Browse Device Recalls
49 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 49 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 49 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Apr 6, 2020 | SKAFFOLD RENU FLOW, 5CC. Product Number: SKMA-FL05, UDI: 813845020849 - Prod... | Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life dur... | Class II | Skeletal Kinetics, Llc |
| Apr 6, 2020 | EXACTECH OSSILIX FORM (MX), 5CC. Product Number: 660-01-05, UDI: 81384502102... | Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life dur... | Class II | Skeletal Kinetics, Llc |
| Apr 6, 2020 | EXACTECH OSSILIX FORM (MX), 10CC. Product Number: 660-01-10, UDI: 8138450210... | Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life dur... | Class II | Skeletal Kinetics, Llc |
| Apr 6, 2020 | OSTEOVATION EX, 3CC, IMPACT FORMULA. Product Number: 390-0203, UDI: 81384502... | Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life dur... | Class II | Skeletal Kinetics, Llc |
| Apr 6, 2020 | ACUMED IMPACT 5CC. Product Number: 65-0105-S, UDI: 813845020252 - Product Us... | Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life dur... | Class II | Skeletal Kinetics, Llc |
| Apr 6, 2020 | ACUMED IMPACT 10CC. Product Number: 65-0110-S, UDI: 813845020269 - Callos is... | Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life dur... | Class II | Skeletal Kinetics, Llc |
| Apr 6, 2020 | OSTEOVATION, 5CC, INJECT FORMULA. Product Number: 390-2005, UDI: 81384502005... | Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life dur... | Class II | Skeletal Kinetics, Llc |
| Apr 6, 2020 | SK SKAFFOLD IMPRESS 10CC. Product Number: SKAF-IM10, UDI: 813845020795 - Pro... | Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life dur... | Class II | Skeletal Kinetics, Llc |
| Apr 6, 2020 | SKAFFOLD RENU FLOW, 10CC. Product Number: SKMA-FL10, UDI: 813845020856 - Pro... | Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life dur... | Class II | Skeletal Kinetics, Llc |
| Apr 6, 2020 | OSTEOVATION, 3CC, IMPACT FORMULA. Product Number: 390-2103, UDI: 81384502007... | Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life dur... | Class II | Skeletal Kinetics, Llc |
| Apr 6, 2020 | CRANIOSCULPT FLOW, 10CC. Product Number: C-FLOW10CC, UDI: 813845020368 - - P... | Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life dur... | Class II | Skeletal Kinetics, Llc |
| Apr 6, 2020 | OSTEOVATIONEX, INJECT 3CC. Product Number: 390-0003, UDI: 813845020016 - Pro... | Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life dur... | Class II | Skeletal Kinetics, Llc |
| Apr 6, 2020 | CRANIOSCULPT, FLOW 5CC. Product Number: C-FLOW5CC, UDI: 813845020337 - Produ... | Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life dur... | Class II | Skeletal Kinetics, Llc |
| Apr 6, 2020 | CRANIOSCULPT, CMF IMPACT, 5CC, Product Number: C-CMF5CC, UDI: 813845020948 -... | Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life dur... | Class II | Skeletal Kinetics, Llc |
| Apr 6, 2020 | MEDTRONIC BONE VOID FILLER, SMALL. Product Number: C07A, UDI: 813845020504 -... | Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life dur... | Class II | Skeletal Kinetics, Llc |
| Apr 6, 2020 | CRANIOSCULPT FLOW, OUS, 5CC Product Number: C-FLOW5CC-OUS, UDI: 813845020351... | Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life dur... | Class II | Skeletal Kinetics, Llc |
| Apr 6, 2020 | CRANIOSCULPT C, 10CC. Product Number: C-C10CC, UDI: 813845021129 - Product U... | Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life dur... | Class II | Skeletal Kinetics, Llc |
| Apr 6, 2020 | CRANIOSCULPT C, 3CC. Product Number: C-C3CC, UDI: 813845021105 - Product Usa... | Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life dur... | Class II | Skeletal Kinetics, Llc |
| Apr 6, 2020 | OSTEOVATIONEX 2CC INJECT FORMULA. Product Number: 390-0002, UDI: 81384502000... | Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life dur... | Class II | Skeletal Kinetics, Llc |
| Apr 6, 2020 | CRANIOSCULPT C, 5CC. Product Number: C-C5CC, UDI: 813845021112 - - Product U... | Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life dur... | Class II | Skeletal Kinetics, Llc |
| Apr 6, 2020 | OSTEOVATION, 10CC, INJECT FORMULA. Product Number: 390-2010, UDI: 8138450200... | Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life dur... | Class II | Skeletal Kinetics, Llc |
| Apr 6, 2020 | SKAFFOLD FLOW, 3CC and SKAFFOLD FLOW (MX) 3CC. Product Number: SKMX-FL03, UD... | Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life dur... | Class II | Skeletal Kinetics, Llc |
| Apr 6, 2020 | SKAFFOLD CMF IMPRESS (MP), 5CC. Product Number: CMMP-IM05, UDI: 813845020689... | Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life dur... | Class II | Skeletal Kinetics, Llc |
| Apr 6, 2020 | ACUMED CALLOS INJECT 3CC. Product Number: 65-0003-S, UDI: 813845020221 - Pr... | Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life dur... | Class II | Skeletal Kinetics, Llc |
| Apr 6, 2020 | ACUMED CALLOS INJECT 10CC. Product Number: 65-0010-S, UDI: 813845020245 - Pr... | Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life dur... | Class II | Skeletal Kinetics, Llc |
| Apr 6, 2020 | OSTEOVATION RMX 5CC. Product Number: 390-6001, UDI: 813845021082 - Product U... | Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life dur... | Class II | Skeletal Kinetics, Llc |
| Apr 6, 2020 | OSTEOVATION IMPACT 10CC and OSTEOVATION, 10CC, IMPACT FORMULA, Product Number... | Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life dur... | Class II | Skeletal Kinetics, Llc |
| Apr 6, 2020 | CRANIOSCULPT FLOW, CAN, 10CC, Product Number: C-FLOW10CC-CAN, UDI: 813845020... | Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life dur... | Class II | Skeletal Kinetics, Llc |
| Apr 6, 2020 | SKAFFOLD FLOW (MX) 5CC. Product Number: SKMX-FL05, UDI: 813845020894 - Produ... | Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life dur... | Class II | Skeletal Kinetics, Llc |
| Apr 6, 2020 | CRANIOSCULPT FLOW, 3CC. Product Number: C-FLOW3CC, UDI: 813845020320 - - Pro... | Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life dur... | Class II | Skeletal Kinetics, Llc |
| Apr 6, 2020 | CRANIOSCULPT, CMF IMPACT, 10CC, Product Number: C-CMF10CC, UDI: 813845020955... | Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life dur... | Class II | Skeletal Kinetics, Llc |
| Apr 6, 2020 | SKAFFOLD FLOW, 10CC. Product Number: SKMX-FL10, UDI: 813845020900 - Product ... | Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life dur... | Class II | Skeletal Kinetics, Llc |
| Apr 6, 2020 | CRANIOSCULPT, CMF IMPACT, 3CC Product Number: C-CMF3CC, UDI: 813845020931 - ... | Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life dur... | Class II | Skeletal Kinetics, Llc |
| Apr 6, 2020 | EXACTECH OSSILIX FIL (MX), 5CC. Product Number: 660-02-05, UDI: 813845021006... | Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life dur... | Class II | Skeletal Kinetics, Llc |
| Apr 6, 2020 | ACUMED CALLOS INJECT 5CC. Product Number: 65-0005-S, UDI: 813845020238 - Pro... | Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life dur... | Class II | Skeletal Kinetics, Llc |
| Apr 6, 2020 | EXACTECH OSSILIX FIL (MX), 10CC. Product Number: 660-02-10, UDI: 81384502101... | Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life dur... | Class II | Skeletal Kinetics, Llc |
| Apr 6, 2020 | MEDTRONIC BONE VOID FILLER, LARGE. Product Number: C07B, UDI: 813845020511 -... | Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life dur... | Class II | Skeletal Kinetics, Llc |
| Apr 6, 2020 | SKAFFOLD CMF IMPRESS (MP), 10CC. Product Number: CMMP-IM10, UDI: 81384502069... | Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life dur... | Class II | Skeletal Kinetics, Llc |
| Apr 6, 2020 | OSTEOVATION RMX 10CC. Product Number: 390-6002, UDI: 813845021099 - Product ... | Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life dur... | Class II | Skeletal Kinetics, Llc |
| Apr 6, 2020 | OSTEOVATION, 5CC, IMPACT FORMULA. Product Number: 390-2105, UDI: 81384502008... | Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life dur... | Class II | Skeletal Kinetics, Llc |
| Apr 6, 2020 | OSTEOVATIONEX 5CC, INJECT FORMULA. Product Number: 390-0005, UDI: 8138450200... | Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life dur... | Class II | Skeletal Kinetics, Llc |
| Apr 6, 2020 | CRANIOSCULPT FLOW, CAN, 5CC. Product Number: C-FLOW5CC-CAN, UDI: 81384502034... | Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life dur... | Class II | Skeletal Kinetics, Llc |
| Apr 6, 2020 | CRANIOSCULPT FLOW, OUS, 10CC. Product Number: C-FLOW10CC-OUS, UDI: 813845020... | Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life dur... | Class II | Skeletal Kinetics, Llc |
| Apr 6, 2020 | EXACTECH OSSILIX MP FIL, 10CC. Product Number: 662-02-10, UDI: 813845021051 ... | Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life dur... | Class II | Skeletal Kinetics, Llc |
| Apr 6, 2020 | OSTEOVATION EX, 5CC, IMPACT FORMULA. Product Number: 390-0205, UDI: 81384502... | Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life dur... | Class II | Skeletal Kinetics, Llc |
| Apr 3, 2020 | Cranio/Sculpt C, 10cc, Bone Void Filler, UDI: 00813845021129 - Product Usage:... | Potential product mix-up. The recalling firm has determined that one unit of OsteoVation EX, 3cc ... | Class II | Skeletal Kinetics, Llc |
| Jun 6, 2019 | OsteoVation, Inject, Bone Filler Kits 10cc (part number 390-2010, manufacturi... | A discrepancy was found between the Mixing Instruction Card and the Instructions for Use for the... | Class II | Skeletal Kinetics, Llc |
| Jun 6, 2019 | OsteoVation, Inject Bone Filler Kits, 5cc (part number 390-2005, manufacturin... | A discrepancy was found between the Mixing Instruction Card and the Instructions for Use for the... | Class II | Skeletal Kinetics, Llc |
| May 29, 2015 | InjectionPlasty 1.0 Bone Void Filler; an injectable and biocompatible calciu... | Reports of venous uptake, DVT, pulmonary embolism in patients who were implanted with Injection P... | Class II | Skeletal Kinetics, 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.