Browse Device Recalls
35,307 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 35,307 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 35,307 FDA device recalls, Class II.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 | CareFusion V. Mueller Neuro/Spine TITANIUM ROUND HANDLE BAYONET BIPOLAR FORCE... | BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content t... | Class II | Carefusion 2200 Inc |
| 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 | 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, 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 | CareFusion V. Mueller TITANIUM ROUND HANDLE BAYONET BIPOLAR FORCEPS, 0.7MM TI... | XXX | Class II | Carefusion 2200 Inc |
| Nov 1, 2022 | IgM Immunoturbidimetric Assay-In vitro determination of IgA and IgM in serum ... | Update to the carryover avoidance technical bulletin to detail that IgA and IgM assays should not... | Class II | Randox Laboratories Ltd. |
| Nov 1, 2022 | IgA Immunoturbidimetric Assay- In vitro determination of IgA and IgM in serum... | Update to the carryover avoidance technical bulletin to detail that IgA and IgM assays should not... | Class II | Randox Laboratories Ltd. |
| Nov 1, 2022 | Dover Closed Urethral Tray with Vinyl Catheter 14 Fr/Ch (4.7 mm), 5 mL Cathet... | Occlusion (blockage) of the bubble inlet port of the urinary drainage bag which may prevent urine... | Class II | Cardinal Health |
| Nov 1, 2022 | Dover Closed Urethral Tray with Hydrogel Coated Red Rubber Catheter 16 Fr/Ch ... | Occlusion (blockage) of the bubble inlet port of the urinary drainage bag which may prevent urine... | Class II | Cardinal Health |
| Nov 1, 2022 | Dover Closed Urethral Tray with Vinyl Catheter Product Code: 3420 Intended... | Occlusion (blockage) of the bubble inlet port of the urinary drainage bag which may prevent urine... | Class II | Cardinal Health |
| Nov 1, 2022 | Various Custom Surgical Instrument Disposable Kits: Part Numbers / Product D... | Due to Customer Convenience Kits containing 3M Steri-Drape Surgical Drapes that have been recalle... | Class II | Windstone Medical Packaging, Inc. |
| Nov 1, 2022 | Dover Closed Urethral Tray with Vinyl Catheter 14 Fr/Ch (4.7 ml) 5ml Catheter... | Occlusion (blockage) of the bubble inlet port of the urinary drainage bag which may prevent urine... | Class II | Cardinal Health |
| Nov 1, 2022 | Dover Closed Urethral Tray with Hydrogel Coated Red Rubber Catheter 14 Fr/Ch ... | Occlusion (blockage) of the bubble inlet port of the urinary drainage bag which may prevent urine... | Class II | Cardinal Health |
| Nov 1, 2022 | NUVASIVE MAGEC MAGEC 2 Rod. The MAGEC System is used to brace the spine dur... | During accelerated shelf-life extension studies it was noted that the final packaging was experie... | Class II | NuVasive Specialized Orthopedics, Inc. |
| Nov 1, 2022 | Dover Closed Urethral Tray with Vinyl Catheter 14 Fr/Ch (4.7 mm), 5 mL Cathet... | Occlusion (blockage) of the bubble inlet port of the urinary drainage bag which may prevent urine... | Class II | Cardinal Health |
| Oct 31, 2022 | Unity Total Knee System. Used for knee prosthesis in total knee replacement | The internal packaging system for devices may have damage to the blisters potentially damaging th... | Class II | Corin Ltd |
| Oct 31, 2022 | Alcon Custom Pak Surgical Procedure Pack | Due to difficulty removing the liner on the adhesive components of the affected drapes and as a r... | Class II | Alcon Research, LLC |
| Oct 31, 2022 | Aero Blue Performance Surgical Gown, XL- Sterile surgical gown Code: 41734 | Potential open seal pouches compromising sterility resulting in the use of a non-sterile product ... | Class II | Owens & Minor Distribution, Inc. |
| Oct 31, 2022 | Baxter Electrocardiograph, ELI 380 -DCS21 | One ELI 380 Electrocardiograph intended to be used for a pilot program was shipped to a customer ... | Class II | Baxter Healthcare Corporation |
| Oct 28, 2022 | EVOLUTION MP Tibial Bases, Size 2+ LEFT, REF ETPKN2PL, knee tibial base | One confirmed incident has been received that ETPKN2PL lot 1916559, size 2 Evolution MP Tibial Ba... | Class II | MicroPort Orthopedics Inc. |
| Oct 28, 2022 | Centricity PACS-IW with Universal Viewer version 5.0. Used to display me... | There is the potential that after installation of the IAS tool, some studies can remain hidden wi... | Class II | GE Medical Systems, LLC |
| Oct 28, 2022 | EVOLUTION MP Tibial Bases, Size 7 LEFT, REF ETPKN7SL, knee tibial base | One confirmed incident has been received that ETPKN2PL lot 1916559, size 2 Evolution MP Tibial Ba... | Class II | MicroPort Orthopedics Inc. |
| Oct 28, 2022 | Centricity Universal Viewer 6.0. Used to display medical images (Includi... | There is the potential that after installation of the IAS tool, some studies can remain hidden wi... | Class II | GE Medical Systems, LLC |
| Oct 27, 2022 | NextAR Shoulder Surgical Technique, Shoulder NextAR RSA Platform, CT based co... | A warning has been added to the Surgical Technique for NextAR Shoulder, advising verification of ... | Class II | Medacta Usa Inc |
| Oct 27, 2022 | CytoCell BCL11B Distal in Texas Red Spectrum- Analyte Specific Reagent Ref: ... | An error with the chromomap on version 1 of the package insert which is incorrect. The nucleotide... | Class II | Cytocell Ltd. |
| Oct 27, 2022 | CytoCell BCL11B Proximal in FITC Spectrum-LDT for investigation T-cell relate... | Device is mislabeled. The package insert for this ASR device contains a chromomap - an image show... | Class II | Cytocell Ltd. |
| Oct 27, 2022 | Southmedic SAFETY CARTRIDGE WITH SOUTHMEDIC PLUS SURGICAL BLADE, REF 73-8020,... | Upon review of its batch record, Southmedic identified that lot # W92761 was not sent out for ste... | Class II | Southmedic, Inc. |
| Oct 25, 2022 | IMMULITE and IMMULITE 1000 Total Testosterone Assay- In vitro diagnostic use ... | Confirmed an average positive bias of 40% for testosterone concentrations of approximately 660 ng... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Oct 25, 2022 | GREER DIA - KIT ANTIGEN M. FAENI, 2.0mL 20 MG/ML, Analyte Specific Reagent, I... | The product was recalled because stability evaluation of the lots indicated a decrease in reactiv... | Class II | Greer Laboratories, Inc. |
| Oct 25, 2022 | GREER M. FAENI, 0.25 mL 20 MG/ML, Item: K6, Analyte Specific Reagent, HYPERSE... | The product was recalled because stability evaluation of the lots indicated a decrease in reactiv... | Class II | Greer Laboratories, Inc. |
| Oct 24, 2022 | TrackX Insight Base Modular Instrument Tracker, 5L, REF #604-3TX, Sterile; a... | The device is breaking and falling off the Nuvasive T-Handle with Hudson Adapter on certain Nuvas... | Class II | Trackx Technology Inc |
| Oct 24, 2022 | eSuction Small Cavity, Model ET2005 | Improper device regulatory classification | Class II | Endo-Therapeutics, Inc. |
| Oct 24, 2022 | Infection Control (IC) Lifting Strap used with the following Cirrus and Pinna... | Two customers reported four incidents in which the lifting strap broke while lifting a patient. I... | Class II | Tollos |
| Oct 21, 2022 | Simplex HV With Gentamicin CE, 10 PACK-Bone cement with Gentomycin Catalog N... | Simplex HV With Gentamicin CE, 10 PACKS (P/N 6193-1-010) were distributed to customers who had o... | Class II | Howmedica Osteonics Corp. |
| Oct 21, 2022 | Busse SPINE INJECTION TRAY-Intended as a nerve block REF No. 8563R1 | Kits containing 3M Steri-Drape Surgical Drapes recalled by 3M due to liner on the adhesive compon... | Class II | Busse Hospital Disposables, Inc. |
| Oct 21, 2022 | Propel Mini Mometasone Furoate Sinus Implant, with Straight Delivery System, ... | Sinus Implant product label displays incorrect product information including: "Straight Delivery ... | Class II | Intersect ENT, Inc. |
| Oct 21, 2022 | Busse JOINT INJECTION TRAY -Intended as a nerve block REF No. 8561 R1 | Kits containing 3M Steri-Drape Surgical Drapes recalled by 3M due to liner on the adhesive compon... | Class II | Busse Hospital Disposables, Inc. |
| Oct 21, 2022 | Philips ProxiDiagnost N90 1.0 (Model 706100) and ProxiDiagnost N90 1.1 (Mode... | Potential table stop due to a broken tabletop cable: On the ProxiDiagnost N90 table there is a c... | Class II | Philips North America Llc |
| Oct 20, 2022 | regard DAVINCI PACK, GS00137W, Item Number 880132023; gastric surgery conven... | Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently ... | Class II | ROi CPS LLC |
| Oct 20, 2022 | regard BASIC NEURO, NU00259R, Item Number 800021018; neuro surgery convenienc... | Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently ... | Class II | ROi CPS LLC |
| Oct 20, 2022 | regard RETINAL PACK, EY00935C, Item Number 800730003; EYE surgery convenience... | Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently ... | Class II | ROi CPS LLC |
| Oct 20, 2022 | regard NEURO PACK, NU00278L, Item Number 800040012; nuero surgery convenience... | Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently ... | Class II | ROi CPS LLC |
| Oct 20, 2022 | regard BASIC NEURO, NU00259S, Item Number 800021019; neuro surgery convenienc... | Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently ... | Class II | ROi CPS LLC |
| Oct 20, 2022 | regard SPINE PACK, NU00260H, Item Number 800022008; ortho surgery convenience... | Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently ... | Class II | ROi CPS LLC |
| Oct 20, 2022 | regard MINOR DAVINCI PACK, GS00349M, Item Number 880251013; general surgery ... | Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently ... | Class II | ROi CPS LLC |
| Oct 20, 2022 | regard VITRECTOMY PK, EY00938C, Item Number 800733003; EYE surgery convenienc... | Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently ... | Class II | ROi CPS LLC |
| Oct 20, 2022 | regard KYPHOPLASTY, OR01101, Item Number 880469; orthopedic surgery convenien... | Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently ... | Class II | ROi CPS LLC |
| Oct 20, 2022 | regard SPINE PACK,NU00395J, Item Number 800241010; ortho surgery convenience kit | Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently ... | Class II | ROi CPS LLC |
| Oct 20, 2022 | regard PEDIATRIC UROLOGY, GS00467J, Item Number 880306010; uro surgery conven... | Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently ... | Class II | ROi CPS LLC |
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.