Browse Device Recalls

676 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 676 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 676 FDA device recalls in GA.

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DateProductReasonClassFirm
Nov 2, 2022 STRADIS HEALTHCARE, Angio Pack, Item No.686-199, 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, VEIN TRAY, Item No.570-2738, 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, Femoral, Vasc, Item No.686-142, 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, Vein, Item No.682-577, 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, Blue Tail Custom Pack, Item No.570-3091, 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, Vein & Laser, Item No.682-334R1, 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, Vein, Item No.682-1732, 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, OMFS, Item No.570-2779, 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, CATH PACK Item No.570-2789 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, 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
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 CAIRE Liberator 45, MODEL 13261699, Liquid Oxygen System Unit An audit discovered some inconsistencies in weld penetration on the longitudinal weld seam on the... Class I Caire, Inc.
Oct 10, 2022 CAIRE Liberator 30, MODEL 13337403, Liquid Oxygen System Unit An audit discovered some inconsistencies in weld penetration on the longitudinal weld seam on the... Class I Caire, Inc.
Oct 10, 2022 CAIRE Liberator 20, MODEL 13256195, Liquid Oxygen System Unit An audit discovered some inconsistencies in weld penetration on the longitudinal weld seam on the... Class I Caire, Inc.
Oct 10, 2022 CAIRE Liberator 45, MODEL 13262253, Liquid Oxygen System Unit An audit discovered some inconsistencies in weld penetration on the longitudinal weld seam on the... Class I Caire, Inc.
Sep 14, 2022 Y-CONNECTOR: 6" Small Kink Resistant Tubing Bifurcated Connector /2 Male Lue... Sterile extension sets were distributed without an expiration date Class II Avanos Medical, Inc.
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
May 19, 2022 Sensica Urine Output System Complaints relating to urine output measurement accuracy. Class II C.R. Bard Inc
Apr 18, 2022 progenamatrix Human Keratin Matrix, sterile, Rx, with the following model num... Inner pouch seal may be inadequate resulting in lack of sterility. Class II ProgenaCare
Mar 25, 2022 CAIRE FreeStyle Comfort Portable Oxygen Concentrator with autoSAT, UltraSense... The device was not cleared for U.S. distribution. Class II Caire, Inc.
Mar 21, 2022 Avanos Cortrak 2 Enteral Access System (EAS) Product labeling is being modified. STOP using the Anonymous Account Mode feature of the CORTRAK ... Class I Avanos Medical, Inc.

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.