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 |
|---|---|---|---|---|
| Jul 27, 2017 | iVue 500 with iScan, D216606. Product non-contact, high resolution tomogr... | FDA determined that a 510(k) is needed for the Vault Mapping software (also known as Lens Fitting). | Class II | Optovue, Inc. |
| Jul 27, 2017 | iVue with Normative Database, Device Listing Number D185549. Product Usage... | FDA determined that a 510(k) is needed for the Vault Mapping software (also known as Lens Fitting). | Class II | Optovue, Inc. |
| Jul 27, 2017 | iFusion, Device Listing Number D203271. Product Usage: The iCam is a non-... | FDA determined that a 510(k) is needed for the Vault Mapping software (also known as Lens Fitting). | Class II | Optovue, Inc. |
| Jul 21, 2017 | Implant Direct Swish Duo-Grip Healing Collar, Length: 3mm, Platform: 4.8 mm, ... | The Swish Duo-Grip Healing Collar part number 9048-13H (4.8mm) package contained a 9037-13H (3.7 ... | Class II | Implant Direct Sybron Manufacturing, LLC |
| Jul 20, 2017 | Sekisui Diagnostics Sekure Chemistry Acetaminophen L3K , Ref. 506-30. The fi... | Reagent carryover from Sekisui ACTH when utilized on the BEC AU 680 analyzer may lead to falsely ... | Class II | Beckman Coulter Inc. |
| Jul 10, 2017 | THREAD RETRIEVAL DRILL REF 2224 | Zimmer Biomet is conducting a medical device field correction for various dental products due to ... | Class II | Zimmer Dental Inc |
| Jul 10, 2017 | IMPRESSION CAP CONT 3.5MM, REF ZOCIMP3A; MPRESSION CAP CONT 3.5MM, REF ZOC... | Zimmer Biomet is conducting a medical device field correction for various dental products due to ... | Class II | Zimmer Dental Inc |
| Jul 10, 2017 | TRY-IN,ABUTMENT, CONT, 3.5X4.5, REF ZOAT34; TRY-IN, ABUTMENT, CONT, 4.5X5.... | Zimmer Biomet is conducting a medical device field correction for various dental products due to ... | Class II | Zimmer Dental Inc |
| Jul 10, 2017 | WAXING COPING, CONT 3.5 MM,ANG, REF ZOCWAX3A; WAXING COPING, CONT 3.5 MM, RE... | Zimmer Biomet is conducting a medical device field correction for various dental products due to ... | Class II | Zimmer Dental Inc |
| Jul 10, 2017 | ABUT GOLD FRICTION-FIT, REF HLA3G; ABUT GOLD FRICTION-FIT, REF HLA4G; COPI... | Zimmer Biomet is conducting a medical device field correction for various dental products due to ... | Class II | Zimmer Dental Inc |
| Jul 10, 2017 | Guide Sleeve 3.25 REF 2220, Guide Sleeve 3.75 REF 2221, Guide Sleeve REF 2222... | Zimmer Biomet is conducting a medical device field correction for various dental products due to ... | Class II | Zimmer Dental Inc |
| Jul 10, 2017 | IMPLANT,1-PC,ANG,3.0X10MM, REF ZOP30A10; IMPLANT, 1-PC, ANG, 3.0X11.5MM, R... | Zimmer Biomet is conducting a medical device field correction for various dental products due to ... | Class II | Zimmer Dental Inc |
| Jul 7, 2017 | Qualigen(R) The FastPack(R) IP Vitamin D Complete Immunoassay Kit, catalog nu... | Specific lots have been reported to produce falsely lower than expected results for Vitamin D | Class II | Qualigen Inc |
| Jul 6, 2017 | Fogarty Adherent Clot Catheter Model Numbers 1408010 and 140806 Product Us... | The diameter of the Fogarty Catheter balloon, measures 6mm instead of 10mm. | Class II | Edwards Lifesciences, LLC |
| Jun 30, 2017 | VersaSafe Plastic Cannula - 11 Gauge, Model 9391-0200 Product Usage: Used... | Punctures in blister packaging that was detected during the packaging process. | Class II | CareFusion 303, Inc. |
| Jun 27, 2017 | Tomcat Instrument, REF ASY-07379, Hologic Incorporated, automated laboratory ... | A Tomcat Instrument software anomaly that causes the pipettor arm to make physical contact with t... | Class II | Hologic, Inc |
| Jun 26, 2017 | Coulter LH 750, Coulter LH 780, and Coulter LH 500 Analyzers Hematology Anal... | Beckman Coulter has determined that additional clarification for the Blast Suspect messages is ne... | Class II | Beckman Coulter Inc. |
| Jun 26, 2017 | Stroke Fast Pack(TM) Trevo XP ProVue Retriever 6 x 25, AXS Catalyst 060x132CM... | Stryker Neurovascular has become aware that some 3-Pack Stroke Fast Packs were manufactured usin... | Class II | Stryker Neurovascular |
| Jun 26, 2017 | Alere iScreen Dx Urine Drug Screen Card, 20 Drug Detection, Kit Contents incl... | The kit box label incorrectly identifies PCP (instead of TCA) as one of the 10 drug analytes incl... | Class III | Ameditech Inc |
| Jun 26, 2017 | Stroke Fast Pack(TM) Trevo XP ProVue Retriever 3 x 20, Trevo Pro 14 Microcath... | Stryker Neurovascular has become aware that some 3-Pack Stroke Fast Packs were manufactured usin... | Class II | Stryker Neurovascular |
| Jun 26, 2017 | Stroke Fast Pack(TM) Trevo XP ProVue Retriever 4 x 30, Trevo Pro 18 Microca... | Stryker Neurovascular has become aware that some 3-Pack Stroke Fast Packs were manufactured usin... | Class II | Stryker Neurovascular |
| Jun 26, 2017 | Spectra-System/Legacy Guided Surgery Handle Kit, Device Listing Number D24588... | The inside diameter of the 2.3mm small drill guide inserts have a smaller diameter than the speci... | Class II | Implant Direct Sybron Manufacturing, LLC |
| Jun 26, 2017 | Stroke Fast Pack(TM) Trevo XP ProVue Retriever 4 x 20, Trevo Pro 18 Microca... | Stryker Neurovascular has become aware that some 3-Pack Stroke Fast Packs were manufactured usin... | Class II | Stryker Neurovascular |
| Jun 26, 2017 | Coulter HmX CP and Coulter HmX AL Analyzers The purpose of the HmX Hematolog... | Beckman Coulter has determined that additional clarification for the Blast Suspect messages is ne... | Class II | Beckman Coulter Inc. |
| Jun 23, 2017 | OptiLITE(TM) Products for Laser Surgery, Catalog Numbers: HTM1020F, HTM1040F... | It has been determined that the reprocessing instructions may not provide sufficiently detailed i... | Class II | Xintec Corp |
| Jun 23, 2017 | POLYURETHANE ENFit(R) AMERITUS NG FEEDING TUBE, WITH SIDE PORT, REF Numbers: ... | Inadequate detectability of radiopaque stripes | Class II | Kentec Medical Inc |
| Jun 23, 2017 | POLYURETHANE ENFit(R) AMERITUS NG FEEDING TUBE, REF Numbers: a) ENF-50P-40... | Inadequate detectability of radiopaque stripes | Class II | Kentec Medical Inc |
| Jun 22, 2017 | InflammaDry(R) AN RPS DIAGNOSTIC SOLUTION, Sample Collectors InflammaDry(R) ... | In-house testing revealed the presence of plastic spurs at the tips of some Sample Collectors. | Class II | Quidel Corporation |
| Jun 20, 2017 | UniCel DxH Slidemaker Stainer Coulter Cellular Analysis System, Software Vers... | The firm has identified that a fitting in some Slidemaker Stainer units may not completely seal a... | Class II | Beckman Coulter Inc. |
| Jun 14, 2017 | SMARTABLATE RF System Generator | Generator may inadvertently deliver RF energy if the foot pedal is placed in close proximity and ... | Class II | Biosense Webster, Inc. |
| Jun 12, 2017 | Alaris PC Unit, Model 8015 | BD initiated the recall of Alaris PC unit model 8015 after the firm identified five scenarios whi... | Class II | CareFusion 303, Inc. |
| Jun 12, 2017 | INVUITY(R) PhotonBlade(TM), REF PB1 | A small number of customer observations were recently received which related to possible unintend... | Class II | Invuity, Inc. |
| Jun 12, 2017 | Alaris Pump Module model 8100 | There is a potential risk that could cause unintended flow in the older, centered sear door latch... | Class II | CareFusion 303, Inc. |
| Jun 9, 2017 | Penumbra 3D Revascularization Device It is indicated for used in the revascu... | Penumbra has identified an issue in these four lots involving a raw material component of the del... | Class I | Penumbra Inc. |
| Jun 1, 2017 | da Vinci Xi Surgical System Product Usage: The da Vinci Xi Surgical Syste... | da Vinci Xi(R) Surgical System Patient Side Carts (PSC) were shipped to the field with potentiall... | Class II | Intuitive Surgical, Inc. |
| May 30, 2017 | Kit w/3 Ext Sets, 3 Drop-In MicroClave¿ Clear. Product Usage: The device is... | The connection between the Female Luer and the NanoClave¿ manifold has the potential for developi... | Class II | ICU Medical, Inc. |
| May 30, 2017 | PROXIMALE - 28 cm (11") Smallbore Ext Set w/6-Port NanoClave¿ Manifold, Check... | The connection between the Female Luer and the NanoClave¿ manifold has the potential for developi... | Class II | ICU Medical, Inc. |
| May 30, 2017 | 10" Smallbore Ext Set w/6-Port NanoClave¿ Manifold (Orange, Red, Blue, Purple... | The connection between the Female Luer and the NanoClave¿ manifold has the potential for developi... | Class II | ICU Medical, Inc. |
| May 30, 2017 | 18 cm (7") PUR Smallbore Ext Set w/6-Port NanoClave¿ Manifold, Check Valve, N... | The connection between the Female Luer and the NanoClave¿ manifold has the potential for developi... | Class II | ICU Medical, Inc. |
| May 30, 2017 | 28 cm (11") PUR Smallbore Ext Set w/6-Port NanoClave¿ Manifold, Check Valve, ... | The connection between the Female Luer and the NanoClave¿ manifold has the potential for developi... | Class II | ICU Medical, Inc. |
| May 30, 2017 | 28 cm (11") PUR Bifuse Ext Set w/6-Port NanoClave¿ Manifold, Check Valve, 2 N... | The connection between the Female Luer and the NanoClave¿ manifold has the potential for developi... | Class II | ICU Medical, Inc. |
| May 30, 2017 | 168 cm (66") Appx 2.6 ml, PVC/PUR Smallbore Ext Set w/6-Port NanoClave¿ Manif... | The connection between the Female Luer and the NanoClave¿ manifold has the potential for developi... | Class II | ICU Medical, Inc. |
| May 30, 2017 | 10" Smallbore Ext Set w/6-Port NanoClave¿ Manifold, Check Valve, Clamp, Rotat... | The connection between the Female Luer and the NanoClave¿ manifold has the potential for developi... | Class II | ICU Medical, Inc. |
| May 30, 2017 | 10" Smallbore Ext Set w/6-Port NanoClave¿ Manifold (Orange, Red, Blue, Purple... | The connection between the Female Luer and the NanoClave¿ manifold has the potential for developi... | Class II | ICU Medical, Inc. |
| May 23, 2017 | SHIMADZU Ceiling Type X-ray Tube Support CH-200/CH-200M Catalog Number: CH-20... | Cracks may occur over time on the tube holding shaft near the base of the tube mounting flange. | Class II | Shimadzu Medical Systems Usa Com |
| May 23, 2017 | SHIMADZU FDR Visionary Catalog Number: FDR Visionary Suite Stationary x-ra... | Cracks may occur over time on the tube holding shaft near the base of the tube mounting flange. | Class II | Shimadzu Medical Systems Usa Com |
| May 23, 2017 | SHIMADZU RADspeed Pro Catalog Number: RADspeed Pro; Stationary x-ray system | Cracks may occur over time on the tube holding shaft near the base of the tube mounting flange. | Class II | Shimadzu Medical Systems Usa Com |
| May 22, 2017 | Coulter PrepPlus 2, Part Number 378600, Product Usage: The COULTER PrepP... | When samples are prepared using the PrepPlus or PrepPlus 2 sample preparation systems and then ru... | Class II | Beckman Coulter Inc. |
| May 22, 2017 | Coulter PrepPlus, Part Number 286600, Product Usage: The COULTER PrepPlu... | When samples are prepared using the PrepPlus or PrepPlus 2 sample preparation systems and then ru... | Class II | Beckman Coulter Inc. |
| May 17, 2017 | PENTARAY NAV High-Density Mapping Catheter. | Contraindication language updated in the Instructions For Use (IFU) to indicate that Pentaray Cat... | Class II | Biosense Webster, 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.