Browse Device Recalls
706 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 706 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 706 FDA device recalls in GA.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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. |
| Mar 21, 2022 | Restrata, Part Number RWM1-2X2 | Misprinted expiration date on the shelf-box | Class II | Acera Surgical Inc |
| 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 |
| Jan 28, 2022 | Brasseler USA, K-WIRE, Double Trocar Smooth, REF KM172-26-35S | One lot of product was distributed in unsealed packaging | Class II | Brasseler USA, Medical L.L.C. |
| Jan 27, 2022 | BARD SURESTEP INTERMITTENT CATHETER TRAY, 14Fr, REF INTS16C | There is a potential to leak from the catheter where it connects to the drain bag | Class II | C.R. Bard Inc |
| Jan 27, 2022 | BARD SURESTEP INTERMITTENT CATHETER TRAY, 14Fr, REF INTS14C | There is a potential to leak from the catheter where it connects to the drain bag | Class II | C.R. Bard Inc |
| Dec 22, 2021 | MIC* Percutaneous Endoscopic Gastrostomy PEG Kit - 20 Fr-PULL | The External Retention Bolster contained in the kit may be a larger diameter than the tube. | Class II | Avanos Medical, Inc. |
| Dec 22, 2021 | MIC* Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors - 20 F... | The External Retention Bolster contained in the kit may be a larger diameter than the tube. | Class II | Avanos Medical, Inc. |
| Nov 22, 2021 | BALLARD* Seal Cassette Replacement MAP - BALLARD* Seal Cassette Replacement f... | Product was distributed with incorrect expiration date. | Class II | Avanos Medical, Inc. |
| Nov 22, 2021 | BALLARD* Multi-Access Port (MAP) Catheter, Double Swivel Y- Adult, 16 French;... | Product was distributed with incorrect expiration date. | Class II | Avanos Medical, Inc. |
| Nov 22, 2021 | BALLARD* Multi-Access Port Catheter, Double Swivel Y Elbow, Adult, 14 French;... | Product was distributed with incorrect expiration date. | Class II | Avanos Medical, Inc. |
| Nov 17, 2021 | DYNANAIL MINI, Endcap +6mm, REF 2600-05-006, Rx Only, Sterile | The firm identified a nonconformance in Lot 04882 involving the endcap being manufactured to a lo... | Class II | Medshape, INC. |
| 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 |
| Oct 13, 2021 | Oncentra Brachy users using version 4.0 and above with Applicator Modeling li... | Under certain circumstances, there can be a difference between the planned and delivered dose of ... | Class II | Elekta, Inc. |
| Oct 7, 2021 | BioGlue Surgical Adhesive, Model BG3510-5-G | Product is not approved for use in the EU and should not have been distributed in the EU. | Class II | CryoLife, Inc. |
| Sep 27, 2021 | HALYARD STERLING ZERO NITRILE POWDER-FREE EXAM GLOVES, Sizes XS, S, M, L, and XL | All lots of the glove may discolor and lose elasticity upon aging, resulting in the inability of ... | Class II | O&M HALYARD INC |
| Sep 17, 2021 | Elekta Medical Linear Accelerator (EMLA), configured as follows: a. Elekta... | There is a risk that the Diode D1 in the Modulator can fail in a destructive manner when removed ... | Class II | Elekta, 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.