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 |
|---|---|---|---|---|
| Oct 12, 2022 | Medical Action Industries Inc. Disposable Instrument Pack, Littauer Scissor, ... | Scissors contained debris. | Class II | Medical Action Industries, Inc. 306 |
| Oct 12, 2022 | Medical Action Industries Inc. Port Access Kit, REF #76511B (on case label), ... | The Port Access Kits were incorrectly labeled as IV Start Kits on the kit label. The case label ... | Class II | Medical Action Industries, Inc. 306 |
| Oct 12, 2022 | BD Nexiva Closed IV Catheter System - Single Port REF 383516 20 GA X1.0o in (... | During needle withdrawal, the tip shield may prematurely separate from the catheter adapter and p... | Class II | Becton Dickinson Infusion Therapy Systems Inc. |
| Oct 12, 2022 | Superion¿ Indirect Decompression System (IDS) Model Numbers and Size: 101... | Due to Indirect Decompression System devices exhibiting a potential for weld breakage at the spin... | Class II | Boston Scientific Neuromodulation Corporation |
| Oct 12, 2022 | BASIN SET, MEBS42K, general surgical kit | Basin Set labeling error: components within the kit are for the Single Basin Set. Therefore, the... | Class II | American Contract Systems, Inc. |
| Oct 10, 2022 | ORISE Gel Submucosal Lifting Agent--Indicated for use in gastrointestinal end... | ***Update12/13/22***:Product removal due to higher incidence of adverse events of foreign body re... | Class II | Boston Scientific Corporation |
| Oct 10, 2022 | ORISE Gel Syringe Submucosal Lifting Agent Kits: indicated for use in gastroi... | ***Update12/13/22***:Product removal due to higher incidence of adverse events of foreign body re... | Class II | Boston Scientific Corporation |
| Oct 10, 2022 | PAJUNK Continuous Epidural Tray, Tuohy Epidural Needle 17G x 4" with EpiLong ... | The tray contains a 2ml ampule of 0.75% Marcaine Spinal in lieu of a 10ml ampule of 0.9% Sodium C... | Class II | Pajunk Medical Systems, L.P. |
| Oct 10, 2022 | ORISE ProKnife Procedure Kits: indicated for use in gastrointestinal endoscop... | ***Update12/13/22***:Product removal due to higher incidence of adverse events of foreign body re... | Class II | Boston Scientific Corporation |
| Oct 10, 2022 | Hologic Sizer Set- sterilization tray and 6 individual sizers, intended as a ... | IFU was not provided with the Sizer Set sterilization tray Revised Sterilization Instructions f... | Class II | Hologic, Inc |
| Oct 10, 2022 | Medfusion Model 4000 Syringe Infusion Pump, with software versions V1.6.0 or ... | Potential for delay in sending Infusion Start Messages to third-party Electronic Health Record sy... | Class II | Smiths Medical ASD Inc. |
| Oct 7, 2022 | FERNO POWER X1 AMBULANCE COT- Item #0015807/UDI-DI 00190790002183 with 36V ... | Batteries could become unstable when not properly maintained and/or subjected to repeated drops, ... | Class II | Ferno-Washington Inc |
| Oct 7, 2022 | INTUITIVE Da Vinci Xi 8mm SureForm 30 Curved-Tip Stapler Da Vinci Xi|X REF 48... | Potential staple deployment failure and device fragment generation | Class II | Intuitive Surgical, Inc. |
| 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, 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 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, 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, 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 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 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, 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, 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, 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 | 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, 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 | 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, Small Drape with Incise Film, REF 1021, 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 1030, general surger... | 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 and Pouch, REF 1061NS, general ... | 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 and Pouch, REF 1061, general su... | 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 1020NS, general surge... | 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 Biliary Balloon Probes Model Number: 410235FP 410405FP 410236FP | Due to an increase of confirmed latex deterioration complaints for arterial embolectomy catheters... | Class II | Edwards Lifesciences, LLC |
| Oct 6, 2022 | 3M Steri-Drape, Small Towel Drape, REF 1000, 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 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. 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 | 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. 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 | 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 |
| 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. |
| 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 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 |
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.