Browse Device Recalls
93 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 93 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 93 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Nov 2, 2022 | STRADIS HEALTHCARE, Phlebectomy Pack, Item No.682-001, | Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may... | Class II | Stradis Medical, LLC dba Stradis Healthcare |
| Nov 2, 2022 | HENRY SCHEIN, BASIC EXTENDED PACK, Item No.570-2890 | Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may... | Class II | Stradis Medical, LLC dba Stradis Healthcare |
| Nov 2, 2022 | STRADIS HEALTHCARE, Surg, Item No.40551TMS. oral surgery tray | Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may... | Class II | Stradis Medical, LLC dba Stradis Healthcare |
| Nov 2, 2022 | STRADIS HEALTHCARE, Endo Pack, Item No.682-509, | Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may... | Class II | Stradis Medical, LLC dba Stradis Healthcare |
| Nov 2, 2022 | HENRY SCHEIN, EXTREMITY PACK, Item No.570-2946 | Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may... | Class II | Stradis Medical, LLC dba Stradis Healthcare |
| Nov 2, 2022 | www.StradisHealthcare.com, Endovenous Pack, Item No.682-494, | Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may... | Class II | Stradis Medical, LLC dba Stradis Healthcare |
| Nov 2, 2022 | HENRY SCHEIN, MAJOR EXTREMITY PACK, Item No.570-2783, | Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may... | Class II | Stradis Medical, LLC dba Stradis Healthcare |
| Nov 2, 2022 | STRADIS HEALTHCARE, Surg Pack, Item No.40450SMS, dental | Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may... | Class II | Stradis Medical, LLC dba Stradis Healthcare |
| Nov 2, 2022 | STRADIS HEALTHCARE, Basic Implant Pack, Item No.40561BIP, oral surgery tray | Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may... | Class II | Stradis Medical, LLC dba Stradis Healthcare |
| Nov 2, 2022 | Surgical room, Implant Pack, Item No.41111UTI, oral surgery tray | Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may... | Class II | Stradis Medical, LLC dba Stradis Healthcare |
| Nov 2, 2022 | HENRY SCHEIN, PACEMAKER PACK IItem No.570-2793 | Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may... | Class II | Stradis Medical, LLC dba Stradis Healthcare |
| Nov 2, 2022 | HENRY SCHEIN, Labiaplasty PackItem No.570-3118, | Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may... | Class II | Stradis Medical, LLC dba Stradis Healthcare |
| Nov 2, 2022 | STRADIS HEALTHCARE, Phleb, Item No.682-1425, | Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may... | Class II | Stradis Medical, LLC dba Stradis Healthcare |
| Nov 2, 2022 | HENRY SCHEIN, Vas Pack, Item No.888-2520, | Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may... | Class II | Stradis Medical, LLC dba Stradis Healthcare |
| Nov 2, 2022 | HENRY SCHEIN, PROCEDURE KIT, Item No.570-1508, general surgery tray | Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may... | Class II | Stradis Medical, LLC dba Stradis Healthcare |
| Nov 2, 2022 | STRADIS HEALTHCARE, CURVED TIP SYRINGE, Item No.60060GCTS, | Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may... | Class II | Stradis Medical, LLC dba Stradis Healthcare |
| Nov 2, 2022 | HENRY SCHEIN, UNIVERSAL TRAY, Item No.570-2787 | Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may... | Class II | Stradis Medical, LLC dba Stradis Healthcare |
| Nov 2, 2022 | HENRY SCHEIN, Novasure Pack, Item No.570-1462, general surgery tray | Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may... | Class II | Stradis Medical, LLC dba Stradis Healthcare |
| Nov 2, 2022 | HENRY SCHEIN, BASIC PACK, Item No.570-2719, UDI/DI (case) H65857027191, UDI/D... | Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may... | Class II | Stradis Medical, LLC dba Stradis Healthcare |
| Nov 2, 2022 | HENRY SCHEIN, Basin Set, Item No.570-1803 | Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may... | Class II | Stradis Medical, LLC dba Stradis Healthcare |
| Nov 2, 2022 | STRADIS HEALTHCARE, Surgery PK, Item No.682-1728, | Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may... | Class II | Stradis Medical, LLC dba Stradis Healthcare |
| Nov 2, 2022 | HENRY SCHEIN, LOOP RECORDER PACK, Item No.570-2891 | Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may... | Class II | Stradis Medical, LLC dba Stradis Healthcare |
| Nov 2, 2022 | HENRY SCHEIN, SURGICAL PAIN TRAY, Item No.570-1482 | Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may... | Class II | Stradis Medical, LLC dba Stradis Healthcare |
| Nov 2, 2022 | STRADIS HEALTHCARE, VENOUS ACCESS PACK, Item No.682-1993R1, | Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may... | Class II | Stradis Medical, LLC dba Stradis Healthcare |
| Nov 2, 2022 | HENRY SCHEIN, SINGLE SHOT EPIDURAL, Item No.570-3089 | Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may... | Class II | Stradis Medical, LLC dba Stradis Healthcare |
| Nov 2, 2022 | STRADIS HEALTHCARE, Surg Pk, Item No.40714IES, oral surgery tray | Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may... | Class II | Stradis Medical, LLC dba Stradis Healthcare |
| Nov 2, 2022 | STRADIS HEALTHCARE, Angioplasty, Item No.682-1937, | Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may... | Class II | Stradis Medical, LLC dba Stradis Healthcare |
| Nov 2, 2022 | HENRY SCHEIN, Vas Reversal Pack, Item No.888-2549, | Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may... | Class II | Stradis Medical, LLC dba Stradis Healthcare |
| Jul 25, 2022 | NARMD MEDICAL DEPOT Scissors Iris Curved 4.5", Part Number ZZ-0697 | The sterile barrier may be compromised. | Class II | Stradis Medical, LLC dba Stradis Healthcare |
| Jul 25, 2022 | NARMD MEDICAL DEPOT Forceps - Kelly Curved 5.5"; Part Number: ZZ-0701 | The sterile barrier may be compromised. | Class II | Stradis Medical, LLC dba Stradis Healthcare |
| Jul 25, 2022 | NARMD MEDICAL DEPOT Forceps - Kelly Straight 5.5"; Part Number: ZZ-0700 | The sterile barrier may be compromised. | Class II | Stradis Medical, LLC dba Stradis Healthcare |
| Feb 25, 2022 | Lum Lam Custom Pack - Anesthesia Kit | The outer bag may be perforated or torn, which may result in a breach in the sterility of the kit. | Class II | Stradis Medical, LLC dba Stradis Healthcare |
| Feb 25, 2022 | Total Knee Pack - Surgical Kit | The outer bag may be perforated or torn, which may result in a breach in the sterility of the kit. | Class II | Stradis Medical, LLC dba Stradis Healthcare |
| Feb 25, 2022 | Anterior Hip Pack - Surgical Kit | The outer bag may be perforated or torn, which may result in a breach in the sterility of the kit. | Class II | Stradis Medical, LLC dba Stradis Healthcare |
| Feb 25, 2022 | Surgicare Neuro Pack - Neurological Kit | The outer bag may be perforated or torn, which may result in a breach in the sterility of the kit. | Class II | Stradis Medical, LLC dba Stradis Healthcare |
| Feb 25, 2022 | Coryell Memorial Hosp Total, Joint Pack - Surgical Kit | The outer bag may be perforated or torn, which may result in a breach in the sterility of the kit. | Class II | Stradis Medical, LLC dba Stradis Healthcare |
| Oct 28, 2021 | Custom Assemblies, Inc., Single Spike Tumescent Set w/o Chamber, Reorder Numb... | This recall has been initiated to address bulk packed, non-sterile Intravascular Administration S... | Class II | Stradis Medical, LLC dba Stradis Healthcare |
| Sep 10, 2021 | Standard IUD Insertion Kit | Firm unable to confirm that the tenaculum devices were produced in accordance with required desig... | Class II | Stradis Medical, LLC dba Stradis Healthcare |
| Sep 10, 2021 | Endometrial Biopsy Kit | Firm unable to confirm that the tenaculum devices were produced in accordance with required desig... | Class II | Stradis Medical, LLC dba Stradis Healthcare |
| Sep 10, 2021 | Tenaculum, Plastic | Firm unable to confirm that the tenaculum devices were produced in accordance with required desig... | Class II | Stradis Medical, LLC dba Stradis Healthcare |
| Sep 10, 2021 | IUD Insertion Kit | Firm unable to confirm that the tenaculum devices were produced in accordance with required desig... | Class II | Stradis Medical, LLC dba Stradis Healthcare |
| Sep 10, 2021 | IUD Insertion Pack | Firm unable to confirm that the tenaculum devices were produced in accordance with required desig... | Class II | Stradis Medical, LLC dba Stradis Healthcare |
| Sep 10, 2021 | Foundation Kit | Firm unable to confirm that the tenaculum devices were produced in accordance with required desig... | Class II | Stradis Medical, LLC dba Stradis Healthcare |
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.