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.

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Date	Product	Reason	Class	Firm
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 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 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 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 27, 2022	Arrow MAC Two-Lumen Central Venous Access Kit fr use with 7 - 7.5 Fr Catheter...	There is the potential for inadequate connection between the top and bottom housings of the Micro...	Class I	ARROW INTERNATIONAL Inc.
Oct 27, 2022	Pressure Injectable Arrowg+ard Blue Plus Three-Lumen CVC Kit, REF numbers: a)...	There is the potential for inadequate connection between the top and bottom housings of the Micro...	Class I	ARROW INTERNATIONAL Inc.
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 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	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	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 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	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 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	eSuction Small Cavity, Model ET2005	Improper device regulatory classification	Class II	Endo-Therapeutics, 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	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 24, 2022	Mighty Bliss Electric Heating Pad, Large (12 x 24 ) Blue Electric Heating Pa...	The products may have the potential to burn customers. Firm has received complaints of burns, mil...	Class I	Whele LLC DBA Perch
Oct 24, 2022	Mighty Bliss Electric Heating Pad, Large (12 x 24 ) Grey Electric Heating P...	The products may have the potential to burn customers. Firm has received complaints of burns, mil...	Class I	Whele LLC DBA Perch
Oct 24, 2022	Mighty Bliss Electric Heating Pad, Extra-Large (20 x 24 ) Blue Electric Heat...	The products may have the potential to burn customers. Firm has received complaints of burns, mil...	Class I	Whele LLC DBA Perch
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	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 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	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	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	Thermo SCIENTIFIC Sensititre Plate, GN4F, Gram Negative IVD AST	An internal technical investigation has confirmed that Thermo Scientific" Gram Negative IVD AST S...	Class I	Remel Inc
Oct 20, 2022	¿regard SHOULDER PK, GS00125U, Item Number 880120021; ortho surgery convenie...	Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently ...	Class II	ROi CPS LLC
Oct 20, 2022	regard SPINE PACK , NU00193N, Item Number 880179014; neuro surgery convenien...	Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently ...	Class II	ROi CPS LLC
Oct 20, 2022	¿regard EYE TRAY, EY00099AE, Item Number 880099031; eye surgery convenience kit	Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently ...	Class II	ROi CPS LLC
Oct 20, 2022	regard MAJOR CRANI, NU00921E, Item Number 800716005; neuro surgery convenienc...	Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently ...	Class II	ROi CPS LLC
Oct 20, 2022	regard VITRECTOMY PACK, EY00266H, Item Number 800028008; eye surgery convenie...	Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently ...	Class II	ROi CPS LLC
Oct 20, 2022	regard LAMINECTOMY, NU01140, Item Number 900940; neuro surgery convenience kit	Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently ...	Class II	ROi CPS LLC
Oct 20, 2022	regard SPINE , NU00974F, Item Number 800769006; neuro surgery convenience kit	Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently ...	Class II	ROi CPS LLC
Oct 20, 2022	regard MAJOR EAR, ET00326J, Item Number 800070010; ear surgery convenience kit	Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently ...	Class II	ROi CPS LLC
Oct 20, 2022	regard NEURO TRAY, NU00160R, Item Number 880158018; neuro surgery convenienc...	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
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 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	Thermo SCIENTIFIC, Sensititre STP7F, Gram Negative IVD AST	An internal technical investigation has confirmed that Thermo Scientific" Gram Negative IVD AST S...	Class I	Remel Inc
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 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	Thermo SCIENTIFIC, Sensititre CMC7AFLF, Gram Negative IVD AST	An internal technical investigation has confirmed that Thermo Scientific" Gram Negative IVD AST S...	Class I	Remel Inc
Oct 20, 2022	NEO-fit Neonatal Endotracheal Tube Grip, Part Number 42-2540	Firm has received 11 complaints involving a loose or detached metal clips, including 3 cases wher...	Class II	CooperSurgical, Inc.
Oct 20, 2022	regard ACDF, NU00698I, Item Number 800246009; neuro surgery convenience kit	Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently ...	Class II	ROi CPS LLC
Oct 20, 2022	Thermo SCIENTIFIC, Sensititre MDRGN3F, Gram Negative IVD AST	An internal technical investigation has confirmed that Thermo Scientific" Gram Negative IVD AST S...	Class I	Remel Inc
Oct 20, 2022	Thermo SCIENTIFIC, Sensititre CMC5VGNF, Gram Negative IVD AST	An internal technical investigation has confirmed that Thermo Scientific" Gram Negative IVD AST S...	Class I	Remel Inc
Oct 20, 2022	regard CATARACT, EY00450L, Item Number 880295012; eye surgery convenience kit	Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently ...	Class II	ROi CPS LLC
Oct 20, 2022	regard CATARACT, EY00450K, Item Number 880295011; eye surgery convenience kit	Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently ...	Class II	ROi CPS LLC
Oct 20, 2022	¿regard SHOULDER ARTHROSCOPY, OR00049Q, Item Number 880044017; ortho surgery ...	Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently ...	Class II	ROi CPS LLC
Oct 20, 2022	Thermo SCIENTIFIC, Sensititre GN6F, Gram Negative IVD AST	An internal technical investigation has confirmed that Thermo Scientific" Gram Negative IVD AST S...	Class I	Remel Inc
Oct 20, 2022	regard HAND PACK, OR00594K, Item Number 800243011; ortho surgery convenience kit	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.