Browse Device Recalls
3,191 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,191 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 3,191 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Nov 29, 2017 | VERSYS 7.5 IN BEADED FC +10 CALCAR 13.5X180MM STR +10 CALCAR 15.5X180MM ST... | The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly... | Class II | Zimmer Biomet, Inc. |
| Nov 29, 2017 | VERSYS 6 INCH BEADED FC 15X160MM STD BODY STD NECK Prosthesis, Hip, Semi-C... | The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly... | Class II | Zimmer Biomet, Inc. |
| Nov 29, 2017 | VERSYS 8 INCH BEADED FC 12X200MM STR STD BODY/NECK 13X200MM STR STD BODY/N... | The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly... | Class II | Zimmer Biomet, Inc. |
| Nov 29, 2017 | LPS-FLEX PRECOAT FEMORAL B-R LPS-FLEX PRECOAT FEMORAL C-L LPS-FLEX PRECOAT ... | The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly... | Class II | Zimmer Biomet, Inc. |
| Nov 29, 2017 | CR PRECOAT FEM COMP SIZE BMR CR PRECOAT FEM COMP SIZE C/R CR PRECOAT FEM CO... | The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly... | Class II | Zimmer Biomet, Inc. |
| Nov 29, 2017 | BIPOLAR METAL SHELL 48 MM OD Use of the MultiPolar Bipolar Cup is indicate... | The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly... | Class II | Zimmer Biomet, Inc. |
| Nov 29, 2017 | FEM PRC LT M/RT L SML FEM PRC RT M/LT L SML FEM PRC LT M/... | The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly... | Class II | Zimmer Biomet, Inc. |
| Nov 29, 2017 | LPS-FLEX GSF OPT SZ C-L¿ LPS-FLEX GSF OPT SZ C-R¿ LPS-FLEX GSF OPT SZ D-L¿ ... | The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly... | Class II | Zimmer Biomet, Inc. |
| Nov 29, 2017 | CR-FLEX POR HATCP FEM C-L CR-FLEX POR HATCP FEM C-R CR-FLEX POR HATCP FEM D... | The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly... | Class II | Zimmer Biomet, Inc. |
| Nov 29, 2017 | smith&nephew, 2.4 MM, 6 HOLE, EVOS, FLEX PLATE, SST Plate, REF CATALOG NUMBER... | One lot of EVOS 2.4MM Flex Plate 6 Hole packaging contained templates. | Class II | Smith & Nephew, Inc. |
| Nov 29, 2017 | LPS-FLEX OPTION FEMORAL C-L LPS-FLEX OPTION FEMORAL C-L LPS-FLEX OPTION FEM... | The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly... | Class II | Zimmer Biomet, Inc. |
| Nov 29, 2017 | CR OPTION FEM COMP SIZE C/L CR OPTION FEM COMP SIZE C/R CR OPTION FEM COMP ... | The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly... | Class II | Zimmer Biomet, Inc. |
| Nov 29, 2017 | LPS PRECOAT FEM SIZE D-RT LPS PRECOAT FEM SIZE E-RT LPS POROUS FEM SIZE F-R... | The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly... | Class II | Zimmer Biomet, Inc. |
| Nov 29, 2017 | VERSYS 6 INCH BEADED FC 13X160MM LM BODY EXT NECK & STD NECK Prosthesis, H... | The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly... | Class II | Zimmer Biomet, Inc. |
| Nov 29, 2017 | CPT 12/14 COCR SIZE 0 STD prosthesis, hip, semi-constrained, metal/polyme... | The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly... | Class II | Zimmer Biomet, Inc. |
| Nov 20, 2017 | Apex Knee System, Tibial Baseplate Size 6 Left, non-porous - KC-2206L The ... | The Apex Knee System Tibial Baseplate identified has an improper expiration date marked on the ex... | Class II | OMNIlife science Inc. |
| Nov 17, 2017 | STRYKER CASSETTE PUMP, AHTO Tube Set, labeled sterile. Includes the followin... | Routine bioburden testing of certain lots were found to have levels higher than internal acceptab... | Class II | Stryker Corporation |
| Nov 15, 2017 | Medacta International MiniMAX CEMENTLESS ANATOMICAL STEM, 12/14: for cementle... | Complaint monitoring noted a trend of packaging being breached for the MiniMAX Stem. | Class II | Medacta Usa Inc |
| Nov 6, 2017 | Unifine Pentips 5mm x 31G pen needles, packaged in 30 ct pen needles. Pro... | Device may potentially be compromised by water in end user packaging. Exposure to liquid may comp... | Class II | Owen Mumford USA, Inc. |
| Nov 6, 2017 | Unifine Pentips 5mm x 31G pen needles, packaged in 100 ct pen needles. Pro... | Device may potentially be compromised by water in end user packaging. Exposure to liquid may comp... | Class II | Owen Mumford USA, Inc. |
| Oct 24, 2017 | ArrowClarke" PleuraSeal¿ Thoracentesis Kit | Product packaging may not be completely sealed. | Class II | Arrow International Inc |
| Oct 24, 2017 | AMS, ALIGNED MEDICAL SOLUTIONS, T&A Pack, AMS6357, STERILE EO. | Custom surgical kits were manufactured with part #63310 Catheter Urethral 10FR 16" which were sub... | Class II | Windstone Medical Packaging, Inc. |
| Oct 24, 2017 | Large Volume Abdominal Paracentesis Kit | Product packaging may not be completely sealed. | Class II | Arrow International Inc |
| Oct 24, 2017 | Pneumothorax Kit | Product packaging may not be completely sealed. | Class II | Arrow International Inc |
| Oct 24, 2017 | Argyle Suction Tubing (Product # 8888301515) Argyle Suction Tubing is an ... | Incorrect packaging. In one lot of Argyle Suction Tubing, the pouch may be incorrectly labeled as... | Class II | Medtronic Minimally Invasive Therapies Group |
| Oct 23, 2017 | Surgical punch; sealed pouches packed in punch shelf box Intended for use... | Surgical punches are being recalled due to potential packaging damage which may have occurred dur... | Class II | Alto Development Corp |
| Oct 20, 2017 | Tissu-Trans Filtron 1000 Catalog Number 3-TT-FILTRON 1000. Used for fat tr... | Potential breach of sterility of the packaging. | Class II | Shippert Medical Technologies |
| Oct 13, 2017 | Disposable Light Handle Cover, Item Number B1-715-65. Packaged 1 device insi... | Sterile packaging of the disposable light handle cover may contain gaps in the seal of the pouch. | Class II | Ecolab, Inc. |
| Sep 13, 2017 | Medtronic Aptus Heli-FX Thoracic EndoAnchor System Heli-FX Guide 42 mm, REF H... | It was determined that the deflection length indicated on the Guide catheter handle does not matc... | Class II | Medtronic Vascular, Inc. |
| Sep 7, 2017 | The 2nd Assist Knee Positioner | Zimmer Biomet is conducting a medical device recall for the 2nd Assistant Knee Positioner due to ... | Class II | Zimmer Biomet, Inc. |
| Jul 24, 2017 | 20Ga x .75 LifeGuard Huber Needle with Y-site. Product Code: CLGY-2034. | Vygon is conducting a voluntary recall of the products and lots listed in this recall, being ini... | Class II | Vygon MFG, Inc., dba/ Churchill Medical Systems... |
| Jul 24, 2017 | NexGen LPS Femoral Component, Left and Right, Size G Replaces the femoral ... | There is a possibility that the protective foam insert used during the packaging of the affected ... | Class II | ZIMMER ORTHOPEDIC MFG LTD |
| Jul 24, 2017 | Nutrisafe 2 35 mL Syringe for Safety Connection. Product Code: 1015.352M | Vygon is conducting a voluntary recall of the products and lots listed in this recall, being ini... | Class II | Vygon MFG, Inc., dba/ Churchill Medical Systems... |
| Jul 24, 2017 | CVC Tray Pediatrics. Product Code: AMS-9335CP-2. | Vygon is conducting a voluntary recall of the products and lots listed in this recall, being ini... | Class II | Vygon MFG, Inc., dba/ Churchill Medical Systems... |
| Jul 24, 2017 | 19Ga x 1 Huber Needle Set. Product Code: MBS-1910. | Vygon is conducting a voluntary recall of the products and lots listed in this recall, being ini... | Class II | Vygon MFG, Inc., dba/ Churchill Medical Systems... |
| Jul 24, 2017 | 3-Way Standardbore Stopcock. Product Code: AMS-100. | Vygon is conducting a voluntary recall of the products and lots listed in this recall, being ini... | Class II | Vygon MFG, Inc., dba/ Churchill Medical Systems... |
| Jul 17, 2017 | Covidien Vistec" X-Ray Detectable Sponges, 7317 Vistec" X-Ray Detectable Spon... | Medtronic is voluntarily recalling two production lots of its Covidien Vistec" x-ray detectable s... | Class II | Covidien LP |
| Jul 5, 2017 | HomeChoice Pro Automated PD system Model numbers: 5C8310, 5C8310R Product... | Baxter Healthcare Corporation has been made aware that users may not be following the instruction... | Class II | Baxter Healthcare Corporation |
| Jul 5, 2017 | HomeChoice Automated PD system Model numbers: 5C4471, 5C4471R Product Usa... | Baxter Healthcare Corporation has been made aware that users may not be following the instruction... | Class II | Baxter Healthcare Corporation |
| Jun 30, 2017 | DELTA CER FEM HD 32/0MM T1 Product Usage: For use in hip arthroplasty | Product may contain the presence of melted sterile packaging upon opening. | Class II | Zimmer Biomet, Inc. |
| Jun 30, 2017 | VersaSafe Plastic Cannula - 11 Gauge, Model 9391-0200 Product Usage: Used... | Punctures in blister packaging that was detected during the packaging process. | Class II | CareFusion 303, Inc. |
| Jun 26, 2017 | Cobalt HV Bone Cement 40GM, REF 402282, QTY 1, STERILE, Rx Only, Mfgr: BIOMET... | Loss of the seal on the sterile Tyvek packaging used with this Cobalt Bone Cement. | Class II | Encore Medical, Lp |
| Jun 26, 2017 | Cobalt MV with Gentamicin, Cobalt Bone Cement 40GM, REF 402439, QTY 1, STERIL... | Loss of the seal on the sterile Tyvek packaging used with this Cobalt Bone Cement. | Class II | Encore Medical, Lp |
| Jun 26, 2017 | Cobalt MV Bone Cement 40GM, REF 402438, QTY 1, STERILE, Rx Only, Mfgr: BIOMET... | Loss of the seal on the sterile Tyvek packaging used with this Cobalt Bone Cement. | Class II | Encore Medical, Lp |
| Jun 26, 2017 | Cobalt HV with Gentamicin, Cobalt Bone Cement 40GM, REF 402283, QTY 1, STERIL... | Loss of the seal on the sterile Tyvek packaging used with this Cobalt Bone Cement. | Class II | Encore Medical, Lp |
| Jun 22, 2017 | DLP Extension Line Adapters 20 in length Used to extend cardioplegia line du... | Identification of small pinholes in a single packaging configuration of sterile pouches. A total... | Class II | Medtronic Perfusion Systems |
| Jun 22, 2017 | DLP Pressure Monitoring Extension Line Adapters Extends the pressure line in... | Identification of small pinholes in a single packaging configuration of sterile pouches. A total... | Class II | Medtronic Perfusion Systems |
| Jun 22, 2017 | DLP Cardioplegia Adapter with Pressure Port Provides access for a pressure m... | Identification of small pinholes in a single packaging configuration of sterile pouches. A total... | Class II | Medtronic Perfusion Systems |
| Jun 22, 2017 | DLP Antegrade/Retrograde Adapter Method for perfusion of cardioplegia altern... | Identification of small pinholes in a single packaging configuration of sterile pouches. A total... | Class II | Medtronic Perfusion Systems |
| Jun 22, 2017 | DLP Pressure Disposable Pressure Display Sets Extends the pressure line in o... | Identification of small pinholes in a single packaging configuration of sterile pouches. A total... | Class II | Medtronic Perfusion Systems |
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.