Medical Device Recalls
This is our largest category by volume. The FDA tracks recalls for an enormous range of medical devices: implants, pacemakers, insulin pumps, surgical tools, blood glucose monitors, X-ray machines, prosthetics, contact lenses, and home health equipment, among many others. We have records dating back to 2005 and add new ones as the FDA publishes them.
Device recalls can happen because of software bugs, manufacturing defects, bacterial contamination, incorrect labeling, or design flaws that lead to inaccurate results or equipment failure. Class I recalls are the most serious and mean the device could cause injury or death.
Showing 22301–22320 of 38,428 recalls
Recalled Item: ZUK PRC FEM SZB RMED/LLAT¿ ZUK PRC FEM SZC LMED/RLAT¿
The Issue: The LDPE bag packaging for various highly polished
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LPS FEM COMP SZ B-L LPS FEM COMP SZ B-R
The Issue: The LDPE bag packaging for various highly polished
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CR-FLEX PCT FEM B-R CR-FLEX PCT FEM C-L CR-FLEX PCT
The Issue: The LDPE bag packaging for various highly polished
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CPT 12/14 COCR SIZE 2 STD prosthesis
The Issue: The LDPE bag packaging for various highly polished
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CR-FLEX GSF PRECOAT SZ C-L¿ CR-FLEX GSF PRECOAT SZ C-R¿
The Issue: The LDPE bag packaging for various highly polished
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CPT 12/14 COCR SIZE 1 EXT prosthesis
The Issue: The LDPE bag packaging for various highly polished
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GENDER SOLUTIONS NATURAL-KNEE FLEX SYSTEM GENDER SOLUTIONS FEMALE (GSF) FEMORAL
The Issue: The LDPE bag packaging for various highly polished
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VERSYS 6 INCH BEADED FC STEM 12X160MM LM 13X160MM LM
The Issue: The LDPE bag packaging for various highly polished
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Rapid for the TLiIQ(R) System
The Issue: Rapid fFN cassettes were manufactured with material (A137
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Rapid for the TLiIQ(R) System
The Issue: Rapid fFN cassettes were manufactured with material (A137
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: smith&nephew
The Issue: One lot of EVOS 2.4MM Flex Plate 6
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: lmmunalysis EDDP Urine Control Set 1 The EDDP Urine Controls
The Issue: The High (125 ng/ml) Control does not meet
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vital-Port Vascular Access System
The Issue: Non-coring needle provided with the Cook Vital-Port¿ Vascular
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The GLOBAL UNITE Platform Shoulder System is intended for cemented
The Issue: The screw in specific lots of the GLOBAL
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Trevo XP ProVue System kit containing 1) Trevo XP ProVue Retriever
The Issue: Stryker Neurovascular has become aware that at least
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Syva¿ EMIT¿ 2000 Theophylline Product Usage: The Syva¿ Emit¿ 2000
The Issue: Lot J1 of the Syva¿ EMIT¿ 2000 Theophylline
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DERMABOND" PRINEO" Skin Closure System Product Usage: DERMABOND PRINEO System
The Issue: Ethicon discovered that specific lots of DERMABOND"PRINEO"System may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ARROWg+ard BLUE PLUS Pressure Injectable Two- Lumen CVC Kit Product
The Issue: Some of the products listed in the recall
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ARROWg+ard Blue¿ MAC" Two-Lumen Central Venous Access Kit Product Usage:
The Issue: Some of the products listed in the recall
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Pressure Injectable Multi- Lumen Central Venous Pressure Injectable ARROW(R)...
The Issue: Some of the products listed in the recall
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.