Browse Device Recalls
3,010 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,010 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 3,010 FDA device recalls in 2019.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Sep 11, 2019 | Cobas c Bilirubin Total Gen.3 Catalog Number: 05795419190 - Product Usage: I... | Due to low Quality Control recovery and invalid Calibration. | Class III | Roche Diagnostics Operations, Inc. |
| Sep 11, 2019 | Roche Diagnostics cobas Integra Albumin Gen.2 Catalog Number: 05166861190 - ... | Due to low Quality Control recovery and invalid Calibration. | Class III | Roche Diagnostics Operations, Inc. |
| Sep 11, 2019 | Loop-Style Ultrasound Transducer (Nautilus), 8-foot Cord 5700LAX, that may ha... | Fetal/maternal monitor/monitoring systems serviced or remanufactured using non-OEM equivalent com... | Class II | Pacific Medical Group Inc. |
| Sep 11, 2019 | Toco M2734A, that may have been serviced with the following: Pacific Medical ... | Fetal/maternal monitor/monitoring systems serviced or remanufactured using non-OEM equivalent com... | Class II | Pacific Medical Group Inc. |
| Sep 11, 2019 | Respironics V60 Ventilator, Service # 850008, REF: 1053613, 1053614, 1053617,... | Ventilator touchscreen may become frozen and fail to respond to touch commands. If a patient requ... | Class II | Respironics California, LLC |
| Sep 11, 2019 | Button-Style Ultrasound Transducer (Nautilus), 8-foot Cord 5700HAX, that may ... | Fetal/maternal monitor/monitoring systems serviced or remanufactured using non-OEM equivalent com... | Class II | Pacific Medical Group Inc. |
| Sep 11, 2019 | Toco MP Transducer (M2734B), that may have been serviced with the following: ... | Fetal/maternal monitor/monitoring systems serviced or remanufactured using non-OEM equivalent com... | Class II | Pacific Medical Group Inc. |
| Sep 11, 2019 | Microsurgical Operating Room Tables;7300B (18-350-70); | Unintended tilting of the Tabletop MST 7300BX and incorrect operation due to infrared operating s... | Class II | Mizuho America, Inc. |
| Sep 11, 2019 | Loop-Style Tocotransducer (Nautilus) 2264LAX, that may have been serviced wit... | Fetal/maternal monitor/monitoring systems serviced or remanufactured using non-OEM equivalent com... | Class II | Pacific Medical Group Inc. |
| Sep 11, 2019 | Microsurgical Operating Room Tables;7300BX (18-351-70). | Unintended tilting of the Tabletop MST 7300BX and incorrect operation due to infrared operating s... | Class II | Mizuho America, Inc. |
| Sep 11, 2019 | Ultrasound Transducer (M1356A), that may have been serviced with the followin... | Fetal/maternal monitor/monitoring systems serviced or remanufactured using non-OEM equivalent com... | Class II | Pacific Medical Group Inc. |
| Sep 10, 2019 | A&E Medical Thorecon Plating System Kits Model No. 94-1300-04-S. For fractur... | Some Thorecon disposable tensioners supplied in different Plating System Kits exhibit a molding d... | Class II | Alto Development Corp |
| Sep 10, 2019 | Canister HFC-134a /980g, ALUM, 15 pack Product Number: 1600-00-0224 Revisio... | The canister neck bushing may become loose and separate from the body of the canister during use.... | Class II | Candela Corporation |
| Sep 10, 2019 | A&E Medical Thorecon Plating System Kits Model No. 94-1500-04-S. For fractur... | Some Thorecon disposable tensioners supplied in different Plating System Kits exhibit a molding d... | Class II | Alto Development Corp |
| Sep 10, 2019 | A&E Medical Thorecon Plating System Kits Model No. 94-1200-08. For fracture ... | Some Thorecon disposable tensioners supplied in different Plating System Kits exhibit a molding d... | Class II | Alto Development Corp |
| Sep 10, 2019 | Ergo 3.2mm K-wire - Product Usage: The devices is used assist the surgeon in ... | Potential for the wire to fracture at the threads and remain in the glenoid. | Class II | Exactech, Inc. |
| Sep 10, 2019 | Canister HFC-134a / 980g, ALUM Product Number: 1600-00-0223 Revision .0C ... | The canister neck bushing may become loose and separate from the body of the canister during use.... | Class II | Candela Corporation |
| Sep 10, 2019 | NovaPACS Diagnostic Viewer. NovaPACS is a picture archiving and communication... | The firm received a report of an atypical dataset being generated. When using the cross-localizat... | Class II | Novarad Corporation |
| Sep 10, 2019 | VITROS chemistry Products Cl- Slides, Catalog No. 6844471 (which supports Uri... | Users may experience intermittent slide dispense issues with some cartridges due to the anti-back... | Class II | Ortho-Clinical Diagnostics |
| Sep 10, 2019 | Philips HeartStart FRx AED, Model 861304, FRx codeRev: E.02.017 | Affected devices contain a Printed Circuit Assembly (PCA) that was not manufactured/repaired in a... | Class II | Philips North America LLC |
| Sep 10, 2019 | Rosa Brain 3.0, Model No. ROSA 3.0. The device is delivered assembled in a wo... | The instrument holder may be sent on a trajectory that is not within the intended target. If it i... | Class I | MEDTECH SAS |
| Sep 10, 2019 | A&E Medical Thorecon Plating System Kits Model No. 94-1700-10. For fracture ... | Some Thorecon disposable tensioners supplied in different Plating System Kits exhibit a molding d... | Class II | Alto Development Corp |
| Sep 10, 2019 | Philips HeartStart HS1 Onsite (Model M5066A) and HSI Home (Model M5068A) AED,... | Affected devices contain a Printed Circuit Assembly (PCA) that was not manufactured/repaired in a... | Class II | Philips North America LLC |
| Sep 10, 2019 | VITROS chemistry Products K+ Slides, Catalog No. 8157596. MicroSlides which c... | Users may experience intermittent slide dispense issues with some cartridges due to the anti-back... | Class II | Ortho-Clinical Diagnostics |
| Sep 10, 2019 | Canister HFC-134a /1000g, ALUM, 15 pack Product Number: 1600-00-0219 Revisi... | The canister neck bushing may become loose and separate from the body of the canister during use.... | Class II | Candela Corporation |
| Sep 10, 2019 | VITROS chemistry Products Cl- Slides, Catalog No. 8445207 (which does NOT sup... | Users may experience intermittent slide dispense issues with some cartridges due to the anti-back... | Class II | Ortho-Clinical Diagnostics |
| Sep 10, 2019 | A&E Medical Thorecon Plating System Kits Model No. 94-1400-04. For fracture ... | Some Thorecon disposable tensioners supplied in different Plating System Kits exhibit a molding d... | Class II | Alto Development Corp |
| Sep 10, 2019 | Canister HFC-134a /1000g, ALUM Product Number: 1600-00-0218 Revision .0C ... | The canister neck bushing may become loose and separate from the body of the canister during use.... | Class II | Candela Corporation |
| Sep 6, 2019 | Convex Two-Piece Ostomy System (Skin Barrier) marketed under the following br... | ConvaTec has received complaints associated with use of convex two-piece skin barriers where the ... | Class II | ConvaTec, Inc |
| Sep 6, 2019 | MEDLINE ELECTRIC SURGICAL CLIPPER AND BASE, REF DYND70800 Product Usage: ... | The recall is being conducted due to a potential defective component on the circuit board causing... | Class II | Medline Industries Inc |
| Sep 5, 2019 | Lemon Prep: MD0019T - 4 oz tubes MD0019--SUP - Single Use Cups Skin prep... | Product has the potential to be contaminated with Burholderia cepacia. | Class II | Carroll-Baccari, Inc. |
| Sep 5, 2019 | MODIFIED INSTRUMENTS: Trial Spacer 7mm with T-Handle Trial Spacer 8mm with ... | Modified outside of approved manufacturing process | Class II | Synthes (USA) Products LLC |
| Sep 5, 2019 | Pedia Prep: MD0033T - 4 oz tubes MD0033--SUP - Single Use Cups Skin pr... | Product has the potential to be contaminated with Burholderia cepacia. | Class II | Carroll-Baccari, Inc. |
| Sep 5, 2019 | Embryology Heated Plate within the RI Witness, Model Numbers 6-70-807, 6-70-8... | The touchpad may not work properly after cleaning. | Class III | CooperSurgical, Inc. |
| Sep 4, 2019 | Opiate 300 Ng Reagent (OP 1 X 250) for use in conjunction with UniCel DxC 600... | Cross-reactivity testing may not meet the claims indicated in the Opiate 300 ng (OP)Instructions ... | Class II | Beckman Coulter Inc. |
| Sep 4, 2019 | MicroScan WalkAway-96 plus Instrument | Instruments were manufactured with a shortened 30mL reagent draw straw which may result in reagen... | Class II | Beckman Coulter Inc. |
| Sep 4, 2019 | lmpella CP with Smart Assist, Model Number: 0048-0003. Left heart support b... | This one pump shipped with incorrect pump programming, the initial production working version of ... | Class II | Abiomed, Inc. |
| Sep 4, 2019 | MicroScan WalkAway-96 plus Reconditioned Instrument | Instruments were manufactured with a shortened 30mL reagent draw straw which may result in reagen... | Class II | Beckman Coulter Inc. |
| Sep 4, 2019 | Synchron Systems Opiate 2000 ng Reagent (OP2 1 x 250); catalogue no. 475006 f... | Cross-reactivity testing may not meet the claims indicated in the Opiate 2000 ng (OP2) Instructio... | Class II | Beckman Coulter Inc. |
| Sep 4, 2019 | Monaco RTP System, 5.40 Unity, radiation treatment planning system Product... | It is possible that the forced electron density settings will be changed for some structures unin... | Class II | Elekta Inc |
| Sep 4, 2019 | Monaco RTP System, 5.50/5.51, radiation treatment planning system Product ... | It is possible that the forced electron density settings will be changed for some structures unin... | Class II | Elekta Inc |
| Sep 4, 2019 | MicroScan WalkAway-40 plus Reconditioned Instrument | Instruments were manufactured with a shortened 30mL reagent draw straw which may result in reagen... | Class II | Beckman Coulter Inc. |
| Sep 4, 2019 | MicroScan WalkAway-40 plus Instrument | Instruments were manufactured with a shortened 30mL reagent draw straw which may result in reagen... | Class II | Beckman Coulter Inc. |
| Sep 3, 2019 | Euphoria Rapid Exchange Balloon Dilatation Catheter, Product Numbers: EUP150... | Medtronic has determined that some catheters have a slightly higher diameter stylette causing rem... | Class II | Medtronic Vascular Galway DBA Medtronic Ireland |
| Sep 3, 2019 | Achilles Insight Bone Sonometer | Certain Achilles Express and Achilles Insight systems were shipped with European CEE-7/7 Type Pow... | Class II | GE Healthcare, LLC |
| Sep 3, 2019 | Achilles Express Bone Sonometer | Certain Achilles Express and Achilles Insight systems were shipped with European CEE-7/7 Type Pow... | Class II | GE Healthcare, LLC |
| Sep 3, 2019 | Solarice Rapid Exchange Balloon Dilatation Catheter, Product Numbers: SLC150... | Medtronic has determined that some catheters have a slightly higher diameter stylette causing rem... | Class II | Medtronic Vascular Galway DBA Medtronic Ireland |
| Aug 30, 2019 | Transducer S7-3t UDI (01)00884838067530 REF 989605439232 Used as accesso... | The firm has discovered an issue associated with some Transesophageal (TEE) transducers that were... | Class II | Philips Ultrasound Inc |
| Aug 30, 2019 | ApexPro Telemetry Server System. Also identified as Modification To: ApexPro... | May not provide visual and/or audible alarms at the CARESCAPE Central Station or Clinical Informa... | Class II | GE Healthcare, LLC |
| Aug 30, 2019 | SPROTTE Lumbar with Introducer, labeled as the following: 1. Sprotte 22G... | Problem with packaging sealing process which affects sterility. | Class II | Pajunk GmbH |
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.