Medical device recalls
38684 federal recalls on file. Federal recalls for medical devices — surgical equipment, monitors, diagnostic tools, implants, home health devices. Sourced from the FDA.
- 2024-04-10FDA-DeviceColoplast Manufacturing US, LLCClass IIUreteral dilator, REF RBD014
A possible sterility issue (e.g. a breach in sterile packaging) was detected in Coloplast's facility on some ureteral dilator products. This issue on the ureteral dilator packaging has been identified during testing in our facility.
- 2024-04-10FDA-DeviceAgfa N.V.Class IIAgfa DX-D 100 system-Digital Radiography mobile X-ray System. A mobile X-Ray modality, consisting of X-Ray console, generator, tube, digital detector, and workstation. This modality is used to generate projection X-Ray images of human patients. Models: 5411/ 050, A5411/ 0300 and A5411/ 0400
Steel cable installed inside the mobile column which supports the weight of the telescopic arm with the tube head has potential risk -an interference could cause the safety system which blocks the arm if the cable is cut off does not work properly, may result in patient injury
- 2024-04-10FDA-DeviceO&M HALYARD, INC.Class IIIHALYARD SURGICAL HOOD, Universal Size, Blue, 300 count (3 x 100)
Product was mislabeled as a Surgical Cap at its dispenser level.
- 2024-04-10FDA-DeviceTechnicality Inc.Class IITrumpet, Needle Guide, Cat# TMS-200
The Ring on the Trump Needle Guide can detach when excessive pressure is applied.
- 2024-04-10FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IIBlood Pressure Unit, Model (REF) Numbers: a) MDS4001, b) MDS4001LA, c) MDS4001PLUS
The firm provided a set of specifications for the device, but some units of the device were manufactured non-compliant with the specifications. However, the firms Receiving Dept. accepted these units into inventory
- 2024-04-10FDA-DeviceCovidien, LPClass IICovidien Signia" Small Diameter Curved Tip Intelligent Reload, Model SIGSDS30CTVT
Under certain firing conditions, reloads were found to articulate in an uncontrolled manner potentially causing disruption to the staple line. The issue is related to components in impacted reloads that are not fully secure, which leads to uncontrolled articulation. The issue can occur using either the Endo GIA" Ultra Universal Stapler or Signia" Stapling System.
- 2024-04-10FDA-DeviceCovidien, LPClass IISignia" Small Diameter Curved Tip Intelligent Reload, Model SIGSDS30CTVT
Under certain firing conditions, reloads were found to articulate in an uncontrolled manner potentially causing disruption to the staple line. The issue is related to components in impacted reloads that are not fully secure, which leads to uncontrolled articulation. The issue can occur using either the Endo GIA" Ultra Universal Stapler or Signia" Stapling System.
- 2024-04-10FDA-DeviceDePuy Orthopaedics, Inc.Class IIATTUNE AFFIXIUM Cementless Fixed Bearing Knee with 3DP Technology, Size 6. Component of the ATTUNE Total Knee Replacement System.
Product incorrectly labelled.
- 2024-04-10FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IIMEDLINE SWABSTICKS ALCOHOL 3PK, Product code DYNDA2723
Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.
- 2024-04-10FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IIMEDLINE 4.5 IN WIRE CUT SCISSORS, Product Code DYND04006
Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.
- 2024-04-10FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IIMEDLINE SWABSTICKS PVP 3 PK, Product Code DYNDA2724
Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.
- 2024-04-10FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IIMEDLINE M1S0179 STRL TAPE/PEN PACK, Product Code P519582A
Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.
- 2024-04-10FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IICenturion DISP.UMBILICAL CORD CLAMP CUTTER(CTR300), Product Code 67335
Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.
- 2024-04-10FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IICenturion Manual surgical kits labeled as: a) HEGAR UTERINE DILATOR, 11-12MM, STERILE, Product Code HUD112ST; b) STERILE UTERINE DILATOR 1MM/2MM, Product Code HUD12ST; c) HEGAR UTERINE DILATOR, 5-6MM, STERILE, Product Code HUD56ST; d) HEGAR UTERINE DILATOR, 9-10MM, STERILE, Product Code HUD910ST; e) HANK UTERINE DILATOR 11" 7/8FR STERILE, Product Code I68920; f) HANK UTERINE DILATOR 11" 13/14FR STERILE, Product Code I68930
Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.
- 2024-04-10FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IICenturion Manual surgical kits labeled as: a) STERILE S/B WIRE SCISSOR, Product Code 65140; b) SHARP/SHARP SCISSORS 41/2", Product Code 65840; c) STERILE WIRE CUTTER (WCS144), Product Code 66240; d) STERILE LISTER BANDAGE SCISSOR (LS122), Product Code 66855; e) STERILE UTILITY SHEARS (USH176), Product Code 67225; f) STERILE ANGLED BANDAGE SCISSOR (LIST55), Product Code TRI66670
Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.
- 2024-04-10FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IICenturion Manual surgical kits labeled as: a) 15ML SAMPLING TUBE WITH CAP, Product Code 15MLVLCP; b) STERILE 9X12 RECLOSABLE BAG, Product Code MG912ST
Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.
- 2024-04-10FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IICenturion PICC LINE SECUREMENT KIT, Product Code IVS565
Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.
- 2024-04-10FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IICenturion STERILE #16 RUBBER BAND, Product Code EB16
Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.
- 2024-04-10FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IICenturion manual surgical kits labeled as: a) SUTURE REMOVAL TRAY, Product Code TRI55405; b) SUTURE REMOVAL SET, Product Code 60265 MEDLINE manual surgical kits labeled as: a) SUTURE REMOVAL TRAY, Product Code 60280; b) SUTURE REMOVAL TRAY, Product Code 86125; c) SUTURE REMOVAL KIT, Product Code SR60555; d) SKIN STAPLE REMOVER, Product Code TRI44105
Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.
- 2024-04-10FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IICenturion manual surgical kits labeled as: a) STERILE 4-1/2" S/S SCISSOR (SS5031), Product Code 65145; b) STERILE S/B SCISSOR 4-1/2" (I142), Product Code 65940; c) STERILE S/B SCISSOR 5-1/2" (I140), Product Code 65945; d) STERILE CURV IRIS SCISSOR (IC164), Product Code 66150; e) STERILE STRT IRIS SCISSOR (IS163), Product Code 66155; f) STERILE LITTAUER SCISSOR (LI027), Product Code 66215; g) STERILE 5-1/2" S/S SCISSOR (SS507), Product Code 66260; h) STERILE STRT MAYO SCISSOR (ST1
Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.
- 2024-04-10FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IICenturion manual surgical kits labeled as: a) STERILE ALLIS TISS FCP 10", Product Code I68905; b) VAGINAL REPAIR KIT, Product Code MNS11505; c) PTCA ADD-ON KIT, Product Code MNS11545; d) INSTRUMENT SET, Product Code SUT21355
Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.
- 2024-04-10FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IICenturion manual surgical kits labeled as: a) ST. VIRTUS SPLINTER FORCEP 6" (SF8246), Product Code 66580; b) DEBRIDEMENT TRAY, Product Code I86630; c) BIOPSY INSTRUMENT PACK, Product Code I86690; d) DEBRIDEMENT TRAY, Product Code I86815; e) IR ADSON FORCEP & NEEDLE HOLDER, Product Code MNS12675; f) TOENAIL REMOVAL KIT, Product Code SUT20350 MEDLINE GENERAL PURPOSE INST. TRAY, Product Code DYNDA2346A
Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.
- 2024-04-10FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IICenturion manual surgical kits labeled as: a) STERILE TUBE OCCLUDING FORCEP (TO8256), Product Code 66225; b) ST. KELLY HEMO W/TIPS (SK8039), Product Code 66565; c) STERILE BUTTERFLY PROBE (P837), Product Code 66810; d) STERILE PROBE (PR5), Product Code 66900; e) STERILE NAIL NIPPER, Product Code 67110; f) STERILE FREER SEPTUM ELEVATOR (FE75B), Product Code 67285; g) STERILE 5 1/2" NAIL NIPPER (32195), Product Code 67365; h) STERILE 4 1/4" CUTICLE NIPPER (32908), Product Code 6742
Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.
- 2024-04-10FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IICenturion Clamp kits labeled as: a) STERILE BACKHAUS TOWEL CLAMP (BTC173), Product Code 66520; b) STERILE TOWEL CLAMP, Product Code A547ST; c) ST TOWEL CLAMPS NON PERFORATING (P/S), Product Code I68080; d) STERILE TOWEL CLAMPS 5 1/2, Product Code I68085; e) STERILE TOWEL CLAMPS 5 1/2", Product Code I68095; f) ZIPSER PENIS CLAMP STERILE (ZC110), Product Code ZC110ST
Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.
- 2024-04-10FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IICenturion Curette kits labeled as: a) STERILE BUCK EAR CURETTE "00" (25697), Product Code 66745; b) STERILE "1" EAR CURETTE (505629), Product Code 67050; c) STERILE FOX DERMAL CURETTE, 5MM(32923), Product Code 67430; d) STERILE EXCAVATOR CURETTE (P/S), Product Code I67970; e) ST BUCK EAR CURETTE BLNT STR SZ 00, Product Code I68040; f) STERILE BRUNS CURETTE #4 (BC400S), Product Code I68340; g) 6MM FOX DERMAL CURETTE STERILE, Product Code I68380; h) STERILE KEVORKIAN CURETTE 4MM (K
Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.
- 2024-04-10FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IICenturion Hemostat kits labeled as: a) STERILE CURV KELLY HEMOSTAT, Product Code 65340; b) STERILE CURV MOSQUITO HEMOSTAT (MHS103), Product Code 66145; c) STERILE STRT KELLY HEMOSTAT (SK8039), Product Code 66170; d) STERILE CURV KELLY HEMOSTAT (CK8040), Product Code 66175; e) STERILE CURV SATIN HEMOSTAT (MHS103S), Product Code 66445; f) STERILE STRT SATIN HEMOSTAT (MHS102S), Product Code 66485; g) STERILE STRT KELLY HEMOSTAT (SK8039S), Product Code 66695; h) STERILE STRAIGHT KELL
Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.
- 2024-04-10FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IICenturion Forcep kits labeled as: a) STERILE F/P SPLINTER FORCEP (SF6141), Product Code 66165; b) STERILE WEBSTER NEEDLEHOLDER, Product Code 66185; c) STERILE ADSON FORCEP SERR (598), Product Code 66195; d) STERILE DRESSING FORCEP SERR (DF6003), Product Code 66200; e) STERILE TISSUE FORCEP W/TEETH (TF6015), Product Code 66205; f) STERILE F/P WEBSTER NEEDLEHOLDER FN8064, Product Code 66220; g) STERILE IRIS FORCEP W/TEETH (IF250), Product Code 66275; h) STERILE TUBE CLAMP (TOC500), Product
Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.
- 2024-04-10FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IICenturion scalpel handle kits labeled as: a) STERILE # 3 SCALPEL HANDLE, Product Code 66825; b) STERILE PAS #3 BLADE HANDLE (BH3PAS), Product Code I68290
Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.
- 2024-04-10FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IICenturion hook kits labeled as: a) STERILE SKIN HOOK FINE (EA3975F), Product Code 66660; b) STERILE SMALL 2 PRONG SKIN HOOK (25754), Product Code 67105; c) STERILE NEWS TRACH HOOK(83300), Product Code 67810; d) STERILE LILLIE EAR HOOK DELICATE 7", Product Code I68655
Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.
- 2024-04-10FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IICenturion retractor kits labeled as: a) STERILE 6-1/2" SENN RETRACTOR (ST7185), Product Code 66795; b) STERILE RAGNELL RETRACTOR (RR602), Product Code 67525; c) ST. SENN RETRACTOR 3 PRG BLUNT (ST7085), Product Code 37535
Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.
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