Browse Device Recalls
3,191 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,191 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 3,191 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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. |
| 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 | Ameda One-Hand Manual Breast Pump (SKU 17161) - Primary packaging is 6 pouche... | Devices were not sterilized | Class II | Ameda, Inc. |
| Feb 12, 2015 | Ameda Dual Short Term HygieniKit Milk Collections System (SKU 17115) - Primar... | Devices were not sterilized | Class II | Ameda, Inc. |
| Feb 11, 2015 | Outer cardboard box labeling: Pinnacle Cure Sleeve, Curing Light Tip Sleeves... | Cases of Cure Sleeve labeled with part number 4513, which fits 13mm tips, have inner boxes label... | Class II | Sybron Dental Specialties |
| Feb 9, 2015 | CooperSurgical PESSARY KIT-CUBE#2, 1-3/8 in , 35 mm Part Number: MXKPEC02 | Incorrect size printed on the Milex Pessary Kit packaging label | Class II | CooperSurgical, Inc. |
| Jan 30, 2015 | Bard 100% Latex-Free Urinary Drainage Bag with Anti-Reflux Chamber and Bard E... | Potential breach of the sterile barrier packaging. | Class II | C.R. Bard, Inc. |
| Jan 22, 2015 | GemLock Long Hex Driver, Catalog RHL2.5; Also distributed within the Tapered ... | The Gemlock Long Hex Driver may not fit into the Fixture Mount Transfer (FMT) or the internal hex... | Class II | Zimmer Dental Inc |
| Jan 15, 2015 | ReliaMed¿ Alginate/CMC. Each dressing is packed in a pouch (primary packagin... | On 08 January 2015 AMS Sole Customer for the products notified AMS of the issue after discovering... | Class II | Advanced Medical Solutions Ltd. |
| Jan 15, 2015 | ReliaMed¿ Silver Alginate/CMC. Each dressing is packed in a pouch (primary pa... | On 08 January 2015 AMS Sole Customer for the products notified AMS of the issue after discoverin... | Class II | Advanced Medical Solutions Ltd. |
| Jan 14, 2015 | Product Code 2C4013, Four Lead TUR Irrigation Set, for use with UROMATIC Pla... | Potential for failure of the pouch packaging seal at high altitudes. | Class II | Baxter Healthcare Corp. |
| Jan 9, 2015 | Ringloc+ Acetabular Shell Finned 52 mm, PN 16-104152, hip prosthesis component. | Biomet recalled the Mallory Head 4 Finned Acetabular Shell 50mm (Lot 364600) and Ringloc + Acetab... | Class II | Biomet, Inc. |
| Jan 9, 2015 | Mallory Head 4 Finned Acetabular Shell 50 mm, PN 13-104150, hip prosthesis co... | Biomet recalled the Mallory Head 4 Finned Acetabular Shell 50mm (Lot 364600) and Ringloc + Acetab... | Class II | Biomet, Inc. |
| Jan 9, 2015 | Hudson RCI, Sheridan, Preformed Tracheal Tubes, Cuffed and Uncuffed, Rx Only,... | Labeling; The affected product packaging is incorrectly labeled as being a cuffed oral ET tube; T... | Class II | Teleflex Medical |
| Jan 8, 2015 | Pilling Modular Verres Body/Obturator, Product Code 140880 | Packaging error in which customers who ordered product code 140880 (Verres cannula for use with a... | Class II | Teleflex Medical |
| Jan 7, 2015 | Comprehensive Reverse Shoulder Glenosphere Mini Baseplate 25mm with Taper Ada... | The taper adaptor is missing from the packaging, which may result in a delay in surgery greater t... | Class II | Biomet, Inc. |
| Dec 4, 2014 | DBX Mix, 20 cc, Product Code: 058200. Demineralized Bone Matrix Mix, bone vo... | The seal on the DBX Mix outer PETG/Aclar tray with foil lid packaging for lot identified above ma... | Class II | Musculoskeletal Transplant Foundation, Inc. |
| Dec 4, 2014 | Stryker Orthobiologics Imbibe Bone Marrow Aspiration Needle, Model Numbers: ... | There is the potential for a breach in the inner or outer packaging pouches of all lots of the Im... | Class II | Orthovita, Inc., dBA Stryker Orthobiologics. |
| Dec 4, 2014 | Stryker Orthobiologics Imbibe Aliquot Needle Bone Cement Needle- Model Number... | There is the potential for a breach in the inner or outer packaging pouches of all lots of the St... | Class II | Orthovita, Inc., dBA Stryker Orthobiologics. |
| Dec 2, 2014 | Sirius Polish Cemented Stem 38C Catalog Number: 51-199335 Lot Number Identi... | After receiving a complaint, Biomet Orthopedic Inc., conducted an investigation which determined ... | Class II | Biomet, Inc. |
| Dec 2, 2014 | Device Brand Name: Sirius Polish Cemented Stem 34B Device Classification Nam... | After receiving a complaint, Biomet Orthopedic Inc., conducted an investigation which determined ... | Class II | Biomet, Inc. |
| Nov 21, 2014 | Cryogenic probe for cardiac ablation surgery, packaged individually in Tyvek ... | Affected product may have compromised sterility due to packaging defects. It was determined that ... | Class II | Atricure Inc |
| Nov 6, 2014 | Abbott Healon EndoCoat Ophthalmic Viscosurgical Device 3% sodium hyaluronate... | AMO has received complaints where the finger grip dislodged while depressing the syringe plunger.... | Class II | Abbott Medical Optics Inc (AMO) |
| Nov 5, 2014 | Polyflux Revaclear Dialyzer, Model Number 110633. The Polyflux Revaclear¿ ... | Gambro is initiating a field action for Polyflux Revaclear Dialyzer and Polyflux Revaclear Max Di... | Class II | Gambro Renal Products 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.