Browse Device Recalls
3,013 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,013 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 3,013 FDA device recalls in 2018.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Apr 26, 2018 | BOX LAPIMBGP1 ZESTAW DO MGBP (LAPIMBGP1) Product Usage: The Endo GIA un... | Device may be missing a sled component. The sled component is responsible for staple deployment. ... | Class II | COVIDIEN MEDTRONIC |
| Apr 26, 2018 | (1) BOX 01KBAR006116V PROC BYPASS 01KBAR0061(Item Code 01KBAR006116V PROC BY... | Device may be missing a sled component. The sled component is responsible for staple deployment. ... | Class II | COVIDIEN MEDTRONIC |
| Apr 26, 2018 | (1)BOX PST01199 BARIATRIC TRISTAPLE (Item Number: PST01199) (2) BO... | Device may be missing a sled component. The sled component is responsible for staple deployment. ... | Class II | COVIDIEN MEDTRONIC |
| Apr 26, 2018 | (1)BOX KITDE0183 APPENDIX LIPPE DETMOLD (KITDE0183) (2) KIT-DE-0083 APPENEKT... | Device may be missing a sled component. The sled component is responsible for staple deployment. ... | Class II | COVIDIEN MEDTRONIC |
| Apr 26, 2018 | MGBX ZESTAW GB LS X1 Product Usage: The Endo GIA universal and Endo GIA ... | Device may be missing a sled component. The sled component is responsible for staple deployment. ... | Class II | COVIDIEN MEDTRONIC |
| Apr 26, 2018 | Endo GIA" Auto Suture" Universal Articulating Loading Unit 60mm - 3.5mm ( It... | Device may be missing a sled component. The sled component is responsible for staple deployment. ... | Class II | COVIDIEN MEDTRONIC |
| Apr 26, 2018 | Covidien" Best Practices" Procedure Kits containing Auto Suture" Endo GIA" ... | Device may be missing a sled component. The sled component is responsible for staple deployment. ... | Class II | COVIDIEN MEDTRONIC |
| Apr 26, 2018 | KIT00486R OBESIDAD D. WORWARLD 2 X1 (Item Number KIT00486R) P... | Device may be missing a sled component. The sled component is responsible for staple deployment. ... | Class II | COVIDIEN MEDTRONIC |
| Apr 26, 2018 | SLEEVEGK1 ZESTAW DO ZABIEGOW SLEEVEX1 Product Usage: The Endo GIA univer... | Device may be missing a sled component. The sled component is responsible for staple deployment. ... | Class II | COVIDIEN MEDTRONIC |
| Apr 26, 2018 | Endo GIA" Auto Suture" Universal Articulating Loading Unit 30mm - 3.5mm ( It... | Device may be missing a sled component. The sled component is responsible for staple deployment. ... | Class II | COVIDIEN MEDTRONIC |
| Apr 26, 2018 | Endo GIA" Auto Suture" Universal Articulating Loading Unit 60mm -2.5mm ( Ite... | Device may be missing a sled component. The sled component is responsible for staple deployment. ... | Class II | COVIDIEN MEDTRONIC |
| Apr 26, 2018 | (1)BOX SLEEVEGK3 (2) BOX SLEEVEGK4 SLEEVE GASTRECTOMY (3)BOX SLEEVEJAWI SLE... | Device may be missing a sled component. The sled component is responsible for staple deployment. ... | Class II | COVIDIEN MEDTRONIC |
| Apr 26, 2018 | BOX MGBGLOGX1 ZESTAW MINI GASTRIC BYPASS Product Usage: The Endo GIA uni... | Device may be missing a sled component. The sled component is responsible for staple deployment. ... | Class II | COVIDIEN MEDTRONIC |
| Apr 26, 2018 | (1) BOX KITDE0143 BYPASS BOX (Item Number: KITDE0143, KITDE0143 BYPASS BO... | Device may be missing a sled component. The sled component is responsible for staple deployment. ... | Class II | COVIDIEN MEDTRONIC |
| Apr 26, 2018 | KIT-DE-0080 BYPASS KIT LOHNE X1( Item KIT-DE-0080) Product Usage: The End... | Device may be missing a sled component. The sled component is responsible for staple deployment. ... | Class II | COVIDIEN MEDTRONIC |
| Apr 26, 2018 | (1)KIT4184 APEN LOBECTOMY KIT X0 Item Number: KIT4184 APEN LOBECTOMY KIT XO... | Device may be missing a sled component. The sled component is responsible for staple deployment. ... | Class II | COVIDIEN MEDTRONIC |
| Apr 26, 2018 | BOX KITDE0108 BYPASS KIT LUEBECK ( KITDE0108) Product Usage: The Endo GIA... | Device may be missing a sled component. The sled component is responsible for staple deployment. ... | Class II | COVIDIEN MEDTRONIC |
| Apr 26, 2018 | BOX VMIN ZESTAW DO VATS PODSTAWOWY Product Usage: The Endo GIA universal... | Device may be missing a sled component. The sled component is responsible for staple deployment. ... | Class II | COVIDIEN MEDTRONIC |
| Apr 26, 2018 | Endo GIA" Auto Suture" Universal Articulating Loading Unit 45mm- 3.5mm( Item... | Device may be missing a sled component. The sled component is responsible for staple deployment. ... | Class II | COVIDIEN MEDTRONIC |
| Apr 26, 2018 | BOX VATS1SCDX DO ZABIEGOW VATS Product Usage: The Endo GIA universal and... | Device may be missing a sled component. The sled component is responsible for staple deployment. ... | Class II | COVIDIEN MEDTRONIC |
| Apr 26, 2018 | (1)BOX PST04089 SLEEVE AIWA CLINIC Item Number:PST04089 SLEEVE AIWA CLINIC ... | Device may be missing a sled component. The sled component is responsible for staple deployment. ... | Class II | COVIDIEN MEDTRONIC |
| Apr 26, 2018 | Endo GIA" 30mm Gray Curved Tip Articulating Vascular Reload with Tri-Staple" ... | Device may be missing a sled component. The sled component is responsible for staple deployment. ... | Class II | COVIDIEN MEDTRONIC |
| Apr 26, 2018 | BOX VWR ZESTAW DO VATS KLIN Product Usage: The Endo GIA universal and En... | Device may be missing a sled component. The sled component is responsible for staple deployment. ... | Class II | COVIDIEN MEDTRONIC |
| Apr 26, 2018 | Endo GIA" Auto Suture" Universal Articulating Loading Unit 30mm - 2.5mm ( It... | Device may be missing a sled component. The sled component is responsible for staple deployment. ... | Class II | COVIDIEN MEDTRONIC |
| Apr 26, 2018 | BOX KIT1095V KIT OBESITAS (Item Code KIT1095V) Product Usage: The Endo GIA ... | Device may be missing a sled component. The sled component is responsible for staple deployment. ... | Class II | COVIDIEN MEDTRONIC |
| Apr 26, 2018 | Endo GIA" 30mm Gray Curved Tip Articulating Vascular Reload with Tri-Staple" ... | Device may be missing a sled component. The sled component is responsible for staple deployment. ... | Class II | COVIDIEN MEDTRONIC |
| Apr 26, 2018 | Endo GIA" 45mm Gray Curved Tip Articulating Vascular Reload with Tri-Staple" ... | Device may be missing a sled component. The sled component is responsible for staple deployment. ... | Class II | COVIDIEN MEDTRONIC |
| Apr 26, 2018 | BOX KIT1171C KIT LAP CYSTECTOMY Product Usage: The Endo GIA universal an... | Device may be missing a sled component. The sled component is responsible for staple deployment. ... | Class II | COVIDIEN MEDTRONIC |
| Apr 26, 2018 | BOX PST03533 KIT APP STAPLER Product Usage: The Endo GIA universal and E... | Device may be missing a sled component. The sled component is responsible for staple deployment. ... | Class II | COVIDIEN MEDTRONIC |
| Apr 26, 2018 | BOX PST03699 KIT APP MED ALTERNATIV STAP Product Usage: The Endo GIA uni... | Device may be missing a sled component. The sled component is responsible for staple deployment. ... | Class II | COVIDIEN MEDTRONIC |
| Apr 26, 2018 | BOX KIT00713 KIT BY PASS Product Usage: The Endo GIA universal and Endo ... | Device may be missing a sled component. The sled component is responsible for staple deployment. ... | Class II | COVIDIEN MEDTRONIC |
| Apr 26, 2018 | (1) BOX LAPZD ZESTAW DO SG (2) BOX LAPISG1 ZESTAW DO SG (3) BOX LAPISGW... | Device may be missing a sled component. The sled component is responsible for staple deployment. ... | Class II | COVIDIEN MEDTRONIC |
| Apr 26, 2018 | ABX Pentra Micro ALBUMIN 2 CP, Serum/Plasma, REF 1300032563 The device i... | When the ABX Pentra Micro ALBUMIN 2 CP (ALBT2) Reagent 2 is sampled and dispensed immediately aft... | Class II | Horiba Instruments, Inc dba Horiba Medical |
| Apr 26, 2018 | (1)BOX HEMIGX1 ZESTAW DO HEMICOLECTOMII (Item Number HEMIGX1 ZESTAW DO HE... | Device may be missing a sled component. The sled component is responsible for staple deployment. ... | Class II | COVIDIEN MEDTRONIC |
| Apr 26, 2018 | BOX TGGLOGOWX1 DO TOTAL GASTRECTOMIII Product Usage: The Endo GIA univer... | Device may be missing a sled component. The sled component is responsible for staple deployment. ... | Class II | COVIDIEN MEDTRONIC |
| Apr 25, 2018 | Baxter EXACTAMIX Inlet, Syringe Inlet, REF H938176 Usage: Exacta-Mix 2400... | Specific lots of EXACTAMIX Inlets listed below due to incorrectly performed over-labeling. The i... | Class II | Baxter Healthcare Corporation |
| Apr 25, 2018 | Baxter EXACTAMIX Inlet, Vented, Micro-Volume Inlet, REF H938175 Usage: Ex... | Specific lots of EXACTAMIX Inlets listed below due to incorrectly performed over-labeling. The i... | Class II | Baxter Healthcare Corporation |
| Apr 25, 2018 | Baxter EXACTAMIX Inlet, Non-Vented, High-Volume Inlet, REF H938173 Product... | Specific lots of EXACTAMIX Inlets listed below due to incorrectly performed over-labeling. The i... | Class II | Baxter Healthcare Corporation |
| Apr 25, 2018 | Flexible Smoothbore Breathing Circuit with Exhalation Port 22mm, Product No. ... | When assembling an HME or Filter on this breathing circuit the tubing may be pushed up and inadv... | Class II | Intersurgical Inc |
| Apr 25, 2018 | Nanosil Spray Gel, "***IMMUNE SYSTEM SUPPORT***ENGINEERED NANO-SILVER SOLUTIO... | A recent FDA inspection of the firm revealed significant Current Good Manufacturing Practices (cG... | Class II | Conseal International, Inc. |
| Apr 25, 2018 | Convatec Esteem(TM) Synergy Stomahesive(R), 7/8 in. / 22mm, REF 405475 Pro... | It was discovered that the stoma hole of one lots of the Esteem synergy Stomahesive Skin Barrier ... | Class II | ConvaTec, Inc |
| Apr 25, 2018 | Baxter EXACTAMIX Inlet, Vented, High-Volume Inlet, REF H938174 Usage: Exa... | Specific lots of EXACTAMIX Inlets listed below due to incorrectly performed over-labeling. The i... | Class II | Baxter Healthcare Corporation |
| Apr 24, 2018 | Vulcan Fast Red Chromogen Kit 2, part of an immunohistochemistry (IHC) proced... | Chromogen failed to develop due to a stability issue caused by environmental factors with a raw m... | Class II | Biocare Medical, LLC |
| Apr 24, 2018 | MEDLINE Sterile* Needle Counter, 100Ct. Double Magnet / Foam Block, reorder: ... | The product packaging seal has the potential to experience seal creep. This may result in gaps to... | Class II | Medline Industries Inc |
| Apr 24, 2018 | MEDLINE Sterile* Needle Counter, 40Ct. Foam Block / Magnet, reorder: DYNJNC40... | The product packaging seal has the potential to experience seal creep. This may result in gaps to... | Class II | Medline Industries Inc |
| Apr 24, 2018 | Prismaflex 5.10 US, Product Code 113081 Intended Use: The Prismaflex Cont... | Baxter Healthcare will be installing new firmware on all Prismaflex control units to address the ... | Class II | Baxter Healthcare Corporation |
| Apr 24, 2018 | Prismaflex 7.XX ROW, Product Code 114870 Intended Use: The Prismaflex Con... | Baxter Healthcare will be installing new firmware on all Prismaflex control units to address the ... | Class II | Baxter Healthcare Corporation |
| Apr 24, 2018 | MEDLINE O.R. Necessities(TM) Sterile* Needle Counter, 40 Ct. Double Magnet / ... | The product packaging seal has the potential to experience seal creep. This may result in gaps to... | Class II | Medline Industries Inc |
| Apr 24, 2018 | MEDLINE O.R. Necessities(TM) Sterile* Needle Counter, 100 Ct. Double Magnet /... | The product packaging seal has the potential to experience seal creep. This may result in gaps to... | Class II | Medline Industries Inc |
| Apr 24, 2018 | Prismaflex 7.XX US, Product Code 115269 Intended Use: The Prismaflex Cont... | Baxter Healthcare will be installing new firmware on all Prismaflex control units to address the ... | Class II | Baxter Healthcare Corporation |
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.