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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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.