Browse Device Recalls
3,264 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,264 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 3,264 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Mar 26, 2015 | 1/4 in. Trocar with Single Drain Curved Trocar with Wound Drain/Double Tro... | Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a pot... | Class II | Stryker Instruments Div. of Stryker Corporation |
| Mar 26, 2015 | 3/16 in. Trocar with Single Drain Curved Trocar with Wound Drain/Double Tr... | Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a pot... | Class II | Stryker Instruments Div. of Stryker Corporation |
| Mar 26, 2015 | 3/16 in. Round Drain with Trocar Curved Trocar with Wound Drain/Double Tro... | Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a pot... | Class II | Stryker Instruments Div. of Stryker Corporation |
| Mar 26, 2015 | 1/8 in. Double Trocar with Wound Drain Curved Trocar with Wound Drain/Doub... | Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a pot... | Class II | Stryker Instruments Div. of Stryker Corporation |
| Mar 26, 2015 | 3/16 in. Double Trocar with Wound Drain Curved Trocar with Wound Drain/Dou... | Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a pot... | Class II | Stryker Instruments Div. of Stryker Corporation |
| Mar 23, 2015 | Covidien Trellis 6 and Trellis 8 Peripheral Infusion Systems, Sterile EO, Rx ... | Medtronic is conducting a voluntary recall of all former Covidien Trellis 6 and Trellis 8 Periphe... | Class II | Medtronic Inc. Cardiac Rhythm Disease Management |
| Mar 13, 2015 | CareFusion Vital Signs LightWand Stylet. A device inserted into an endotra... | Vital Signs Colorado (dba CareFusion) is recalling Vital Signs LightWand Stylet catalog numbers 3... | Class II | Vital Signs Colorado Inc. |
| Mar 13, 2015 | Introduction Pack. A device inserted into an endotracheal tube to aid in the... | Vital Signs Colorado (dba CareFusion) is recalling Vital Signs LightWand Stylet catalog numbers 3... | Class II | Vital Signs Colorado Inc. |
| Mar 10, 2015 | LASER RESISTANT WAND - STERILE, 7/8" X 8" (2.22cm x 20.32cm), REF 24013, QT... | This recall is being conducted because a cohesive band used to package the devices contains latex... | Class II | Microtek Medical Inc |
| Mar 10, 2015 | VACUUM TUBING 7/8" X 6' (2.22cm X 182.88cm), WITH TUBING EXTENDER, STERILE, R... | This recall is being conducted because a cohesive band used to package the devices contains latex... | Class II | Microtek Medical Inc |
| Mar 10, 2015 | LAPAROSCOPIC TUBING SET, 3/16" ¿ X 10' (48cm x 304.8cm) WITH MALE LUER LOCK -... | This recall is being conducted because a cohesive band used to package the devices contains latex... | Class II | Microtek Medical Inc |
| Mar 10, 2015 | TUBING 7/8' X 10', W/WAND & TIP, 24/CS, REF 24187, QTY 24\CS, STERILE EO I... | This recall is being conducted because a cohesive band used to package the devices contains latex... | Class II | Microtek Medical Inc |
| Mar 10, 2015 | TUBING SET 7/8" X 6' WITH 1/4" x 24" TUBING, REF 24136, QTY 3/CS, NON STERILE... | This recall is being conducted because a cohesive band used to package the devices contains latex... | Class II | Microtek Medical Inc |
| Mar 10, 2015 | FREEDOMAIRE(R) MOTOR MODULE, REF 11112STK, QTY 1/CS, NON STERILE, NO LATEX ... | This recall is being conducted because a cohesive band used to package the devices contains latex... | Class II | Microtek Medical Inc |
| Mar 10, 2015 | Smoke Evacuation Tubing Set for Coherent CPG Handpiece, 7/8" x 16' (2.22 cm ... | This recall is being conducted because a cohesive band used to package the devices contains latex... | Class II | Microtek Medical Inc |
| Mar 10, 2015 | FREEDOMAIRE(R) HELMET WITH MOTOR MODULE, REF 11113STK, QTY 1/CS, NON STERILE,... | This recall is being conducted because a cohesive band used to package the devices contains latex... | Class II | Microtek Medical Inc |
| Mar 10, 2015 | FREEDOMAIRE(R) HELMET SYSTEM WITH BELT, REF 11114STK, QTY 1/CS, NON STERILE, ... | This recall is being conducted because a cohesive band used to package the devices contains latex... | Class II | Microtek Medical Inc |
| Mar 10, 2015 | FREEDOMAIRE(R) HELMET SYSTEM WITH SUPER POWER PAK BATTERY, LUMBAR BELT AND MO... | This recall is being conducted because a cohesive band used to package the devices contains latex... | Class II | Microtek Medical Inc |
| Mar 10, 2015 | (S) TUBE SET 1/4" X 10' (0.64 cm X 304.8 cm) with 7/8" (2.22 cm) Adaptor, Ste... | This recall is being conducted because a cohesive band used to package the devices contains latex... | Class II | Microtek Medical Inc |
| Mar 10, 2015 | INTEGRAL WAND W/TUBING, STERILE, REF 24185, QTY 24/CS, STERILE EO Intended... | This recall is being conducted because a cohesive band used to package the devices contains latex... | Class II | Microtek Medical Inc |
| Mar 10, 2015 | VACUUM TUBING 7/8" X 6' (2.22cm X 182.88cm), REF 24009, QTY 24\CS, NON-STERIL... | This recall is being conducted because a cohesive band used to package the devices contains latex... | Class II | Microtek Medical Inc |
| Mar 9, 2015 | NOBELREPLACE Tapered Groovy RP 4.3x8mm, Article No. 32215. 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 RP 4.3x10mm, Article No. 37291. | 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 5.0x8mm, Article No. 36710. | 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 3.5x10mm, Article No. 29401. 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 4.3x13mm, Article No. 36708. | 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 5.0x13mm, 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 |
| Feb 26, 2015 | ToggleLoc; fastener, fixation, non degradable, soft tissue; Artificial Ligame... | The firm is recalling ToggleLocs and Ziploops manufactured in May and July of 2014 as they were n... | Class II | Biomet, Inc. |
| Feb 26, 2015 | Ziploop Button Product Usage: The Ziploop Button is a non-resorbable syst... | The firm is recalling ToggleLocs and Ziploops manufactured in May and July of 2014 as they were n... | Class II | Biomet, 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.