Browse Device Recalls
2,276 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,276 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 2,276 FDA device recalls in 2022.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Nov 2, 2022 | CareFusion V. Mueller TITANIUM BAYONET BIPOLAR FORCEPS, STRAIGHT, FINE 0.5MM ... | 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 | 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 | CareFusion V. Mueller ROUND HANDLE BAYONET BIPOLAR FORCEPS 1.0MM TIP OVERALL ... | 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 | 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 | Carefusion V. Mueller SCOVILLE-GREENWOOD BAYONET BIPOLAR FORCEPS 1.5MM TIPS, ... | 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 | 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 | CareFusion V. Mueller euro/Spine TITANIUM ROUND HANDLE BAYONET BIPOLAR FORCEP... | 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, 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 | Carefusion V. Mueller ADSON BIPOLAR FORCEPS 1.0MM TIP OVERALL LENGTH 4-3/4" (... | 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 | 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 | Carefusion V. Mueller Neuro/Spine JEWELERS BIPOLAR FORCEPS 0.4MM TIP, CURVED,... | 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 | CareFusion V. Mueller TITANIUM BAYONET BIPOLAR FORCEPS, 1.0MM TIP, STRAIGHT M... | 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 | CareFusion V. Mueller TITANIUM BAYONET INSULATED IRRIGATING BIPOLAR FORCEPS 1... | 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 | 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 | CareFusion V. Mueller TITANIUM BAYONET BIPOLAR FORCEPS, 0.5MM TIP, ANGLED-UP ... | 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 | 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 | Carefusion V. Mueller" HARDY-STYLE BAYONET BIPOLAR FORCEPS, 0.5MM TIP, INSULA... | 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 | 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 | Carefusion V. Mueller"GERALD BIPOLAR FORCEPS INSULATED, 1.0MM TIP OVERALL LEN... | 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, 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 | Carefusion V. Mueller" CUSHING BAYONET BIPOLAR FORCEPS, 2.0MM TIP, INSULATED ... | 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 | 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 |
| 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 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 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 | 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 | 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 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 | 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 | 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 | 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 | 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. |
| 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 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 | 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 | 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 |
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.