adhesive component of the affected d... | Class II | 3M Healthcare Business |
| Oct 6, 2022 | 3M Steri-Drape, Medium Drape with Adhesive Aperture, REF 1030NS, general surg... | During a recent investigation, 3M confirmed the liner on the adhesive component of the affected d... | Class II | 3M Healthcare Business |
| Oct 6, 2022 | 3M Steri-Drape, Medium Drape with Wide Adhesive Aperture, REF 1033, general s... | During a recent investigation, 3M confirmed the liner on the adhesive component of the affected d... | Class II | 3M Healthcare Business |
| Oct 6, 2022 | 3M Steri-Drape, Large Towel Drape, REF 1010NSD, general surgery drape | During a recent investigation, 3M confirmed the liner on the adhesive component of the affected d... | Class II | 3M Healthcare Business |
| Oct 6, 2022 | Fogarty Arterial Embolectomy Catheters Model Number: 120602FP 120403FP 12... | Due to an increase of confirmed latex deterioration complaints for arterial embolectomy catheters... | Class II | Edwards Lifesciences, LLC |
| Oct 6, 2022 | 3M Steri-Drape, Urological Drape, REF 1071, general surgery (urology) drape | During a recent investigation, 3M confirmed the liner on the adhesive component of the affected d... | Class II | 3M Healthcare Business |
| Oct 6, 2022 | 3M Steri-Drape, Small Towel Drape, REF 1000NSD, general surgery drape | During a recent investigation, 3M confirmed the liner on the adhesive component of the affected d... | Class II | 3M Healthcare Business |
| Oct 6, 2022 | 3M Steri-Drape, Medium Drape with Incise Film, REF 1060, general surgery drape | During a recent investigation, 3M confirmed the liner on the adhesive component of the affected d... | Class II | 3M Healthcare Business |
| Oct 6, 2022 | 3M Steri-Drape, Large Towel Drape, REF 1010, general surgery drape | During a recent investigation, 3M confirmed the liner on the adhesive component of the affected d... | Class II | 3M Healthcare Business |
| Oct 6, 2022 | 3M Steri-Drape, Small Drape with Adhesive Aperture, REF 1020, general surgery... | During a recent investigation, 3M confirmed the liner on the adhesive component of the affected d... | Class II | 3M Healthcare Business |
| Oct 4, 2022 | EasyStand Bantam, with the following sizes. a. Small; b. Extra Small. ... | Some EasyStand Bantam Small and Extra Small standers with the non-supine option may have been man... | Class II | Altimate Medical, Inc. |
| Oct 4, 2022 | NaturaLyte Liquid Acid concentrate, Part Number 08-0231-4, four (4) one-gallo... | The "Nominal Chemical Composition" section of the label incorrectly lists 5.62g/L KCL (potassium ... | Class II | Fresenius Medical Care Holdings, Inc. |
| Oct 3, 2022 | BD Trucount Tubes (Cat. No. 340334), used for determining absolute counts of ... | Due to partial label detachment on tubes. This can cause tubes to become stuck together in the po... | Class II | Becton, Dickinson and Company, BD Biosciences |
| Oct 3, 2022 | Blinq Pediatric Vision Scanner-Pediatric Vision Scanner-intended for automate... | Unable to charge the battery pack- battery packs will allow the batteries to be charged if the vo... | Class II | Rebiscan, Inc. |
| Oct 3, 2022 | BD Trucount Tubes (Cat. No. 663028), used for determining absolute counts of ... | Due to partial label detachment on tubes. This can cause tubes to become stuck together in the po... | Class II | Becton, Dickinson and Company, BD Biosciences |
| Oct 3, 2022 | MicroScan autoSCAN-4 Instrument, Catalog Number B1018-280 | Due to MicroScan autoSCAN-4 Instruments being manufactured with an incorrect diffuser plate. | Class II | Beckman Coulter, Inc. |
| Oct 3, 2022 | BD Multitest 6-Color TBNK with optional BD Trucount Tubes (Cat. No. 662995), ... | Due to partial label detachment on tubes. This can cause tubes to become stuck together in the po... | Class II | Becton, Dickinson and Company, BD Biosciences |
| Sep 30, 2022 | Hillrom Hospital Bed Accessory, WatchCare Incontinence Management System for ... | Radio frequency emission from a functioning WatchCare device may potentially impact other devices... | Class I | Baxter Healthcare Corporation |
| Sep 30, 2022 | Hillrom Hospital Bed Accessory, Watch Care Incontinence Management System for... | Radio frequency emission from a functioning WatchCare device may potentially impact other devices... | Class I | Baxter Healthcare Corporation |
| Sep 30, 2022 | BAUSCH + LOMB EYE MUSCLE, REF VAL036EMESB. Convenience kit used in surgical ... | Medline received complaints on some of the breather pouches with in the sterile surgical kits sho... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Sep 30, 2022 | BAUSCH + LOMB CATARACT PACK, REF VAL009CTSGA. Convenience kit used in surgic... | Medline received complaints on some of the breather pouches with in the sterile surgical kits sho... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Sep 30, 2022 | MEDLINE LINQ TRAY, REF DYNJ65880A. Convenience kit used in medical/surgical ... | Medline received complaints on some of the breather pouches with in the sterile surgical kits sho... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Sep 30, 2022 | Hillrom Centrella Hospital Bed with WatchCare Incontinence Management System,... | Radio frequency emission from a functioning WatchCare device may potentially impact other devices... | Class I | Baxter Healthcare Corporation |
| Sep 30, 2022 | BAUSCH + LOMB CATARACT PACK, REF VAL001CPMEA. Convenience kit used in surgic... | Medline received complaints on some of the breather pouches with in the sterile surgical kits sho... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Sep 30, 2022 | BAUSCH + LOMB EYE PACK, REF LYN003EYSPA. Convenience kit used in surgical pr... | Medline received complaints on some of the breather pouches with in the sterile surgical kits sho... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Sep 30, 2022 | EMBLEM MRI S-ICD, Subcutaneous Implantable Defibrillator, Model A219, sterile. | There is an incorrect manufacturing date/timestamp within the software which causes an inaccurate... | Class II | Boston Scientific Corporation |
| Sep 30, 2022 | Beaver Arthro-Lok Pointed Tip Curve L 4mm Blade-an orthopedic blade, which ma... | Incorrect configuration of the blades in the package. The blades curve to the right instead of cu... | Class II | Beaver Visitec International, Inc. |
| Sep 30, 2022 | BAUSCH + LOMB PHACO PACK, REF LYN011PHNHD. Convenience kit used in surgical ... | Medline received complaints on some of the breather pouches with in the sterile surgical kits sho... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Sep 30, 2022 | MEDLINE LITHOTOMY, REF DYNJ50099C. Convenience kit used in medical/surgical ... | Medline received complaints on some of the breather pouches with in the sterile surgical kits sho... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Sep 30, 2022 | Stryker INBONE Tibial Tray, Left Plasma Spray Ti6Al4V, CPti, Use w/ 18mm Stem... | The tibial tray lock detail is oversized (larger than specification). | Class II | Wright Medical Technology, Inc. |
| Sep 30, 2022 | BAUSCH + LOMB CATARACT TRAY, REF LYN023FACTB. Convenience kit used in surgic... | Medline received complaints on some of the breather pouches with in the sterile surgical kits sho... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Sep 30, 2022 | Hillrom Hospital Bed Accessory, Watch Care Incontinence Management System for... | Radio frequency emission from a functioning WatchCare device may potentially impact other devices... | Class I | Baxter Healthcare Corporation |
| Sep 30, 2022 | TufTex Embolectomy Catheter, Model No. This catheter has a latex balloon ... | Three lots tied by two trainees were released without performing the required pull test. If tied ... | Class II | LeMaitre Vascular, Inc. |
| Sep 30, 2022 | BAUSCH + LOMB BASIC OPHTHALMIC PACK, REF LYN023BSBLB. Convenience kit used i... | Medline received complaints on some of the breather pouches with in the sterile surgical kits sho... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Sep 30, 2022 | Stryker INBONE Tibial Tray, Left Plasma Spray Ti6Al4V, CPti, Use w/ 16mm Stem... | The tibial tray lock detail is oversized (larger than specification). | Class II | Wright Medical Technology, Inc. |
| Sep 30, 2022 | MEDLINE RADIOLOGY PROCEDURE PACK, REF DYNJ67150A. Convenience kit used in me... | Medline received complaints on some of the breather pouches with in the sterile surgical kits sho... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Sep 30, 2022 | MEDLINE CVC BARRIER KIT, REF DYNJ80485. Convenience kit used in medical proc... | Medline received complaints on some of the breather pouches with in the sterile surgical kits sho... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Sep 30, 2022 | MEDLINE DENTAL PACK, REF DYNJ66983. Convenience kit used in medical procedures. | Medline received complaints on some of the breather pouches with in the sterile surgical kits sho... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Sep 30, 2022 | Hillrom Hospital Bed Accessory, Watch Care Incontinence Management System for... | Radio frequency emission from a functioning WatchCare device may potentially impact other devices... | Class I | Baxter Healthcare Corporation |
| Sep 30, 2022 | EMBLEM S-ICD, Subcutaneous Implantable Defibrillators, Model A209, sterile. | There is an incorrect manufacturing date/timestamp within the software which causes an inaccurate... | Class II | Boston Scientific Corporation |
| Sep 30, 2022 | CENTURION MEDICAL PRODUCTS NICU PICC INSERTION BUNDLE W/O, REF CVI4470. Conv... | Medline received complaints on some of the breather pouches with in the sterile surgical kits sho... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Sep 29, 2022 | Canon Aplio ultrasound system, Model: Aplio i900 TUS-AI900, Aplio i800 TUS-AI... | After completion, ultrasound system's Stress Echo may not terminate if user does not manually ter... | Class II | Canon Medical System, USA, INC. |
| Sep 28, 2022 | Zio AT Clinical Reference Manual, Part: ALB0031, and Zio AT Important Informa... | Ambulatory ECG monitoring system labeling update: 1) Clinically actionable arrhythmia notificatio... | Class II | iRhythm Technologies, Inc. |
| Sep 28, 2022 | Endo Stitch V-Loc PBT Non-Absorbable Reload, Models VLOCN004L, VLOCN006L, VLO... | Medtronic has received 210 reports of needles breaking during endoscopic suturing. The potential ... | Class II | Covidien, LP |
| Sep 28, 2022 | biokitHSV-2 Rapid Test, REF: 300028001 | HSV-2 rapid test may report false positive results. | Class II | Biokit, S.A. |
| Sep 28, 2022 | Cardinal Health INSULATED GEL PACK REUSABLE, LARGE, Cat. 80104 | Users are being informed that the product should not be used on infants/neonates. A caution state... | Class II | Cardinal Health 200, LLC |
| Sep 28, 2022 | Cardinal Health HOT AND COLD GEL PACK REUSABLE, M, Cat. 70304 | Users are being informed that the product should not be used on infants/neonates. A caution state... | Class II | Cardinal Health 200, LLC |
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.