Browse Device Recalls
4,686 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 4,686 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 4,686 FDA device recalls in CA.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Mar 9, 2015 | NobelReplace CC RP 5.0x13mm, Article No. 36713. | A material used in the packaging of the dental implants may impart a sticky substance on the top ... | Class II | Nobel Biocare Usa Llc |
| Mar 9, 2015 | Replace Select Tapered TiU WP 5.0x13mm, Article No. 29424. Nobel Biocare's D... | A material used in the packaging of the dental implants may impart a sticky substance on the top ... | Class II | Nobel Biocare Usa Llc |
| Mar 9, 2015 | Replace Select Tapered TiU NP 3.5x16mm, Article No. 29403. Nobel Biocare's D... | A material used in the packaging of the dental implants may impart a sticky substance on the top ... | Class II | Nobel Biocare Usa Llc |
| Mar 9, 2015 | NobRpl Tapered Groovy 6.0mm 6x11.5mm, Article No. 36103. Nobel Biocare's Den... | A material used in the packaging of the dental implants may impart a sticky substance on the top ... | Class II | Nobel Biocare Usa Llc |
| Mar 9, 2015 | Replace Select Tapered TiU WP 5.0x10mm, Article No. 29423. Nobel Biocare's D... | A material used in the packaging of the dental implants may impart a sticky substance on the top ... | Class II | Nobel Biocare Usa Llc |
| Mar 9, 2015 | NobelReplace CC PMC NP 3.5x11.5mm, Article No. 37287. | A material used in the packaging of the dental implants may impart a sticky substance on the top ... | Class II | Nobel Biocare Usa Llc |
| Mar 9, 2015 | Replace Select Tapered TiU NP 3.5x13mm, Article No. 29402. Nobel Biocare's D... | A material used in the packaging of the dental implants may impart a sticky substance on the top ... | Class II | Nobel Biocare Usa Llc |
| Mar 9, 2015 | NobelReplace CC RP 4.3x11.5mm, Article No. 36707. | A material used in the packaging of the dental implants may impart a sticky substance on the top ... | Class II | Nobel Biocare Usa Llc |
| Mar 9, 2015 | NobelReplace CC RP 5.0x10mm, Article No. 36711. | A material used in the packaging of the dental implants may impart a sticky substance on the top ... | Class II | Nobel Biocare Usa Llc |
| Mar 9, 2015 | NOBELREPLACE Tapered Groovy 6.0 6x8mm, Article No. 32223. Nobel Biocare's De... | A material used in the packaging of the dental implants may impart a sticky substance on the top ... | Class II | Nobel Biocare Usa Llc |
| Mar 9, 2015 | NobelReplace CC RP 4.3x10mm, Article No. 36705. | A material used in the packaging of the dental implants may impart a sticky substance on the top ... | Class II | Nobel Biocare Usa Llc |
| Mar 9, 2015 | NobelReplace CC PMC RP 5.0x10mm, Article No. 37296. | A material used in the packaging of the dental implants may impart a sticky substance on the top ... | Class II | Nobel Biocare Usa Llc |
| Mar 9, 2015 | Replace Select Tapered TiU NP 3.5x11.5mm, Article No. 36105. Nobel Biocare's... | A material used in the packaging of the dental implants may impart a sticky substance on the top ... | Class II | Nobel Biocare Usa Llc |
| Mar 9, 2015 | NobelReplace CC NP 3.5x11.5mm, Article No. 36701. | A material used in the packaging of the dental implants may impart a sticky substance on the top ... | Class II | Nobel Biocare Usa Llc |
| Mar 9, 2015 | NobelReplace CC NP 3.5x13mm, Article No. 36702. | A material used in the packaging of the dental implants may impart a sticky substance on the top ... | Class II | Nobel Biocare Usa Llc |
| Mar 9, 2015 | NobelReplace CC RP 4.3x8mm, Article No. 36704. | A material used in the packaging of the dental implants may impart a sticky substance on the top ... | Class II | Nobel Biocare Usa Llc |
| Mar 9, 2015 | NobelReplace CC PMC RP 4.3x8mm, Article No. 37290. | A material used in the packaging of the dental implants may impart a sticky substance on the top ... | Class II | Nobel Biocare Usa Llc |
| Mar 9, 2015 | NOBELREPLACE Tapered Groovy RP 4.3x10mm, Article No. 32216. Nobel Biocare's ... | A material used in the packaging of the dental implants may impart a sticky substance on the top ... | Class II | Nobel Biocare Usa Llc |
| Mar 9, 2015 | NobelReplace CC PMC NP 3.5x13mm, Article No. 37288. | A material used in the packaging of the dental implants may impart a sticky substance on the top ... | Class II | Nobel Biocare Usa Llc |
| Mar 9, 2015 | NobelReplace CC NP 3.5x10mm, Article No. 36700. | A material used in the packaging of the dental implants may impart a sticky substance on the top ... | Class II | Nobel Biocare Usa Llc |
| Mar 9, 2015 | Replace Select Tapered TiU RP 4.3x11.5mm, Article No. 36107. | A material used in the packaging of the dental implants may impart a sticky substance on the top ... | Class II | Nobel Biocare Usa Llc |
| Mar 9, 2015 | NobelReplace CC PMC RP 5.0x13mm, Article No. 37298. | A material used in the packaging of the dental implants may impart a sticky substance on the top ... | Class II | Nobel Biocare Usa Llc |
| Mar 6, 2015 | YC-1800 OPHTHALMIC YAG LASER SYSTEM; The YC-1800 allows the safe and blood... | Dear Doctor letter and Quick Reference Guide is being sent to users of the YC-1800 to reiterate i... | Class II | Nidek Inc |
| Mar 6, 2015 | BD FACSCalibur; Catalog Numbers 342973, 342975, 34976 In vitro Diagnostic... | The circuit breakers on some BD FACSCalibur instruments may have the incorrect rated amperage (20... | Class II | BD Biosciences, Systems & Reagents |
| Mar 4, 2015 | Hardy Diagnostics cat no. G327 HardyCHROM SS Agar (HardyCHROM Salmonella Shi... | The firm is recalling HardyCHROM SS, Cat. no. G327 Lot no. 15037 due to a report of possible lack... | Class II | Hardy Diagnostics |
| Mar 3, 2015 | da Vinci Xi Surgical System, IS4000; ASSY,USM,IS4000, Material number: 3806... | Correction due to a fault that causes distal SUJ (DSUJ) failures that indicates a mismatch betwee... | Class II | Intuitive Surgical, Inc. |
| Mar 3, 2015 | da Vinci Xi Surgical System, IS4000; Assy, Distal SUJ, Inner, IS4000 Materi... | Correction due to a fault that causes distal SUJ (DSUJ) failures that indicates a mismatch betwee... | Class II | Intuitive Surgical, Inc. |
| Mar 3, 2015 | da Vinci Xi Surgical System, IS4000; ASSY,DISTAL SUJ,OUTER,IS4000, Material... | Correction due to a fault that causes distal SUJ (DSUJ) failures that indicates a mismatch betwee... | Class II | Intuitive Surgical, Inc. |
| Feb 25, 2015 | LASSO NAV Duo Loop eco Catheters, Catalog No. D-1354-01, D-1354-02, D-1354-03... | Biosense Webster is recalling the LASSO NAV Duo Loop eco Catheters because of reports of difficul... | Class II | Biosense Webster, Inc. |
| Feb 20, 2015 | Catalys Precision Laser System-Catalys - U - US product; Catalys-1 - Internat... | Software anomaly on OptiMedica CATALYS System version 3.00.05 that may result in incorrect parame... | Class II | Optimedica Corporation |
| Feb 20, 2015 | OptiMedica Catalys Precision Laser System; Model No(s). Catalys-U (US), and C... | Device may experience loss of suction during treatment resulting in scoring the cornea during len... | Class II | Abbott Medical Optics, Inc. |
| Feb 16, 2015 | Vacuum Source Tubing Set for the EndoWrist Stabilizer for da Vinci S (IS2000)... | There is the possibility that the Vacuum Source Tubing set for the Endo Wrist Stabilizer may have... | Class II | Intuitive Surgical, Inc. |
| Feb 13, 2015 | Intraocular Lens (IOL), Part No. EC-3 PAL, Diopter: 17.5, 18.0, 18.5, 19.0, 1... | Aaren Scientific is recalling intraocular lenses because the instructions for use (IFU) are not f... | Class II | Aaren Scientific, Incorporated |
| Feb 13, 2015 | - NTL-30 30ml Nutrio Enteral Feeding Syringe (sterile) - NTL-60 60ml Nutrio ... | The firm is recalling sterile enteral feeding syringes due to determining that the sterility of t... | Class II | Medela Inc. EF Division |
| Feb 12, 2015 | Autostainer Link 48 (AS480), Autostainer Plus Link Instrument (AS100), Autost... | A false negative result affecting the diagnosis may occur. A defect in the syringe assembly stopc... | Class II | Dako North America Inc. |
| Feb 11, 2015 | Medical Device Exchange X-SAW BLADE; Pouch, Tyvek/Mylar, Sterile, Single Us... | EXP did not register as a medical device establishment, list the devices being recalled, or esta... | Class II | EXP Pharmaceutical Services Corp |
| Feb 11, 2015 | Medical Device Exchange PhysioMesh Flexible Composite Mesh 10cm x 15cm; Pou... | EXP did not register as a medical device establishment, list the devices being recalled, or estab... | Class II | EXP Pharmaceutical Services Corp |
| Feb 11, 2015 | Medical Device Exchange FEMORAL CANAL TIP; Pouch, Tyvek/Mylar, Sterile, Sin... | EXP did not register as a medical device establishment, list the devices being recalled, or esta... | Class II | EXP Pharmaceutical Services Corp |
| Feb 11, 2015 | Medical Device Exchange - GIA Auto Suture Loading Unit w/ DST Series Techno... | EXP did not register as a medical device establishment, list the devices being recalled, or esta... | Class II | EXP Pharmaceutical Services Corp |
| Feb 11, 2015 | Medical Device Exchange BAG, SPECIMEN RETRIEVER ENDO; Pouch, Tyvek/Mylar, S... | EXP did not register as a medical device establishment, list the devices being recalled, or esta... | Class II | EXP Pharmaceutical Services Corp |
| Feb 11, 2015 | Medical Device Exchange -APPLIER, MULTICLIP ROTATING; Pouch, Tyvek/Mylar, S... | EXP did not register as a medical device establishment, list the devices being recalled, or esta... | Class II | EXP Pharmaceutical Services Corp |
| Feb 11, 2015 | Medical Device Exchange - Dilating Tip Trocar w/Stability Sleeve 11mm; Pouc... | EXP did not register as a medical device establishment, list the devices being recalled, or esta... | Class II | EXP Pharmaceutical Services Corp |
| Feb 11, 2015 | Medical Device Exchange Surgical Gown - Flyte Hood Pouch, Tyvek/Mylar, Steri... | EXP did not register as a medical device establishment, list the devices being recalled, or esta... | Class II | EXP Pharmaceutical Services Corp |
| Feb 11, 2015 | Medical Device Exchange Aerosizer Stent Sizing Device; Pouch, Tyvek/Mylar, ... | EXP did not register as a medical device establishment, list the devices being recalled, or estab... | Class II | EXP Pharmaceutical Services Corp |
| Feb 11, 2015 | Medical Device Exchange - Silicone Round Drain; Pouch, Tyvek/Mylar, Sterile... | EXP did not register as a medical device establishment, list the devices being recalled, or esta... | Class II | EXP Pharmaceutical Services Corp |
| Feb 11, 2015 | Medical Device Exchange - Versaport Bladeless Trocar w/ Fixation Cannula 5m... | EXP did not register as a medical device establishment, list the devices being recalled, or esta... | Class II | EXP Pharmaceutical Services Corp |
| Feb 11, 2015 | Medical Device Exchange - KII FIOS FIRST ENTRY 5X100MM; Pouch, Tyvek/Mylar,... | EXP did not register as a medical device establishment, list the devices being recalled, or esta... | Class II | EXP Pharmaceutical Services Corp |
| Feb 11, 2015 | Medical Device Exchange - Loading Unit w/ DST Series Technology 60mm - 3.5m... | EXP did not register as a medical device establishment, list the devices being recalled, or esta... | Class II | EXP Pharmaceutical Services Corp |
| Feb 11, 2015 | Medical Device Exchange - GelPort Laparoscopic System; Pouch, Tyvek/Mylar, ... | EXP did not register as a medical device establishment, list the devices being recalled, or esta... | Class II | EXP Pharmaceutical Services Corp |
| Feb 11, 2015 | Medical Device Exchange 6.0mm Round Fluted Bur Soft Touch; Pouch, Tyvek/Myl... | EXP did not register as a medical device establishment, list the devices being recalled, or estab... | Class II | EXP Pharmaceutical Services Corp |
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.