Browse Device Recalls
278 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 278 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 278 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Nov 9, 2015 | Smith & Nephew GENESIS(R) II/LEGION(TM) PATELLAR COMPONENT, RESURFACING ROUN... | One lot of 35 mm patella implants is labeled as 32 mm. These implants have pegs which are spaced... | Class II | Smith & Nephew, Inc. |
| Oct 20, 2015 | Smith & Nephew PERI-LOC VOLAR DISTAL RADIUS PLATE STANDARD 3 HOLE SHORT, LEFT... | The devices were packaged and laser marked anatomically incorrect. The Left plates were laser mar... | Class II | Smith & Nephew, Inc. |
| Oct 20, 2015 | Smith & Nephew PERI-LOC VOLAR DISTAL RADIUS PLATE STANDARD 3 HOLE SHORT, RIGH... | The devices were packaged and laser marked anatomically incorrect. The Left plates were laser mar... | Class II | Smith & Nephew, Inc. |
| Sep 10, 2015 | Smith & Nephew MOSAICPLASTY DP- Disposable Harvesting System 8.5 mm, Sterile ... | Sterility of device is compromised due to breach in the packaging | Class II | Smith & Nephew, Inc., Endoscopy Div. |
| Sep 10, 2015 | Smith & Nephew MOSAICPLASTY DP- Disposable Harvesting System 6.5 mm, Sterile ... | Sterility of device is compromised due to breach in the packaging | Class II | Smith & Nephew, Inc., Endoscopy Div. |
| Sep 10, 2015 | Smith & Nephew MOSAICPLASTY DP- Disposable Harvesting System 4.5 mm, Sterile ... | Sterility of device is compromised due to breach in the packaging | Class II | Smith & Nephew, Inc., Endoscopy Div. |
| Sep 10, 2015 | Smith & Nephew MOSAICPLASTY DP- Disposable Harvesting System 3.5 mm, Sterile ... | Sterility of device is compromised due to breach in the packaging | Class II | Smith & Nephew, Inc., Endoscopy Div. |
| Jun 3, 2015 | Smith & Nephew BIRMINGHAM HIP (TM) RESURFACING DYSPLASIA CUP W/IMPACTOR, REF ... | The firm observed that the BIRMINGHAM HIP(TM) Resurfacing (BHR) System had revision rates which w... | Class II | Smith & Nephew, Inc. |
| Jun 3, 2015 | Smith & Nephew BIRMINGHAM HIP (TM) RESURFACING ACETABULAR CUP W/IMPACTOR, REF... | The firm observed that the BIRMINGHAM HIP(TM) Resurfacing (BHR) System had revision rates which w... | Class II | Smith & Nephew, Inc. |
| Jun 3, 2015 | Smith & Nephew BIRMINGHAM HIP (TM) RESURFACING FEMORAL HEAD, STERILE R, Rx on... | The firm observed that the BIRMINGHAM HIP(TM) Resurfacing (BHR) System had revision rates which w... | Class II | Smith & Nephew, Inc. |
| May 6, 2015 | R3(TM) 22 MM I.D., 52 MM O.D. CONSTRAINED LINER, REF 71339152, QTY: (1), STER... | The R3 Constrained outer liner locking groove diameter is 0.030 inches oversized and may not allo... | Class II | Smith & Nephew, Inc. |
| May 6, 2015 | R3(TM) 28 MM I.D., 62 MM O.D. CONSTRAINED LINER, REF 71339162, QTY: (1), STER... | The R3 Constrained outer liner locking groove diameter is 0.030 inches oversized and may not allo... | Class II | Smith & Nephew, Inc. |
| May 6, 2015 | R3(TM) 22 MM I.D., 56 MM O.D. CONSTRAINED LINER, REF 71339156, QTY: (1), STER... | The R3 Constrained outer liner locking groove diameter is 0.030 inches oversized and may not allo... | Class II | Smith & Nephew, Inc. |
| May 6, 2015 | R3(TM) 22 MM I.D., 58 MM O.D. CONSTRAINED LINER, REF 71339158, QTY: (1), STER... | The R3 Constrained outer liner locking groove diameter is 0.030 inches oversized and may not allo... | Class II | Smith & Nephew, Inc. |
| May 6, 2015 | R3(TM) 28 MM I.D., 60 MM O.D. CONSTRAINED LINER, REF 71339160, QTY: (1), STER... | The R3 Constrained outer liner locking groove diameter is 0.030 inches oversized and may not allo... | Class II | Smith & Nephew, Inc. |
| Apr 30, 2015 | ULTRA-FAST FIX Knot Pusher Suture Cutters Product Number: 72201537 Intend... | Sterility of device maybe compromised | Class II | Smith & Nephew, Inc. |
| Nov 4, 2014 | LEGION(TM) COCR CONSTRAINED FEMORAL COMPONENT, SIZE 4, LEFT, REF 71425004, QT... | The stem taper on this device is undersized; the gauge point is not deep enough. | Class II | Smith & Nephew, Inc. |
| Nov 4, 2014 | LEGION(TM) COCR CONSTRAINED FEMORAL COMPONENT, SIZE 6, LEFT, REF 71426006, QT... | The stem taper on this device is undersized; the gauge point is not deep enough. | Class II | Smith & Nephew, Inc. |
| Nov 4, 2014 | LEGION(TM) COCR CONSTRAINED FEMORAL COMPONENT, SIZE 5, RIGHT, REF 71426005, Q... | The stem taper on this device is undersized; the gauge point is not deep enough. | Class II | Smith & Nephew, Inc. |
| Aug 13, 2014 | RENASYS EZ Negative Pressure Wound Therapy (NPWT) System (RENASYS EZ) for pat... | Modification were made to the RENASYS EZ NPWT Systems without a 510(k) or PreMarket Approval noti... | Class II | Smith & Nephew, Inc. |
| Jul 18, 2014 | RENASYS EZ/ RENASYS EZ Plus 800 mL canister (w/o CLP) with Solidifier Prod... | RENASYS EZ Canisters exhibiting visible evidence of deformation of the inlet port on the canister... | Class II | Smith & Nephew, Inc. |
| Jul 18, 2014 | RENASYS EZ/ RENASYS EZ Plus 250 mL canister with Solidifier Product Usage:... | RENASYS EZ Canisters exhibiting visible evidence of deformation of the inlet port on the canister... | Class II | Smith & Nephew, Inc. |
| Jul 18, 2014 | RENASYS EZ/ RENASYS EZ Plus 800 mL canister with Solidifier Product Usage:... | RENASYS EZ Canisters exhibiting visible evidence of deformation of the inlet port on the canister... | Class II | Smith & Nephew, Inc. |
| Jul 2, 2014 | TRIGEN(R) INTERTAN(TM) 10MM X 18 CM NAIL, 125o, REF 71675201, QTY (1), STERIL... | There was an error in manufacturing which resulted in the proximal lag screw hole being positione... | Class II | Smith & Nephew, Inc. |
| Jun 2, 2014 | SUTUREFIX Ultra Anchor XL with one (#2) Ultrabraid Cobraid Suture Product Co... | Sterility of device is compromised due to breach in sterile barrier | Class II | Smith & Nephew, Inc. Endoscopy Division |
| Jun 2, 2014 | SUTUREFIX Ultra Anchor XL with one (#2) Ultrabraid Blue Product Code: 722038... | Sterility of device is compromised due to breach in sterile barrier | Class II | Smith & Nephew, Inc. Endoscopy Division |
| Jun 2, 2014 | SUTUREFIX Ultra S Double Loaded Suture Product Code: 72203854 Fastener, f... | Sterility of device is compromised due to breach in sterile barrier | Class II | Smith & Nephew, Inc. Endoscopy Division |
| Jun 2, 2014 | SUTUREFIX Ultra S with 1 #2 Ultrabraid Suture (blue/white) Product Code: 722... | Sterility of device is compromised due to breach in sterile barrier | Class II | Smith & Nephew, Inc. Endoscopy Division |
| Jun 2, 2014 | SUTUREFIX Ultra S with 1 #2 Ultrabraid (blue) Product Code: 72203852 Fast... | Sterility of device is compromised due to breach in sterile barrier | Class II | Smith & Nephew, Inc. Endoscopy Division |
| Apr 4, 2014 | TRIGEN INTERTAN 1.5 NAIL: (1) REF 71676515, 10 MM X 10 CM, 125 degree, LEFT... | A manufacturing error resulted in the set screw being inserted too deep in the affected nails. | Class II | Smith & Nephew Inc |
| Apr 4, 2014 | TRIGEN INTERTAN NAIL: (1) REF 71675201, 10 MM X 18 CM, 125 degree, (2) RE... | A manufacturing error resulted in the set screw being inserted too deep in the affected nails. | Class II | Smith & Nephew Inc |
| Jan 23, 2014 | Reflection Interfit Shell, 52 MM OD, 3 HOLE, REF 71336052, QTY 1, STERILE R, ... | Inner spherical radius of the shell is undersized. | Class II | Smith & Nephew Inc |
| Nov 25, 2013 | REFLECTION(R), MICROSTABLE(R), ACETABULAR LINER, 20o OVERHANG, 28 MM ID, 54-5... | One batch of the Reflection(TM) Polyethylene Acetabular Liners may be out of tolerance causing th... | Class II | Smith & Nephew Inc |
| Aug 27, 2013 | GENESIS(R) II, PS HIGH FLEXION ARTICULAR INSERT, SIZE 5-6, 9 MM QTY: (1), R... | The Tyvek(TM) lid on one, or both, of the two trays that form a double barrier around the insert... | Class II | Smith & Nephew Inc |
| Aug 27, 2013 | GENESIS(R) II, MOBILE BEARING ARTICULAR INSERT RIGHT, SIZE 5, 9 MM QTY: (1), ... | The Tyvek(TM) lid on one, or both, of the two trays that form a double barrier around the insert... | Class II | Smith & Nephew Inc |
| Aug 27, 2013 | GENESIS(R) II, PS HIGH FLEXION ARTICULAR INSERT, SIZE 3-4, 13 MM QTY: (1), R... | The Tyvek(TM) lid on one, or both, of the two trays that form a double barrier around the insert... | Class II | Smith & Nephew Inc |
| Aug 27, 2013 | GENESIS(R) II, PS HIGH FLEXION ARTICULAR INSERT, SIZE 3-4, 9 MM QTY: (1), R... | The Tyvek(TM) lid on one, or both, of the two trays that form a double barrier around the insert... | Class II | Smith & Nephew Inc |
| Aug 27, 2013 | GENESIS(R) II, PS HIGH FLEXION ARTICULAR INSERT, SIZE 5-6, 11 MM QTY: (1), RE... | The Tyvek(TM) lid on one, or both, of the two trays that form a double barrier around the insert... | Class II | Smith & Nephew Inc |
| Aug 27, 2013 | GENESIS(R) II, POSTERIOR STABILIZED ARTICULAR INSERT, SIZE 1-2, 13 MM QTY: (1... | The Tyvek(TM) lid on one, or both, of the two trays that form a double barrier around the insert... | Class II | Smith & Nephew Inc |
| Aug 6, 2013 | TWINFIX Ultra HA 4.5 mm Suture Anchor with 2 ULTRABRAID Suture, Blue / Black;... | Pinholes detected in a small number of primary pouches that may constitute a breach of the steril... | Class II | Smith & Nephew, Inc. Endoscopy Division |
| Aug 6, 2013 | OSTEORAPTOR 2.3 mm Suture Anchor with ULTRABRAID COBRAID Suture, Blue; Part ... | Pinholes detected in a small number of primary pouches that may constitute a breach of the steril... | Class II | Smith & Nephew, Inc. Endoscopy Division |
| Aug 6, 2013 | TWINFIX" Ultra 4.5 mm PLLA-HA Suture Anchor with two #2 ULTRABRAID Sutures (b... | Pinholes detected in a small number of primary pouches that may constitute a breach of the steril... | Class II | Smith & Nephew, Inc. Endoscopy Division |
| Aug 6, 2013 | TWINFIX Ultra 6.5 mm PLLA-HA Suture Anchor with two #2 ULTRABRAID Sutures (bl... | Pinholes detected in a small number of primary pouches that may constitute a breach of the steril... | Class II | Smith & Nephew, Inc. Endoscopy Division |
| Aug 6, 2013 | OSTEORAPTOR CURVED 2.3 mm Suture Anchor ULTRABRAID COBRAID Suture, Black; Par... | Pinholes detected in a small number of primary pouches that may constitute a breach of the steril... | Class II | Smith & Nephew, Inc. Endoscopy Division |
| Aug 6, 2013 | OSTEORAPTOR 2.3 mm with 1 ULTRABRAID Suture, White; Part Number: 72201991 ... | Pinholes detected in a small number of primary pouches that may constitute a breach of the steril... | Class II | Smith & Nephew, Inc. Endoscopy Division |
| Aug 6, 2013 | TWINFIX Ultra HA 4.5 mm Suture Anchor with 2 ULTRABRAID Suture, White / Blue;... | Pinholes detected in a small number of primary pouches that may constitute a breach of the steril... | Class II | Smith & Nephew, Inc. Endoscopy Division |
| Aug 6, 2013 | BIORAPTOR 2.9 mm Suture Anchor with DURABRAID" Suture; Part Number: 72200783 ... | Pinholes detected in a small number of primary pouches that may constitute a breach of the steril... | Class II | Smith & Nephew, Inc. Endoscopy Division |
| Aug 6, 2013 | RAPTORMITE" 3.7 mm PLLA with two ULTRABRAID" Sutures Size 0 and Needles; Part... | Pinholes detected in a small number of primary pouches that may constitute a breach of the steril... | Class II | Smith & Nephew, Inc. Endoscopy Division |
| Aug 6, 2013 | BIORAPTOR 2.9 mm Suture Anchor with 2 ULTRABRAID Suture; Part Number: 7220077... | Pinholes detected in a small number of primary pouches that may constitute a breach of the steril... | Class II | Smith & Nephew, Inc. Endoscopy Division |
| Aug 6, 2013 | TWINFIX Ultra HA 6.5 mm with 2 ULTRABRAID Suture, Blue / Black; Part Number: ... | Pinholes detected in a small number of primary pouches that may constitute a breach of the steril... | Class II | Smith & Nephew, Inc. Endoscopy Division |
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.