Browse Device Recalls
3,164 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,164 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 3,164 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jun 15, 2017 | Vis-U-All High Temperature Tubing 9"x100'. One roll per box; 10 boxes per cas... | On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All... | Class II | Steris Corporation |
| Jun 15, 2017 | Vis-U-All High Temp 5"x15" Heat Seal Pouch 200 pouches per box; 4 boxes per c... | On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All... | Class II | Steris Corporation |
| Jun 15, 2017 | Vis-U-All High Temp 5"x15" Self Seal Pouch 200 pouches per box; 4 boxes per c... | On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All... | Class II | Steris Corporation |
| Jun 15, 2017 | Vis-U-All High Temp 16"x16" Self Seal Pouch 100 pouches per box; 6 boxes per ... | On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All... | Class II | Steris Corporation |
| Jun 15, 2017 | Vis-U-All High Temp 8"x16" Heat Seal Pouch 100 pouches per box; 9 boxes per c... | On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All... | Class II | Steris Corporation |
| Jun 15, 2017 | Vis-U-All High Temp 3"x8" Heat Seal Pouch 200 pouches per box; 5 boxes per ca... | On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All... | Class II | Steris Corporation |
| Jun 15, 2017 | Vis-U-All High Temp 7.5"x13.5" Heat Seal Pouch 200 pouches per box; 5 boxes p... | On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All... | Class II | Steris Corporation |
| Jun 15, 2017 | Vis-U-All High Temp 18"x22" Heat Seal Pouch 100 pouches per box; 5 boxes per ... | On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All... | Class II | Steris Corporation |
| Jun 15, 2017 | Vis-U-All High Temp 18"x22" Self Seal Pouch 100 pouches per box; 5 boxes per ... | On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All... | Class II | Steris Corporation |
| Jun 15, 2017 | Vis-U-All High Temp 13"x18" Heat Seal Pouch 100 pouches per box; 4 boxes per ... | On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All... | Class II | Steris Corporation |
| Jun 15, 2017 | Vis-U-All High Temp 6"x10" Heat Seal Pouch 200 pouches per box; 5 boxes per c... | On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All... | Class II | Steris Corporation |
| Jun 15, 2017 | Vis-U-All High Temp 3.5"x22" Heat Seal Pouch 200 pouches per box; 5 boxes per... | On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All... | Class II | Steris Corporation |
| Jun 15, 2017 | Vis-U-All High Temp 13"x18" Self Seal Pouch 100 pouches per box; 4 boxes per ... | On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All... | Class II | Steris Corporation |
| Jun 15, 2017 | Vis-U-All High Temp 3.5"x22" Self Seal Pouch 200 pouches per box; 4 boxes per... | On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All... | Class II | Steris Corporation |
| Jun 15, 2017 | Vis-U-All High Temp 4"x11" Self Seal Pouch 200 pouches per box; 4 boxes per c... | On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All... | Class II | Steris Corporation |
| Jun 15, 2017 | Vis-U-All High Temp 3.5"x9" Self Seal Pouch 200 pouches per box; 4 boxes per ... | On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All... | Class II | Steris Corporation |
| Jun 15, 2017 | Vis-U-All High Temp 7.5"x13" Self Seal Pouch 200 pouches per box; 4 boxes per... | On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All... | Class II | Steris Corporation |
| Jun 15, 2017 | Vis-U-All High Temp 8"x10" Heat Seal Pouch 200 pouches per box; 5 boxes per c... | On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All... | Class II | Steris Corporation |
| Jun 15, 2017 | Vis-U-All High Temp 7.5"x13" Self Seal Pouch 200 pouches per box; 4 boxes per... | On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All... | Class II | Steris Corporation |
| Jun 15, 2017 | Vis-U-All High Temp 16"x16" Heat Seal Pouch 100 pouches per box; 5 boxes per ... | On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All... | Class II | Steris Corporation |
| Jun 15, 2017 | Vis-U-All High Temp 4.5"x11" Heat Seal Pouch 200 pouches per box; 5 boxes per... | On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All... | Class II | Steris Corporation |
| Jun 15, 2017 | Vis-U-All High Temp 10"x15" Heat Seal Pouch 100 pouches per box; 5 boxes per ... | On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All... | Class II | Steris Corporation |
| Jun 15, 2017 | Vis-U-All High Temp 4"x8" Heat Seal Pouch 200 pouches per box; 5 boxes per ca... | On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All... | Class II | Steris Corporation |
| Jun 7, 2017 | Glidesheath Slender Hydrophilic Coated Introducer Sheath, 6FR - 10CM (0.021),... | An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introdu... | Class II | Terumo Medical Corp |
| Jun 7, 2017 | Glidesheath Slender Hydrophilic Coated Introducer Sheath, 7FR - 10CM (0.021),... | An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introdu... | Class II | Terumo Medical Corp |
| Jun 7, 2017 | Glidesheath Slender Hydrophilic Coated Introducer Sheath, 5FR - 10CM (0.021),... | An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introdu... | Class II | Terumo Medical Corp |
| Jun 7, 2017 | Glidesheath Slender Hydrophilic Coated Introducer Sheath, 6FR - 16CM (0.021),... | An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introdu... | Class II | Terumo Medical Corp |
| Jun 7, 2017 | Glidesheath Slender Hydrophilic Coated Introducer Sheath, 5FR - 16CM (0.021),... | An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introdu... | Class II | Terumo Medical Corp |
| Jun 7, 2017 | Glidesheath Slender Hydrophilic Coated Introducer Sheath A-Kit, 6FR - 10CM (0... | An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introdu... | Class II | Terumo Medical Corp |
| Jun 7, 2017 | Glidesheath Slender Hydrophilic Coated Introducer Sheath, 5FR - 10CM (0.021),... | An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introdu... | Class II | Terumo Medical Corp |
| Jun 7, 2017 | DeRoyal(R) Dolphin Inflation Device, REF 0185ND, Rx Only, STERILE EO, Dolp... | Lack of sterility assurance. There is a defect in the primary packaging of the device, which may... | Class II | DeRoyal Industries Inc |
| Jun 7, 2017 | Glidesheath Slender Hydrophilic Coated Introducer Sheath A-Kit, 5FR - 16CM (0... | An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introdu... | Class II | Terumo Medical Corp |
| Jun 7, 2017 | Glidesheath Slender Hydrophilic Coated Introducer Sheath A-Kit, 5FR - 10CM (0... | An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introdu... | Class II | Terumo Medical Corp |
| Jun 7, 2017 | Glidesheath Slender Hydrophilic Coated Introducer Sheath A-Kit, 6FR - 16CM (0... | An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introdu... | Class II | Terumo Medical Corp |
| Jun 7, 2017 | Glidesheath Slender Hydrophilic Coated Introducer Sheath, 5FR - 10CM (0.025),... | An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introdu... | Class II | Terumo Medical Corp |
| Jun 7, 2017 | Glidesheath Slender Hydrophilic Coated Introducer Sheath, 7FR - 10CM (0.021),... | An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introdu... | Class II | Terumo Medical Corp |
| Jun 7, 2017 | Glidesheath Slender Hydrophilic Coated Introducer Sheath, 6FR - 10CM (0.025),... | An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introdu... | Class II | Terumo Medical Corp |
| Jun 7, 2017 | Glidesheath Slender Hydrophilic Coated Introducer Sheath A-Kit, 6FR - 10CM (0... | An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introdu... | Class II | Terumo Medical Corp |
| Jun 7, 2017 | Glidesheath Slender Hydrophilic Coated Introducer Sheath A-Kit, 5FR - 10CM (0... | An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introdu... | Class II | Terumo Medical Corp |
| Jun 7, 2017 | Glidesheath Slender Hydrophilic Coated Introducer Sheath, 6FR - 10CM (0.021),... | An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introdu... | Class II | Terumo Medical Corp |
| Jun 7, 2017 | Glidesheath Slender Hydrophilic Coated Introducer Sheath, 7FR - 16CM (0.021),... | An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introdu... | Class II | Terumo Medical Corp |
| May 22, 2017 | TUMARK Q, Length 12 cm, Diameter 18G, GTIN 04250195603081, REF 271500, STERILE | There is a potential risk of puncture to the packaging material which can compromise the devices ... | Class II | Somatex Medical Technologies GmbH |
| May 22, 2017 | Boston Scientific Zurpaz(TM) MEDIUM CURL, ASYMMETRIC CURVE, Steerable Sheath,... | Lack of sterility assurance. | Class II | Creganna Medical Devices |
| May 22, 2017 | Boston Scientific Zurpaz(TM) MEDIUM CURL, SYMMETRIC CURVE, Steerable Sheath, ... | Lack of sterility assurance. | Class II | Creganna Medical Devices |
| May 22, 2017 | Boston Scientific Zurpaz(TM) MEDIUM CURL, ASYMMETRIC CURVE, Steerable Sheath,... | Lack of sterility assurance. | Class II | Creganna Medical Devices |
| May 22, 2017 | Boston Scientific Zurpaz(TM) MEDIUM CURL, ASYMMETRIC CURVE, Steerable Sheath,... | Lack of sterility assurance. | Class II | Creganna Medical Devices |
| May 17, 2017 | QuikClot TraumaPad, , sterile, soft, white, X-ray detectable hemostatic dres... | Packaging breach may compromise sterility | Class II | Z-Medica, LLC |
| May 9, 2017 | Arrow MAC Two-Lumen Central Venous Access Kit Introducer Catheter The Arrow... | Arrow International is recalling the affected product because the packaging may not be completely... | Class II | Arrow International Inc |
| May 9, 2017 | 1) ARROWg+ard Blue You-Blend Two-Lumen Hemodialysis Catheterization Kit for H... | Arrow International is recalling the affected product because the packaging may not be completely... | Class II | Arrow International Inc |
| May 9, 2017 | 1) ARROWg+ard Blue MAC Two-Lumen Central Venous Access Kit 2) ARROWg+ard Blu... | Arrow International is recalling the affected product because the packaging may not be completely... | Class II | Arrow International 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.