Browse Device Recalls
4,602 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 4,602 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 4,602 FDA device recalls in CA.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Sep 27, 2016 | Cath Lab Kit w/3 Port "ON" Manifold (600 psi), Transpac¿ IV, 2 Admin Sets and... | ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... | Class II | ICU Medical, Inc. |
| Sep 27, 2016 | ART LINE KIT W/ 3ML FLUSH DEVICE FOR JACKSON MEM. HOSP., Item No. 46053-14 T... | ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... | Class II | ICU Medical, Inc. |
| Sep 27, 2016 | TRIPLE (3) DISPOSABLE TRANSDUCER KIT WITH 03ML FLUSH DEVICE FOR LUTHERAN GEN.... | ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... | Class II | ICU Medical, Inc. |
| Sep 27, 2016 | SINGLE A LINE KIT CC5 W/03ML FLUSH DEVICE FOR ALBERT EINSTEIN M.C., Item No. ... | ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... | Class II | ICU Medical, Inc. |
| Sep 27, 2016 | MONITORING KIT W/30 ML FLUSH DEVICE FOR EGLESTON HOSP., Item No. 46094-50 Th... | ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... | Class II | ICU Medical, Inc. |
| Sep 27, 2016 | TRANSPAC¿ IV MONITORING KIT, 60", DISPOSABLE TRANSDUCER, 3 ML SQUEEZE FLUSH, ... | ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... | Class II | ICU Medical, Inc. |
| Sep 27, 2016 | TRANSPAC¿ IV MONITORING KIT, DISPOSABLE TRANSDUCER, 3 ML SQUEEZE FLUSH, MACRO... | ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... | Class II | ICU Medical, Inc. |
| Sep 27, 2016 | KIT FOR UNIVERSITY OF MICH. MOTT CATH LAB, Item No. 46061-49 The Transpac Di... | ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... | Class II | ICU Medical, Inc. |
| Sep 27, 2016 | MONITORING KIT WITH 03ML FLUSH DEVICE FOR CHRIST HOSPITAL, Item No. 46054-42 ... | ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... | Class II | ICU Medical, Inc. |
| Sep 27, 2016 | MONITORING KIT W/03ML FLUSH DEVICE FOR PITT CO. MEM. HOSP., Item No. 46076-19... | ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... | Class II | ICU Medical, Inc. |
| Sep 27, 2016 | TRANSPAC¿ IV MONITORING KIT NEONATAL, 24", DISPOSABLE TRANSDUCER, 30 ML SQUEE... | ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... | Class II | ICU Medical, Inc. |
| Sep 27, 2016 | TRANSPAC¿ IV MONITORING KIT WITH SAFESET" RESERVOIR AND BLOOD SAMPLING PORT, ... | ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... | Class II | ICU Medical, Inc. |
| Sep 27, 2016 | TRIFURCATED DISP. TRANSDUCER W/03ML FLUSH DEVICE FOR JOHNS HOPKINS HOSP, Item... | ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... | Class II | ICU Medical, Inc. |
| Sep 27, 2016 | TRIFURCATED MK W/03ML FLUSH DEVICE FOR UNIV. HEALTH SYSTEM, Item No. 46097-62... | ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... | Class II | ICU Medical, Inc. |
| Sep 27, 2016 | Transpac¿ IV Bifurcated Monitoring Kit w/03 ml Squeeze Flush Device, PT Tubin... | ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... | Class II | ICU Medical, Inc. |
| Sep 27, 2016 | CATH LAB KIT, Item No. 46096-25 The Transpac Disposable Straight Pressure Tr... | ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... | Class II | ICU Medical, Inc. |
| Sep 23, 2016 | VIA 27 Microcatheter, Part No. FG27-154-01, Model No. VIA-27-154-01 The V... | Sequent Medical is recalling the VIA 27 Microcatheter because it may not adequately re-sheath the... | Class II | Sequent Medical Inc |
| Sep 21, 2016 | CD79b PE (ASR) , Catalog number 335816 ; Hematology: The CD79b antibody r... | CD79b (SN8) PE is contaminated with a FITC conjugate of unknown antigenic specificity | Class II | Becton, Dickinson and Company, BD Biosciences |
| Sep 19, 2016 | VariaBreeze; Catalog number: 7300-0035-2. Podiatry: ablation, vaporizat... | FDA inspection found that customers who had received devices with promotional material with outs... | Class II | New Star Lasers, Inc. |
| Sep 19, 2016 | CT3Plus (a.k.a. CT3PZ); Catalog number: 7300-0038/ 7300-0038-1. Dermato... | FDA inspection found that customers who had received devices with promotional material with outs... | Class II | New Star Lasers, Inc. |
| Sep 19, 2016 | ReNew (a.k.a. Trio) Dermatology: for use in dermatology for incision, exc... | FDA inspection found that customers who had received devices with promotional material with outs... | Class II | New Star Lasers, Inc. |
| Sep 14, 2016 | Agee-WristJack¿ Fracture Reduction System; Item number: CFD-147. The WristJ... | A number of Agee WristJack¿ Fracture Reduction Systems have been manufactured with a molded beam ... | Class II | Hand Biomechanics Lab Inc |
| Sep 13, 2016 | Varian Head Frame - Model number HHF -ALL Head Frame Posts (PN1008016 ) and P... | Varian Medical Systems has received a report that a user was able to easily rotate the head frame... | Class II | Varian Medical Systems, Inc. |
| Sep 12, 2016 | Blood Pressure Monitor UA-767PBT-Ci for small cuff. Designed to be used by e... | A&D may have shipped blood pressure monitors that were not labeled for use with small cuff. | Class II | A & D Enginering Inc |
| Sep 6, 2016 | AQUIOS CL Flow Cytometer, Catalog No. B30166; Intended for use with in vitro ... | Beckman Coulter is recalling the AQUIOS CL System because the use of the reagent carousel can lea... | Class II | Beckman Coulter Inc. |
| Aug 31, 2016 | Sealapex Xpress, Part No. 33639 The brand name of the device is Sealapex X... | SybronEndo is recalling the Sealapex Xpress because it was labeled with an incorrect expiration d... | Class II | Ormco/Sybronendo |
| Aug 29, 2016 | TriMed Semi-Tubular Plate, 10-Hole, Model No. SMTP-10 Contoured plate with... | TriMed is recalling the Semi-Tubular Plates with 10 holes (SMTP-10) because a non-locking screw p... | Class II | Trimed Inc |
| Aug 26, 2016 | AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model No. Z9002 Th... | Abbott Medical Optics is recalling Intraocular Lenses (IOLs) because they were not being checked ... | Class II | Abbott Medical Optics Inc. (AMO) |
| Aug 26, 2016 | TECNIS Multifocal 1-Piece Intraocular Lens, Model No. ZKB00, ZLB00; The pro... | Abbott Medical Optics is recalling Intraocular Lenses (IOLs) because they were not being checked ... | Class II | Abbott Medical Optics Inc. (AMO) |
| Aug 26, 2016 | TECNIS 1-Piece IOL, Model No. ZCB00 The product is indicated for implantatio... | Abbott Medical Optics is recalling Intraocular Lenses (IOLs) because they were not being checked ... | Class II | Abbott Medical Optics Inc. (AMO) |
| Aug 26, 2016 | TECNIS OptiBlue 1-Piece IOL with the TECNIS iTec Preloaded Delivery System, ... | Abbott Medical Optics is recalling Intraocular Lenses (IOLs) because they were not being checked ... | Class II | Abbott Medical Optics Inc. (AMO) |
| Aug 26, 2016 | TECNIS Multifocal Foldable Acrylic Intraocular Lens, Model No. ZMA00 The pro... | Abbott Medical Optics is recalling Intraocular Lenses (IOLs) because they were not being checked ... | Class II | Abbott Medical Optics Inc. (AMO) |
| Aug 26, 2016 | SENSAR 1-Piece IOL, Model No. AAB00 The product is indicated for implantatio... | Abbott Medical Optics is recalling Intraocular Lenses (IOLs) because they were not being checked ... | Class II | Abbott Medical Optics Inc. (AMO) |
| Aug 26, 2016 | SENSAR Foldable IOL with OptiEdge Design, Model No. AR40e The product is ind... | Abbott Medical Optics is recalling Intraocular Lenses (IOLs) because they were not being checked ... | Class II | Abbott Medical Optics Inc. (AMO) |
| Aug 26, 2016 | TECNIS Symfony Extended Range of Vision IOL, Model No. ZXR00 The product is ... | Abbott Medical Optics is recalling Intraocular Lenses (IOLs) because they were not being checked ... | Class II | Abbott Medical Optics Inc. (AMO) |
| Aug 26, 2016 | TECNIS 1-Piece IOL with the TECNIS iTec Preloaded Delivery System, Model No. ... | Abbott Medical Optics is recalling Intraocular Lenses (IOLs) because they were not being checked ... | Class II | Abbott Medical Optics Inc. (AMO) |
| Aug 26, 2016 | TECNIS OptiBlue 1-Piece Intraocular Lens (IOL), Model No. ZCB00V The product... | Abbott Medical Optics is recalling Intraocular Lenses (IOLs) because they were not being checked ... | Class II | Abbott Medical Optics Inc. (AMO) |
| Aug 24, 2016 | Tego Connector, Item No. D1000, NM1000 The Tego¿ Needle Free Access Device... | ICU Medical Inc. has identified a potential risk of leaking with certain Tego Connector devices. | Class II | ICU Medical, Inc. |
| Aug 15, 2016 | CARTO 3 EP Navigation System and Accessories, Product Codes: FG540000 and FG5... | Biosense Webster, Inc. is initiating a voluntary correction to re-install identified CARTO 3 Syst... | Class II | Biosense Webster, Inc. |
| Aug 15, 2016 | Thermo Scientific QMS Everolimus Assay; Model number: 0380000 (US Distribut... | A reagent stability issue (still under investigation) causes less separation in the calibration c... | Class II | Microgenics Corporation |
| Aug 15, 2016 | BruxZir Shaded, Model No. 70-1167-NOW0001, 70-1167-NOW0002, 70-1167-NOW0003, ... | Prismatik Dentalcraft is recalling BruxZir Shaded because the new design was manufactured at risk... | Class II | Prismatik Dentalcraft, Inc |
| Aug 10, 2016 | Double Kit with SafeSet and 03mL Flush Device, Item No. 46080-37 Product... | ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... | Class II | ICU Medical, Inc. |
| Aug 10, 2016 | TP4 Kit with 10cc SafeSet Reservoir, Needleless Valve, Filter Millex and Adm... | ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... | Class II | ICU Medical, Inc. |
| Aug 10, 2016 | Single Monitoring Kit with 30mL Flush Device, Item No. 46073-38 Product ... | ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... | Class II | ICU Medical, Inc. |
| Aug 10, 2016 | Transpac IV Monitoring Kit with 2 SafeSet Reservoir and 2 Blood Sampling Port... | ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... | Class II | ICU Medical, Inc. |
| Aug 10, 2016 | Transpac IV Trifurcated Monitoring Kit with SafeSet Reservoir, Port and 03 m... | ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... | Class II | ICU Medical, Inc. |
| Aug 10, 2016 | Transpac IV Trifurcated Monitoring Kit with SafeSet Reservoir and 2 Blood Sam... | ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... | Class II | ICU Medical, Inc. |
| Aug 10, 2016 | Triple Line SafeSet Kit with 03mL Flush Device, Item No. 46076-27 Produc... | ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... | Class II | ICU Medical, Inc. |
| Aug 10, 2016 | Transpac IV Monitoring Kit with SafeSet 84" Arterial Pressure Tubing, Reservo... | ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... | Class II | ICU Medical, Inc. |
| Aug 10, 2016 | Bifurcated SafeSet Kit with 03mL Flush Device, Item No. 46091-75 Product... | ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam... | Class II | ICU 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.